ConditionsNCT03139175
Association Between TMD and LBP Back Pain
A study testing balance assessment with Biodex balance system in people with Conditions, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
Investigate the relationships between temporomandibular disorder and low back pain Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Conditions
- What is being tested?
- balance assessment with Biodex balance system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 May 2017to 30 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- unilateral LBP for more than 1 year
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei
About this study
Official title: Association Between Temporomadibular Disorder and Low Back Pain
Investigate the relationships between temporomandibular disorder and low back pain
Read the 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.
- Conditions
- Conditions
- Being tested
- balance assessment with Biodex balance system
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance assessment with Biodex balance systemDevice
All subjects of three groups will be assessed with the evaluation device( balance system).
| Study group | Role | What they receive |
|---|---|---|
| temporomandibular disorder group | Experimental | subjects with TMD and CLBP symptoms undergo balance assessment with Biodex balance system Receives: 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 Receives: 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 Receives: Device: balance assessment with Biodex balance system |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance assesment
The subjects from three groups all receive the balance assessment with the Biodex balance system, and compare the difference.
Measured: only measure the balance performance before the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start6 May 2017
- Primary completion20 Dec 2017
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuei-Chen Lee, Tri-Service General Hospital (TSGH)
- Investigators
- Kuei-Chen Lee, MS, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139175
- Sponsor's protocol ID
- KLee
- Status last verified
- Sep 2018
- First submitted
- 19 Apr 2017
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I can share the conclusions of my research.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Temporomadibular Disorder and Low Back Pain
- ClinicalTrials.gov ID
- NCT03139175
- Acronym / sponsor ID
- KLee
- Conditions
- Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 6 May 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| temporomandibular disorder group | Experimental | Device: balance assessment with Biodex balance systemsubjects with TMD and CLBP symptoms undergo balance assessment with Biodex balance system |
| chronic low back pain group | Active comparator | Device: balance assessment with Biodex balance systemsubjects only with LBP symptoms undergo balance assessment with Biodex balance system |
| Normal | Other | Device: balance assessment with Biodex balance systemsubjects without temporomandibular disorder and low back pain symptoms undergo balance assessment with Biodex balance system |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- unilateral LBP for more than 1 year
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balance assessment with Biodex balance systemAll subjects of three groups will be assessed with the evaluation device( balance system). | Device | Normal, chronic low back pain group, temporomandibular disorder group |
Primary outcome
balance assesment
Time frame: only measure the balance performance before the treatment
The subjects from three groups all receive the balance assessment with the Biodex balance system, and compare the difference.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Individual participant dataSharing planned: No. I can share the conclusions of my research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuei-Chen Lee, MS principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balance assessment with Biodex balance system in people with Conditions, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance assesment (time frame: only measure the balance performance before the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018; AzTrials last refreshed its copy on 26 Oct 2026.