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Clinical Trials in Israel / NCT06912438
Enrolling by invitation Observational

Emotional Release After Trigger Point Needling to Treat Myofascial Pain of the Head and Neck - Prospective Study

NCT06912438 · tracked via the Priya Life Science Israel tracker
Sponsor
Tel-Aviv Sourasky Medical Center
Phase
Observational
Started
2025-03-13
Last updated
2025-04-04

Condition(s) studied

Temporomandibular Disorders (TMD)Temporomandibular Dysfunction (TMD)Temporomandibular Joint and Muscle Disorder

Investigational drug(s) / intervention(s)

Fill out questionnaire

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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: * PLT count under 80,000 * Active or chronic infection at site of pain * Known allergy to amide local anesthetics * Severe bleeding disorder such as Hemophilia * If treated with Warfarin INR over 3

Primary outcome measure(s)

  • Shift in mood state — From enrollment to the end of the needling session (4-8 weeks)
    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.
  • Pain reducation — From enrollment to the end of the needling session (4-8 weeks)
    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.

Trial sites (1)

FacilityCityRegionStatus
Oral Medicine Unite, Tel Aviv Sourasky Medical Center Tel Aviv Israel

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06912438 on ClinicalTrials.gov ↗ ← All trials in Israel