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Clinical Trials/NCT02664688
NCT02664688
Completed
Not Applicable

Lumbar Stabilization Exercises vs Flexor Exercises in Patients With Chronic Low Back Pain and Degenerative Spondylolisthesis

Instituto Nacional de Rehabilitacion1 site in 1 country92 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Degenerative Spondylolisthesis
Sponsor
Instituto Nacional de Rehabilitacion
Enrollment
92
Locations
1
Primary Endpoint
Change in Pain (VAS)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to compare the effectiveness of pain control and functional improvement in patients with degenerative spondylolisthesis treated with "lumbar stabilization exercises" vs "flexor exercises (williams exercises)"

Detailed Description

This study is a randomized controlled trial in patients with the diagnosis of degenerative spondylolisthesis. To date, it is known that lumbar stabilization exercises are an effective treatment option in controlling pain and improving function in patients with degenerative spondylolisthesis based on previous studies, but it is not known if is this a better treatment that another exercises routine for chronic LBP (Low Back Pain). The purpose is to compare the effectiveness on pain control and functional improvement of "lumbar stabilization exercises" vs "flexor exercises (williams exercises)". All clinical evaluations are performed by a single physician who is blinded to the exercises, and include a full medical history, physical examination, and x-ray measurement. After initial evaluation, patients are given a sealed envelope containing the treatment (by simple randomization assigned by the investigator). The envelope is opened by the physical therapist which schedules a monthly session and verify the correct execution of each exercise. Each patient receives a sheet with instructions of the exercises to continue daily at home. Scales to assess pain and function will be recorded at baseline, 4 weeks, 3 months and at 6 months to complete the follow up.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
February 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tania Ines Nava-Bringas

MSc; MD

Instituto Nacional de Rehabilitacion

Eligibility Criteria

Inclusion Criteria

  • Degenerative spondylolisthesis at L4-L5 and chronic LBP with or without radicular pain
  • Attending the Spinal Rehabilitation Service of the National Institute for Rehabilitation (Mexico City).
  • Without previous treatment
  • Agree to participate through informed consent.

Exclusion Criteria

  • History of lumbar surgery,
  • Rheumatic diseases: Rheumatoid Arthritis, Lupus Erythematosus Systemic, Fibromyalgia, etc.
  • Cauda equine symptoms,
  • Ischemic heart disease
  • Diabetic polyneuropathy
  • Illiterate

Outcomes

Primary Outcomes

Change in Pain (VAS)

Time Frame: At baseline, 4 weeks, 3 months and 6 months

Visual Analog Scale (VAS), considering "no pain" to be at 0mm, and 100mm to be "unbearable pain."

Change in Disability (The Roland Morris Scale)

Time Frame: At baseline, 4 weeks, 3 months and 6 months

The Roland Morris Scale: a self-administered questionnaire consisting of 24 items. The total score can range from 0 (no disability) to 24 (maximum disability)

Secondary Outcomes

  • Change in use of analgesics(At baseline, 4 weeks, 3 months and 6 months)

Study Sites (1)

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