Back to resultsAssociation Between TMD and LBP Back Pain
Primary Purpose
Conditions
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
balance assessment with Biodex balance system
Sponsored by
About this trial
This is an interventional prevention trial for Conditions
Eligibility Criteria
Inclusion Criteria:
- unilateral LBP for more than 1 year
Exclusion Criteria:
- sensory or neurologic disorders; structural defect of the spine or lower extremities; a history of spine or TMD surgery; recent hip, knee, or ankle pain; any medication that could affect balance; a history of uncorrected visual impairment; and vestibular disorders.
Sites / Locations
- Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
temporomandibular disorder group
chronic low back pain group
Normal
Arm Description
subjects with TMD and CLBP symptoms undergo balance assessment with Biodex balance system
subjects only with LBP symptoms undergo balance assessment with Biodex balance system
subjects without temporomandibular disorder and low back pain symptoms undergo balance assessment with Biodex balance system
Outcomes
Primary Outcome Measures
balance assesment
The subjects from three groups all receive the balance assessment with the Biodex balance system, and compare the difference.
Secondary Outcome Measures
Full Information
NCT ID
NCT03139175
First Posted
April 19, 2017
Last Updated
September 12, 2018
Sponsor
Tri-Service General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03139175
Brief Title
Association Between TMD and LBP Back Pain
Official Title
Association Between Temporomadibular Disorder and Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 6, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
January 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Investigate the relationships between temporomandibular disorder and low back pain
Detailed Description
Some patients with chronic low back pain reveal temporomandibular disorder,and others do not. So the aims of my study were to find out the risk factors that contribute to the concurrence of temporomandibular disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conditions
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
temporomandibular disorder group
Arm Type
Experimental
Arm Description
subjects with TMD and CLBP symptoms undergo balance assessment with Biodex balance system
Arm Title
chronic low back pain group
Arm Type
Active Comparator
Arm Description
subjects only with LBP symptoms undergo balance assessment with Biodex balance system
Arm Title
Normal
Arm Type
Other
Arm Description
subjects without temporomandibular disorder and low back pain symptoms undergo balance assessment with Biodex balance system
Intervention Type
Device
Intervention Name(s)
balance assessment with Biodex balance system
Intervention Description
All subjects of three groups will be assessed with the evaluation device( balance system).
Primary Outcome Measure Information:
Title
balance assesment
Description
The subjects from three groups all receive the balance assessment with the Biodex balance system, and compare the difference.
Time Frame
only measure the balance performance before the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
unilateral LBP for more than 1 year
Exclusion Criteria:
sensory or neurologic disorders; structural defect of the spine or lower extremities; a history of spine or TMD surgery; recent hip, knee, or ankle pain; any medication that could affect balance; a history of uncorrected visual impairment; and vestibular disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuei-Chen Lee, MS
Organizational Affiliation
Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
I can share the conclusions of my research.
Learn more about this trial
Association Between TMD and LBP Back Pain
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