Clinical trial NCT03420196: Efficacy of a Supervised Physical Therapy Rehabilitation Program vs Nonsupervised in Non-specific Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Physical Activity
Keywords: low back pain
physical therapy
randomized clinical trial
exercise program
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
timeFrame: at baseline,immediate post-treatment and at 6 months
Secondary outcomes:
measure: Change from baseline in disability. Oswestry Low Back Pain Disability Index.
timeFrame: At baseline, immediate post-treatment and at 6 months
measure: Change from baseline in pain intensity (Visual Analogue Scale).
timeFrame: At baseline, immediate post-treatment and at 6 months
measure: Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
timeFrame: At baseline, immediate post-treatment and at 6 months
measure: Change from baseline on Quality of Life.
timeFrame: At baseline, immediate post-treatment and at 6 months
measure: Change from Mcquade Test
timeFrame: at baseline, immediate post-treatment and at 6 months
measure: Change from baseline in lumbar mobility flexion
timeFrame: at baseline, immediate post-treatment and at 6 months
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Universidad de Almería
state: Andalucía
Study officials:
References:
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