search
Back to results

Lumbar Stabilization Exercises vs Flexor Exercises in Degenerative Spondylolisthesis

Primary Purpose

Degenerative Spondylolisthesis, Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Lumbar stabilization exercises
Flexor exercises
Sponsored by
National Institute of Rehabilitation, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Spondylolisthesis focused on measuring spondylolisthesis, low back pain, stabilization exercise

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • INRMexico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lumbar stabilization exercises

Flexor Exercises

Arm Description

Home exercise program to perform daily for 6 months

Home exercise program to perform daily for 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in use of analgesics
Total number of days consuming analgesics in the 30 days prior to the evaluation.

Full Information

First Posted
January 20, 2016
Last Updated
March 15, 2019
Sponsor
National Institute of Rehabilitation, Mexico
search

1. Study Identification

Unique Protocol Identification Number
NCT02664688
Brief Title
Lumbar Stabilization Exercises vs Flexor Exercises in Degenerative Spondylolisthesis
Official Title
Lumbar Stabilization Exercises vs Flexor Exercises in Patients With Chronic Low Back Pain and Degenerative Spondylolisthesis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Rehabilitation, Mexico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Spondylolisthesis, Chronic Low Back Pain
Keywords
spondylolisthesis, low back pain, stabilization exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbar stabilization exercises
Arm Type
Experimental
Arm Description
Home exercise program to perform daily for 6 months
Arm Title
Flexor Exercises
Arm Type
Active Comparator
Arm Description
Home exercise program to perform daily for 6 months
Intervention Type
Other
Intervention Name(s)
Lumbar stabilization exercises
Intervention Description
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")
Intervention Type
Other
Intervention Name(s)
Flexor exercises
Other Intervention Name(s)
Williams exercises
Intervention Description
The home-exercise program included a hot pack for 15 minutes and flexor exercises routine
Primary Outcome Measure Information:
Title
Change in Pain (VAS)
Description
Visual Analog Scale (VAS), considering "no pain" to be at 0mm, and 100mm to be "unbearable pain."
Time Frame
At baseline, 4 weeks, 3 months and 6 months
Title
Change in Disability (The Roland Morris Scale)
Description
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)
Time Frame
At baseline, 4 weeks, 3 months and 6 months
Secondary Outcome Measure Information:
Title
Change in use of analgesics
Description
Total number of days consuming analgesics in the 30 days prior to the evaluation.
Time Frame
At baseline, 4 weeks, 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TANIA I NAVA-BRINGAS, MSc
Organizational Affiliation
National Institute of Rehabilitation, Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
INRMexico
City
Mexico City
ZIP/Postal Code
14389
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23948848
Citation
Nava-Bringas TI, Hernandez-Lopez M, Ramirez-Mora I, Coronado-Zarco R, Israel Macias-Hernandez S, Cruz-Medina E, Arellano-Hernandez A, Leon-Hernandez SR. Effects of a stabilization exercise program in functionality and pain in patients with degenerative spondylolisthesis. J Back Musculoskelet Rehabil. 2014;27(1):41-6. doi: 10.3233/BMR-130417.
Results Reference
result
PubMed Identifier
25238480
Citation
Vasquez-Rios JR, Nava-Bringas TI. [Lumbar stabilization exercises]. Cir Cir. 2014 May-Jun;82(3):352-9. Spanish.
Results Reference
result
PubMed Identifier
33792726
Citation
Nava-Bringas TI, Romero-Fierro LO, Trani-Chagoya YP, Macias-Hernandez SI, Garcia-Guerrero E, Hernandez-Lopez M, Roberto CZ. Stabilization Exercises Versus Flexion Exercises in Degenerative Spondylolisthesis: A Randomized Controlled Trial. Phys Ther. 2021 Aug 1;101(8):pzab108. doi: 10.1093/ptj/pzab108.
Results Reference
derived

Learn more about this trial

Lumbar Stabilization Exercises vs Flexor Exercises in Degenerative Spondylolisthesis

We'll reach out to this number within 24 hrs