An Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversitat de Lleida
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Osteopathic manual therapy
Other interventionosteopathic manual treatment aimed at improving the function and pain of the temporomandibular joint.
Sham osteopathic manual therapy
Other interventiona sham osteopathic manual treatment without therapeutic effect
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: experimentalExperimental treatment 1 intervention
Group B: shamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
catastrophizing
The Pain Catastrophizing scale (PCS), evaluates the degree og catastrophic thinking gdue to pain.It is a 13-item scale, with a total range from 0 to 52. Higher scores are associated with a greater degree of pain catastrophizing.
Time frame
From enrollment to the end of treatment at 6 weeks2
functional limitation
evaluated with tue short version of the Jaw functional limitation scale (JFLS-8). Evaluates the functional status of the masticatory system. Questionnaire with 8 items, each with a scale from 0 to 10. A higher score suggests a greater limitation.
Time frame
From enrollment to the end of treatment at 6 weeks3
functional status, disability and pain
collected in the craniofacial pain and disability inventory (CFPDI). Self administered questionnaire of 21 items. Each item is scored on a Likert scale from 0 to 3.
Time frame
From enrollment to the end of treatment at 6 weeks4
pain and tinnitus
evaluated with a visual analog scale (VAS). Scale from 0 to 10, where 0 indicates no pain and 10 the worst pain imaginable.
Time frame
From enrollment to the end of treatment at 6 weeksSponsors and contacts
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Source ClinicalTrials.gov