An interventional study of Osteopathic manual therapy and Sham osteopathic manual therapy in Fibromyalgia and Temporomandibular Disorder, sponsored by Universitat de Lleida. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Universitat de Lleida · Not applicable, Interventional, and Treatment
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.
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's planned enrollment of 114 is above the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Universitat de Lleida is the lead sponsor of 33 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
treatment will be carried out following a previously validated approach algorithm. Articulatory techniques, soft tissue mobilization techniques, trigger point inhibition, etc. will be used.
Other: Osteopathic manual therapy
A sham treatment will be performed following a previously validated approach algorithm. techniques will be simulated in such a way that they will have no therapeutic effect.
Other: Sham osteopathic manual therapy
osteopathic manual treatment aimed at improving the function and pain of the temporomandibular joint.
a sham osteopathic manual treatment without therapeutic effect
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 weeks
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 weeks
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 weeks
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 weeks
myofascial trigger points
presence of a palpable tight band, presence of a hyperirritable tenderpoint within te tight band, local twitch response elicited by acute palpation of the tight band, and presence refered pain in response ot trigger point compression.
Time frame: From enrollment to 4 weeks
Range of motion
measurements taken with a ruler: maximum opening, maximun active opening without pain and lateralization.
Time frame: From enrollment to 4 weeks
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Universitat de Lleida