Exercise TrainingNCT03493438
Different Physiotherapy Interventions on Chronic Low Back Pain
A study testing exercise in people with Exercise Training, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Low back pain is an extremely common health problem that most people suffers at any point in their life. Low back pain is the leading cause of activity limitation and work absence throughout much of the world and it causes some economic problems for just not only individuals but also governments. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Exercise Training
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Mar 2018to 26 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients had to have LBP for at least 3 months,
- Patients who reported osteoarthritis or disk lesions (without neurologic compromise) with or without leg pain,
- Patients between 18 and 65 years of age,
Who cannot join
- Patients were excluded if they demonstrated any of the following;
- They had neurologic signs, specific spinal pathology (eg, malignancy, inflammatory joint disease, bone disease),
- They had undergone back and lower extremity surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Physiotherapy Interventions on Patients With Chronic Low Back Pain
Low back pain is an extremely common health problem that most people suffers at any point in their life. Low back pain is the leading cause of activity limitation and work absence throughout much of the world and it causes some economic problems for just not only individuals but also governments. ) The purpose of the study was to investigate the effects of different physical therapy techniques on pain, function and core stability in patients with low back pain.
Read the detailed description
Low back pain is an extremely common health problem that most people suffers at any point in their life. Low back pain is the leading cause of activity limitation and work absence throughout much of the world and it causes some economic problems for just not only individuals but also governments. Low back pain is a symptom rather than a disease. Non-specific low back pain term is used when the pathoanatomical cause of the pain cannot be determined. Most patients had pain that caused interference with daily function. Low back pain can be triggered by physical factors (eg, lifting awkwardly) or psychosocial factors (eg, being fatigued or tired), or by a combination of the two (eg, being distracted while lifting). There are several nonpharmacologic treatment options that include analgesics, muscle relaxants, physical therapy modalities, spinal manipulative therapy, psychological therapies and others for back pain. Unfortunately, none of the therapies has been established as superior to others. Controversly some of the investigators suggest individuals with chronic LBP can more benefit from exercise therapy interventions but still evidence on the effectiveness of nonpharmacologic therapies was very limited. The purpose of the study was to investigate the effects of different physical therapy techniques on pain, function and core stability in patients with low back pain.
Female patients with chronic, nonspecific LBP who were either undergoing or initiating physical therapy treatment at the Baskent University Ankara Hospital Physical Therapy and Rehabilitation outpatient clinic participated in the study.
Before the study began patients were randomized into four groups: Relaxation, Proprioceptive Neuromuscular Facilitation (PNF), core stability and control groups.
Descriptive characteristic of patients was evaluated at the beginning of the study. Pain, functionality, kinesiophobia and core stability was evaluated before and after the treatments. Pain and functionality were the primer outcome measures of this study, kinesiophobia, core stability and satisfaction were seconder. Patient satisfaction was assessed after the treatments.
A hot pack and conventional transcutaneous electrical stimulation (TENS) will be applied with a Chattanoga Intelect® stimulator for 20 minutes at a frequency of 100 Hz and a transition time of 60 μs. The duration of application was 3 days per week and six weeks for each of the four groups. These practices were also applied to individuals in all four groups.
The program was involved one of the following techniques of relaxation: proprioceptive neuromuscular facilitation: core stability or control. At the end of the treatments, the individuals in each group were given exercise as home brochure.
- Conditions
- Exercise Training
- Being tested
- exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
Also called A hot pack, conventional transcutaneous electrical stimulation (TENS) and exersice
A hot pack and conventional transcutaneous electrical stimulation (TENS) will be applied with a Chattanoga Intelect® stimulator for 20 minutes at a frequency of 100 Hz and a transition time of 60 μs. The duration of application was 3 days per week and six weeks for each of the four groups. These practices were also applied to individuals in all four groups.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation Group | Experimental | Patients performed Jacobson relaxation technique in supine position. Respiration control and various visual imaging techniques were used during the technique. Relaxation exercises were made within the supervision of a physiotherapist. The application period was 20 minutes for one session, 3 days a week and totally six weeks. Receives: Other: exercise |
| Proprioceptive Neuromuscular Facilitation Group | Experimental | Patients exercised with proprioceptive neuromuscular facilitation technique for trunk muscles using chopping and lifting patterns with ritmic initiation PNF exercises were made by the physiotherapist. The application period was 20 minutes for one session, 3 days a week and totally six weeks. Receives: Other: exercise |
| Core stabilization group | Experimental | Patients had core stabilization exercises that involved spinal mobility. The patients performed the drawing-in maneuver within various visual imaging techniques during all exercises, especially with respiratory control. Exercises were made within the supervision of a physiotherapist. The application period was 20 minutes for one session, 3 days a week and totally six weeks. Receives: Other: exercise |
| control group | Other | Patients in the control group were told the importance of a single session exercise Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity was measured with visual analog scale (VAS). For VAS, it is desirable that patients express their pain with a (X) mark on a scale of 100 mm. According to this, "0" means that the patients have no pain and "100" means that they have worst pain. The distance between the marking point and the start of the line is measured in millimeters and the numerical value found determines the pain intensity of patients. The total pain intensity is measured with the scale of Likert type of 6 points. In this scale "0" indicates no pain and "5" indicates worst pain.
Measured: 6 weeks
Functionality
The Oswestry Low Back Pain Questionnaire was used to assess the functioning of daily living activities in low back pain. There are 10 questions in the questionnaire, 6 options in each question, ranging from 0 to 5 points. The patient is asked to choose the expression that best describes the situation. The highest score was 50, with mild functional impairment between 1-10 points, moderate functional impairment between 11-30 points, and severe functional impairment between 31-50 points. The Turkish version of the questionnaire was validated and reliable.
Measured: 6 weeks
Kinesiophobia
Individuals' kinesiophobia were assessed by using the Tampa Kinesiophobia Scale. The questionnaire is a 17-item measure designed to measure fear of movement / re-injury. The scale includes injury / re-injury and fear-avoidance parameters in work-related activities. A 4-point Likert Scale (1 = strongly disagree, 4 = fully agree) is used on the scale. A total score is calculated after the reversal of 4, 8, 12, and 16 questions. The patient has a total score between 17-68. The high score on the scale indicates that the kinesophobia is also high. The Turkish version of the questionnaire was validated and reliable
Measured: 6 weeks
core stability
Core stability was assessed with the pressure device (Stabilizer Pressure Biofeedback, USA, Chattanooga Group, Hixson, TN). For transversus abdominus (TrA) and multifidus (MF) muscle strength the patients performed the drawing-in maneuver in a supine position, with their knees flexed at 90°. To perform abdominal drawing-in maneuver, all the subjects were instructed to slowly draw in their lower abdomen as if they were holding their urine and then draw up their pelvic floor muscle so that it could contract, together with their lower abdomen, while continuing normal breathing. The end part of the pressure device was placed on the posterior superior iliac spine. The pressure gauge was set to indicate 40 mmHg before the drawing-in maneuver began. The subjects were told to increase the pressure by 10 mmHg using the drawing-in maneuver on the verbal instruction, "start", and to maintain the state for 5 seconds. Pressure changes were recorded as mmHg.
Measured: 6 weeks
Secondary outcomes (1)
patient satisfaction
Patient satisfaction was measured with VAS for pain and functionality. The patients asked to express their satisfaction with a (X) mark on a scale of 10 cm. According to this, "0" means that the patients have worst satisfaction and "100" means that they greatest satisfaction. The distance between the marking point and the start of the line is measured and numerical value taken as a satisfaction level of patients.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start26 Mar 2018
- Primary completion26 Jun 2018
- Study completion26 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controled clinical trial
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aydan aytar, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493438
- Sponsor's protocol ID
- KA 18/27
- Status last verified
- Jul 2020
- First submitted
- 4 Apr 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Physiotherapy Interventions on Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03493438
- Acronym / sponsor ID
- KA 18/27
- Conditions
- Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low back pain is an extremely common health problem that most people suffers at any point in their life. Low back pain is the leading cause of activity limitation and work absence throughout much of the world and it causes some economic problems for just not only individuals but also governments. ) The purpose of the study was to investigate the effects of different physical therapy techniques on pain, function and core stability in patients with low back pain.
Detailed description
Low back pain is an extremely common health problem that most people suffers at any point in their life. Low back pain is the leading cause of activity limitation and work absence throughout much of the world and it causes some economic problems for just not only individuals but also governments. Low back pain is a symptom rather than a disease. Non-specific low back pain term is used when the pathoanatomical cause of the pain cannot be determined. Most patients had pain that caused interference with daily function. Low back pain can be triggered by physical factors (eg, lifting awkwardly) or psychosocial factors (eg, being fatigued or tired), or by a combination of the two (eg, being distracted while lifting). There are several nonpharmacologic treatment options that include analgesics, muscle relaxants, physical therapy modalities, spinal manipulative therapy, psychological therapies and others for back pain. Unfortunately, none of the therapies has been established as superior to others. Controversly some of the investigators suggest individuals with chronic LBP can more benefit from exercise therapy interventions but still evidence on the effectiveness of nonpharmacologic therapies was very limited. The purpose of the study was to investigate the effects of different physical therapy techniques on pain, function and core stability in patients with low back pain.
Female patients with chronic, nonspecific LBP who were either undergoing or initiating physical therapy treatment at the Baskent University Ankara Hospital Physical Therapy and Rehabilitation outpatient clinic participated in the study.
Before the study began patients were randomized into four groups: Relaxation, Proprioceptive Neuromuscular Facilitation (PNF), core stability and control groups.
Descriptive characteristic of patients was evaluated at the beginning of the study. Pain, functionality, kinesiophobia and core stability was evaluated before and after the treatments. Pain and functionality were the primer outcome measures of this study, kinesiophobia, core stability and satisfaction were seconder. Patient satisfaction was assessed after the treatments.
A hot pack and conventional transcutaneous electrical stimulation (TENS) will be applied with a Chattanoga Intelect® stimulator for 20 minutes at a frequency of 100 Hz and a transition time of 60 μs. The duration of application was 3 days per week and six weeks for each of the four groups. These practices were also applied to individuals in all four groups.
The program was involved one of the following techniques of relaxation: proprioceptive neuromuscular facilitation: core stability or control. At the end of the treatments, the individuals in each group were given exercise as home brochure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized controled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Relaxation Group | Experimental | Other: exercisePatients performed Jacobson relaxation technique in supine position. Respiration control and various visual imaging techniques were used during the technique. Relaxation exercises were made within the supervision of a physiotherapist. The application period was 20 minutes for one session, 3 days a week and totally six weeks. |
| Proprioceptive Neuromuscular Facilitation Group | Experimental | Other: exercisePatients exercised with proprioceptive neuromuscular facilitation technique for trunk muscles using chopping and lifting patterns with ritmic initiation PNF exercises were made by the physiotherapist. The application period was 20 minutes for one session, 3 days a week and totally six weeks. |
| Core stabilization group | Experimental | Other: exercisePatients had core stabilization exercises that involved spinal mobility. The patients performed the drawing-in maneuver within various visual imaging techniques during all exercises, especially with respiratory control. Exercises were made within the supervision of a physiotherapist. The application period was 20 minutes for one session, 3 days a week and totally six weeks. |
| control group | Other | Other: exercisePatients in the control group were told the importance of a single session exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (3 listed)
- Patients were excluded if they demonstrated any of the following;
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 |
|---|---|---|
| exerciseAlso: A hot pack, conventional transcutaneous electrical stimulation (TENS) and exersiceA hot pack and conventional transcutaneous electrical stimulation (TENS) will be applied with a Chattanoga Intelect® stimulator for 20 minutes at a frequency of 100 Hz and a transition time of 60 μs. The duration of application was 3 days per week and six weeks for each of the four groups. These practices were also applied to individuals in all four groups. | Other | Core stabilization group, Proprioceptive Neuromuscular Facilitation Group, Relaxation Group, control group |
Primary outcome
Pain Intensity
Time frame: 6 weeks
Pain intensity was measured with visual analog scale (VAS). For VAS, it is desirable that patients express their pain with a (X) mark on a scale of 100 mm. According to this, "0" means that the patients have no pain and "100" means that they have worst pain. The distance between the marking point and the start of the line is measured in millimeters and the numerical value found determines the pain intensity of patients. The total pain intensity is measured with the scale of Likert type of 6 points. In this scale "0" indicates no pain and "5" indicates worst pain.
Functionality
Time frame: 6 weeks
The Oswestry Low Back Pain Questionnaire was used to assess the functioning of daily living activities in low back pain. There are 10 questions in the questionnaire, 6 options in each question, ranging from 0 to 5 points. The patient is asked to choose the expression that best describes the situation. The highest score was 50, with mild functional impairment between 1-10 points, moderate functional impairment between 11-30 points, and severe functional impairment between 31-50 points. The Turkish version of the questionnaire was validated and reliable.
Kinesiophobia
Time frame: 6 weeks
Individuals' kinesiophobia were assessed by using the Tampa Kinesiophobia Scale. The questionnaire is a 17-item measure designed to measure fear of movement / re-injury. The scale includes injury / re-injury and fear-avoidance parameters in work-related activities. A 4-point Likert Scale (1 = strongly disagree, 4 = fully agree) is used on the scale. A total score is calculated after the reversal of 4, 8, 12, and 16 questions. The patient has a total score between 17-68. The high score on the scale indicates that the kinesophobia is also high. The Turkish version of the questionnaire was validated and reliable
core stability
Time frame: 6 weeks
Core stability was assessed with the pressure device (Stabilizer Pressure Biofeedback, USA, Chattanooga Group, Hixson, TN). For transversus abdominus (TrA) and multifidus (MF) muscle strength the patients performed the drawing-in maneuver in a supine position, with their knees flexed at 90°. To perform abdominal drawing-in maneuver, all the subjects were instructed to slowly draw in their lower abdomen as if they were holding their urine and then draw up their pelvic floor muscle so that it could contract, together with their lower abdomen, while continuing normal breathing. The end part of the pressure device was placed on the posterior superior iliac spine. The pressure gauge was set to indicate 40 mmHg before the drawing-in maneuver began. The subjects were told to increase the pressure by 10 mmHg using the drawing-in maneuver on the verbal instruction, "start", and to maintain the state for 5 seconds. Pressure changes were recorded as mmHg.
1 secondary outcome
patient satisfaction
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Exercise Training, run by Baskent University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Intensity (time frame: 6 weeks). 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 8 Jul 2020.