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

Fibromyalgia Clinical Trial

Official title:

Effectiveness of an Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06365151
• Other study ID #: TMDs fibromyalgia
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2024
• Est. completion date: April 5, 2026

Study information

• Verified date: April 2024
• Source: Universitat de Lleida
• Contact: Llanos de la Iglesia, MsC
• Phone: +4679536992
• Email: llanos.delaiglesia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: April 5, 2026
• Est. primary completion date: April 5, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• Osteopathic manual therapy
osteopathic manual treatment aimed at improving the function and pain of the temporomandibular joint.
• Sham osteopathic manual therapy
a sham osteopathic manual treatment without therapeutic effect

Locations

Country	Name	City	State
Spain	Osteopatia i Fisioteràpia Cornellà	Cornella de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Universitat de Lleida

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	week 1, week 4, week 6
Primary	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.	week 1, week 4, week 6
Primary	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.	week 1, week 4, week 6
Primary	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.	week 1, week 4, week 6
Primary	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.	week 1, week 4, week 6
Primary	Range of motion	measurements taken with a ruler: maximum opening, maximun active opening without pain and lateralization.	week 1, week 4, week 6