Efficacy of a Supervised Physical Therapy Rehabilitation Program vs Nonsupervised in Non-specific Low Back Pain
- Conditions
- Physical ActivityLow Back Pain
- Registration Number
- NCT03420196
- Lead Sponsor
- Universidad de Almeria
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in Roland Morris Disability Questionnaire (RMDQ) at baseline,immediate post-treatment and at 6 months 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
- Secondary Outcome Measures
Name Time Method Change from baseline in disability. Oswestry Low Back Pain Disability Index. At baseline, immediate post-treatment and at 6 months It has 10 items associated to activities of daily living, each item has a puntuation fron 0 to 5 points
Change from baseline in pain intensity (Visual Analogue Scale). At baseline, immediate post-treatment and at 6 months A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain
Change from baseline in lumbar mobility flexion at baseline, immediate post-treatment and at 6 months It is determined by measuring the finger-to-floor distance.
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia. At baseline, immediate post-treatment and at 6 months It is a 17-item questionnaire that measures the fear of movement and (re)injury
Change from Mcquade Test at baseline, immediate post-treatment and at 6 months It measures the isometric endurance of trunk flexion muscles
Change from baseline on Quality of Life. At baseline, immediate post-treatment and at 6 months SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
Trial Locations
- Locations (1)
Universidad de Almería
🇪🇸Almería, Andalucía, Spain
Universidad de Almería🇪🇸Almería, Andalucía, Spain