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| Name | Class |
|---|---|
| Pain Cure Center, California | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nocipoint Therapy | Experimental | 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:
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| Physical Therapy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nocipoint Therapy | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) for pain | VAS is measured before each treatment session and at the follow-up:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | SF-36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wan-Ling Kuo, BS | Contact | +886-0919-306-856 | lingerkuo@gmail.com | |
| Charlie Koo, PhD | Contact | +1-6504248818 | charlie.koo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alex YJ Chen, DDS, PHD | National Taiwan University | Principal Investigator |
| Charles C Koo, PhD | National Taiwan University and Pain Cure Center California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan | Taiwan |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Physical Therapy |
| Procedure |
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| Measurements will be taken before the first session and at the follow-up. |
| Jau-Yih Tsauo, PhD |
| National Taiwan University |
| Principal Investigator |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |