Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome
Primary Purpose
Temporomandibular Joint Dysfunction Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multidisciplinary therapy
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Joint Dysfunction Syndrome focused on measuring Pain, Temporomandibular joint, Manual therapy, Physical therapy, Fibromyalgia Syndrome
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Fibromyalgia Syndrome
- Agreement to attend evening therapy sessions
- A chief complaint of acute pain (duration < 6 months) in the temporomandibular joint on at least one side.
- The presence of joint clicking during jaw opening that was eliminated on protrusive opening.
Exclusion Criteria:
- History of recent trauma.
- Therapeutic co-interventions during treatment.
- Indication for surgical treatment of temporomandibular joint.
- Edentulism.
- Physical or mental illness that precludes attendance at therapy sessions.
Sites / Locations
- Fibromyalgia Association (AGRAFIM)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Multidisplinary Therapy
One technique of myofascial release
Arm Description
The multidisciplinary therapy involves the application of physical therapy, manual therapy and deontology therapy. This multidisciplinary therapy will be administered twice a week for 15 weeks.
A physiotherapist administered 15 sessions of "induction occipital" once a week.
Outcomes
Primary Outcome Measures
Change on pain intensity
The visual analog scales designed to measure the intensity of pain and degree of relief experienced by the patient; with the value 0 refers to the situation of no pain and score 100 refers to the situation of unbearable pain.
Secondary Outcome Measures
Change in temporomandibular dysfunction
Dworkin and LeResche present a multiaxial evaluation system that integrates the relevant aspects for the temporomandibular dysfunction in two axes. The exploration model consists of a protocol detailing the tests to be applied, and other specifications of the procedure to be followed by the professional: temporomandibular pain, pattern jaw opening, vertical movement range, sounds of the temporomandibular joint in palpation during vertical movement, mandibular excursive movements, pain extraoral muscle tenderness, joint pain on palpation, muscle pain during intraoral palpation.
Change in quality of life SF-36
The assessment of Quality of Life SF-36 covers 8 dimensions of health status. It contains 36 items covering two areas, the functional status and the emotional wellness. The area of the functional state is represented by the following dimensions: physical function (10 items), social function (2 items), role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items). The wellness area includes the dimensions of mental health (5 items), vitality (4 items), pain (2 items). Finally, the general health assessment includes the dimension of perception of general health (5 items) and the health change over the time (one item, which is not part of the final score).
Change on index of widespread pain and symptom severity
This simple clinical case definition of fibromyalgia properly classifies the 88.1% of the cases classified by the American College of Rheumatology classification criteria, and it does not require a physical or tender point. The Symptom Severity Score allows the assessment of the severity of the symptoms of fibromyalgia in people with current or previous fibromyalgia, and those in which the criteria have not been applied yet. This questionnaire is especially useful in the longitudinal assessment of patients with marked symptom variability.
Change in physical function
The fibromyalgia impact questionnaire consists of 10 items. The first item is composed of 11 subitems in which is valued the physical function. In the second and third items, patients indicate the number of days in which they disrupt their daily activity due to pain, or otherwise the days they find improvement. The impact caused by the symptoms of fibromyalgia in the physical and mental health of the patients was measured by the Spanish version of the Impact of Fibromyalgia Questionnaire. This questionnaire assesses the following dimensions: feeling good, physical function, missing work and work capacity, physical, psychological and social components and global wellness. Also, it includes six visual analog scales for assessing fatigue, pain, stiffness, morning tiredness, anxiety and depression.
Change on quality of sleep
Pittsburgh Sleep Quality Index Questionnaire consists of 24 items, and which interrogate issues such as the quality of sleep that the subject he has, or the frequency of certain events - such as difficulty falling asleep during the first half an hour or the presence of nightmares- are answered by an ordinal scale with four grades. In the correction of this questionnaire, seven scores are obtained which inform us of the components of sleep quality: subjective quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, the use of hypnotic medication, and daytime dysfunction. Each of these components receives a discrete score which can range from 0 to 3. A score of 0 indicates that there are no problems in this respect, and a score of 3 indicates serious problems at that level. The sum of the scores in each partial component generates a total score, which can range from 0 to 21.
Change on rates of depression
The Beck inventory for depression is a self-administered questionnaire of 21 items that assesses a wide range of depressive symptoms. Its content emphasizes more the cognitive component of depression, and the symptoms of this area represent about 50% of the total score of the questionnaire, with symptoms of somatic / vegetative. In the second block, of the 21 items, 15 refer to eco-cognitive symptoms, and the remaining 6 to somatic-vegetative symptoms. Each item has four response alternatives listed from low to high severity, assessing the severity / intensity of the symptom. The range of the score is 0-63 points. The aim of this questionnaire is to quantify the symptoms, not provide a diagnosis. The breakpoints usually accepted to graduate the intensity/severity are the followings:
No Depression: 0-9 points.
Mild depression: 10-18 points
Moderate Depression: 19-29 points
Severe depression: ≥ 30 points
Change on state-trait anxiety
The State-Trait Anxiety Inventory measures a stable personality dimension (trait anxiety or tendency to anxiety), also includes a subscale of state, to detect anxiety behaviors. In the questionnaire, consisting of 40 items (20 for each level), the subjects have to describe how they feel generally, in the case of the trait anxiety scale, and how they feel when they answer, in the case of anxiety scale as a state. This inventory allows obtaining the scores of both scales separately.
Full Information
NCT ID
NCT01825629
First Posted
March 25, 2013
Last Updated
December 9, 2013
Sponsor
Universidad de Almeria
Collaborators
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT01825629
Brief Title
Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome
Official Title
Benefits of a Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria
Collaborators
Universidad de Granada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy of a multidisciplinary therapy with physical, manual and deontology therapies in the treatment of temporomandibular joint dysfunction in patients with fibromyalgia syndrome.
Detailed Description
Design: Randomized clinical trial. Objective: to compare the therapeutic effects of physical therapy, manual therapy and deontology therapy to improve pain, quality of life, physical function, quality of sleep, depression, anxiety, clinical severity, clinical improvement, and temporomandibular dysfunction in patients with fibromyalgia syndrome.
Methods and measures: seventy patients will be randomly assigned to experimental or placebo control group. The experimental group will receive 30 sessions (twice a weeks) of physical therapy, manual therapy and deontology therapy. Pain intensity, impact of fibromyalgia symptoms, quality of sleep, depression, anxiety, clinical severity, clinical improvement and temporomandibular dysfunction will be collected in both groups al baseline, 15 weeks and 20 weeks after 48-hr the last intervention in the experimental and placebo control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups with independent Student t-test for continuous data and chi-square tests of independence for categorical data. Separate 2x3 model ANOVA with time (baseline, 15 weeks and 20 weeks) as the within-subjects factor, group (experimental, placebo control) will be determine the effects of the multidisciplinary treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Dysfunction Syndrome
Keywords
Pain, Temporomandibular joint, Manual therapy, Physical therapy, Fibromyalgia Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multidisplinary Therapy
Arm Type
Experimental
Arm Description
The multidisciplinary therapy involves the application of physical therapy, manual therapy and deontology therapy. This multidisciplinary therapy will be administered twice a week for 15 weeks.
Arm Title
One technique of myofascial release
Arm Type
Placebo Comparator
Arm Description
A physiotherapist administered 15 sessions of "induction occipital" once a week.
Intervention Type
Other
Intervention Name(s)
Multidisciplinary therapy
Intervention Description
Physical Therapy: Cervical traction, Cranium fore flexion 15 °, Open-close mouth dental contactless (10 mm), Opening movement with a small resistor (one finger on chin), Flexion of the head, without actually lifting, resisting in the front, Occipital extension, Cranium fore flexion 15 °, Cervical traction.
Myofascial Therapy: Induction suboccipital, compression - decompression of the temporomandibular joint, horizontal induction of the temporomandibular joint, deep fascia induction in the temporal region, deep induction of the masseter fascia, deep induction of the external pterygoid, and induction of intraoral pterygoid.
Deontology therapy: the patient are going to port a deprogramming occlusal splint every night, an average of 8 hours per day, for 15 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change on pain intensity
Description
The visual analog scales designed to measure the intensity of pain and degree of relief experienced by the patient; with the value 0 refers to the situation of no pain and score 100 refers to the situation of unbearable pain.
Time Frame
At baseline, 15 weeks and 20 weeks
Secondary Outcome Measure Information:
Title
Change in temporomandibular dysfunction
Description
Dworkin and LeResche present a multiaxial evaluation system that integrates the relevant aspects for the temporomandibular dysfunction in two axes. The exploration model consists of a protocol detailing the tests to be applied, and other specifications of the procedure to be followed by the professional: temporomandibular pain, pattern jaw opening, vertical movement range, sounds of the temporomandibular joint in palpation during vertical movement, mandibular excursive movements, pain extraoral muscle tenderness, joint pain on palpation, muscle pain during intraoral palpation.
Time Frame
At baseline, 15 weeks and 20 weeks
Title
Change in quality of life SF-36
Description
The assessment of Quality of Life SF-36 covers 8 dimensions of health status. It contains 36 items covering two areas, the functional status and the emotional wellness. The area of the functional state is represented by the following dimensions: physical function (10 items), social function (2 items), role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items). The wellness area includes the dimensions of mental health (5 items), vitality (4 items), pain (2 items). Finally, the general health assessment includes the dimension of perception of general health (5 items) and the health change over the time (one item, which is not part of the final score).
Time Frame
At baseline, 15 weeks and 20 weeks
Title
Change on index of widespread pain and symptom severity
Description
This simple clinical case definition of fibromyalgia properly classifies the 88.1% of the cases classified by the American College of Rheumatology classification criteria, and it does not require a physical or tender point. The Symptom Severity Score allows the assessment of the severity of the symptoms of fibromyalgia in people with current or previous fibromyalgia, and those in which the criteria have not been applied yet. This questionnaire is especially useful in the longitudinal assessment of patients with marked symptom variability.
Time Frame
At baseline, 15 weeks and 20 weeks
Title
Change in physical function
Description
The fibromyalgia impact questionnaire consists of 10 items. The first item is composed of 11 subitems in which is valued the physical function. In the second and third items, patients indicate the number of days in which they disrupt their daily activity due to pain, or otherwise the days they find improvement. The impact caused by the symptoms of fibromyalgia in the physical and mental health of the patients was measured by the Spanish version of the Impact of Fibromyalgia Questionnaire. This questionnaire assesses the following dimensions: feeling good, physical function, missing work and work capacity, physical, psychological and social components and global wellness. Also, it includes six visual analog scales for assessing fatigue, pain, stiffness, morning tiredness, anxiety and depression.
Time Frame
At baseline, 15 weeks and 20 weeks
Title
Change on quality of sleep
Description
Pittsburgh Sleep Quality Index Questionnaire consists of 24 items, and which interrogate issues such as the quality of sleep that the subject he has, or the frequency of certain events - such as difficulty falling asleep during the first half an hour or the presence of nightmares- are answered by an ordinal scale with four grades. In the correction of this questionnaire, seven scores are obtained which inform us of the components of sleep quality: subjective quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, the use of hypnotic medication, and daytime dysfunction. Each of these components receives a discrete score which can range from 0 to 3. A score of 0 indicates that there are no problems in this respect, and a score of 3 indicates serious problems at that level. The sum of the scores in each partial component generates a total score, which can range from 0 to 21.
Time Frame
At baseline, 15 weeks and 20 weeks
Title
Change on rates of depression
Description
The Beck inventory for depression is a self-administered questionnaire of 21 items that assesses a wide range of depressive symptoms. Its content emphasizes more the cognitive component of depression, and the symptoms of this area represent about 50% of the total score of the questionnaire, with symptoms of somatic / vegetative. In the second block, of the 21 items, 15 refer to eco-cognitive symptoms, and the remaining 6 to somatic-vegetative symptoms. Each item has four response alternatives listed from low to high severity, assessing the severity / intensity of the symptom. The range of the score is 0-63 points. The aim of this questionnaire is to quantify the symptoms, not provide a diagnosis. The breakpoints usually accepted to graduate the intensity/severity are the followings:
No Depression: 0-9 points.
Mild depression: 10-18 points
Moderate Depression: 19-29 points
Severe depression: ≥ 30 points
Time Frame
At baseline, 15 weeks and 20 weeks
Title
Change on state-trait anxiety
Description
The State-Trait Anxiety Inventory measures a stable personality dimension (trait anxiety or tendency to anxiety), also includes a subscale of state, to detect anxiety behaviors. In the questionnaire, consisting of 40 items (20 for each level), the subjects have to describe how they feel generally, in the case of the trait anxiety scale, and how they feel when they answer, in the case of anxiety scale as a state. This inventory allows obtaining the scores of both scales separately.
Time Frame
At baseline, 15 weeks and 20 weeks
Other Pre-specified Outcome Measures:
Title
Change in clinical impression of severity
Description
This scale assesses the severity level regarding the patient's physical condition. It comprises a Likert scale extending from a value of 1 (no disease) to a value of 7 (extremely ill).
Time Frame
At baseline, 15 weeks and 20 weeks
Title
Change in clinical global impression of improvement
Description
This scale allows to evaluate the improvement perceived by the patient. It comprises a Likert scale which extends from a value of 1 (very much improved) to a value of 7 (extremely ill).
Time Frame
15 weeks and 20 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Fibromyalgia Syndrome
Agreement to attend evening therapy sessions
A chief complaint of acute pain (duration < 6 months) in the temporomandibular joint on at least one side.
The presence of joint clicking during jaw opening that was eliminated on protrusive opening.
Exclusion Criteria:
History of recent trauma.
Therapeutic co-interventions during treatment.
Indication for surgical treatment of temporomandibular joint.
Edentulism.
Physical or mental illness that precludes attendance at therapy sessions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelaida M Castro-Sánchez, PhD
Organizational Affiliation
Universidad de Almeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fibromyalgia Association (AGRAFIM)
City
Granada
State/Province
Almeria
ZIP/Postal Code
04120
Country
Spain
12. IPD Sharing Statement
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Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome
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