Nocipoint Therapy Versus Standard Physical Therapy Using Electrical Stimulation in Treating Pain From TMJ Disorder
NCT ID: NCT01676129
Last Updated: 2012-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2012-07-31
2013-03-31
Brief Summary
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Detailed Description
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In preliminary observations of clinical applications, Nocipoint Therapy has been found to rapidly and substantially relieve TMD-related MFP within 2-3 sessions of the treatment.
This clinical study compares the effect of Nocipoint Therapy on TMD with that of standard Physical therapy (PT). TENS will be used in the control group both as a part of the standard of care (i.e., PT) and as placebo.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Nocipoint Therapy
Nocipoint therapy (NT) follows rules of TENS stimulation in each session, all within the general FDA guidelines of TENS uses. The key points of Nocipoint Therapy include the following:
* The stimulation pads are located at the skin surface location of the nociceptors of the muscle/tissue in pain (i.e., "Nocipoint")
* The intensity is set to induce C-fiber response during the stimulation
* The duration of stimulation (about 1.5-4 minutes for each tissue stimulation)
* Stimulations for different tissues (muscles, ligaments) are sequenced such that later stimulations will not cause re-injury of previously treated tissues.
* Patient are instructed not to use the newly recovered muscle/tissue too much for an estimated "rest period" depending on his/her age.
Nocipoint Therapy
Physical Therapy
Patients in this group will be treated with comprehensive physical therapy program including typical electrical stimulation using a standard transcutaneous electrical nerve stimulation (TENS) device, manual myofascial release and postural correction exercise.
The application of TENS will follow general physical therapy guidelines, especially for TMD. Manual myofacial release will be applied on orofacial muscles and neck muscles.
TENS will serve both as a part of the standard of care and as placebo, as the same TENS device is used in both arms.
Physical Therapy
Interventions
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Nocipoint Therapy
Physical Therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed as MFP subtype of TMD according to RDC/TMD
* Pain duration over 3 month
* Tender point in masseter
* Asymmetrical pain intensity
* Subsided symptoms of joint inflammation
Exclusion Criteria
* History of traumatic cervical injury
* Presence of systemic disease
* Fibromyalgia
* Co-interventions for cervical problems or TMD during study period
* Signs of psychosomatic illness
* Unwilling to be randomized
20 Years
65 Years
ALL
No
Sponsors
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Pain Cure Center, California
INDUSTRY
National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Alex YJ Chen, DDS, PHD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University
Charles C Koo, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University and Pain Cure Center California
Jau-Yih Tsauo, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University
Locations
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National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Wan-Ling Kuo, BS
Role: primary
Charles C. Koo, PhD
Role: backup
Related Links
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Other Identifiers
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101R104054-TMJ
Identifier Type: -
Identifier Source: org_study_id