NCT02112760

Brief Summary

  1. 1.Specific aim 1:Identify factors that influence muscle performance by use of ultrasound imaging.
  2. 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.
  3. 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.
  4. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

1.5 years

First QC Date

April 10, 2014

Last Update Submit

April 10, 2014

Conditions

Keywords

specific stabilization exerciseultrasoundlow back pain

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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)

Study Arms (1)

Patient

EXPERIMENTAL

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

Other: specific stabilization exercise

Interventions

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

Patient

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Physical Therapy, National Taiwan University

Taipei, ZhongZeng District, 10060, Taiwan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shwu-Fen Wang, Ph.D

    chool of Physical Therapy, National Taiwan University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2014

First Posted

April 14, 2014

Study Start

June 1, 2011

Primary Completion

December 1, 2012

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations