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Temporomandibular DisorderNCT05426655

Effects of a Self-management Program for Temporomandibular Myalgia in Subjects With Fibromyalgia: a Single Arm Study

A study testing Self management in people with Temporomandibular Disorder and Fibromyalgia, run by Jose Edgar Ferrandez Gomez at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Fibromyalgia is one of the most prevalent chronic widespread pain entities today. One of the most common problems in patients with fibromyalgia are alterations of the temporomandibular region, present in approximately 80% of the subjects, being, in turn, alterations of muscular origin the most common with a prevalence… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Self management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
1 siteSpain
Study dates
16 Jun 2022to 11 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults over 18 years old.
  • Subjects diagnosed with fibromyalgia.
  • Orofacial pain of at least 3 months of evolution (considered chronic, according to IASP).
  • Presence of myalgia, local myalgia, myofascial pain or referred myofascial pain in the temporomandibular region (according to DC/TMD).

Who cannot join

  • Internal temporal-romandibular joint disorder with anterior disc displacement, joint pathology (arthritis), facial paralysis (active), mandibular fracture (active), infectious-inflammatory picture of odontogenic origin (active).
  • Pregnancy.
  • Neuropsychiatric pathologies (schizophrenia, bipolarity, cognitive alteration).
  • Subjects receiving any other physiotherapy treatment in the mandibular region.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Fibrofamur

    Murcia, Murcia

Other trials in Spain

About this study

Fibromyalgia is one of the most prevalent chronic widespread pain entities today. One of the most common problems in patients with fibromyalgia are alterations of the temporomandibular region, present in approximately 80% of the subjects, being, in turn, alterations of muscular origin the most common with a prevalence of 84%. One of the most promising therapeutic strategies is one that leads to self-management by the patient. The main objective of this study is to analyze the effect of a self-management program for myalgia in the temporomandibular region in subjects with fibromyalgia. For this, an experimental study of the uncontrolled Clinical Trial type will be carried out. Participants must be over 18 years of age, have a diagnosis of fibromyalgia and have myalgia or myofascial pain syndrome in the temporomandibular region. Demographic data, mandibular function, pain level, quality of life related to oral health, kinesiophobia, anxiety and depression, sleep, patient oral habits, catastrophizing, knowledge about pain, central sensitization, self-efficacy, coping with pain patient expectations, and patient satisfaction with the treatment received. An initial data collection will be carried out. The intervention will be carried out in 3 online sessions in which different pain processes will be explained, mandibular mobility exercises, masticatory muscle self-massage, as well as recommendations and advice on its pathology. Data will be collected again 4 weeks after the end of the program and at months 6 and 12. The appearance of adverse effects linked to the therapeutic program is not contemplated.

Read the detailed description

Study design Analytical, prospective experimental study: uncontrolled clinical trial.

Population and study sample The study sample will be made up of subjects diagnosed with fibromyalgia who present with local myalgia, myofascial pain or referred myofascial pain in the temporomandibular region, according to the diagnostic criteria (DC/TMD). The subjects will be recruited after the mandatory acceptance and authorization by the corresponding bodies, during a recruitment period of approximately eight weeks, through different associations of fibromyalgia patients.

Intervention In a first visit, demographic data will be recorded and an examination will be performed to assess the presence of local myalgia, myofascial pain or referred myofascial pain in the temporomandibular region, according to the diagnostic criteria (DC/TMD). You will also be given, to read and sign, the informed consent for participation in the study, as well as the data protection document. After this visit, the defined eligibility criteria (inclusion and exclusion) will be applied.

In a second visit, a preliminary assessment will be carried out that will consist of mandibular function, pain level, quality of life related to oral health, kinesiophobia, anxiety and depression, sleep, patient oral habits, catastrophizing, knowledge about pain, central sensitization, self-efficacy, coping with pain patient expectations, and patient satisfaction with the treatment received.

One week later, the intervention program will begin. The program will consist of 3 online sessions (visits 3, 4 and 5) in which everything related to pain and its management will be explained. In a first workshop, a first educational session on the neurophysiology of pain will be given by means of a Power point presentation. In a second workshop, a tool will be used to locate those factors that can improve/worse the pain, physical documentation will be delivered with instructions for performing a self-massage and exercises of the temporomandibular region as well as advice and recommendations to manage different situations that may appear on a daily basis and on Lifestyle. A meditation session will also be held. In the third and last workshop, the game "the painometer" will be played and a meditation session will be held.

On a sixth visit, 4 weeks after the end of the program, a new measurement and assessment will be taken. This measurement will be very similar to the one performed on the second visit, except for 1 variable: the patient's expectations will not be recorded, and the patient's satisfaction with the treatment received will be recorded. The objective will be to record the changes produced after the application of the treatment program.

On a seventh visit, at 6 months (medium-term follow-up), all the measurements and assessments made on the sixth visit will be repeated, with the aim of recording their status after six months.

At an eighth visit, at 12 months (long-term follow-up), all the measurements and assessments made at the seventh visit will be repeated, with the aim of recording their status after twelve months.

Being tested
Self management
Keywords
self-management, self-care, pain neuroscience education, temporomandibular disorder, fibromyalgia
Medical subject headings
Temporomandibular Joint Disorders, Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self managementOther

    The program will consist of 3 sessions in which everything related to pain and its management will be explained. In a first workshop, a first educational session on the neurophysiology of pain will be given by means of a Power Point presentation. In a second workshop, a tool will be used to locate those factors that can improve/worse the pain, physical documentation will be delivered with instructions for performing a self-massage and exercises of the temporomandibular region as well as advice and recommendations to manage different situations that may appear on a daily basis and on Lifestyle. A meditation session will also be held. In the third and last workshop, the game "the painometer" will be played and a meditation session will be held.

Study groups in NCT05426655
Study groupRoleWhat they receive
Self managementExperimentalIntervention group: education in pain neuroscience + self-massage + exercises + advice and recommendations.
Receives: Other: Self management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from the Baseline in the Oral Health-Related Quality of Life (OHRQoL)

    Spanish version of Oral Health Impact Profile 5 items (OHIP-5 items).Responses are presented on a 5-point ordinal scale (0, never; 1, hardly ever; 2, occasionally; 3, fairly often; and 4, very often). Summing all responses resulted in a score ranging from a minimum of 0 to a maximum of 20. A larger score indicated more negative impacts of oral health problems.

    Measured: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

Secondary outcomes (14)
  1. Change from the Baseline in the Fear of temporomandibular movement (kinesiophobia)

    Assessed with the Spanish version of Tampa Scale for Temporomandibular Joint Disorder, an 11-item scale. The score for each item ranges from 0 (totally disagree) to 4 (totally agree), the higher the score, the greater the degree of kinesiophobia. The optimal cut-off point for considering kinesiophobia is 23 points.

    Measured: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

  2. Change from the Baseline in pain maladaptation

    Assessed with the Spanish version of Pain Catastrophizing Scale. It is a self-administered scale of 13 items. It comprises 3 dimensions: rumination; magnification and despair. Each item is valued from 0 to 4, with the maximum score being 52 points. The higher the score, the higher degree of catastrophizing.

    Measured: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

  3. Change from the Baseline in symptoms related to central sensitization

    Assessed with the Spanish version of Central Sensitization Inventory. It is divided in 2 parts. Part A contains a list of 25 items about how often the person experiences each symptom ("never, rarely, sometimes, often, or always"). Individual items are scored from "0" (never) to "4" (always), resulting in a total score range for all 25 items from "0" to "100." Part B is about if the person has been previously diagnosed with seven common central sensitization diagnoses (tension headaches/migraines, fibromyalgia, irritable bowel syndrome, restless leg syndrome, temporomandibular joint disorder, chronic fatigue syndrome, and multiple chemical sensitivities) and three central sensitization-related diagnoses (depression, anxiety/panic attacks, and neck injury). This part is for information only and is not scored. A score of 40 or higher has been recommended as a reasonable cutoff.

    Measured: Baseline, 4 weeks after the end of the intervention at month 6, at month 12.

  4. Change from the Baseline in self-efficacy expectations

    Assessed with the Spanish version of Chronic Self-efficacy Scale. It is a scale of 19 questions divided into 3 parts. The first part (8 questions) refers to whether the subject believes they are capable of carrying out different activities. The second part (6 questions) refers to whether the subject believes they are capable of carrying out a series of activities without help. The third part (5 questions) refers to the ability that the subject believes he has, at this time, to carry out a series of activities. The subject responds using an 11-point Likert-type scale (0=I do not think I am capable at all, 10=I think I am totally capable). The maximum score is 190 points. The higher the score, the higher the degree of self-efficacy.

    Measured: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

  5. Change from the Baseline in pain coping strategies

    Assessed with Reduced Chronic Pain Coping Strategies Questionnaire. It is a scale of 24 items. It is answered on a 5-point Likert scale (never = 1, always = 5). The first-order scales are religion (use of religious beliefs), catharsis (seeking social emotional support), distraction (avoidance by paying attention to pain), self-affirmation (not fainting, encouraging oneself), mental self-control (mental control of pain) and search for information (advice, queries about what to do). The second-order scales are called active strategies (distraction, mental self-control, self-affirmation, and information seeking) and passive strategies (religion and catharsis).

    Measured: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

  6. Change from the Pain intensity

    Evaluated with the numerical rating scale for pain. It's An 11-point numeric scale with 0 representing one pain extreme ("no pain") and 10 representing the other pain extreme ("pain as bad as you can imagine" and "worst pain imaginable"). The subject is asked to indicate the numeric value on the segmented scale that best describes their pain intensity. Higher scores indicate greater pain intensity. A reduction of approximately two points or a reduction of approximately 30% represented a clinically important difference.

    Measured: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

  7. Change from the Baseline in the functional status of the masticatory system

    Assessed with the Spanish version of Jaw Functional Limitation Scale-8 (JFLS8). A scale that evaluates 8 items on a scale from 0 (no limitation) to 10 (severe limitation). The higher the score, the greater the limitation.

    Measured: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

  8. Change from the Baseline in sleep difficulties

    Assessed with Athens Insomnia Scale. It is an 8-item scale. Participants are asked to score each item from 0 (no problem at all) to 3 (very serious problem). The total score ranges from 0 to 24.

    Measured: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

  9. Change from the Baseline in emotional state

    Assessed with the Spanish version of Hospital Anxiety and Depression Scale. 14-item questionnaire. Two subscales of 7 items each, on a 0-3 Likert scale. Odd items assess anxiety, even items assess depression, with a score range in each subscale of 0-21. Higher score, greater anxiety and depression. For both subscales, the authors suggest that scores greater than eleven would indicate "case" and greater than eight would be considered "probable case".

    Measured: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

  10. Change from the Baseline in oral behaviors

    Assessed with the Spanish version of Oral Behaviors Checklist. It's a self-reported questionnaire (diagnostic criteria for temporomandibular disorder, axis II assessment) used to identify and quantify the frequency of different oral habits. It is conformed by 21 questions, with each having 5 possible answers: none of the time=0; a little of the time=1; some of the time=2; most of the time=3; and all of the time=4. For the first 2 questions, which are about oral habits that occur at night, the possible answers are: none of the time=0; <1 night per month=1; 1 to 3 nights per month=2; 1 to 3 nights per week=3; and 4 to 7 nights per week=4. A score of 3 or 4 indicated that the patient had that particular oral habit.

    Measured: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

  11. Change from the knowledge about neurophysiology of pain and conceptualization of pain

    Assessed with the Spanish version of Neurophysiology of Pain Questionnaire. It contains 12 items relating to the neurophysiology of pain. Each item has three response options: true, false, undecided. It is scored out of 12 with 1 point awarded for each correct response. A score of 0 is attributed to incorrect responses and those marked as undecided. The higher the score, the greater the knowledge about the neurophysiology of pain.

    Measured: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

  12. Treatment expectations

    Assessed with a questionnaire proposed by Puentedura et al (Development of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Thrust Joint Manipulation to the Cervical Spine). In this proposal, the subject is asked if he thinks that the treatment can help him. There are 5 possible responses: completely disagree, slightly disagree, neutral, somewhat agree, completely agree. The treatments they ask about are: education in the physiology of pain, jaw mobility exercises, jaw strength exercises, sleep hygiene, relaxation techniques, rest, avoiding bad oral habits, medication, surgery.

    Measured: Pre-intervention

  13. Degree of satisfaction with the intervention

    Assessed with the Spanish version of Consumer Reports Effectiveness Scale (CRES-4). It consists of 4 items: a satisfaction question, a question to rate the degree of resolution of the main problem, a question about the emotional state before starting treatment and, finally, a question about the emotional state at the time of answering. To obtain the global score of the CRES-4, the results of the previous components are added together as represented by the following formula: CRES-4 = (20 x satisfaction) + (20 x problem solution) + [12.5 x (4 + current emotional state - pre-treatment emotional state)] Therefore, to interpret the CRES-4 globally, a score on a scale ranging from 0 to 300 points is considered. The higher the total score, the more effective the treatment according to the patient.

    Measured: 4 weeks after the end of the intervention

  14. Adverse effects

    Questionnaire in which you will be asked if you have had adverse effects. If so, the subject will be asked to specify what it consists of.

    Measured: 4 weeks after the end of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2022
  2. Study start16 Jun 2022
  3. Primary completion11 Feb 2025
  4. Study completion11 Feb 2025

Resources

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
Not applicable
Intervention model
Single group
Model description
Analytical, prospective experimental study: uncontrolled clinical trial.
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05426655
Sponsor's protocol ID
EFG012022
Status last verified
Feb 2026
First submitted
13 Jun 2022
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Di Venere D, Corsalini M, Stefanachi G, Tafuri S, De Tommaso M, Cervinara F, Re A, Pettini F. Quality of life in fibromyalgia patients with craniomandibular disorders. Open Dent J. 2015 Jan 30;9:9-14. doi: 10.2174/1874210601509010009. eCollection 2015.

    PubMed 25674166
  • Salvetti G, Manfredini D, Bazzichi L, Bosco M. Clinical features of the stomatognathic involvement in fibromyalgia syndrome: a comparison with temporomandibular disorders patients. Cranio. 2007 Apr;25(2):127-33. doi: 10.1179/crn.2007.019.

    PubMed 17508633
  • Santiago V, Raphael KG. Perceived helpfulness of treatments for myofascial TMD as a function of comorbid widespread pain. Clin Oral Investig. 2019 Jul;23(7):2929-2939. doi: 10.1007/s00784-018-02797-6. Epub 2019 Jan 8.

    PubMed 30623307
  • Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.

    PubMed 27351541
  • Kim, Hyunjoong, and Seungwon Lee. Effects of Pain Neuroscience Education on Kinesiophobia in Patients with Chronic Pain: A Systematic Review and Meta-Analysis. Physical Therapy Rehabilitation Science. 2020 Dec; 9(4):309-317. doi:10.14474/ptrs.2020.9.4.309.

  • Leake HB, Moseley GL, Stanton TR, O'Hagan ET, Heathcote LC. What do patients value learning about pain? A mixed-methods survey on the relevance of target concepts after pain science education. Pain. 2021 Oct 1;162(10):2558-2568. doi: 10.1097/j.pain.0000000000002244.

    PubMed 33960326
  • Shala R, Roussel N, Lorimer Moseley G, Osinski T, Puentedura EJ. Can we just talk our patients out of pain? Should pain neuroscience education be our only tool? J Man Manip Ther. 2021 Feb;29(1):1-3. doi: 10.1080/10669817.2021.1873259. Epub 2021 Jan 11. No abstract available.

    PubMed 33427587
  • Watson JA, Ryan CG, Cooper L, Ellington D, Whittle R, Lavender M, Dixon J, Atkinson G, Cooper K, Martin DJ. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019 Oct;20(10):1140.e1-1140.e22. doi: 10.1016/j.jpain.2019.02.011. Epub 2019 Mar 1.

    PubMed 30831273
  • Siddall B, Ram A, Jones MD, Booth J, Perriman D, Summers SJ. Short-term impact of combining pain neuroscience education with exercise for chronic musculoskeletal pain: a systematic review and meta-analysis. Pain. 2022 Jan 1;163(1):e20-e30. doi: 10.1097/j.pain.0000000000002308.

    PubMed 33863860
  • Shaffer SM, Brismee JM, Courtney CA, Sizer PS. The status of temporomandibular and cervical spine education in credentialed orthopedic manual physical therapy fellowship programs: a comparison of didactic and clinical education exposure. J Man Manip Ther. 2015 Feb;23(1):51-6. doi: 10.1179/2042618614Y.0000000087.

    PubMed 26674266
  • Romm MJ, Ahn S, Fiebert I, Cahalin LP. A Meta-Analysis of Therapeutic Pain Neuroscience Education, Using Dosage and Treatment Format as Moderator Variables. Pain Pract. 2021 Mar;21(3):366-380. doi: 10.1111/papr.12962. Epub 2020 Nov 22.

    PubMed 33131210
  • Kapos FP, Exposto FG, Oyarzo JF, Durham J. Temporomandibular disorders: a review of current concepts in aetiology, diagnosis and management. Oral Surg. 2020 Nov;13(4):321-334. doi: 10.1111/ors.12473. Epub 2020 Jan 25.

    PubMed 34853604
  • Figueiro C, Knorst JK, Fensterseifer CK, Folchini S, Milanesi JM, Bernardon Silva T, Marquezan M. Changes in oral health-related quality of life after self-care treatment in patients with myofascial pain. Cranio. 2024 Mar;42(2):199-205. doi: 10.1080/08869634.2021.1922229. Epub 2021 Apr 30.

    PubMed 33928869
  • de Freitas RF, Ferreira MA, Barbosa GA, Calderon PS. Counselling and self-management therapies for temporomandibular disorders: a systematic review. J Oral Rehabil. 2013 Nov;40(11):864-74. doi: 10.1111/joor.12098. Epub 2013 Sep 18.

    PubMed 24102692
  • Michelotti A, Iodice G, Vollaro S, Steenks MH, Farella M. Evaluation of the short-term effectiveness of education versus an occlusal splint for the treatment of myofascial pain of the jaw muscles. J Am Dent Assoc. 2012 Jan;143(1):47-53. doi: 10.14219/jada.archive.2012.0018.

    PubMed 22207667

Questions about this trial

What is this clinical trial studying?

A study testing Self management in people with Temporomandibular Disorder and Fibromyalgia, run by Jose Edgar Ferrandez Gomez 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 4 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: finished, as of the sponsor's last update on 9 Feb 2026. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from the Baseline in the Oral Health-Related Quality of Life (OHRQoL) (time frame: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05426655, which also lists 58 linked publications.

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 9 Feb 2026.

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