NCT02459366

Brief Summary

The objective of three-year research is to investigate the relationship between thoracolumbar fascia tissue characteristics, lumbopelvic asymmetry, core muscle contractility, proprioception and standing balance in different ages of asymptomatic participants and patients with CMLBP.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

3.2 years

First QC Date

May 26, 2015

Last Update Submit

December 29, 2015

Conditions

Keywords

Thoracolumbar fasciaMechanical propertiesLow back pain

Outcome Measures

Primary Outcomes (1)

  • Tissue characteristics of thoracolumbar

    30 minutes

Secondary Outcomes (3)

  • Contraction ability of core muscles

    30 minutes

  • The re-position range of motion of lumbar spine

    30 minutes

  • Scale of standing balance

    30 minutes

Study Arms (2)

control

establish the reliability of measurement of lumbopelvic asymmetry, mechanical and physical properties of thoracolumbar fascia, and the norm of different age

low back pain

compare the differences among asymptomatic subjects and patients with and without lumbopelvic asymmetry, and investigate whether lumbopelvic symmetry, core muscle contractility, proprioception and standing balance change after manipulating thoracolumbar fascia tissue by physical therapy

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • Asymptomatic subjects
  • Age between 20-74 years old
  • In the past three months did not feel uncomfortable more than one day on waist region, and did not relapsed more than once within three months
  • Subjects with chronic low back pain
  • Age between 20-74 years old
  • In the past three months felt uncomfortable more than one day on waist region, and relapsed more than once within three months
  • Visual pain scores (VAS ≧ 3)

You may not qualify if:

  • Can not communicate clearly with people
  • Any open wounds
  • Any history of cancer or malignancy
  • The bleeding disorders
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Test2, test3, Taiwan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shwu-Fen Wang

    NTUH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shwu-Fen Wang

CONTACT

Wei-Ju Lin

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 2, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations