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

Not Applicable
Completed
Conditions
Physical Activity
Low Back Pain
Interventions
Other: Supervised exercise program
Other: Non supervised exercise program
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
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Supervised Rehabilitation programSupervised exercise programIt 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
Nonsupervised rehabilitation programNon supervised exercise programIt 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.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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 flexionat 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 Testat 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

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