Specific Stabilization Exercise With Ultrasound Feedback... | NCT02112760

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

NCT02112760

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Apr 14, 2014Estimated

Enrollment

72Actual

Phase

Not Applicable

Conditions

Recurrent Low Back Pain

Interventions

specific stabilization exercise

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Not provided

First Submitted Date

Apr 10, 2014

First Submission Date that Met QC Criteria

Apr 10, 2014

First Posted Date

Apr 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2014

Last Update Posted Date

Apr 14, 2014Estimated

Name	Class
National Health Research Institutes, Taiwan	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient	Experimental	To evaluate the effect of specific stabilization intervention in recurrent low back pain participants	Other: specific stabilization exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
specific stabilization exercise	Other	The specific stabilization exercise refers to an exercise that targets the deep trunk muscle, including the multifidus and transversus abdominis with ultrasound feedback.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shwu-Fen Wang, Ph.D	chool of Physical Therapy, National Taiwan University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
School of Physical Therapy, National Taiwan University		Taipei	ZhongZeng District	10060	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

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Browse Branches

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