- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03554746
Additional Gluteal Control Training for Low Back Pain With Functional Leg Length Inequality
Additional Gluteal Control Training for Low Back Pain With Functional Leg Length Inequality: A Ramdomized Controlled Trail
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Low back pain (LBP) is a prevalent musculoskeletal disorder. A variety of exercise interventions which were designed as randomized control trails (RCTs) have been studied and shown effectiveness in improving pain and disability. These exercises typically focus on the abdominal and back musculature strength. However, many LBP patients did not show any improvement in their symptom after they carry out those exercise programs. Some authors consider that this type of low back pain may be caused by leg length inequality (LLI) in these patients, which resulted from poor gluteal neuromuscular control or muscles' imbalance.
In consideration of few studies have been done for investigating the effects of gluteal muscles control training in LBP. Thus, the purpose of this study is to investigate the effect of additional gluteal muscles control training on improving functional LLI in patients with LBP. We hypothesized that gluteal muscle control training would be more effective in self-reported pain, and their functional disability would be improve after 6-week training program than control training group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan, 11221
- National Yang Ming University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- non-specific LBP (from inferior rib margin to the gluteal fold)
- more than 3 months
- Visual Analog Scale ≧5 (in past one month)
- pelvic innominate rotation (anterior rotation in dominant side)
Exclusion Criteria:
- history of fracture or surgery
- congenital anomalies in the spine, pelvis, or lower limbs
- recent trauma, tumor, pregnancy or scoliosis
- lower extremity paresthesia, unknown weakness
- bowel and bladder dysfunction
- predominant lower extremity pain with standing
- presence of system illness, no reasoning weight loss, predominant night pain
- specific sacroiliac joint dysfunction
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GC group
It mainly involve core stability exercise, stretching exercise and gluteal control training.
All of above will be arranged 3 times a week for a total 6 weeks.
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Other Names:
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Experimental: CG group
It involve core stability exercise and stretching exercise.
All of above will be arranged 3 times a week for a total 6 weeks.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Leg Length Inequality
Time Frame: change from baseline at 6 weeks later
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functional leg length inequality
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change from baseline at 6 weeks later
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Ilium Anterior Tilt Difference
Time Frame: change from baseline at 6 weeks later
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bilateral ilium anterior tilt difference
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change from baseline at 6 weeks later
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Pelvic Inclination
Time Frame: change from baseline at 6 weeks later
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bilateral pelvic inclination
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change from baseline at 6 weeks later
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity
Time Frame: change from baseline at 6 weeks later
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Visual Analog Scale (VAS) (0-10) Maximum: 10 Minimal: 0 higher scores mean a worse outcome
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change from baseline at 6 weeks later
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Functional Disability
Time Frame: change from baseline at 6 weeks later
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Oswestry disability index (ODI) Maximum: 100 Minimal: 0 higher scores mean a worse outcome
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change from baseline at 6 weeks later
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Functional Ability
Time Frame: change from baseline at 6 weeks later
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PSFS (0-10) Maximum: 10 Minimal: 0 higher scores mean a better outcome
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change from baseline at 6 weeks later
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yi-Fen Shih, PhD, Department of Physical Therapy and Assistive Technology, National Yang-Ming University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YM106055F
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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