Lumbar Stabilization Exercises vs Flexor Exercises in Degenerative Spondylolisthesis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Degenerative Spondylolisthesis, Chronic Low Back Pain

Intervention / Treatment
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* Other: Lumbar stabilization exercises
* Other: Flexor exercises


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumbar stabilization exercises<br>Home exercise program to perform daily for 6 months | Other: Lumbar stabilization exercises<br>* The home-exercise program included an initial phase, with use of therapeutic heat via a hot pack for 15 minutes at the lumbosacral region, stretching exercises of the thoracolumbar fascia, hip flexors, hamstrings plus the stabilization exercises to encourage stabilizing motor patterns and determine the neutral position of the spine, with the target in control of transversus and internal oblique abdominis, multifidus, pelvic floor muscles, and diaphragmatic breathing control. Progression stages included hot packs, stretching exercises, and lateral, anterior bridges, leg raises in supine position, and arm and leg lifts in quadruped position (bird-dog)<br>|
| Active Comparator: Flexor Exercises<br>Home exercise program to perform daily for 6 months | Other: Flexor exercises<br>* The home-exercise program included a hot pack for 15 minutes and flexor exercises routine<br>* Other names: Williams exercises;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain (VAS) | Visual Analog Scale (VAS), considering no pain to be at 0mm, and 100mm to be unbearable pain. | At baseline, 4 weeks, 3 months and 6 months | 
| Change in Disability (The Roland Morris Scale) | 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) | At baseline, 4 weeks, 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in use of analgesics | Total number of days consuming analgesics in the 30 days prior to the evaluation. | At baseline, 4 weeks, 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spondylolisthesis, low back pain, stabilization exercise