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

Primary Purpose

Temporomandibular Joint Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Nocipoint Therapy
Physical Therapy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring temporomandibular joint disorders, nocipoint, physical therapy

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nocipoint Therapy

Physical Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximal mouth opening range (MMO)
Quality of Life (QoL)
SF-36

Full Information

First Posted
August 28, 2012
Last Updated
August 28, 2012
Sponsor
National Taiwan University Hospital
Collaborators
Pain Cure Center, California
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1. Study Identification

Unique Protocol Identification Number
NCT01676129
Brief Title
Nocipoint Therapy Versus Standard Physical Therapy Using Electrical Stimulation in Treating Pain From TMJ Disorder
Official Title
Comparing the Effect of Typical Electrical Stimulation Therapy With Nocipoint Stimulation Therapy on TMD-Related Myofascial Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Pain Cure Center, California

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
temporomandibular joint disorders, nocipoint, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nocipoint Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Nocipoint Therapy
Other Intervention Name(s)
Charles Koo's Pain Cure Therapy
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) for pain
Description
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.
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
Secondary Outcome Measure Information:
Title
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
Title
Quality of Life (QoL)
Description
SF-36
Time Frame
Measurements will be taken before the first session and at the follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wan-Ling Kuo, BS
Phone
+886-0919-306-856
Email
lingerkuo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Charlie Koo, PhD
Phone
+1-6504248818
Email
charlie.koo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex YJ Chen, DDS, PHD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles C Koo, PhD
Organizational Affiliation
National Taiwan University and Pain Cure Center California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jau-Yih Tsauo, PhD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan-Ling Kuo, BS
Phone
+886-0919-306-856
Email
lingerkuo@gmail.com
First Name & Middle Initial & Last Name & Degree
Charles C. Koo, PhD
Phone
+1-650-996-8168
Email
charlie.koo@gmail.com
First Name & Middle Initial & Last Name & Degree
Alex YJ Chen, DDS, PhD
First Name & Middle Initial & Last Name & Degree
Charles C Koo, PhD
First Name & Middle Initial & Last Name & Degree
Jau-Yih Tsauo, PhD

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.gov/ct2/show/NCT01578148?term=pain+cure+center+california&rank=1
Description
Related Info

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

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