Trial record 4 of 18 for:    Open Studies | "Temporomandibular Joint Disorders"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by National Taiwan University Hospital
Sponsor:
Collaborator:
Pain Cure Center, California
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01676129
First received: August 28, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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:

    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:
  • 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:

  • 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 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676129

Contacts
Contact: Wan-Ling Kuo, BS +886-0919-306-856 lingerkuo@gmail.com
Contact: Charlie Koo, PhD +1-6504248818 charlie.koo@gmail.com

Locations
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         
Sponsors and Collaborators
National Taiwan University Hospital
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
  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 July 22, 2014