NCT03139175

Brief Summary

Investigate the relationships between temporomandibular disorder and low back pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 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

First Submitted

Initial submission to the registry

April 19, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

May 6, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

April 19, 2017

Last Update Submit

September 12, 2018

Conditions

Conditions

Outcome Measures

Primary Outcomes (1)

  • balance assesment

    The subjects from three groups all receive the balance assessment with the Biodex balance system, and compare the difference.

    only measure the balance performance before the treatment

Study Arms (3)

temporomandibular disorder group

EXPERIMENTAL

subjects with TMD and CLBP symptoms undergo balance assessment with Biodex balance system

Device: balance assessment with Biodex balance system

chronic low back pain group

ACTIVE COMPARATOR

subjects only with LBP symptoms undergo balance assessment with Biodex balance system

Device: balance assessment with Biodex balance system

Normal

OTHER

subjects without temporomandibular disorder and low back pain symptoms undergo balance assessment with Biodex balance system

Device: balance assessment with Biodex balance system

Interventions

balance assessment with Biodex balance systemDEVICE

All subjects of three groups will be assessed with the evaluation device( balance system).

Normalchronic low back pain grouptemporomandibular disorder group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral LBP for more than 1 year

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kuei-Chen Lee, MS

    Tri-Service General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapist

Study Record Dates

First Submitted

April 19, 2017

First Posted

May 3, 2017

Study Start

May 6, 2017

Primary Completion

December 20, 2017

Study Completion

January 30, 2018

Last Updated

September 14, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

I can share the conclusions of my research.

Locations

TW(1)