Nocipoint Therapy Versus Standard Physical Therapy Using Electrical Stimulation in Treating Pain From TMJ Disorder
Recruitment status was: Recruiting
Temporomandibular Joint Disorders
Procedure: Nocipoint Therapy
Procedure: Physical Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Comparing the Effect of Typical Electrical Stimulation Therapy With Nocipoint Stimulation Therapy on TMD-Related Myofascial Pain|
- Visual Analog Scale (VAS) for pain [ Time Frame: 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 ] [ Designated as safety issue: No ]
VAS is measured before each treatment session and at the follow-up:
- VAS - overall
- VAS - most painful
- VAS - when biting hard food
- VAS - at maximal mouth opening range (MMO)
- VAS of pressure pain- measured at the three most painful pressure points.
1,2, and 5 are also measured after each treatment session.
- Maximal mouth opening range (MMO) [ Time Frame: 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 ] [ Designated as safety issue: No ]
- Quality of Life (QoL) [ Time Frame: Measurements will be taken before the first session and at the follow-up. ] [ Designated as safety issue: No ]SF-36
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: 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:
Procedure: Nocipoint Therapy
Other Name: Charles Koo's Pain Cure Therapy
Active Comparator: 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.
|Procedure: Physical Therapy|
The prevalence of temporomandibular disorders (TMD) is about 20% to 60% of dental patients. Most patients suffer from myofascial pain (MFP) subtype of TMD. Analgesics, local muscle injection or oral appliance are often used to treat TMD-related MFP. Patients are also referred to physical therapists frequently. Many physical therapy (PT) modalities and techniques are applied to these patients, including non-invasive transcutaneous electrical nerve stimulation (TENS) using TENS devices. However, the exact application of TENS devices, including the location of the stimulation, duration and intensity of stimulation, is largely decided by physical therapists. Nocipoint Therapy, a unique combination of precise location, duration and intensity of TENS has been found to substantially relieve general myofascial pain and recover the muscle function with lasting effect.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676129
|National Taiwan University Hospital|
|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|