Lumbar Stabilization Exercises vs Flexor Exercises in Degenerative Spondylolisthesis

March 15, 2019 updated by: Tania Ines Nava-Bringas, National Institute of Rehabilitation, Mexico

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

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)"

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 14389
        • INRMexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lumbar stabilization exercises
Home exercise program to perform daily for 6 months
Other: Lumbar stabilization exercises
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")
Active Comparator: Flexor Exercises
Home exercise program to perform daily for 6 months
Other: Flexor exercises
The home-exercise program included a hot pack for 15 minutes and flexor exercises routine
Other Names:
  • Williams exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
At baseline, 4 weeks, 3 months and 6 months
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)
At baseline, 4 weeks, 3 months and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Rehabilitation, Mexico

Investigators

  • Principal Investigator: TANIA I NAVA-BRINGAS, MSc, National Institute of Rehabilitation, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 15, 2019

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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