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

August 28, 2012 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • Jau-Yih Tsauo, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alex YJ Chen, DDS, PhD
        • Principal Investigator:
          • Charles C Koo, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:

  • The stimulation pads are located at the skin surface location of the nociceptors of the muscle/tissue in pain (i.e., "Nocipoint")
  • The intensity is set to induce C-fiber response during the stimulation
  • The duration of stimulation (about 1.5-4 minutes for each tissue stimulation)
  • Stimulations for different tissues (muscles, ligaments) are sequenced such that later stimulations will not cause re-injury of previously treated tissues.
  • Patient are instructed not to use the newly recovered muscle/tissue too much for an estimated "rest period" depending on his/her age.
Procedure: Nocipoint Therapy
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Measurements will be taken before the first session and at the follow-up.
SF-36
Measurements will be taken before the first session and at the follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Pain Cure Center, California

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

August 28, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 30, 2012

Study Record Updates

Last Update Posted (Estimate)

August 30, 2012

Last Update Submitted That Met QC Criteria

August 28, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101R104054-TMJ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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