An Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patie… (NCT06365151) | Clinical Trial Compass
RecruitingNot Applicable
An Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia
Spain114 participantsStarted 2024-04-05
Plain-language summary
Nowadays, fibromyalgia is the rheumatic disorder with the highest levels of deterioration in quality of life. Among the comorbidities it presents, one of the most frequent is temporomandibular disorders. A randomized clinical study will be conducted to evaluate the effectiveness of an osteopathic manual therapy approach algorithm in a group of patients with fibromyalgia and temporomandibular disorders.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* be diagnosed as suffering from fibromyalgia,
* present moderate pain or dysfunction of more than 3 months' duration in the temporomandibular joint,
* be over 18 years old,
* understand Spanish and/or Catalan correctly,
* and read and accept the informed consent form
Exclusion Criteria:
* history of trauma or recent surgery to the head, face or neck;
* systemic, rheumatic or central nervous system diseases;
* diagnosis of malignant tumors or cancer in the orofacial region;
* participate in other studies at the same time.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
catastrophizing
Timeframe: From enrollment to the end of treatment at 6 weeks
2
functional limitation
Timeframe: From enrollment to the end of treatment at 6 weeks
3
functional status, disability and pain
Timeframe: From enrollment to the end of treatment at 6 weeks
4
pain and tinnitus
Timeframe: From enrollment to the end of treatment at 6 weeks