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

NCT06912438 | Enrolling By Invitation

• 1 other identifier: TASMC-25-0050-CTIL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Myofascial Pain; Dry Needling

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrollment to the end of the needling session (4-8 weeks)

Secondary Outcomes (1)

• Decrease in distress, anxiety, depression.

  From enrollment to the end of the needling session (4-8 weeks)

Study Arms (1)

Study Group

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

Interventions

Fill out questionnaire OTHER

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 Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Orofacial Pain clinic at the Oral Medicine Unite - Tel Aviv Medical Center.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Oral Medicine Unite, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, Israel

Location

Related Publications (4)

• Netz Y, Zeav A, Arnon M, Daniel S. Translating a single-word items scale with multiple subcomponents--A Hebrew translation of the Profile of Mood States. Isr J Psychiatry Relat Sci. 2005;42(4):263-70.

  PMID: 16618060 BACKGROUND

• Haller H, Saha FJ, Ebner B, Kowoll A, Anheyer D, Dobos G, Berger B, Choi KE. Emotional release and physical symptom improvement: a qualitative analysis of self-reported outcomes and mechanisms in patients treated with neural therapy. BMC Complement Altern Med. 2018 Nov 27;18(1):311. doi: 10.1186/s12906-018-2369-4.

  PMID: 30482194 BACKGROUND

• Cerezo-Tellez E, Torres-Lacomba M, Fuentes-Gallardo I, Perez-Munoz M, Mayoral-Del-Moral O, Lluch-Girbes E, Prieto-Valiente L, Falla D. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial. Pain. 2016 Sep;157(9):1905-1917. doi: 10.1097/j.pain.0000000000000591.

  PMID: 27537209 BACKGROUND

• 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.

  PMID: 24482784 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Muscular Diseases

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Stomatognathic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 4, 2025
• Study Start: March 13, 2025
• Primary Completion (Estimated): March 13, 2027
• Study Completion (Estimated): March 13, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

IL (1)