An Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia

Not Applicable

Recruiting

• Conditions: Fibromyalgia; Temporomandibular Disorder
• Interventions: Other: Osteopathic manual therapy; Other: Sham osteopathic manual therapy

• Registration Number: NCT06365151
• Lead Sponsor: Universitat de Lleida

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-05
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-04-05
• Study Completion: 2026-04-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	Osteopathic manual therapy	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 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.

Primary Outcome Measures

Name	Time	Method
myofascial trigger points	week 1, week 4, week 6	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.
functional status, disability and pain	week 1, week 4, week 6	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.
pain and tinnitus	week 1, week 4, week 6	evaluated with a visual analog scale (VAS). Scale from 0 to 10, where 0 indicates no pain and 10 the worst pain imaginable.
Range of motion	week 1, week 4, week 6	measurements taken with a ruler: maximum opening, maximun active opening without pain and lateralization.
catastrophizing	week 1, week 4, week 6	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.
functional limitation	week 1, week 4, week 6	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.

Trial Locations

Locations (1)

Osteopatia i Fisioteràpia Cornellà; 🇪🇸 Cornella de Llobregat, Barcelona, Spain