Skip to main content
OpenTrials
Completed

NCT Number: NCT02664688

Lumbar Stabilization Exercises vs Flexor Exercises in 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)"

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Degenerative Spondylolisthesis Back Pain Bone Diseases Chronic Low Back Pain Low Back Pain Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INRMexico

Mexico City, 14389, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lumbar stabilization exercises

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

Other

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

Other names: Williams exercises

Primary outcomes

  1. 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."

  2. 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)

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Rehabilitacion

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 27, 2016
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.