Temporomandibular Joint DisordersNCT01676129
Nocipoint Therapy Versus Standard Physical Therapy Using Electrical Stimulation in Treating Pain From TMJ Disorder
A study testing Nocipoint Therapy and Physical Therapy in people with Temporomandibular Joint Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Nocipoint Therapy and Physical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan
Wan-Ling Kuo, BS, +886-0919-306-856, lingerkuo@gmail.com
Charles C. Koo, PhD, +1-650-996-8168, charlie.koo@gmail.com
About this study
Official title: Comparing the Effect of Typical Electrical Stimulation Therapy With Nocipoint Stimulation Therapy on TMD-Related Myofascial Pain
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.
Read the 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.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Nocipoint Therapy, Physical Therapy
- Keywords
- temporomandibular joint disorders, nocipoint, physical therapy
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nocipoint TherapyProcedure or surgery
Also called Charles Koo's Pain Cure Therapy
Physical TherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Nocipoint Therapy | Experimental | 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. Receives: Procedure: Nocipoint Therapy |
| Physical Therapy | Active comparator | 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. Receives: Procedure: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (2)
Maximal mouth opening range (MMO)
Measured: 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)
SF-36
Measured: Measurements will be taken before the first session and at the follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pain Cure Center, California
- Responsible party
- Sponsor
- Investigators
- Alex YJ Chen, DDS, PHD, Principal investigator, National Taiwan UniversityCharles C Koo, PhD, Principal investigator, National Taiwan University and Pain Cure Center CaliforniaJau-Yih Tsauo, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676129
- Sponsor's protocol ID
- 101R104054-TMJ
- Status last verified
- Aug 2012
- First submitted
- 28 Aug 2012
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Typical Electrical Stimulation Therapy With Nocipoint Stimulation Therapy on TMD-Related Myofascial Pain
- ClinicalTrials.gov ID
- NCT01676129
- Acronym / sponsor ID
- 101R104054-TMJ
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- temporomandibular joint disorders, nocipoint, physical therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Pain Cure Center, California
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nocipoint Therapy | Experimental | Procedure: Nocipoint TherapyNocipoint 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. |
| Physical Therapy | Active comparator | Procedure: Physical TherapyPatients 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nocipoint TherapyAlso: Charles Koo's Pain Cure Therapy | Procedure or surgery | Nocipoint Therapy |
| Physical Therapy | Procedure or surgery | Physical Therapy |
Primary outcome
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.
2 secondary outcomes
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
Quality of Life (QoL)
Time frame: Measurements will be taken before the first session and at the follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex YJ Chen, DDS, PHD principal investigator
National Taiwan University
Charles C Koo, PhD principal investigator
National Taiwan University and Pain Cure Center California
Jau-Yih Tsauo, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nocipoint Therapy and Physical Therapy in people with Temporomandibular Joint Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan-Ling Kuo, BS (+886-0919-306-856, lingerkuo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2012.