Efficacy of a Supervised Physical Therapy Rehabilitation Program vs Nonsupervised in Non-specific Low Back Pain

Study Overview
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Brief Summary
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This study compares the efficacy of a supervised rehabilitation program vs a non supervised rehabilitation program on pain, disability, quality of life and kinesiophobia in patients with non-specific low back pain.

Detailed Description
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Low back pain is one of the most common problems of population, being a priority for health systems. It has got a high prevalence and recurrence, affecting in a social and economic way, and, it is one of principal causes of laboral absenteism. A randomized clinical trial will be conducted comparing a supervised physical therapy rehabilitation program vs a non supervised rehabilitation program. Objective: to compare the efficacy of a supervised rehabilitation program vs a non supervised rehabilitation program in patients with non-specific low back pain. Methods: Sixt-four subjects with chronic non-specific low back pain will be assigned to supervised rehabilitation program or non supervised rehabilitation program during 4 weeks (5 sessions/week). Outcomes measures will be the following: disability, pain intensity, fear of movement, quality of life, McQuade Test, and lumbar mobility flexion.

Official Title
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Efficacy of a Supervised Physical Therapy Rehabilitation Program vs Nonsupervised on Pain, Disability, Quality of Life and Kinesiophobia in Patients With Non-specific Low Back Pain

Conditions
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Low Back Pain, Physical Activity

Intervention / Treatment
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* Other: Supervised exercise program
* Other: Non supervised exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic non-specific low back pain persisting ≥ 3 months. Age between 18 and 65 years. A score ≥ 4 in Roland Morris Disability Questionnaire. Not currently receiving physical therapy. Exclusion Criteria: Presence of lumbar stenosis. Presence of clinical signs of radiculopathy. Diagnosis of spondylolisthesis. Diagnosis of fibromyalgia. Treatment with corticosteroid or pharmachological medication within the paset 2 weeks. A history of spinal surgery. Central or peripheral nervous system disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised Rehabilitation program<br>It will be consist in a supervised exercise program by physical therapist, including the following structures: diaphragm, tranverse abdominis muscle, pelvic, gluteus, CORE and spinal mobility | Other: Supervised exercise program<br>* It will consist in a supervised exercise program, including the following exercises: Diaphragmatic breathing. Transverse abdomLateral leg raise for gluteus mediuminis muscle activation. Pelvic swing. Gluteus bridge. Spinal mobility. Spinal extensor muscles strengthening Frontal plank Side plank. Lateral leg raise for gluteus medium<br>|
| Active Comparator: Nonsupervised rehabilitation program<br>It will consist in an exercise program for home, nonsupervised, including the following structures: diaphragm, tranverse abdominis muscle, pelvic, gluteus, CORE and spinal mobility. The patients will perform an exercise program at home. | Other: Non supervised exercise program<br>* It will consist in a non supervised exercise program, including the following exercises: Diaphragmatic breathing. Transverse abdomLateral leg raise for gluteus mediuminis muscle activation. Pelvic swing. Gluteus bridge. Spinal mobility. Spinal extensor muscles strengthening Frontal plank Side plank. Lateral leg raise for gluteus medium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Roland Morris Disability Questionnaire (RMDQ) | This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities | at baseline,immediate post-treatment and at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in disability. Oswestry Low Back Pain Disability Index. | It has 10 items associated to activities of daily living, each item has a puntuation fron 0 to 5 points | At baseline, immediate post-treatment and at 6 months | 
| Change from baseline in pain intensity (Visual Analogue Scale). | A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain | At baseline, immediate post-treatment and at 6 months | 
| Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia. | It is a 17-item questionnaire that measures the fear of movement and (re)injury | At baseline, immediate post-treatment and at 6 months | 
| Change from baseline on Quality of Life. | SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life. | At baseline, immediate post-treatment and at 6 months | 
| Change from Mcquade Test | It measures the isometric endurance of trunk flexion muscles | at baseline, immediate post-treatment and at 6 months | 
| Change from baseline in lumbar mobility flexion | It is determined by measuring the finger-to-floor distance. | at baseline, immediate post-treatment and at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, physical therapy, randomized clinical trial, exercise program