FibromyalgiaNCT06365151
An Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia
A study testing Osteopathic manual therapy in people with Fibromyalgia and Temporomandibular Disorder, run by Universitat de Lleida at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Temporomandibular Disorder
- What is being tested?
- Osteopathic manual therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- 5 Apr 2024to 5 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Osteopatia i Fisioteràpia Cornellà
Cornellà de Llobregat, Barcelona, 08940
Llanos de la Iglesia, MsC, +34679536992, llanos.delaiglesia@gmail.com
About this study
Official title: Effectiveness of an Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia
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.
- Conditions
- Fibromyalgia, Temporomandibular Disorder
- Being tested
- Osteopathic manual therapy, Sham osteopathic manual therapy
- Keywords
- temporomandibular joint disorders, fibromyalgia, Osteopathic medicine, chronic pain, musculoskeletal manipulations
- Medical subject headings
- Fibromyalgia, Temporomandibular Joint Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manual therapyOther
osteopathic manual treatment aimed at improving the function and pain of the temporomandibular joint.
Sham osteopathic manual therapyOther
a sham osteopathic manual treatment without therapeutic effect
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Osteopathic manual therapy |
| 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. Receives: Other: Sham osteopathic manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to 4 weeks
Range of motion
measurements taken with a ruler: maximum opening, maximun active opening without pain and lateralization.
Measured: From enrollment to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start5 Apr 2024
- Primary completion31 Jul 2025
- Study completion5 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Llanos de la Iglesia, Universitat de Lleida
- Investigators
- Llanos de la Iglesia, Principal investigator, Departament de infermeria i fisioterapia. universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365151
- Sponsor's protocol ID
- TMDs fibromyalgia
- Status last verified
- Aug 2025
- First submitted
- 8 Apr 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06365151
- Acronym / sponsor ID
- TMDs fibromyalgia
- Conditions
- Fibromyalgia, Temporomandibular Disorder
- Keywords
- temporomandibular joint disorders, fibromyalgia, Osteopathic medicine, chronic pain, musculoskeletal manipulations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 5 Apr 2026 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: Osteopathic manual therapytreatment 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 | Other: Sham osteopathic manual therapyA 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic manual therapyosteopathic manual treatment aimed at improving the function and pain of the temporomandibular joint. | Other | experimental |
| Sham osteopathic manual therapya sham osteopathic manual treatment without therapeutic effect | Other | sham |
Primary outcome
catastrophizing
Time frame: From enrollment to the end of treatment at 6 weeks
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
Time frame: From enrollment to the end of treatment at 6 weeks
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.
functional status, disability and pain
Time frame: From enrollment to the end of treatment at 6 weeks
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
Time frame: From enrollment to the end of treatment at 6 weeks
evaluated with a visual analog scale (VAS). Scale from 0 to 10, where 0 indicates no pain and 10 the worst pain imaginable.
myofascial trigger points
Time frame: From enrollment to 4 weeks
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.
Range of motion
Time frame: From enrollment to 4 weeks
measurements taken with a ruler: maximum opening, maximun active opening without pain and lateralization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Llanos de la Iglesia principal investigator
Departament de infermeria i fisioterapia. universitat de Lleida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic manual therapy in people with Fibromyalgia and Temporomandibular Disorder, run by Universitat de Lleida at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Llanos de la Iglesia, MsC (+4679536992, llanos.delaiglesia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
catastrophizing (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025; AzTrials last refreshed its copy on 30 Oct 2026.