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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental | Experimental | treatment will be carried out following a previously validated approach algorithm. Articulatory techniques, soft tissue mobilization techniques, trigger point inhibition, etc. will be used. |
|
| sham | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic manual therapy | Other | osteopathic manual treatment aimed at improving the function and pain of the temporomandibular joint. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | From enrollment to 4 weeks |
| Range of motion | measurements taken with a ruler: maximum opening, maximun active opening without pain and lateralization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Llanos de la Iglesia, MsC | Contact | +4679536992 | llanos.delaiglesia@gmail.com | |
| Llanos de la Iglesia | Contact | +34679536992 | llanos.delaiglesia@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Llanos de la Iglesia | Departament de infermeria i fisioterapia. universitat de Lleida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osteopatia i Fisioterà pia Cornellà | Recruiting | Cornellà de Llobregat | Barcelona | 08940 | Spain |
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| Sham osteopathic manual therapy | Other | a sham osteopathic manual treatment without therapeutic effect |
|
| From enrollment to 4 weeks |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D013705 | Temporomandibular Joint Disorders |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D007592 | Joint Diseases |
| D009057 | Stomatognathic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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