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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05426655
• Other study ID #: EFG012022
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Universidad de Murcia
• Contact: J. Édgar Ferrández-Gómez
• Phone: +34663063594
• Email: edgarferrandez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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, maximum oral opening and mandibular function, pressure pain threshold and pain level, quality of life related to oral health, kinesiophobia, anxiety and depression, sleep, patient expectations, patient satisfaction with the treatment received, patient habits, catastrophizing, knowledge about pain, central sensitization, self-efficacy, and coping with pain. An initial data collection will be carried out. The intervention will be carried out in 3 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.

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 measuring the maximum oral opening with and without pain, pressure pain threshold in the temporomandibular joint and masseter and temporal muscles, and the level of pain in the temporomandibular joint. In addition, the subject will have to fill out a questionnaire on different aspects such as jaw function, quality of life related to oral health, kinesiophobia, anxiety and depression, sleep, patient expectations, patient habits, catastrophizing, knowledge about pain, central sensitization , self-efficacy, and coping with pain.

One week later, the intervention program will begin. The program will consist of 3 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Self management
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.

Locations

Country	Name	City	State
Spain	FIBROFAMUR (Asociación fibromialgia de Murcia)	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Jose Edgar Ferrandez Gomez

Country where clinical trial is conducted

Spain, 

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* Note: There are 58 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Secondary	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.	Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Secondary	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.	Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Secondary	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.	Baseline, 4 weeks after the end of the intervention at month 6, at month 12.
Secondary	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.	Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Secondary	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).	Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Secondary	Change from the Baseline in the Range of Motion of the Temporomandibular Joint	Measured with a ruler (expressed in centimeters). Normal mobility is considered from 4.5 centimeters. It is measured maximum mouth opening with and without pain.	Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Secondary	Change from the Baseline in the Pain Pressure Threshold	Measured with an algometer, expressed in Kg/Cm2. It is performed on the mandibular condyle and both masseter and temporal muscles, bilaterally.	Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Secondary	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.	Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Secondary	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.	Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Secondary	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.	Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Secondary	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".	Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Secondary	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.	Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Secondary	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.	Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Secondary	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.	Pre-intervention
Secondary	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.	4 weeks after the end of the intervention
Secondary	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.	4 weeks after the end of the intervention