- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02112760
Specific Stabilization Exercise With Ultrasound Feedback For Patient With Recurrent Low Back Pain
Specific aim 1:Identify factors that influence muscle performance by use of ultrasound imaging.
Hypothesis: Gender, age, and BMI affect the muscle performance of deep trunk muscles.
Specific aim 2. To compare the performance of trunk deep muscles (transversus abdominis and multifidus) and the sensation and pain thresholds of patients with recurrent low back pain with asymptomatic subjects.
Hypothesis: patients with recurrent low back pain have:
(A) less activation of the transversus abdominis and multifidus, (B) peripheral and central sensitization, with decreased sensation and pain thresholds in the lumbar and foot areas.
Specific aim 3. To determine the performance of the transversus abdominis and multifidus, and the sensation and pain thresholds by use of ultrasound feedback training in asymptomatic adults, and to compare these results with the traditional training protocols for trunk stabilization.
Hypothesis: Specific stabilization exercise using ultrasound feedback training is more effective in activating deep trunk muscles and increasing sensation and pain thresholds than the traditional stabilization training protocol in asymptomatic adults.
- Specific aim 4. To determine the performance of the transversus abdominis and multifidus, and the sensation and pain thresholds by using the ultrasound feedback training in adults with low back pain, and to compare these results with the traditional training protocols for trunk stabilization.
Hypothesis: Specific stabilization exercise using ultrasound feedback training is more effective in activating deep trunk muscles and increasing sensation and pain thresholds than the traditional stabilization training protocol in adults with low back pain.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ZhongZeng District
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Taipei, ZhongZeng District, Taiwan, 10060
- School of Physical Therapy, National Taiwan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- recurrent low back pain for at least the past year
- lumbar region discomfort more than one day in the past three months
- recurrent discomfort more than one time in the past three months
Exclusion Criteria:
- pregnancy
- carcinoma
- systematic disease (rheumatic arthritis, ankylosing spondylitis etc)
- had surgery on lumbar region or lower extremities
- neurological symptom on lower extremities(numbness, pain etc)
- spondylolisthesis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patient
To evaluate the effect of specific stabilization intervention in recurrent low back pain participants
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The specific stabilization exercise refers to an exercise that targets the deep trunk muscle, including the multifidus and transversus abdominis with ultrasound feedback.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Increased change of sliding of transversus abdominis muscle and change of thickness on multifidus muscle in asymptomatic and low back pain group
Time Frame: pre treatment (0 week), post treatment(6 week)
|
pre treatment (0 week), post treatment(6 week)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Decrease cold sensation threshold on left back and hot sensation threshold on left leg in both group
Time Frame: pre treatment (0 week), post treatment(6 week)
|
pre treatment (0 week), post treatment(6 week)
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Shwu-Fen Wang, Ph.D, chool of Physical Therapy, National Taiwan University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200903075R
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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