Nocipoint Therapy Versus Standard Physical Therapy Using Electrical Stimulation in Treating Pain From TMJ Disorder

Temporomandibular Joint Disorders Clinical Trial

Official title:

Comparing the Effect of Typical Electrical Stimulation Therapy With Nocipoint Stimulation Therapy on TMD-Related Myofascial Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01676129
• Other study ID #: 101R104054-TMJ
• Status: Recruiting
• Phase: N/A
• First received: August 28, 2012
• Last updated: August 28, 2012
• Start date: July 2012
• Est. completion date: March 2013

Study information

• Verified date: August 2012
• Source: National Taiwan University Hospital
• Contact: Wan-Ling Kuo, BS
• Phone: +886-0919-306-856
• Email: lingerkuo[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• Nocipoint Therapy

• Physical Therapy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Pain Cure Center, California

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS) for pain	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.	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	No
Secondary	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	No
Secondary	Quality of Life (QoL)	SF-36	Measurements will be taken before the first session and at the follow-up.	No

External Links

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