Effect of Acupuncture on Craniomandibular Pain of Myofascial Origin.
Primary Purpose
Myofascial Pain, Craniofacial Pain
Status
Active
Phase
Not Applicable
Locations
Uruguay
Study Type
Interventional
Intervention
real acupuncture
Placebo acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain focused on measuring acupuncture, myofascial pain, placebo, facial pain
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of miofascial pain in the craniomandibular/temporomandibular region (DC-TMD published criteria).
Exclusion Criteria:
- Pregnant woman
- Recent history of facial trauma
- Systemic diseases that can affect the musculoskeletal system (e.g. rheumatoid arthritis, lupus, etc).
Sites / Locations
- Universidad de la República, School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Real acupuncture
Placebo acupuncture
Arm Description
The patient receives five sessions (weekly) of real acupuncture treatment in the acupuncture points LI4, S6, S7 and SI18. Each session lasts 30 minutes.
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.
Outcomes
Primary Outcome Measures
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').
Secondary Outcome Measures
Graded Chronic Pain Scale Version 2.0
Validated instrument for assessment of chronic pain in epidemiological and health services research
Muscle pain upon palpation.
Performed by calibrated and blind researchers following the DC-TMD criteria (www.rdc-tmdinternational.org/)
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').
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05414695
Brief Title
Effect of Acupuncture on Craniomandibular Pain of Myofascial Origin.
Official Title
Effect of Acupuncture on Craniomandibular Pain of Myofascial Origin. A Randomized, Triple-blind, Placebo-controlled, Crossover Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de la Republica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain, Craniofacial Pain
Keywords
acupuncture, myofascial pain, placebo, facial pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a randomized, placebo-controlled, crossover and triple blind study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The intervention is unknown to the patients, the acupuncturist and the persons who assess the outcomes. Both devices (placebo and real acupuncture) have the exactly same visual appearance. Its double blinding potential was confirmed in preliminary validation studies.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Real acupuncture
Arm Type
Experimental
Arm Description
The patient receives five sessions (weekly) of real acupuncture treatment in the acupuncture points LI4, S6, S7 and SI18. Each session lasts 30 minutes.
Arm Title
Placebo acupuncture
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
real acupuncture
Intervention Description
Device with acupuncture needles 25 × 0.22 mm, Cloud & Dragon Medical Device Co, Ltd, China. Needle penetrates the skin 4 mm
Intervention Type
Device
Intervention Name(s)
Placebo acupuncture
Intervention Description
Device with acupuncture needles 25 × 0.22 mm, Cloud & Dragon Medical Device Co, Ltd, China. Needle does not touch the skin.
Primary Outcome Measure Information:
Title
Pain intensity change from baseline to follow-up.
Description
A Visual Analogue Scale (VAS) which consists of a 100mm line, with two end points representing 0 ('no pain') and 100 ('worst pain').
Time Frame
through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Graded Chronic Pain Scale Version 2.0
Description
Validated instrument for assessment of chronic pain in epidemiological and health services research
Time Frame
through study completion, an average of 6 months
Title
Muscle pain upon palpation.
Description
Performed by calibrated and blind researchers following the DC-TMD criteria (www.rdc-tmdinternational.org/)
Time Frame
through study completion, an average of 6 months
Title
Clinical stress assessment using a visual analogue scale
Description
The stress VAS consisted of a 100mm line, with two end points representing 0 ('none') and 100 ('as bad as it could be').
Time Frame
through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of miofascial pain in the craniomandibular/temporomandibular region (DC-TMD published criteria).
Exclusion Criteria:
Pregnant woman
Recent history of facial trauma
Systemic diseases that can affect the musculoskeletal system (e.g. rheumatoid arthritis, lupus, etc).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Kreiner, PhD
Organizational Affiliation
Universidad de la Republica
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de la República, School of Dentistry
City
Montevideo
ZIP/Postal Code
11400
Country
Uruguay
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication.
IPD Sharing Time Frame
Starting one month after publication and for one year.
IPD Sharing Access Criteria
IPD and any additional supporting information will be shared to researchers worldwide upon direct request to the Principal Investigator (Marcelo Kreiner).
Citations:
PubMed Identifier
24482784
Citation
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.
Results Reference
result
PubMed Identifier
22965867
Citation
Lesage 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.
Results Reference
result
Links:
URL
https://stricta.info/
Description
STRICTA criteria
Learn more about this trial
Effect of Acupuncture on Craniomandibular Pain of Myofascial Origin.
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