Low Back PainLUMCRONCT01899469
Efficiency of Physiotherapy Treatments for Low Back Pain in Women.
A study testing Electromagnetic Therapy, Transcutaneous Electrical Neurological Stimulation and Back School in people with Low Back Pain, run by University Rovira i Virgili at 1 site in Spain.
Trial summary
Aim: To evaluate and compare the effectiveness of a combined treatment of TENS or Elec-tromagnetic and Back School with the effectiveness of only the Back School treatment. Design: Single-blind experimental prospective study of clinic intervention. Read more about this study
- Who is it for?
- Ages 50 to 85 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Electromagnetic Therapy, Transcutaneous Electrical Neurological Stimulation and Back School
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2012to Aug 2015
- 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 50 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between 50 and 85 years.
- Chronic LBP condition for at least three months ago.
- Patient's agreement by signing the consent.
Who cannot join
- Cardiac pacemaker carriers.
- Patients with parts of osteosynthesis and / or prostheses.
- Patients with a not well balanced medical condition.
- Patients with TENS at home and / or having completed physiotherapy during the last three months.
- Patients with skin infectious diseases or skin lesions and / or areas of hypoesthesia.
- Patients with malignant tumours.
- Patients who received any spinal injection during the last six weeks.
- Patients who participate or have participated in a study in the last three months
Trial locations and contacts
1 site in 1 country.
About this study
Aim: To evaluate and compare the effectiveness of a combined treatment of TENS or Elec-tromagnetic and Back School with the effectiveness of only the Back School treatment.
Design: Single-blind experimental prospective study of clinic intervention. Setting: Physiotherapy and Speech Therapy Unit at the Cambrils Slight Hospital. Spain.
Population: 96 women (50-85 years) with chronic low back pathology. Methods: Subjects were divided into three randomized groups: Back School (group 1), TENS with Back School (group 2), and Magnetic therapy with Back School (group 3). They have re-ceived 20 sessions of treatment. The intensity of pain (EVA Scale) and the quality of life (Oswestry Scale) were measured, at the beginning and at the end of the treatment and after three and six months. Anthropometric and physical activity variables were collected.
- Conditions
- Low Back Pain
- Being tested
- Electromagnetic Therapy, Transcutaneous Electrical Neurological Stimulation, Back School
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic TherapyProcedure or surgery
20 sessions from Monday to Friday of 20 minutes of Electromagnetic Therapy, using the next parameters: 10 Hz of frequency and 60% of intensity, and 20 sessions from Monday to Friday of 25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.
Transcutaneous Electrical Neurological StimulationProcedure or surgery
Procedure/Surgery: Transcutaneous Electrical Neurological Stimulation (TENS)
20 sessions from Monday to Friday of 20 minutes of TENS Therapy using the next parameters: 100μs of impulse width, 80 Hz of impulse frequency, and 20 sessions from Monday to Friday of 25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.
Back SchoolProcedure or surgery
25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.
| Study group | Role | What they receive |
|---|---|---|
| Electromagnetic therapy (EM) | Experimental | The group had performed 20 sessions of EM therapy for 20 minutes and after had a 25 minutes from Back School intervention. Receives: Procedure: Electromagnetic Therapy; Procedure: Back School |
| Transcutaneous Electrical Neurological Stimulation (TENS) | Experimental | The group had performed 20 sessions of TENS therapy for 20 minutes and after had a 25 minutes from Back School intervention. Receives: Procedure: Transcutaneous Electrical Neurological Stimulation; Procedure: Back School |
| Back School (BS) | Experimental | The group had performed 20 sessions of Back School therapy for 25 minutes. Receives: Procedure: Back School |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain was measured at the beginning and after the treatment with the Visual Scale Analogue (VAS)
The VAS scale represents the pain intensity on a line of 10 cm, at one end there are the words "no pain" and the other end "the worst imaginable pain " written, the distance in centimetres from the "no pain" point to the place marked by the patient represents the intensity of pain
Measured: 24 weeks
Oswestry disability index (ODI)
. The ODI assesses nine different aspects of disability, affecting various functions of daily life (personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). The questionnaire is scored using a global percentage score. For every section, one of six options is chosen. Each section is scored 0-5, with 0 indicating no limitation of function due to pain, and with 5 indicating major functional disability due to back pain.
Measured: 24 weeks
Secondary outcomes (1)
Questionnaire of Physical Activity (ClassAF)
Is a method developed by the Health Department of the Catalan Government. The ClassAf is a comprehensive questionnaire which contains a few items (1-4) to measure the general level of Physical Activity, it is calculated in METS (basal metabolic expenditure: mlO2/kg.min) and it allows to classify people into physically active or physically inactive.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Romeu Ferran, University Rovira i Virgili
- Investigators
- Ester Poblet, PT, Principal investigator, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899469
- Sponsor's protocol ID
- LUMCRO
- Acronym
- LUMCRO
- Status last verified
- May 2016
- First submitted
- 4 Jul 2013
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Physiotherapy Treatments for Low Back Pain in Women.
- ClinicalTrials.gov ID
- NCT01899469
- Acronym / sponsor ID
- LUMCRO / LUMCRO
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Jul 2013 (estimated)
- 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.
Aim: To evaluate and compare the effectiveness of a combined treatment of TENS or Elec-tromagnetic and Back School with the effectiveness of only the Back School treatment.
Design: Single-blind experimental prospective study of clinic intervention. Setting: Physiotherapy and Speech Therapy Unit at the Cambrils Slight Hospital. Spain.
Population: 96 women (50-85 years) with chronic low back pathology. Methods: Subjects were divided into three randomized groups: Back School (group 1), TENS with Back School (group 2), and Magnetic therapy with Back School (group 3). They have re-ceived 20 sessions of treatment. The intensity of pain (EVA Scale) and the quality of life (Oswestry Scale) were measured, at the beginning and at the end of the treatment and after three and six months. Anthropometric and physical activity variables were collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electromagnetic therapy (EM) | Experimental | Procedure: Electromagnetic Therapy, Procedure: Back SchoolThe group had performed 20 sessions of EM therapy for 20 minutes and after had a 25 minutes from Back School intervention. |
| Transcutaneous Electrical Neurological Stimulation (TENS) | Experimental | Procedure: Transcutaneous Electrical Neurological Stimulation, Procedure: Back SchoolThe group had performed 20 sessions of TENS therapy for 20 minutes and after had a 25 minutes from Back School intervention. |
| Back School (BS) | Experimental | Procedure: Back SchoolThe group had performed 20 sessions of Back School therapy for 25 minutes. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women between 50 and 85 years.
- Chronic LBP condition for at least three months ago.
- Patient's agreement by signing the consent.
Key exclusion criteria (8 listed)
- Cardiac pacemaker carriers.
- Patients with parts of osteosynthesis and / or prostheses.
- Patients with a not well balanced medical condition.
- Patients with TENS at home and / or having completed physiotherapy during the last three months.
- Patients with skin infectious diseases or skin lesions and / or areas of hypoesthesia.
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 |
|---|---|---|
| Electromagnetic Therapy20 sessions from Monday to Friday of 20 minutes of Electromagnetic Therapy, using the next parameters: 10 Hz of frequency and 60% of intensity, and 20 sessions from Monday to Friday of 25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home. | Procedure or surgery | Electromagnetic therapy (EM) |
| Transcutaneous Electrical Neurological StimulationProcedure/Surgery: Transcutaneous Electrical Neurological Stimulation (TENS) 20 sessions from Monday to Friday of 20 minutes of TENS Therapy using the next parameters: 100μs of impulse width, 80 Hz of impulse frequency, and 20 sessions from Monday to Friday of 25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home. | Procedure or surgery | Transcutaneous Electrical Neurological Stimulation (TENS) |
| Back School25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home. | Procedure or surgery | Back School (BS), Electromagnetic therapy (EM), Transcutaneous Electrical Neurological Stimulation (TENS) |
Primary outcome
Pain was measured at the beginning and after the treatment with the Visual Scale Analogue (VAS)
Time frame: 24 weeks
The VAS scale represents the pain intensity on a line of 10 cm, at one end there are the words "no pain" and the other end "the worst imaginable pain " written, the distance in centimetres from the "no pain" point to the place marked by the patient represents the intensity of pain
Oswestry disability index (ODI)
Time frame: 24 weeks
. The ODI assesses nine different aspects of disability, affecting various functions of daily life (personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). The questionnaire is scored using a global percentage score. For every section, one of six options is chosen. Each section is scored 0-5, with 0 indicating no limitation of function due to pain, and with 5 indicating major functional disability due to back pain.
1 secondary outcome
Questionnaire of Physical Activity (ClassAF)
Time frame: 4 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 23 May 2016.
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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.
Ester Poblet, PT principal investigator
University Rovira i Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic Therapy, Transcutaneous Electrical Neurological Stimulation and Back School in people with Low Back Pain, run by University Rovira i Virgili at 1 site in Spain.
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 8 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 23 May 2016. 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 Spain. 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 was measured at the beginning and after the treatment with the Visual Scale Analogue (VAS) (time frame: 24 weeks). The study lists 2 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 23 May 2016.