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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02112760
Other study ID # 200903075R
Secondary ID
Status Completed
Phase N/A
First received April 10, 2014
Last updated April 10, 2014
Start date June 2011

Study information

Verified date April 2014
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

1. 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.

2. 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.

3. 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.

4. 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 50 Years
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
specific stabilization exercise
The specific stabilization exercise refers to an exercise that targets the deep trunk muscle, including the multifidus and transversus abdominis with ultrasound feedback.

Locations

Country Name City State
Taiwan School of Physical Therapy, National Taiwan University Taipei ZhongZeng District

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Increased change of sliding of transversus abdominis muscle and change of thickness on multifidus muscle in asymptomatic and low back pain group pre treatment (0 week), post treatment(6 week) No
Secondary Decrease cold sensation threshold on left back and hot sensation threshold on left leg in both group pre treatment (0 week), post treatment(6 week) No
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