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

Sponsor

Universidad de Almeria (Other)

Overall Status

Completed

CT.gov ID

NCT03420196

Collaborator

(none)

Enrollment

Location

Arms

13.9

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain Physical Activity	Other: Supervised exercise program Other: Non supervised exercise program	N/A

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

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Single-Blind

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2018

Actual Primary Completion Date :

Jan 31, 2019

Actual Study Completion Date :

Apr 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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 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 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.
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 in lumbar mobility flexion [at baseline, immediate post-treatment and at 6 months]
It is determined by measuring the finger-to-floor distance.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.