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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01676129
Enrollment
90
Registered
2012-08-30
Start date
2012-07-31
Completion date
2013-03-31
Last updated
2012-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disorders

Keywords

temporomandibular joint disorders, nocipoint, physical therapy

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.

Interventions

PROCEDURENocipoint Therapy
PROCEDUREPhysical Therapy

Sponsors

Pain Cure Center, California
CollaboratorINDUSTRY
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale (VAS) for painMeasurements will be taken before and after each session, and at the follow-up, which is about 4 to 6 weeks after the last sessionVAS 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

MeasureTime frameDescription
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

Countries

Taiwan

Contacts

Primary ContactWan-Ling Kuo, BS
lingerkuo@gmail.com+886-0919-306-856
Backup ContactCharlie Koo, PhD
charlie.koo@gmail.com+1-6504248818

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026