Nocipoint Therapy Versus Standard Physical Therapy Using Electrical Stimulation in Treating Pain From TMJ Disorder
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Temporomandibular Joint Disorders |
Procedure: Nocipoint Therapy Procedure: Physical Therapy |
| Study Type: | Interventional |
| 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
| Estimated Enrollment: | 90 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 20-65 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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Wan-Ling Kuo, BS | +886-0919-306-856 | lingerkuo@gmail.com |
| Contact: Charlie Koo, PhD | +1-6504248818 | charlie.koo@gmail.com |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan | |
| Contact: Wan-Ling Kuo, BS +886-0919-306-856 lingerkuo@gmail.com | |
| Contact: Charles C. Koo, PhD +1-650-996-8168 charlie.koo@gmail.com | |
| Principal Investigator: Alex YJ Chen, DDS, PhD | |
| Principal Investigator: Charles C Koo, PhD | |
| Principal Investigator: Jau-Yih Tsauo, PhD | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01676129 History of Changes |
| Other Study ID Numbers: | 101R104054-TMJ |
| Study First Received: | August 28, 2012 |
| Last Updated: | August 28, 2012 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
temporomandibular joint disorders nocipoint physical therapy |
Additional relevant MeSH terms:
|
Joint Diseases Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Musculoskeletal Diseases Craniomandibular Disorders |
Mandibular Diseases Jaw Diseases Muscular Diseases Stomatognathic Diseases Myofascial Pain Syndromes |
ClinicalTrials.gov processed this record on June 17, 2013