Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03420196
Enrollment
64
Registered
2018-02-05
Start date
2018-02-01
Completion date
2019-04-01
Last updated
2019-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Physical Activity

Keywords

low back pain, physical therapy, randomized clinical trial, exercise program

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.

Interventions

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

OTHERNon 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

Sponsors

Universidad de Almeria
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Single-Blind

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in Roland Morris Disability Questionnaire (RMDQ)at baseline,immediate post-treatment and at 6 monthsThis 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

MeasureTime frameDescription
Change from baseline in pain intensity (Visual Analogue Scale).At baseline, immediate post-treatment and at 6 monthsA 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 monthsIt is a 17-item questionnaire that measures the fear of movement and (re)injury
Change from baseline in disability. Oswestry Low Back Pain Disability Index.At baseline, immediate post-treatment and at 6 monthsIt has 10 items associated to activities of daily living, each item has a puntuation fron 0 to 5 points
Change from Mcquade Testat baseline, immediate post-treatment and at 6 monthsIt measures the isometric endurance of trunk flexion muscles
Change from baseline in lumbar mobility flexionat baseline, immediate post-treatment and at 6 monthsIt is determined by measuring the finger-to-floor distance.
Change from baseline on Quality of Life.At baseline, immediate post-treatment and at 6 monthsSF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026