Myofascial PainNCT05414695
Effect of Acupuncture on Craniomandibular Pain of Myofascial Origin.
A study testing real acupuncture in people with Myofascial Pain and Craniofacial Pain, run by Universidad de la Republica at 1 site in Uruguay.
Trial summary
Myofascial pain is one of the most prevalent conditions within temporomandibular disorders. Despite its high prevalence, health systems pay insufficient attention to it. Patients frequently receive multiple unnecessary and sometimes aggressive treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Pain, Craniofacial Pain
- What is being tested?
- real acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUruguay
- Study dates
- 14 Mar 2022to Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of miofascial pain in the craniomandibular/temporomandibular region (DC-TMD published criteria).
Who cannot join
- Pregnant woman
- Recent history of facial trauma
- Systemic diseases that can affect the musculoskeletal system (e.g. rheumatoid arthritis, lupus, etc).
Trial locations and contacts
1 site in 1 country.
Uruguay1 site
Universidad de la República, School of Dentistry
Montevideo, 11400
About this study
Official title: Effect of Acupuncture on Craniomandibular Pain of Myofascial Origin. A Randomized, Triple-blind, Placebo-controlled, Crossover Clinical Trial.
Myofascial pain is one of the most prevalent conditions within temporomandibular disorders. Despite its high prevalence, health systems pay insufficient attention to it. Patients frequently receive multiple unnecessary and sometimes aggressive treatments. In this context, acupuncture has been studied as a plausible therapy for these conditions. However, researchers have encountered various methodological difficulties when demonstrating its actual effect. The main historical challenge in this area involves the difficulties inherent to using appropriate acupuncture controls such as placebos that allow for double blinding and cause minimum tactile stimulation.
In a previous study, a validated an improved novel placebo acupuncture non-penetrating device with double blinding capability was presented. This project will allow to test the performance of this new placebo acupuncture device in a clinical experimental setting. The study will try to determine the actual effectiveness of acupuncture in treating craniomandibular pain of myofascial origin. The design will be a randomized, triple blind, placebo controlled, crossover clinical trial. The protocol follows the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) recommendations, and ethical approval was obtained.
Read more
The central hypothesis is that acupuncture will be more effective than a placebo. Another hypothesis is that neither patients nor acupuncturists will be able to distinguish real acupuncture devices from placebo devices.
The study will include consecutive patients diagnosed with pain in the craniomandibular region of muscular/myofascial origin according to accepted criteria. Sample size calculations were made with the assumption of an 80% power and a statistical difference accepted at the 5% level. A total of 60 patients will be included.
Patients will be randomly divided into two groups: real acupuncture or placebo. Five sessions will be performed on each patient on a weekly basis. The total time for each intervention will be 30 minutes. A crossover design will be applied after a "washout" period of 14 days.
Outcome measures will include pain, stress levels, quality of life, and mandibular dynamics, using validated and published criteria. Baseline measurements will be taken pre-treatment and at each treatment session. Follow-up outcomes will be measured after three and six months.
A strict protocol for bias control will be followed. The triple-blind design will prevent the patient, the acupuncturist, and the person performing the statistical analysis from knowing what type of treatment each patient receives each time. Examiners will be calibrated and blinded to the treatment status.
Data will be analyzed using a generalized mixed model framework and logistic regression models. Also, Fisher's exact test will be used to analyze the devices' blinding capability.
- Conditions
- Myofascial Pain, Craniofacial Pain
- Being tested
- real acupuncture, Placebo acupuncture
- Keywords
- acupuncture, myofascial pain, placebo, facial pain
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real acupunctureDevice
Device with acupuncture needles 25 × 0.22 mm, Cloud \& Dragon Medical Device Co, Ltd, China. Needle penetrates the skin 4 mm
Placebo acupunctureDevice
Device with acupuncture needles 25 × 0.22 mm, Cloud \& Dragon Medical Device Co, Ltd, China. Needle does not touch the skin.
| Study group | Role | What they receive |
|---|---|---|
| Real acupuncture | Experimental | The patient receives five sessions (weekly) of real acupuncture treatment in the acupuncture points LI4, S6, S7 and SI18. Each session lasts 30 minutes. Receives: Device: real acupuncture |
| Placebo acupuncture | Placebo comparator | The patient receives five sessions (weekly) of placebo acupuncture in the same acupuncture points LI4, S6, S7 and SI18. Each session lasts 30 minutes. The placebo and real acupuncture devices have the same visual features but in the placebo device the needle does not even touch the skin. Receives: Device: Placebo acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity change from baseline to follow-up.
A Visual Analogue Scale (VAS) which consists of a 100mm line, with two end points representing 0 ('no pain') and 100 ('worst pain').
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
Graded Chronic Pain Scale Version 2.0
Validated instrument for assessment of chronic pain in epidemiological and health services research
Measured: through study completion, an average of 6 months
Muscle pain upon palpation.
Performed by calibrated and blind researchers following the DC-TMD criteria (www.rdc-tmdinternational.org/)
Measured: through study completion, an average of 6 months
Clinical stress assessment using a visual analogue scale
The stress VAS consisted of a 100mm line, with two end points representing 0 ('none') and 100 ('as bad as it could be').
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start14 Mar 2022
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myofascial PainStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- This is a randomized, placebo-controlled, crossover and triple blind study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de la Republica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Kreiner, Universidad de la Republica
- Investigators
- Marcelo Kreiner, PhD, Principal investigator, Universidad de la Republica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414695
- Sponsor's protocol ID
- 091900-000127-20
- Status last verified
- Jun 2022
- First submitted
- 2 Jun 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
PubMed 24482784Lesage FX, Berjot S, Deschamps F. Clinical stress assessment using a visual analogue scale. Occup Med (Lond). 2012 Dec;62(8):600-5. doi: 10.1093/occmed/kqs140. Epub 2012 Sep 10.
PubMed 22965867
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on Craniomandibular Pain of Myofascial Origin. A Randomized, Triple-blind, Placebo-controlled, Crossover Clinical Trial.
- ClinicalTrials.gov ID
- NCT05414695
- Acronym / sponsor ID
- 091900-000127-20
- Conditions
- Myofascial Pain, Craniofacial Pain
- Keywords
- acupuncture, myofascial pain, placebo, facial pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de la RepublicaUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Jun 2022 (actual)
- 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.
Myofascial pain is one of the most prevalent conditions within temporomandibular disorders. Despite its high prevalence, health systems pay insufficient attention to it. Patients frequently receive multiple unnecessary and sometimes aggressive treatments. In this context, acupuncture has been studied as a plausible therapy for these conditions. However, researchers have encountered various methodological difficulties when demonstrating its actual effect. The main historical challenge in this area involves the difficulties inherent to using appropriate acupuncture controls such as placebos that allow for double blinding and cause minimum tactile stimulation.
In a previous study, a validated an improved novel placebo acupuncture non-penetrating device with double blinding capability was presented. This project will allow to test the performance of this new placebo acupuncture device in a clinical experimental setting. The study will try to determine the actual effectiveness of acupuncture in treating craniomandibular pain of myofascial origin. The design will be a randomized, triple blind, placebo controlled, crossover clinical trial. The protocol follows the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) recommendations, and ethical approval was obtained.
The central hypothesis is that acupuncture will be more effective than a placebo. Another hypothesis is that neither patients nor acupuncturists will be able to distinguish real acupuncture devices from placebo devices.
The study will include consecutive patients diagnosed with pain in the craniomandibular region of muscular/myofascial origin according to accepted criteria. Sample size calculations were made with the assumption of an 80% power and a statistical difference accepted at the 5% level. A total of 60 patients will be included.
Patients will be randomly divided into two groups: real acupuncture or placebo. Five sessions will be performed on each patient on a weekly basis. The total time for each intervention will be 30 minutes. A crossover design will be applied after a "washout" period of 14 days.
Outcome measures will include pain, stress levels, quality of life, and mandibular dynamics, using validated and published criteria. Baseline measurements will be taken pre-treatment and at each treatment session. Follow-up outcomes will be measured after three and six months.
A strict protocol for bias control will be followed. The triple-blind design will prevent the patient, the acupuncturist, and the person performing the statistical analysis from knowing what type of treatment each patient receives each time. Examiners will be calibrated and blinded to the treatment status.
Data will be analyzed using a generalized mixed model framework and logistic regression models. Also, Fisher's exact test will be used to analyze the devices' blinding capability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, placebo-controlled, crossover and triple blind study
| Arm | Type | Receives |
|---|---|---|
| Real acupuncture | Experimental | Device: real acupunctureThe patient receives five sessions (weekly) of real acupuncture treatment in the acupuncture points LI4, S6, S7 and SI18. Each session lasts 30 minutes. |
| Placebo acupuncture | Placebo comparator | Device: Placebo acupunctureThe patient receives five sessions (weekly) of placebo acupuncture in the same acupuncture points LI4, S6, S7 and SI18. Each session lasts 30 minutes. The placebo and real acupuncture devices have the same visual features but in the placebo device the needle does not even touch the skin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of miofascial pain in the craniomandibular/temporomandibular region (DC-TMD published criteria).
Key exclusion criteria (3 listed)
- Pregnant woman
- Recent history of facial trauma
- Systemic diseases that can affect the musculoskeletal system (e.g. rheumatoid arthritis, lupus, etc).
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 |
|---|---|---|
| real acupunctureDevice with acupuncture needles 25 × 0.22 mm, Cloud \& Dragon Medical Device Co, Ltd, China. Needle penetrates the skin 4 mm | Device | Real acupuncture |
| Placebo acupunctureDevice with acupuncture needles 25 × 0.22 mm, Cloud \& Dragon Medical Device Co, Ltd, China. Needle does not touch the skin. | Device | Placebo acupuncture |
Primary outcome
Pain intensity change from baseline to follow-up.
Time frame: through study completion, an average of 6 months
A Visual Analogue Scale (VAS) which consists of a 100mm line, with two end points representing 0 ('no pain') and 100 ('worst pain').
3 secondary outcomes
Graded Chronic Pain Scale Version 2.0
Time frame: through study completion, an average of 6 months
Muscle pain upon palpation.
Time frame: through study completion, an average of 6 months
Clinical stress assessment using a visual analogue scale
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Results publication: PubMed 24482784Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
- Results publication: PubMed 22965867Lesage FX, Berjot S, Deschamps F. Clinical stress assessment using a visual analogue scale. Occup Med (Lond). 2012 Dec;62(8):600-5. doi: 10.1093/occmed/kqs140. Epub 2012 Sep 10.
- STRICTA criteriaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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.
Marcelo Kreiner, PhD principal investigator
Universidad de la Republica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real acupuncture in people with Myofascial Pain and Craniofacial Pain, run by Universidad de la Republica at 1 site in Uruguay.
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 1 inclusion and 3 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 10 Jun 2022. 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 Uruguay. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity change from baseline to follow-up. (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05414695, which also lists 2 linked publications.
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 10 Jun 2022.