Lumbar Stabilization Exercises vs Flexor Exercises in Degenerative Spondylolisthesis

NCT ID: NCT02664688

Last Updated: 2019-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-02-28

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.

Conditions

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Degenerative Spondylolisthesis Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lumbar stabilization exercises

Home exercise program to perform daily for 6 months

Group Type EXPERIMENTAL

Lumbar stabilization exercises

Intervention Type OTHER

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")

Flexor Exercises

Home exercise program to perform daily for 6 months

Group Type ACTIVE_COMPARATOR

Flexor exercises

Intervention Type OTHER

The home-exercise program included a hot pack for 15 minutes and flexor exercises routine

Interventions

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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")

Intervention Type OTHER

Flexor exercises

The home-exercise program included a hot pack for 15 minutes and flexor exercises routine

Intervention Type OTHER

Other Intervention Names

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Williams exercises

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Rehabilitacion

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tania Ines Nava-Bringas

MSc; MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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TANIA I NAVA-BRINGAS, MSc

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Rehabilitacion

Locations

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INRMexico

Mexico City, , Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type RESULT
PMID: 23948848 (View on PubMed)

Vasquez-Rios JR, Nava-Bringas TI. [Lumbar stabilization exercises]. Cir Cir. 2014 May-Jun;82(3):352-9. Spanish.

Reference Type RESULT
PMID: 25238480 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33792726 (View on PubMed)

Other Identifiers

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19/15

Identifier Type: -

Identifier Source: org_study_id

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