Spinal Instability Clinical Trial
Official title:
The Rehabilitation Outcome of Patients With Lumbar Spondylolisthesis. A Prospective Randomized Study
NCT number | NCT02435485 |
Other study ID # | CMRPG8D0911 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | February 2019 |
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 .
Status | Recruiting |
Enrollment | 90 |
Est. completion date | February 2019 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility |
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. - |
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital. | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biodex balance test | Postural stability test: overall index___, anterior-posterior index___, medial-lateral index____ Limits of stability test: forward___, backward___, right___, left___, forward/right___, forward/left___, backward/right___, backward/left___ Modified clinical test of sensory integration: sway index: eye open, firm___; eye close,firm___, eye open, foam___, eye close foam___ Fall risk test: actual score, STD_______ |
8 weeks, 6 months | |
Secondary | Oswestry Disability Index (Oswestry Low Back Pain Disability Questionnaire) | To measure a patient's permanent functional disability | 8 week, 6 months | |
Secondary | Quebec back pain disability scale | This questionnaire is about the way patient's back pain affecting their daily life | 8 weeks, 6 months | |
Secondary | Visual analog scale (VAS) of low back pain and radicular pain | Visual analog scale [VAS] is a measure of pain intensity | 8 weeks, 6 months |
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