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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06365151
Enrollment
114
Registered
2024-04-15
Start date
2024-04-05
Completion date
2026-04-05
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia, Temporomandibular Disorder

Keywords

temporomandibular joint disorders, fibromyalgia, Osteopathic medicine, chronic pain, musculoskeletal manipulations

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.

Interventions

osteopathic manual treatment aimed at improving the function and pain of the temporomandibular joint.

OTHERSham osteopathic manual therapy

a sham osteopathic manual treatment without therapeutic effect

Sponsors

Universitat de Lleida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
catastrophizingFrom enrollment to the end of treatment at 6 weeksThe 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 limitationFrom enrollment to the end of treatment at 6 weeksevaluated 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.
functional status, disability and painFrom enrollment to the end of treatment at 6 weekscollected 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 tinnitusFrom enrollment to the end of treatment at 6 weeksevaluated with a visual analog scale (VAS). Scale from 0 to 10, where 0 indicates no pain and 10 the worst pain imaginable.
myofascial trigger pointsFrom enrollment to 4 weekspresence 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.
Range of motionFrom enrollment to 4 weeksmeasurements taken with a ruler: maximum opening, maximun active opening without pain and lateralization.

Countries

Spain

Contacts

Primary ContactLlanos de la Iglesia, MsC
llanos.delaiglesia@gmail.com+4679536992
Backup ContactLlanos de la Iglesia
llanos.delaiglesia@gmail.com+34679536992

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026