An observational study in Temporomandibular Disorders (TMD), Temporomandibular Dysfunction (TMD) and Temporomandibular Joint and Muscle Disorder, sponsored by Tel-Aviv Sourasky Medical Center. Enrolling by invitation at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Tel-Aviv Sourasky Medical Center · Observational
Temporomandibular Dysfunction (TMD) as classified by the DC-TMD has a significant psychosocial component referred to as "Axis II".
One of the methods of treatment for myofascial TMD is "needing" which could be "dry needling" using only a needle or "wet needling" using local anesthetics.
Practitioners of needling commonly observe an emotional release by the patient undergoing needling.
This study aims to record and measure the emotional state of patients just before and just after needling for myofascial TMD via questionnaires.
The most common chronic pain of the orofacial region is myofascial pain related to the muscles of mastication and the neck.
Which is classified according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
In the DC-TMD, the "Axis I" arm, namely the "physical diagnosis" includes "muscular" disorders as well as "joint" disorders.
The DC/TMD also includes the Axis II - psychosocial arm with comorbidities such as Anxiety, Depression, PTSD.
The cause of myofascial pain is poorly understood - there is no clear organic cause and the modern understanding is that most of the pain is related to processes originating in the central nervous system or specifically in the "mind" such as poor coping mechanisms, history of trauma or PTSD, anxiety, depression, as well as issues related to emotions such as emotional repression.
There are no wide consensus guidelines for the treatment of chronic myofascial pain of the masticatory muscles and various modalities are available: physiotherapy, occlusal stabilization splints, pharmacotherapy, acupuncture, biofeedback, trigger point needling, behavioral changes, psychotherapy, and hypnotherapy.
One of the most common and effective treatments of myofascial pain in general is "needling" of trigger points namely insertion of a dry needle or injection of saline, local anesthetic, or steroids into trigger points (wet needling).
This treatment is also known as "Intramuscular Stimulation" (IMS). Our department has been treating myofascial pain with trigger point injections for over 6 years. Our standard protocol is 4 separate appointments spaced 1-2 weeks apart.
Practitioners of IMS report that for many patients, shortly after needling there is a n "emotional release" expressed as change in mood, crying, recollection of memories, calmness and relaxation. This has been our experience as well.
Despite the fact that this phenomenon is well observed among practitioners - there are very few reports in the literature.
In this study, we aim to measure the qualitative dynamics of emotions following IMS as well as asses the efficacy of treatment as a product of emotional change. There would be no change in the muscles needled or the technique but rather data is collected in regards to the emotional state before and after the standard treatment.
Methods After signed consent all patients will be asked to fill a series of questionnaires in print. The questionnaires administered are standardized and validated in Hebrew.
Patients will be asked to fill out:
At each injection session, all patients will be asked to fill out the Profile of Mood States Hebrew translation (POMS-H) before and after trigger point injections. The pain using the Numerical Rating Scale (NRS) would also be recorded as well as the personal impression of improvement using a percentage scale.
Patients Study patients with relevant DC/TMD axis I diagnosis who could benefit from IMS therapy would be offered a chance to join the study.
Number of participants 100 study patients
Age range 18-99
Gender Males and females
Inclusion criteria The study group will include patients which consent to the study and are diagnosed with: Myalgia/Local Myalgia or Myofascial Pain or Myofascial pain with referral or Headache attributed to TMD with or without concurrent diagnosis related to the temporomandibular joint itself.
Exclusion criteria
Patients who are not eligible for IMS therapy will be excluded:
Criteria for participation ceasing -
Special population - excluded
Duration of study: 2 years
Risk for the participants:
Equivalent to risk from IMS:
609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 165 observational studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.
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Patients admitted to the Orofacial Pain clinic at the Oral Medicine Unite - Tel Aviv Medical Center.
The study group will include patients which consent to the study and are diagnosed with: Myalgia/Local Myalgia or Myofascial Pain or Myofascial pain with referral or Headache attributed to TMD with or without concurrent diagnosis related to the temporomandibular joint itself.
Exclusion Criteria:
Patients who are not eligible for IMS therapy will be excluded:
Patients diagnosed with TMD myofascial pain which my benefit from needling and who are willing to participate would be asked to answer a series of standardized questionnaires and would be invited to 4 needling session spaced 1-2 weeks apart. At each injection session, all patients would be asked to fill out the "Profile of Mood States Hebrew translation" (POMS-H) questionnaire just before and just after trigger point injections. The pain using the Numerical Rating Scale (NRS) would also be recorded as well as the personal impression of improvement using a percentage scale.
Other: Fill out questionnaire
After signed consent all patients will be asked to fill a series of questionnaires in print. The questionnaires administered are standardized and validated in Hebrew. Patients will be asked to fill out: Diagnostic Criteria for Temporomandibular Disorders (DC-TMD) questionnaire. Patient Health Questionnaire 9 PHQ-9-HEB Emotion Regulation Questionnaire (ERQ) Toronto Alexithymia Scale (TAS - 20) At each injection session, all patients will be asked to fill out the Profile of Mood States Hebrew translation (POMS-H) before and after trigger point injections.
Shift in mood state
The researchers expect to see a shift in the mood state of patients undergoing needling. There are 28 domains in the POMS-H questionnaire, grouped into 5 states: Fatigue (3,12,18,23,28), Tension (1,10,19), Depression (4,8,11,15,16,21,22) and Anger (2,6,13,14,20,25), Vigor (5,7,9,17,24,26,27). Between the before and after of each needling session values of Fatigue, Tension, Depression, and Anger are expected to decrease and values of Vigor are expected to increase. This shift is expected to be seen between the beginning and the end of each needling session as well as a trend between the 1st needling session and the 4th.
Time frame: From enrollment to the end of the needling session (4-8 weeks)
Pain reducation
The researchers expect to see a decrease in pain as quantified on the Numerical Rate Scale as well as an overall improvement in pain related to baseline as depicted in percentage by the patients.
Time frame: From enrollment to the end of the needling session (4-8 weeks)
Decrease in distress, anxiety, depression.
The researchers expect an improvement in rates of anxiety, depression, distress as depicted in the GAD-7, ERQ, PHQ-4, PHQ-9 questionnaire. The total value of each questionnaire is expected to decrease between the 1st and the 4th needling session.
Time frame: From enrollment to the end of the needling session (4-8 weeks)
Plan to share: Undecided — Needs local Helsinki Committee authorizations.
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