Comparing the Effect of Typical Electrical Stimulation Therapy With Nocipoint Stimulation Therapy on TMD-Related Myofascial Pain
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS) for pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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
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 Outcomes
- 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.)