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The Rehabilitation Outcome of Patients With Lumbar Spondylolisthesis. A Prospective Randomized Study

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ClinicalTrials.gov Identifier: NCT02435485
Recruitment Status : Recruiting
First Posted : May 6, 2015
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Mei-Yun Liaw, Chang Gung Memorial Hospital

Brief Summary:

Patients with degenerative lumbar spondylolisthesis usually are present with low back pain, muscle spasm and weakness, radicular symptoms, intermittent claudication, insomnia, even urine or stool incontinence. There are very few research on the effectiveness of core spine stabilization exercise, balance training, and the balance effect while wearing lumbar corset in these patients.

Purpose: To investigate 1) the correlation of dynamic balance and the degree of disability with the characteristics of spinopelvic alignment. 2) potential predictors of dynamic spino-pelvic instability, 3) the effectiveness of core spine stabilization exercise, balance training and balance effect of the wearing of lumbar corset in patients with degenerative lumbar spondylolisthesis .


Condition or disease Intervention/treatment Phase
Spinal Instability Device: Biodex balance training Other: Rehabilitation including core spinal stabilization exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Rehabilitation Outcome of Patients With Lumbar Spondylolisthesis. A Prospective Randomized Study
Study Start Date : October 2014
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: spondylolisthesis with balance training
Intervention: 1. Biodex balance training including weight shift training and random control training, 2. Regular rehabilitation including core spinal stabilization exercise.
Device: Biodex balance training
1.weight shift training, 2. random control training with Biodex balance system.

Other: Rehabilitation including core spinal stabilization exercise
Rehabilitation: 2-3 times a week, up to 8 weeks, 15 sessions in total. Each session will include hot packing, interferential therapy, core spine stablilzation exercise and low extremity strengthening exercise.

Active Comparator: spondylolisthesis, no balance training
Intervention: Regular rehabilitation including core spinal stabilization exercise
Other: Rehabilitation including core spinal stabilization exercise
Rehabilitation: 2-3 times a week, up to 8 weeks, 15 sessions in total. Each session will include hot packing, interferential therapy, core spine stablilzation exercise and low extremity strengthening exercise.

Active Comparator: lumbar spondylitis
Intervention: Regular rehabilitation including core spinal stabilization exercise
Other: Rehabilitation including core spinal stabilization exercise
Rehabilitation: 2-3 times a week, up to 8 weeks, 15 sessions in total. Each session will include hot packing, interferential therapy, core spine stablilzation exercise and low extremity strengthening exercise.




Primary Outcome Measures :
  1. Biodex balance test [ Time Frame: 8 weeks, 6 months ]
    1. Postural stability test: overall index___, anterior-posterior index___, medial-lateral index____
    2. Limits of stability test: forward___, backward___, right___, left___, forward/right___, forward/left___, backward/right___, backward/left___
    3. Modified clinical test of sensory integration: sway index: eye open, firm___; eye close,firm___, eye open, foam___, eye close foam___
    4. Fall risk test: actual score, STD_______


Secondary Outcome Measures :
  1. Oswestry Disability Index (Oswestry Low Back Pain Disability Questionnaire) [ Time Frame: 8 week, 6 months ]
    To measure a patient's permanent functional disability

  2. Quebec back pain disability scale [ Time Frame: 8 weeks, 6 months ]
    This questionnaire is about the way patient's back pain affecting their daily life

  3. Visual analog scale (VAS) of low back pain and radicular pain [ Time Frame: 8 weeks, 6 months ]
    Visual analog scale [VAS] is a measure of pain intensity



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 50 years of age with lumbar spondylitis or degenerative lumbar spondylolisthesis, low back pain, or radicular symptoms and diagnosed by KUB and lateral radiography of the lumbar-sacral spine in neutral, flexion-extension, will be recruited. Among them, seventy patients with degenerative lumbar spondylolisthesis as the experimental group and thirty-five patients with lumbar spondylitis will be included as the control group.

Exclusion Criteria:

  • Patient older than 80 years of age, with stroke, spinal cord injury, head injury or other neurological deficits, previous operation of vertebrae fracture, pelvis or lower limb, isthmic lumbar spondylolisthesis, or cognitive impairment. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435485


Contacts
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Contact: Mei-Yun Liaw, MD 886-7-7317123 ext 6286 meiyunliaw@cgmh.org.tw
Contact: Ling-Yi Wang, MD 886-7-7317123 ext 6286 s801121@cloud.cgmh.org.tw

Locations
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Taiwan
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital. Recruiting
Kaohsiung, Taiwan, 83305
Contact: Mei-Yun Liaw, MD    886-7-7317123 ext 6286    meiyunliaw@cgmh.org.tw   
Contact: Ling-Yi Wang, MD    886-7-7317123 ext 6286    s801121@cloud.cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Mei-Yun Liaw, MD Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.

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Responsible Party: Mei-Yun Liaw, Department of physical medicine and rehabilitation, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02435485     History of Changes
Other Study ID Numbers: CMRPG8D0911
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mei-Yun Liaw, Chang Gung Memorial Hospital:
degerative lumbar spondylolisthesis
rehabilitation
balance

Additional relevant MeSH terms:
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Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases