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

U

Universidad de Almeria

Status

Completed

Conditions

Physical Activity
Low Back Pain

Treatments

Other: Supervised exercise program
Other: Non supervised exercise program

Study type

Interventional

Funder types

Other

Identifiers

NCT03420196
UAL-476

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups

Supervised Rehabilitation program
Experimental group
Description:
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
Treatment:
Other: Supervised exercise program
Nonsupervised rehabilitation program
Active Comparator group
Description:
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.
Treatment:
Other: Non supervised exercise program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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