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

October 11, 2019 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Andalucía
      • Almería, Andalucía, Spain, 04120
        • Universidad de Almeria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: Supervised exercise program

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
Active Comparator: 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.
Other: Non supervised exercise program

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Time Frame: 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
At baseline, immediate post-treatment and at 6 months
Change from baseline in pain intensity (Visual Analogue Scale).
Time Frame: 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
At baseline, immediate post-treatment and at 6 months
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
Time Frame: At baseline, immediate post-treatment and at 6 months
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.
Time Frame: 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.
At baseline, immediate post-treatment and at 6 months
Change from Mcquade Test
Time Frame: at baseline, immediate post-treatment and at 6 months
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
Time Frame: at baseline, immediate post-treatment and at 6 months
It is determined by measuring the finger-to-floor distance.
at baseline, immediate post-treatment and at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

January 28, 2018

First Submitted That Met QC Criteria

January 28, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

October 14, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAL-476

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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