Psychosomatic SymptomsPsychosomaticNCT07385781
Psychosomatic Symptoms in Patients With Myofascial Pain and Temporomandibular Joint Dysfunction
An observational study of Psychosomatic Symptoms and Temporomandibular Disorder (TMD), run by Bahria University at 1 site in Pakistan.
Trial summary
Temporomandibular joint disorder poses an intricate etiology. Biomechanical, neuromuscular and psychosocial factors may contribute to the disorder among which psychological and psychosocial disturbances have shown strong direct or indirect contribution to the disease especially when the pain is of muscular origin. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosomatic Symptoms, Temporomandibular Disorder (TMD)
- What is being tested?
- Casr
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2026to 30 Aug 2026
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Temporomandibular joint dysfunction patient
Who may be able to join
- diagnosed patients with myofascial pain and TMD for at least six months based on Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), Axis I, age between 20 and 60 years, literate and able to comprehend the questionnaire no prior psychological treatment for pain.
Who cannot join
- age <20 or >60 years, low literacy (less than five years of formal education), history of major psychiatric or neurological disorders, diagnosed joint pathologies (e.g., arthritis, disc displacement with reduction), history of migraine or facial trauma, drug dependency and pregnancy or current use of psychotropic medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arsalan Khalid, BDS contact
Pakistan1 site
Bahria University
Karachi
Rida Zulfiqar, bds, +923203409531, ridazul34@gmail.com
About this study
Official title: Psychosomatic Symptoms in Patients With Myofascial Pain and Temporomandibular Joint Dysfunction- A Case Control Study
Temporomandibular joint disorder poses an intricate etiology. Biomechanical, neuromuscular and psychosocial factors may contribute to the disorder among which psychological and psychosocial disturbances have shown strong direct or indirect contribution to the disease especially when the pain is of muscular origin.
Read the detailed description
Temporomandibular disorders (TMDs) are defined as the group of musculoskeletal and neuromuscular conditions that involves temporomandibular joint (TMJ), masticatory muscles, and their associated structures (1). Clinically, TMDs are characterized by jaw pain, mandibular movement limitation, joint sounds, and often referred pain in the head, neck, or shoulders region (2). The myofascial pain, a subtype of TMD, is most prevalent condition and it accounts for approximately 50% of all TMD cases in clinical settings (3). Although it's a prevalent condition, but its complex aetiology makes it difficult to diagnose (4).
- Being tested
- Casr
- Keywords
- Anxiety, Depression, myofascial facial pain, Perceived stress, Somatization
- Medical subject headings
- Temporomandibular Joint Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CasrOther
case study participants
| Study group | Role | What they receive |
|---|---|---|
| Case | A total of 300 participants aged between 20 and 60 years were recruited using survivor sampling, consisting of 150 patients with a confirmed diagnosis of myofascial pain and temporomandibular joint dysfunction (TMD) and 150 age- and gender-matched healthy controls Receives: Other: Casr | |
| Control | A total of 300 participants aged between 20 and 60 years were recruited using survivor sampling, consisting of 150 patients with a confirmed diagnosis of myofascial pain and temporomandibular joint dysfunction (TMD) and 150 age- and gender-matched healthy controls Receives: Other: Casr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosomatic symptom burden
Psychosomatic symptom burden is defined as the overall severity and frequency of physical symptoms that are influenced or maintained by psychological factors. It will be assessed using a validated self-report questionnaire that captures multiple somatic symptom domains (e.g., pain, gastrointestinal, cardiovascular, and fatigue-related symptoms). Higher scores indicate a greater psychosomatic symptom burden.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychosomatic SymptomsStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Rida Zulfiqar, Bahria University
- Investigators
- Rida Zulfiqar, Principal investigator, Bahria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385781
- Sponsor's protocol ID
- 17/2023
- Other IDs
- bahria university
- Acronym
- Psychosomatic
- Status last verified
- Mar 2026
- First submitted
- 11 Dec 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
1. Szarejko KD, Gołębiewska M, Lukomska-Szymanska M, Kuć J. Stress experience, depression and neck disability in patients with temporomandibular disorder-myofascial pain with referral. Journal of Clinical Medicine. 2023;12(5):1988. 2. Kuć J, Szarejko KD, Maciejczyk M, Dymicka-Piekarska V, Żendzian-Piotrowska M, Zalewska A. Oxidative imbalance as a co-player in jaw functional limitations and biopsychosocial profile in patients with temporomandibular disorder-Myofascial pain with referral. Frontiers in Neurology. 2025;15:1509845. 3. Gomes AKP, Ximenes TA, Fonseca APR, de Barros Silva PG, Magalhães IA, da Silva Rodrigues AK, et al. Relationship between temporomandibular joint dysfunctions and psychosomatic factors. Revista Eletrônica Acervo Saúde. 2024;24(5):e16019-e. 4. Syroishko M, Kostiuk T. Dysfunction of the temporomandibular joints associated with post-traumatic stress disorders in patients. Reports of Vinnytsia National Medical University. 2023;27(2):253-7. 5. Matos M, Thumati P, Sutter B, Ruiz-Velasco G, Goldberg J, Booth J, et al. Are Temporomandibular Disorders Really Somatic Symptom Disorders? Part II-Joint Vibration Analysis of the Temporomandibular Joint. Advanced Dental Technologies & Techniques. 2021. 6. Patil DJ, Dheer DS, Puri G, Konidena A, Dixit A, Gupta R. Psychological appraisal in temporomandibular disorders: A cross-sectional study. Indian Journal of pain. 2016;30(1):13-8. 7. Canales GDLT, Guarda-Nardini L, Rizzatti-Barbosa CM, Conti PCR, Manfredini D. Distribution of depression, somatization and pain-related impairment in patients with chronic temporomandibular disorders. Journal of Applied Oral Science. 2019;27:e20180210. 8. Urits I, Charipova K, Gress K, Schaaf AL, Gupta S, Kiernan HC, et al. Treatment and management of myofascial pain syndrome. Best Practice & Research Clinical Anaesthesiology. 2020;34(3):427-48. 9. Cao Q-W, Peng B-G, Wang L, Huang Y-Q, Jia D-L, Jiang H, et al. Expert consensus on the diagnosis and treatment of myofascial pai
Szarejko KD, Golebiewska M, Lukomska-Szymanska M, Kuc J. Stress Experience, Depression and Neck Disability in Patients with Temporomandibular Disorder-Myofascial Pain with Referral. J Clin Med. 2023 Mar 2;12(5):1988. doi: 10.3390/jcm12051988.
PubMed 36902775
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosomatic Symptoms in Patients With Myofascial Pain and Temporomandibular Joint Dysfunction- A Case Control Study
- ClinicalTrials.gov ID
- NCT07385781
- Acronym / sponsor ID
- Psychosomatic / 17/2023
- Keywords
- Anxiety, Depression, myofascial facial pain, Perceived stress, Somatization
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bahria UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 4 Feb 2026 (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 joint disorder poses an intricate etiology. Biomechanical, neuromuscular and psychosocial factors may contribute to the disorder among which psychological and psychosocial disturbances have shown strong direct or indirect contribution to the disease especially when the pain is of muscular origin.
Detailed description
Temporomandibular disorders (TMDs) are defined as the group of musculoskeletal and neuromuscular conditions that involves temporomandibular joint (TMJ), masticatory muscles, and their associated structures (1). Clinically, TMDs are characterized by jaw pain, mandibular movement limitation, joint sounds, and often referred pain in the head, neck, or shoulders region (2). The myofascial pain, a subtype of TMD, is most prevalent condition and it accounts for approximately 50% of all TMD cases in clinical settings (3). Although it's a prevalent condition, but its complex aetiology makes it difficult to diagnose (4).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: CasrA total of 300 participants aged between 20 and 60 years were recruited using survivor sampling, consisting of 150 patients with a confirmed diagnosis of myofascial pain and temporomandibular joint dysfunction (TMD) and 150 age- and gender-matched healthy controls |
| Control | – | Other: CasrA total of 300 participants aged between 20 and 60 years were recruited using survivor sampling, consisting of 150 patients with a confirmed diagnosis of myofascial pain and temporomandibular joint dysfunction (TMD) and 150 age- and gender-matched healthy controls |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Temporomandibular joint dysfunction patient
Key inclusion criteria (1 listed)
- diagnosed patients with myofascial pain and TMD for at least six months based on Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), Axis I, age between 20 and 60 years, literate and able to comprehend the questionnaire no prior psychological treatment for pain.
Key exclusion criteria (1 listed)
- age <20 or >60 years, low literacy (less than five years of formal education), history of major psychiatric or neurological disorders, diagnosed joint pathologies (e.g., arthritis, disc displacement with reduction), history of migraine or facial trauma, drug dependency and pregnancy or current use of psychotropic medication.
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 |
|---|---|---|
| Casrcase study participants | Other | Case, Control |
Primary outcome
Psychosomatic symptom burden
Time frame: 2 months
Psychosomatic symptom burden is defined as the overall severity and frequency of physical symptoms that are influenced or maintained by psychological factors. It will be assessed using a validated self-report questionnaire that captures multiple somatic symptom domains (e.g., pain, gastrointestinal, cardiovascular, and fatigue-related symptoms). Higher scores indicate a greater psychosomatic symptom burden.
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 18 Mar 2026.
- Results publication1. Szarejko KD, Gołębiewska M, Lukomska-Szymanska M, Kuć J. Stress experience, depression and neck disability in patients with temporomandibular disorder-myofascial pain with referral. Journal of Clinical Medicine. 2023;12(5):1988. 2. Kuć J, Szarejko KD, Maciejczyk M, Dymicka-Piekarska V, Żendzian-Piotrowska M, Zalewska A. Oxidative imbalance as a co-player in jaw functional limitations and biopsychosocial profile in patients with temporomandibular disorder-Myofascial pain with referral. Frontiers in Neurology. 2025;15:1509845. 3. Gomes AKP, Ximenes TA, Fonseca APR, de Barros Silva PG, Magalhães IA, da Silva Rodrigues AK, et al. Relationship between temporomandibular joint dysfunctions and psychosomatic factors. Revista Eletrônica Acervo Saúde. 2024;24(5):e16019-e. 4. Syroishko M, Kostiuk T. Dysfunction of the temporomandibular joints associated with post-traumatic stress disorders in patients. Reports of Vinnytsia National Medical University. 2023;27(2):253-7. 5. Matos M, Thumati P, Sutter B, Ruiz-Velasco G, Goldberg J, Booth J, et al. Are Temporomandibular Disorders Really Somatic Symptom Disorders? Part II-Joint Vibration Analysis of the Temporomandibular Joint. Advanced Dental Technologies & Techniques. 2021. 6. Patil DJ, Dheer DS, Puri G, Konidena A, Dixit A, Gupta R. Psychological appraisal in temporomandibular disorders: A cross-sectional study. Indian Journal of pain. 2016;30(1):13-8. 7. Canales GDLT, Guarda-Nardini L, Rizzatti-Barbosa CM, Conti PCR, Manfredini D. Distribution of depression, somatization and pain-related impairment in patients with chronic temporomandibular disorders. Journal of Applied Oral Science. 2019;27:e20180210. 8. Urits I, Charipova K, Gress K, Schaaf AL, Gupta S, Kiernan HC, et al. Treatment and management of myofascial pain syndrome. Best Practice & Research Clinical Anaesthesiology. 2020;34(3):427-48. 9. Cao Q-W, Peng B-G, Wang L, Huang Y-Q, Jia D-L, Jiang H, et al. Expert consensus on the diagnosis and treatment of myofascial pai
- Results publication: PubMed 36902775Szarejko KD, Golebiewska M, Lukomska-Szymanska M, Kuc J. Stress Experience, Depression and Neck Disability in Patients with Temporomandibular Disorder-Myofascial Pain with Referral. J Clin Med. 2023 Mar 2;12(5):1988. doi: 10.3390/jcm12051988.
- Individual participant dataSharing planned: Yes
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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.
Arsalan Khalid, BDS contact
Rida Zulfiqar principal investigator
Bahria University
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 Psychosomatic Symptoms and Temporomandibular Disorder (TMD), run by Bahria University at 1 site in Pakistan.
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 1 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: opening soon, as of the sponsor's last update on 18 Mar 2026. 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 Pakistan. 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?
Contact rida Zulfiqar, BDS (+923203409531, ridazul34@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosomatic symptom burden (time frame: 2 months). 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 NCT07385781, which also lists 2 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 18 Mar 2026.