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

Not Applicable

• Conditions: Temporomandibular Joint Disorders

• Registration Number: NCT01676129
• Lead Sponsor: National Taiwan University Hospital

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.

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.

Study Timeline

• Study Start: 2012-07
• Status Verified: 2012-08
• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-28
• Last Update Submitted: 2012-08-28
• Study First Posted: 2012-08-30
• Last Update Posted: 2012-08-30
• Primary Completion: 2012-12
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) for pain	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	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.

Secondary Outcome Measures

Name	Time	Method
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.	SF-36

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan