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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Almeria
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Single-Blind
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Supervised Rehabilitation program
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
Intervention: Supervised exercise program (Other)
Nonsupervised rehabilitation program
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.
Intervention: Non supervised exercise program (Other)
Outcomes
Primary Outcomes
Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
Time Frame: 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 Outcomes
- Change from baseline in disability. Oswestry Low Back Pain Disability Index.(At baseline, immediate post-treatment and at 6 months)
- Change from baseline in pain intensity (Visual Analogue Scale).(At baseline, immediate post-treatment and at 6 months)
- Change from baseline in lumbar mobility flexion(at baseline, immediate post-treatment and at 6 months)
- Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.(At baseline, immediate post-treatment and at 6 months)
- Change from Mcquade Test(at baseline, immediate post-treatment and at 6 months)
- Change from baseline on Quality of Life.(At baseline, immediate post-treatment and at 6 months)
Investigators
Adelaida María Castro-Sánchez
PhD (Lecturer)
Universidad de Almeria