Clinical trial NCT01676129: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: temporomandibular joint disorders
nocipoint
physical therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Pain Cure Center, California
First posted: 2012-08-30
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analog Scale (VAS) for pain
timeFrame: 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 outcomes:
measure: Maximal mouth opening range (MMO)
timeFrame: 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
measure: Quality of Life (QoL)
timeFrame: Measurements will be taken before the first session and at the follow-up.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Alex YJ Chen, DDS, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University and Pain Cure Center California
name: Charles C Koo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University
name: Jau-Yih Tsauo, PhD
role: PRINCIPAL_INVESTIGATOR
References: