Actively Recruiting
Effectiveness of an Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia
Led by Universitat de Lleida · Updated on 2025-09-04
114
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Fibromyalgia is a rheumatic disorder known for significantly reducing quality of life, and it often occurs alongside temporomandibular disorders. This study is designed as a randomized clinical trial to evaluate the effectiveness of a specific osteopathic manual therapy approach algorithm in patients who have both fibromyalgia and temporomandibular disorders. The trial aims to assess how this therapy impacts symptoms and function in this patient group. Participants will be randomly assigned to one of two groups. One group will receive osteopathic manual therapy using articulatory techniques, soft tissue mobilization, and trigger point inhibition based on a validated treatment algorithm. The other group will undergo a sham treatment designed to simulate these techniques without therapeutic effect. This single-masked approach will help measure the true effect of the osteopathic therapy over a treatment period lasting six weeks. During the study, participants will be evaluated at enrollment and throughout treatment for several outcomes, including catastrophizing, functional limitation, disability, pain, tinnitus, myofascial trigger points, and range of motion. These assessments will occur from enrollment to four or six weeks depending on the measure. The trial includes monitoring the participants' progress and response to therapy over this period to gather comprehensive data on the therapy's impact.
CONDITIONS
Brief Title
An Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with fibromyalgia
- Moderate pain or dysfunction in the temporomandibular joint lasting more than 3 months
- Age over 18 years and up to 75 years
- Understand Spanish and/or Catalan
- Able to read and accept the informed consent form
You will not qualify if you...
- History of trauma or recent surgery to the head, face, or neck
- Presence of systemic, rheumatic, or central nervous system diseases
- Diagnosis of malignant tumors or cancer in the orofacial region
- Participation in other studies at the same time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive osteopathic manual therapy or a sham treatment aimed at improving temporomandibular joint function and pain following a validated approach algorithm.
Weekly visits for up to 6 weeks
Trial Site Locations
Total: 1 location
1
Osteopatia i Fisioteràpia Cornellà
Cornellà de Llobregat, Barcelona, Spain, 08940
Actively Recruiting
Research Team
L
Llanos de la Iglesia, MsC
L
Llanos de la Iglesia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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