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.
1This trial is specifically for people who have both fibromyalgia and temporomandibular disorder — do I actually have both of these conditions confirmed, and would my care team consider me a good candidate to discuss this study with the researchers?
2The trial uses osteopathic manual therapy on the jaw and surrounding areas — given that fibromyalgia can make me sensitive to touch and physical manipulation, what risks or discomfort should I realistically expect from this type of hands-on treatment?
3This study is listed as 'Phase NA,' which often means it's testing a clinical algorithm or approach rather than a drug — can you help me understand what that means for how much is already known about whether this approach is safe and helpful for someone with my combination of conditions?
4The trial is measuring things like pain catastrophizing, tinnitus, and myofascial trigger points — are these specific problems I'm currently experiencing, and would addressing them through a structured osteopathic algorithm make sense as part of my overall fibromyalgia management plan?
5Before considering this trial, are there standard treatments for my temporomandibular disorder and fibromyalgia that I haven't yet tried, and would it make more sense to explore those first rather than enrolling in a research study?
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