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Specific Stabilization Exercise With Ultrasound Feedback For Patient With Recurrent Low Back Pain

Primary Purpose

Recurrent Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
specific stabilization exercise
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Low Back Pain focused on measuring specific stabilization exercise, ultrasound, low back pain

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Physical Therapy, National Taiwan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient

Arm Description

To evaluate the effect of specific stabilization intervention in recurrent low back pain participants

Outcomes

Primary Outcome Measures

Increased change of sliding of transversus abdominis muscle and change of thickness on multifidus muscle in asymptomatic and low back pain group

Secondary Outcome Measures

Decrease cold sensation threshold on left back and hot sensation threshold on left leg in both group

Full Information

First Posted
April 10, 2014
Last Updated
April 10, 2014
Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT02112760
Brief Title
Specific Stabilization Exercise With Ultrasound Feedback For Patient With Recurrent Low Back Pain
Official Title
Specific Stabilization Exercise With Ultrasound Feedback For Patient With Recurrent Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Low Back Pain
Keywords
specific stabilization exercise, ultrasound, low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient
Arm Type
Experimental
Arm Description
To evaluate the effect of specific stabilization intervention in recurrent low back pain participants
Intervention Type
Other
Intervention Name(s)
specific stabilization exercise
Intervention Description
The specific stabilization exercise refers to an exercise that targets the deep trunk muscle, including the multifidus and transversus abdominis with ultrasound feedback.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shwu-Fen Wang, Ph.D
Organizational Affiliation
chool of Physical Therapy, National Taiwan University
Official's Role
Study Director
Facility Information:
Facility Name
School of Physical Therapy, National Taiwan University
City
Taipei
State/Province
ZhongZeng District
ZIP/Postal Code
10060
Country
Taiwan

12. IPD Sharing Statement

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Specific Stabilization Exercise With Ultrasound Feedback For Patient With Recurrent Low Back Pain

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