Temporomandibular Disorders (TMD)NCT06912438
Emotional Release After Trigger Point Needling to Treat Myofascial Pain of the Head and Neck - Prospective Study
An observational study of Temporomandibular Disorders (TMD) and Temporomandibular Dysfunction (TMD), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorders (TMD), Temporomandibular Dysfunction (TMD), Temporomandibular Joint and Muscle Disorder
- What is being tested?
- Fill out questionnaire
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Mar 2025to 13 Mar 2027
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients admitted to the Orofacial Pain clinic at the Oral Medicine Unite - Tel Aviv Medical Center.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Oral Medicine Unite, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
About this study
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.
Read the detailed description
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:
- Diagnostic Criteria for Temporomandibular Disorders (DC-TMD) questionnaire.
- Patient Health Questionnaire 9 PHQ-9-HEB
- Emotion Regulation Questionnaire (ERQ)
- Toronto Alexithymia Scale (TAS - 20) Clinical data will be entered in EMR (Chameleon). Patients would receive 4 appointments for treatment spaced 1 or 2 weeks apart over a period of 1-2 months.
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:
- 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
Criteria for participation ceasing -
- Patient choice
- Pain is not improving after 3 sessions
Special population - excluded
- Patients under 18
- Patients with cognitive impairments unable to fully understand the questionnaires
Duration of study: 2 years
Risk for the participants:
Equivalent to risk from IMS:
- Local hematoma
- Elevated pain after injection
- Conditions
- Temporomandibular Disorders (TMD), Temporomandibular Dysfunction (TMD), Temporomandibular Joint and Muscle Disorder
- Being tested
- Fill out questionnaire
- Keywords
- Myofascial Pain, Dry Needling
- Medical subject headings
- Temporomandibular Joint Disorders, Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fill out questionnaireOther
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fill out questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of the needling session (4-8 weeks)
Secondary outcomes (1)
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.
Measured: From enrollment to the end of the needling session (4-8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start13 Mar 2025
- Primary completion13 Mar 2027 (estimated)
- Study completion13 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912438
- Sponsor's protocol ID
- TASMC-25-0050-CTIL
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Needs local Helsinki Committee authorizations.
Publications
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.
PubMed 16618060Haller 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.
PubMed 30482194Cerezo-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.
PubMed 27537209Schiffman 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 24482784
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Release After Trigger Point Needling to Treat Myofascial Pain of the Head and Neck - Prospective Study
- ClinicalTrials.gov ID
- NCT06912438
- Acronym / sponsor ID
- TASMC-25-0050-CTIL
- Conditions
- Temporomandibular Disorders (TMD), Temporomandibular Dysfunction (TMD), Temporomandibular Joint and Muscle Disorder
- Keywords
- Myofascial Pain, Dry Needling
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 13 Mar 2027 (estimated)
- Study completion
- 13 Mar 2027 (estimated)
- First posted
- 4 Apr 2025 (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.
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.
Detailed description
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:
- Diagnostic Criteria for Temporomandibular Disorders (DC-TMD) questionnaire.
- Patient Health Questionnaire 9 PHQ-9-HEB
- Emotion Regulation Questionnaire (ERQ)
- Toronto Alexithymia Scale (TAS - 20) Clinical data will be entered in EMR (Chameleon). Patients would receive 4 appointments for treatment spaced 1 or 2 weeks apart over a period of 1-2 months.
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:
- 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
Criteria for participation ceasing -
- Patient choice
- Pain is not improving after 3 sessions
Special population - excluded
- Patients under 18
- Patients with cognitive impairments unable to fully understand the questionnaires
Duration of study: 2 years
Risk for the participants:
Equivalent to risk from IMS:
- Local hematoma
- Elevated pain after injection
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Fill out questionnairePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Orofacial Pain clinic at the Oral Medicine Unite - Tel Aviv Medical Center.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Fill out questionnaireAfter 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. | Other | Study Group |
Primary outcome
Shift in mood state
Time frame: 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
Time frame: 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.
1 secondary outcome
Decrease in distress, anxiety, depression.
Time frame: From enrollment to the end of the needling session (4-8 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 16618060Netz 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.
- Background: PubMed 30482194Haller 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.
- Background: PubMed 27537209Cerezo-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.
- Background: 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.
- Individual participant dataSharing planned: Undecided. Needs local Helsinki Committee authorizations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorders (TMD) and Temporomandibular Dysfunction (TMD), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 6 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: enrolling by invitation, as of the sponsor's last update on 4 Apr 2025. 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 Israel. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Shift in mood state (time frame: From enrollment to the end of the needling session (4-8 weeks)). The study lists 2 primary outcomes in all. 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 NCT06912438, which also lists 4 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 4 Apr 2025.