Lumbar Stabilization Exercises vs Flexor Exercises in Degenerative Spondylolisthesis

Not Applicable

Completed

• Conditions: Degenerative Spondylolisthesis; Chronic Low Back Pain
• Interventions: Other: Flexor exercises; Other: Lumbar stabilization exercises

• Registration Number: NCT02664688
• Lead Sponsor: Instituto Nacional de Rehabilitacion

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2018-03
• Last Update Submitted: 2019-03-15
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flexor Exercises	Flexor exercises	Home exercise program to perform daily for 6 months
Lumbar stabilization exercises	Lumbar stabilization exercises	Home exercise program to perform daily for 6 months

Primary Outcome Measures

Name	Time	Method
Change in Pain (VAS)	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)	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 Outcome Measures

Name	Time	Method
Change in use of analgesics	At baseline, 4 weeks, 3 months and 6 months	Total number of days consuming analgesics in the 30 days prior to the evaluation.

Trial Locations

Locations (1)

INRMexico; 🇲🇽 Mexico City, Mexico