Nocipoint Therapy Versus Standard Physical Therapy Using Electrical Stimulation in Treating Pain From TMJ Disorder
Comparing the Effect of Typical Electrical Stimulation Therapy With Nocipoint Stimulation Therapy on TMD-Related Myofascial Pain
1 other identifier
interventional
90
1 country
1
Brief Summary
The purpose of this study is to measure the effect of nocipoint therapy on patients with temporomandibular joint disorders (TMD) and compare it with the effect of standard electrical stimulation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2012
Shorter than P25 for not_applicable
1 active site
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
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 28, 2012
CompletedFirst Posted
Study publicly available on registry
August 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedAugust 30, 2012
August 1, 2012
5 months
August 28, 2012
August 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analog Scale (VAS) for pain
VAS is measured before each treatment session and at the follow-up: 1. VAS - overall 2. VAS - most painful 3. VAS - when biting hard food 4. VAS - at maximal mouth opening range (MMO) 5. VAS of pressure pain- measured at the three most painful pressure points. 1,2, and 5 are also measured after each treatment session.
Measurements will be taken before and after each session, and at the follow-up, which is about 4 to 6 weeks after the last session
Secondary Outcomes (2)
Maximal mouth opening range (MMO)
Measurements will be taken before and after each session, and at the follow-up, which is about 4 to 6 weeks after the last session
Quality of Life (QoL)
Measurements will be taken before the first session and at the follow-up.
Study Arms (2)
Nocipoint Therapy
EXPERIMENTALNocipoint 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.
Physical Therapy
ACTIVE COMPARATORPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- years old female or male
- 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
You may not qualify if:
- Traumatic TMD from external impact force
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Taiwan University Hospitallead
- Pain Cure Center, Californiacollaborator
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alex YJ Chen, DDS, PHD
National Taiwan University
- PRINCIPAL INVESTIGATOR
Charles C Koo, PhD
National Taiwan University and Pain Cure Center California
- PRINCIPAL INVESTIGATOR
Jau-Yih Tsauo, PhD
National Taiwan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2012
First Posted
August 30, 2012
Study Start
July 1, 2012
Primary Completion
December 1, 2012
Study Completion
March 1, 2013
Last Updated
August 30, 2012
Record last verified: 2012-08