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

National Taiwan University

Status: Unknown

Conditions: Temporomandibular Joint Disorders

Treatments: Procedure: Physical Therapy; Procedure: Nocipoint Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01676129

101R104054-TMJ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Nocipoint Therapy

Experimental group

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.

Treatment:

Procedure: Nocipoint Therapy

Physical Therapy

Active Comparator group

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.

Treatment:

Procedure: Physical Therapy