Back Pain Lower BackPhase 4DLSEANCT01374269
Improvement in Pain,Function and HRQoL ( Health Related Quality of Life) in Subacute Low Back Pain: A Controlled Clinical Trial of Exercise vs NSAIDs (Nonsteroidal Antiinflammatory)
A Phase 4 study testing Exercise program and NSAID (Nonsteroidal anti-inflammatory drugs) in people with Back Pain Lower Back, run by Grupo Rehabilitacion en Salud at 2 sites in Colombia.
Trial summary
Our clinical trial has the purpose to evaluate the effectiveness in reducing pain and improving function and quality of life during a 6-months follow-up of a therapeutic exercise program compared to pharmacological treatment with NSAIDs in patients with subacute low back pain attending the physiatrist consultation of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Back Pain Lower Back
- What is being tested?
- Exercise program and NSAID (Nonsteroidal anti-inflammatory drugs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesColombia
- Study dates
- Jun 2009to Mar 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged between 18 and 60 years old
- Subacute low back pain -evolution time more than 4 weeks and less than 3 months.
- That have social security system
- Live in the metropolitan area
Who cannot join
- Antecedents of spinal, pelvis or abdominal trauma
- Cancer
- Diabetes mellitus
- Steroids use
- Men and Women over 60 years
- Cauda equine syndrome
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- Women and men with osteoporosis or compression fractures
- Suspicion of infection.
- Insidious onset, constitutional symptoms
- Intravenous drugs abuse
- HIV
- Immunosuppression or previous surgery
- Rheumatic diseases
- Urinary tract infections
- Neurological symptoms in lower limbs
- Mental illness (schizophrenia, bipolar or somatomorphic disorder, major depression)
- Deformities in the spine (scoliosis greater than 15º)
- History of peptic acid disease
- Renal failure
- Intake of anticoagulants or antiplatelet drugs
- Allergy to NSAIDs.
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
Clínica de Las Américas
Medellín, Antioquia
Ips Universitaria
Medellín, Antioquia
About this study
Official title: Improvement in Pain, Function and Quality of Life With a Protocolized Exercise Program Compared With Non-steroidal Anti-inflammatory Analgesics in Patients With Subacute Low Back Pain in Medellín, Colombia, 2009-2010
Our clinical trial has the purpose to evaluate the effectiveness in reducing pain and improving function and quality of life during a 6-months follow-up of a therapeutic exercise program compared to pharmacological treatment with NSAIDs in patients with subacute low back pain attending the physiatrist consultation of several ambulatory health centers in Medellín during the years 2009-2010.
Read the detailed description
General Purpose To evaluate the effectiveness in reducing pain and improving function and quality of life during a 6-months follow-up of a therapeutic exercise program compared to pharmacological treatment with NSAIDs in patients with subacute low back pain attending the physiatrist consultation of several ambulatory health centers in Medellín during the years 2009-2010.
Specific Objectives
- To evaluate the efficacy of a protocolized exercise program in reducing low back pain.
- To evaluate the efficacy of a protocolized exercise program in improving the function.
- To compare the effects of both interventions on quality of life and work absenteeism in the two groups of patients.
- To compare the safety of both interventions.
- To estimate adherence and causes of non-adherence of patients to different treatments proposed.
- To compare in both groups the number of relapses, general and specialized medical consultations, screening studies, images and other treatments associated with low back pain. Null Hypothesis Management of subacute low back pain patients with a protocolized exercise program is not more effective than treatment with NSAIDs to reduce pain at least in 25 mm, measured with a Visual Analog Scale 0-100 mm. Alternative hypothesis Management of subacute low back pain patients with a protocolized exercise program is not more effective than treatment with NSAIDs to reduce pain at least in 25 mm, measured with a Visual Analog Scale 0-100 mm. Methodology: Type of study: randomized controlled clinical trial, single-blinded with independent evaluators. Reference population: Patients consulting physiatrists in different physical medicine and rehabilitation departments in Medellin, Colombia. Study population: patients with subacute low back pain -evolution time more than 6 weeks and less than 3 months-, with or without radiculopathy, and that fulfill inclusion criteria. In addition patients must sign an informed consent to participate in research. Inclusion criteria:
- Patients aged between 18 and 60 years with subacute low back pain.
- Evolution time more than 6 weeks and less than 3 months.
- That were included in the social security system and live in the metropolitan area. Exclusion criteria:
- Antecedents of spinal, pelvis or abdominal trauma.
- Cancer.
- Diabetes mellitus.
- Steroid use.
- Women over 60 years.
- Cauda equine syndrome.
- Men with osteoporosis or compression fractures.
- Suspicion of infection
- Insidious onset
- Constitutional symptoms
- Intravenous drugs abuse
- HIV
- Immunosuppression
- Previous surgery
- Rheumatic diseases
- Urinary tract infections
- Neurological symptoms in lower limbs
- Mental illness (schizophrenia, bipolar or somatomorphic disorder, major depression)
- Deformities in the spine (scoliosis greater than 15º)
- History of peptic acid disease
- Renal failure
- Intake of anticoagulants or antiplatelet drugs
- Allergy to NSAIDs. Primary outcome Pain relief more than 25 mm on the Visual Analogue Scale, ranging from 0 to 100, assessed 4 weeks after intervention. Secondary outcomes: Improvement in function assessed by the Oswestry Disability Index and Roland-Morris questionnaire comparing baseline to first, three and six months follow-up. Improvement in quality of life assessed by SF-36 (The Short Form Health Survey) questionnaire at baseline and at first, third and sixth months. Work absenteeism decrease. Decrease in the number of relapses, general and specialized medical consultations, screening studies, images and other treatments associated with low back pain at 6 months. Safety of both treatments evaluated in the exercise group by tolerance to training and presence or not of side effects, and in the NSAIDs group by the presence or absence of adverse reactions. Sample: Sampling type: simple random. Sample size calculation was based on software "Sample size Javeriana University" Type I error: 0.05 Type II Error: 0.2 Assessments number prior to randomization: 1 Assessments number after randomization: 3 Correlation between evaluations: 0.8 Clinically important difference: 0.33 Number of patients per group: 33 Experimental group control group ratio : 1 to 1 10% of loss: 7 Total: 73 Randomization Randomization was done by means of permuted blocks of size 2, 4 and 6, generated by computer (Ralloc program, co Stata 8.2, College Station, TX, USA). Allocation will be confidential and will not be opened until the investigation is completed, this will be monitored by the Committee of Data Security. Enrollment Patients with subacute low back pain consulting Physical Medicine and Rehabilitation Departments of hospitals in Medellín, Colombia. There will be an initial assessment, and if patient is considered eligible will be invited to participate and asked to sign an informed consent (Appendix 1). Treatment assignment will be given in an opaque envelope. Masking Medical researchers who evaluate the patients, research assistants who perform the application of different measure instruments and statistical will be blinded to treatment allocation. Initial assessment Clinical evaluation will be performed by one of the research physiatrists. Evaluation will include: epidemiological and clinical, Visual Analog Scale (VAS), Oswestry scale, Rolland Morris Scale, and SF-36 quality of life scale. Intervention One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered. The second group will receive NSAID for 10 days, there will be two different options (naproxen or celecoxib) according to indications and contraindications. In case of increase in pain intensity in either of the two groups, acetaminophen in doses of 1.5 to 2.0 g / day will be used as a rescue. Adherence to different treatments. To ensure adherence to different treatments each patient will receive a phone call weekly to inquire about assistance, difficulties, tolerance, use of medications, and adverse effects. Patients will be given a questionnaire to verify drugs intake, dosage, time and side effects. They should also register any other drug ingestion. Telephone calls will be made every 15 days to ask about the health status and ensuring assistance to new assessments. Assessment will be scheduled at 1, 3, and 6 months Clinical evaluation will be performed by one of the researcher physiatrists or a postgraduate student. Committee of safety and quality of data. This committee will consist of two researchers and one professional information management responsible for the database. This will be done in Access and SPSS 15 (Statistical Product and Service Solutions) before starting information recollection. Analysis Plan Categorical univariate variables will be analyzed by frequency distributions and quantitative variables by measures of central tendency (mean, standard deviation, median or range). Both groups will be compared after randomization and before intervention for all variables. Initially, it will be established for each group if the quantitative variables are of normal distribution, by using the Kolmogorov-Smirnov test. Pain (primary outcome) will be evaluated in each patient at 1, 3 and 6 months and will be compared with initial pain (mean and confidence intervals) by using Student t test or Mann Whitney for each time period. The same procedure would be for the other outcomes measured quantitatively. An analysis of variance with repeated measures for the variability between groups and intragroup will be made. Comparison of categorical variables at each assessment will be done using the Chi2 test. The level of statistical significance to be used in all cases is 0.05. An analysis by intention to treat and per protocol will be made. Ethics This research and informed consent is according to "Scientific, technical and administrative standards for health research" of the Ministry of Health and the Decree 309 of 2000 of the Ministry of Environment. This is considered a minimal risk research, because therapeutic interventions are widely used to treat patients with these conditions.
- Conditions
- Back Pain Lower Back
- Being tested
- Exercise program, NSAID (Nonsteroidal anti-inflammatory drugs)
- Keywords
- NSAIDS (Nonsteroidal anti-inflammatory drugs), Exercise, Physiotherapy, Subacute Low Back Pain, Pain, Visual Analogue Scale, oswesrty, Roland Morris, SF-36, Quality of life
- Medical subject headings
- Low Back Pain, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
Also called Therapeutic exercise, Physiotherapy
Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.
NSAID (Nonsteroidal anti-inflammatory drugs)Drug
Also called Naproxen, Celecoxib, Acetaminophen
The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.
| Study group | Role | What they receive |
|---|---|---|
| Excercise | Experimental | One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered Receives: Other: Exercise program |
| NSAID | Active comparator | Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue Receives: Drug: NSAID (Nonsteroidal anti-inflammatory drugs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale of Pain
In the Visual Analogue Sacale the best result is 0 and the worst is 100, The primary outcome was pain the mesurement of the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at the beginning.
Measured: At the beginning
Visual Analogue Scale of Pain
In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 4 weeks.
Measured: 4 weeks
Visual Analogue Scale of Pain
In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 12 weeks.
Measured: 12 weeks
Visual Analogue Scale of Pain
The best result is 0 and the worst is 100, Pain relief more than 25 mm on the Visual Analogue Scale, assessed 24 weeks after intervention.
Measured: 24 weeks
Secondary outcomes (58)
Oswestry Disability Index
Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.
Measured: At the beginning
Oswestry Disability Index
Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.
Measured: 4 weeks
Oswestry Disability Index
Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.
Measured: 12 weeks
Oswestry Disability Index
Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.
Measured: 24 weeks
Roland-Morris Questionnaire
Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.
Measured: At the beginning
Roland-Morris Questionnaire
Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.
Measured: 4 weeks
Roland-Morris Questionnaire
Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.
Measured: 12 weeks
Roland-Morris Questionnaire
Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.
Measured: 24 weeks
Quality of Life, Change in Health
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.
Measured: At the beginning
Quality of Life, Change in Health
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.
Measured: 4 weeks
Quality of Life, Change in Health
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.
Measured: 12 weeks
Quality of Life, Change in Health
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.
Measured: 24 weeks
Quality of Life, Bodily Pain
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.
Measured: At the beginning
Quality of Life, Bodily Pain
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.
Measured: 4 weeks
Quality of Life, Bodily Pain
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.
Measured: 12 weeks
Quality of Life, Bodily Pain
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.
Measured: 24 weeks
Quality of Life, Emotional Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.
Measured: At the beginning
Quality of Life, Emotional Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.
Measured: 4 weeks
Quality of Life, Emotional Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.
Measured: 12 weeks
Quality of Life, Emotional Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.
Measured: 24 weeks
Quality of Life, Physical Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance
Measured: At the beginning
Quality of Life, Physical Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance
Measured: 4 weeks
Quality of Life, Physical Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance
Measured: 12 weeks
Quality of Life, Physical Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance.
Measured: 24 weeks
Quality of Life, Physical Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.
Measured: At the beginning
Quality of Life, Physical Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.
Measured: 4 weeks
Quality of Life, Physical Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.
Measured: 12 weeks
Quality of Life, Physical Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.
Measured: 24 weeks
Quality of Life, Social Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.
Measured: At the beginning
Quality of Life, Social Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.
Measured: 4 weeks
Quality of Life, Social Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.
Measured: 12 weeks
Quality of Life, Social Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.
Measured: 24 weeks
Quality of Life, General Health Perceptions.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.
Measured: At the beginning
Quality of Life, General Health Perceptions.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.
Measured: 4 weeks
Quality of Life, General Health Perceptions.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.
Measured: 12 weeks
Quality of Life, General Health Perceptions.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.
Measured: 24 weeks
Quality of Life, Mental Health.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.
Measured: At the beginning
Quality of Life, Mental Health.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.
Measured: 4 weeks
Quality of Life, Mental Health.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.
Measured: 12 weeks
Quality of Life, Mental Health.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.
Measured: 24 weeks
Quality of Life, Vitality.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.
Measured: At the beginning
Quality of Life, Vitality.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.
Measured: 4 weeks
Quality of Life, Vitality.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.
Measured: 12 weeks
Quality of Life, Vitality.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.
Measured: 24 weeks
PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).
Measured: 4 weeks
PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).
Measured: At the beginning
PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).
Measured: 12 weeks
PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).
Measured: 24 weeks
Relapses of Lumbar Pain
The percentage of patients with relapsed of low back pain was measured.
Measured: 12 weeks
Relapses of Lumbar Pain
The percentage of patients with relapsed of low back pain was measured.
Measured: 24 weeks
Treatments Associated With Low Back Pain at 6 Months
we are showing in this result, the number of patients who had to receive any additional treatment in either group. The measure is the number of participants who received additional treatment throughout the duration of the study.
Measured: 6 months
Missing Workdays
This result shows the average of the number of missed work days.
Measured: 6 weeks before starting
Missing Workdays
This result shows the average of the number of missed work days.
Measured: 4 weeks
Missing Workdays
This result shows the average of the number of missed work days.
Measured: 12 weeks
Missing Workdays
This result shows the average of the number of missed work days.
Measured: 24 weeks
Medical Consultations.
This result shows, the total number of participants received additional medical consultations.
Measured: 4 weeks
Medical Consultations.
This result shows, the total number of participants received additional medical consultations.
Measured: 12 weeks
Medical Consultations.
This result shows, the total number of participants received additional medical consultations.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJun 2009
- Primary completionOct 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Back Pain Lower BackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Rehabilitacion en Salud
- Sponsor type
- Research network
- Collaborators
- Universidad de Antioquia
- Responsible party
- Principal investigator, Fabio Alonso Salinas Duran, Grupo Rehabilitacion en Salud
- Investigators
- Luz H Lugo, Professor, Study director, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374269
- Sponsor's protocol ID
- DLSejervsaine
- Other IDs
- DLSEjercicioyAINES
- Acronym
- DLSEA
- Status last verified
- Mar 2014
- First submitted
- 14 Jun 2011
- Last updated
- 29 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Pain, Function and Quality of Life With a Protocolized Exercise Program Compared With Non-steroidal Anti-inflammatory Analgesics in Patients With Subacute Low Back Pain in Medellín, Colombia, 2009-2010
- ClinicalTrials.gov ID
- NCT01374269
- Acronym / sponsor ID
- DLSEA / DLSejervsaine
- Conditions
- Back Pain Lower Back
- Keywords
- NSAIDS (Nonsteroidal anti-inflammatory drugs), Exercise, Physiotherapy, Subacute Low Back Pain, Pain, Visual Analogue Scale, oswesrty, Roland Morris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Grupo Rehabilitacion en SaludResearch network
- Collaborators
- Universidad de Antioquia
- Study start
- Jun 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Posted 29 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our clinical trial has the purpose to evaluate the effectiveness in reducing pain and improving function and quality of life during a 6-months follow-up of a therapeutic exercise program compared to pharmacological treatment with NSAIDs in patients with subacute low back pain attending the physiatrist consultation of several ambulatory health centers in Medellín during the years 2009-2010.
Detailed description
General Purpose To evaluate the effectiveness in reducing pain and improving function and quality of life during a 6-months follow-up of a therapeutic exercise program compared to pharmacological treatment with NSAIDs in patients with subacute low back pain attending the physiatrist consultation of several ambulatory health centers in Medellín during the years 2009-2010.
Specific Objectives
- To evaluate the efficacy of a protocolized exercise program in reducing low back pain.
- To evaluate the efficacy of a protocolized exercise program in improving the function.
- To compare the effects of both interventions on quality of life and work absenteeism in the two groups of patients.
- To compare the safety of both interventions.
- To estimate adherence and causes of non-adherence of patients to different treatments proposed.
- To compare in both groups the number of relapses, general and specialized medical consultations, screening studies, images and other treatments associated with low back pain. Null Hypothesis Management of subacute low back pain patients with a protocolized exercise program is not more effective than treatment with NSAIDs to reduce pain at least in 25 mm, measured with a Visual Analog Scale 0-100 mm. Alternative hypothesis Management of subacute low back pain patients with a protocolized exercise program is not more effective than treatment with NSAIDs to reduce pain at least in 25 mm, measured with a Visual Analog Scale 0-100 mm. Methodology: Type of study: randomized controlled clinical trial, single-blinded with independent evaluators. Reference population: Patients consulting physiatrists in different physical medicine and rehabilitation departments in Medellin, Colombia. Study population: patients with subacute low back pain -evolution time more than 6 weeks and less than 3 months-, with or without radiculopathy, and that fulfill inclusion criteria. In addition patients must sign an informed consent to participate in research. Inclusion criteria:
- Patients aged between 18 and 60 years with subacute low back pain.
- Evolution time more than 6 weeks and less than 3 months.
- That were included in the social security system and live in the metropolitan area. Exclusion criteria:
- Antecedents of spinal, pelvis or abdominal trauma.
- Cancer.
- Diabetes mellitus.
- Steroid use.
- Women over 60 years.
- Cauda equine syndrome.
- Men with osteoporosis or compression fractures.
- Suspicion of infection
- Insidious onset
- Constitutional symptoms
- Intravenous drugs abuse
- HIV
- Immunosuppression
- Previous surgery
- Rheumatic diseases
- Urinary tract infections
- Neurological symptoms in lower limbs
- Mental illness (schizophrenia, bipolar or somatomorphic disorder, major depression)
- Deformities in the spine (scoliosis greater than 15º)
- History of peptic acid disease
- Renal failure
- Intake of anticoagulants or antiplatelet drugs
- Allergy to NSAIDs. Primary outcome Pain relief more than 25 mm on the Visual Analogue Scale, ranging from 0 to 100, assessed 4 weeks after intervention. Secondary outcomes: Improvement in function assessed by the Oswestry Disability Index and Roland-Morris questionnaire comparing baseline to first, three and six months follow-up. Improvement in quality of life assessed by SF-36 (The Short Form Health Survey) questionnaire at baseline and at first, third and sixth months. Work absenteeism decrease. Decrease in the number of relapses, general and specialized medical consultations, screening studies, images and other treatments associated with low back pain at 6 months. Safety of both treatments evaluated in the exercise group by tolerance to training and presence or not of side effects, and in the NSAIDs group by the presence or absence of adverse reactions. Sample: Sampling type: simple random. Sample size calculation was based on software "Sample size Javeriana University" Type I error: 0.05 Type II Error: 0.2 Assessments number prior to randomization: 1 Assessments number after randomization: 3 Correlation between evaluations: 0.8 Clinically important difference: 0.33 Number of patients per group: 33 Experimental group control group ratio : 1 to 1 10% of loss: 7 Total: 73 Randomization Randomization was done by means of permuted blocks of size 2, 4 and 6, generated by computer (Ralloc program, co Stata 8.2, College Station, TX, USA). Allocation will be confidential and will not be opened until the investigation is completed, this will be monitored by the Committee of Data Security. Enrollment Patients with subacute low back pain consulting Physical Medicine and Rehabilitation Departments of hospitals in Medellín, Colombia. There will be an initial assessment, and if patient is considered eligible will be invited to participate and asked to sign an informed consent (Appendix 1). Treatment assignment will be given in an opaque envelope. Masking Medical researchers who evaluate the patients, research assistants who perform the application of different measure instruments and statistical will be blinded to treatment allocation. Initial assessment Clinical evaluation will be performed by one of the research physiatrists. Evaluation will include: epidemiological and clinical, Visual Analog Scale (VAS), Oswestry scale, Rolland Morris Scale, and SF-36 quality of life scale. Intervention One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered. The second group will receive NSAID for 10 days, there will be two different options (naproxen or celecoxib) according to indications and contraindications. In case of increase in pain intensity in either of the two groups, acetaminophen in doses of 1.5 to 2.0 g / day will be used as a rescue. Adherence to different treatments. To ensure adherence to different treatments each patient will receive a phone call weekly to inquire about assistance, difficulties, tolerance, use of medications, and adverse effects. Patients will be given a questionnaire to verify drugs intake, dosage, time and side effects. They should also register any other drug ingestion. Telephone calls will be made every 15 days to ask about the health status and ensuring assistance to new assessments. Assessment will be scheduled at 1, 3, and 6 months Clinical evaluation will be performed by one of the researcher physiatrists or a postgraduate student. Committee of safety and quality of data. This committee will consist of two researchers and one professional information management responsible for the database. This will be done in Access and SPSS 15 (Statistical Product and Service Solutions) before starting information recollection. Analysis Plan Categorical univariate variables will be analyzed by frequency distributions and quantitative variables by measures of central tendency (mean, standard deviation, median or range). Both groups will be compared after randomization and before intervention for all variables. Initially, it will be established for each group if the quantitative variables are of normal distribution, by using the Kolmogorov-Smirnov test. Pain (primary outcome) will be evaluated in each patient at 1, 3 and 6 months and will be compared with initial pain (mean and confidence intervals) by using Student t test or Mann Whitney for each time period. The same procedure would be for the other outcomes measured quantitatively. An analysis of variance with repeated measures for the variability between groups and intragroup will be made. Comparison of categorical variables at each assessment will be done using the Chi2 test. The level of statistical significance to be used in all cases is 0.05. An analysis by intention to treat and per protocol will be made. Ethics This research and informed consent is according to "Scientific, technical and administrative standards for health research" of the Ministry of Health and the Decree 309 of 2000 of the Ministry of Environment. This is considered a minimal risk research, because therapeutic interventions are widely used to treat patients with these conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Excercise | Experimental | Other: Exercise programOne group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered |
| NSAID | Active comparator | Drug: NSAID (Nonsteroidal anti-inflammatory drugs)Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged between 18 and 60 years old
- Subacute low back pain -evolution time more than 4 weeks and less than 3 months.
- That have social security system
- Live in the metropolitan area
Key exclusion criteria (21 listed)
- Antecedents of spinal, pelvis or abdominal trauma
- Cancer
- Diabetes mellitus
- Steroids use
- Men and Women over 60 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise programAlso: Therapeutic exercise, PhysiotherapyStandardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week. | Other | Excercise |
| NSAID (Nonsteroidal anti-inflammatory drugs)Also: Naproxen, Celecoxib, AcetaminophenThe second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure. | Drug | NSAID |
Primary outcome
Visual Analogue Scale of Pain
Time frame: At the beginning
In the Visual Analogue Sacale the best result is 0 and the worst is 100, The primary outcome was pain the mesurement of the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at the beginning.
Visual Analogue Scale of Pain
Time frame: 4 weeks
In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 4 weeks.
Visual Analogue Scale of Pain
Time frame: 12 weeks
In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 12 weeks.
Visual Analogue Scale of Pain
Time frame: 24 weeks
The best result is 0 and the worst is 100, Pain relief more than 25 mm on the Visual Analogue Scale, assessed 24 weeks after intervention.
58 secondary outcomes
Oswestry Disability Index
Time frame: At the beginning
Oswestry Disability Index
Time frame: 4 weeks
Oswestry Disability Index
Time frame: 12 weeks
Oswestry Disability Index
Time frame: 24 weeks
Roland-Morris Questionnaire
Time frame: At the beginning
Roland-Morris Questionnaire
Time frame: 4 weeks
Roland-Morris Questionnaire
Time frame: 12 weeks
Roland-Morris Questionnaire
Time frame: 24 weeks
Quality of Life, Change in Health
Time frame: At the beginning
Quality of Life, Change in Health
Time frame: 4 weeks
Quality of Life, Change in Health
Time frame: 12 weeks
Quality of Life, Change in Health
Time frame: 24 weeks
Quality of Life, Bodily Pain
Time frame: At the beginning
Quality of Life, Bodily Pain
Time frame: 4 weeks
Quality of Life, Bodily Pain
Time frame: 12 weeks
Quality of Life, Bodily Pain
Time frame: 24 weeks
Quality of Life, Emotional Performance.
Time frame: At the beginning
Quality of Life, Emotional Performance.
Time frame: 4 weeks
Quality of Life, Emotional Performance.
Time frame: 12 weeks
Quality of Life, Emotional Performance.
Time frame: 24 weeks
Quality of Life, Physical Performance.
Time frame: At the beginning
Quality of Life, Physical Performance.
Time frame: 4 weeks
Quality of Life, Physical Performance.
Time frame: 12 weeks
Quality of Life, Physical Performance.
Time frame: 24 weeks
Quality of Life, Physical Function.
Time frame: At the beginning
Quality of Life, Physical Function.
Time frame: 4 weeks
Quality of Life, Physical Function.
Time frame: 12 weeks
Quality of Life, Physical Function.
Time frame: 24 weeks
Quality of Life, Social Function.
Time frame: At the beginning
Quality of Life, Social Function.
Time frame: 4 weeks
Quality of Life, Social Function.
Time frame: 12 weeks
Quality of Life, Social Function.
Time frame: 24 weeks
Quality of Life, General Health Perceptions.
Time frame: At the beginning
Quality of Life, General Health Perceptions.
Time frame: 4 weeks
Quality of Life, General Health Perceptions.
Time frame: 12 weeks
Quality of Life, General Health Perceptions.
Time frame: 24 weeks
Quality of Life, Mental Health.
Time frame: At the beginning
Quality of Life, Mental Health.
Time frame: 4 weeks
Quality of Life, Mental Health.
Time frame: 12 weeks
Quality of Life, Mental Health.
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luz H Lugo, Professor study director
Universidad de Antioquia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exercise program and NSAID (Nonsteroidal anti-inflammatory drugs) in people with Back Pain Lower Back, run by Grupo Rehabilitacion en Salud at 2 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale of Pain (time frame: At the beginning). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2014.