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Clinical Trials/NCT03420196
NCT03420196
Completed
Not Applicable

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

Universidad de Almeria1 site in 1 country64 target enrollmentFebruary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Universidad de Almeria
Enrollment
64
Locations
1
Primary Endpoint
Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
April 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adelaida María Castro-Sánchez

PhD (Lecturer)

Universidad de Almeria

Eligibility Criteria

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.

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 lumbar mobility flexion(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 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)

Study Sites (1)

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