Temporomandibular Joint DisordersNCT02540863
Miofascial Release and Exercises Therapy in the Treatment of Temporomandibular Disorders
A study testing myofascial release protocol and Rocabado exercise therapy and exercise therapy in people with Temporomandibular Joint Disorders, run by Universidad de Almeria.
Trial summary
Objectives: The aim of this research is to compare the effectiveness of myofascial release therapy and exercise therapy on pain, quality of sleep, anxiety, trigger points, and joint sounds in individuals with temporomandibular disorders and myofascial pain-dysfunction syndrome. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- myofascial release protocol and Rocabado exercise therapy and exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Sep 2015
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of myofascial pain with or without jaw opening limitation (Ia and Ib) according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD).
- 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.
- Agreement to attend evening therapy sessions.
Who cannot join
- Subjects with dental pain or tender muscles caused by systemic diseases.
- Major psychological disorders.
- A recent history of trauma in the face and neck area.
- Subjects wearing full or partial dentures.
- Edentulism.
- Therapeutic co-interventions during treatment.
- Indication for surgical treatment of temporomandibular joint.
About this study
Official title: Effectiveness of Myofascial Release and Exercises Therapy in the Treatment of Temporomandibular Disorders: a Randomized Clinical Trial
Objectives: The aim of this research is to compare the effectiveness of myofascial release therapy and exercise therapy on pain, quality of sleep, anxiety, trigger points, and joint sounds in individuals with temporomandibular disorders and myofascial pain-dysfunction syndrome.
Material and Methods: A single-blind randomized clinical trial will be conducted in a university research clinic. Sixty-four subjects with temporomandibular disorders and myofascial pain-dysfunction syndrome will be randomly assigned to physical therapy group (myofascial release protocol and Rocabado exercise therapy) and control group (exercise therapy). Intensity of pain, quality of life, quality of sleep, anxiety, trigger points, and joint sounds will be collected at baseline, and forty-eight hours after the intervention phase.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- myofascial release protocol and Rocabado exercise therapy, exercise therapy
- Keywords
- myofascial pain syndrome, exercise therapy, randomized controlled trial
- Medical subject headings
- Temporomandibular Joint Disorders, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myofascial release protocol and Rocabado exercise therapyOther
exercise therapyOther
| Study group | Role | What they receive |
|---|---|---|
| myofascial release protocol and Rocabado exercise therapy | Experimental | Myofascial Release Protocol:
* Suboccipital release.
* Compression - decompression of temporomandibular joint.
* Horizontal release of temporomandibular joint.
* Deep fascia release in temporal region.
* Masseter deep fascia release.
* Pterygoiddeep fascia release.
* Intraoral pterygoid deep fascia release. Receives: Other: myofascial release protocol and Rocabado exercise therapy |
| exercise therapy | Active comparator | Rocabado´s 6 x 6 exercises program utilizes six exercises six times by day. The patient is in supine position with a loop of 6 cm in the cervical area, and the therapist sits at the head of the bed. Receives: Other: exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain (100-mm VAS)
A 100-mm VAS was used for determining pain intensity, ranging from 0 (no pain) to 100 (very severe pain).
Measured: Changes from baseline in intensity of pain at twelve weeks
Secondary outcomes (8)
Quality of Sleep (Pittsburgh Sleep Quality Index - PSQI)
PSQI was used to study the quality of sleep. It comprises 24 items where the individuals respond to 19 of these items, and individual living in the same dwelling (or hospital room) responds to remaining 5. Scores are obtained on each of 7 components of sleep quality: subjective quality, sleep latency, sleep duration, habitual sleep efficacy, sleep perturbations, use of hypnotic medication, and daily dysfunction. Each component is scored from 0 to 3 (0: no problems; 3: severe problems).
Measured: Changes from baseline in quality of sleep at twelve weeks
State and trait anxiety (state anxiety questionnaire and trait - STAI)
Anxiety level were determined with the 40-item State-Trait Anxiety Inventory (STAI), which measures anxiety as a stable dimension of personality (trait or tendency to anxiety) and also includes a state subscale to detect anxiety behaviors. Subjects report their feelings in general for the trait scale and how they feel at the time of questionnaire completion for the state anxiety scale. The state anxiety scale indicates the feelings or sensations of anxiety (not at all, somewhat, moderately so, very much so) at a specific moment in time. The trait anxiety scale indicates the frequency with which anxiety is experienced (almost never, sometimes, often, almost, and always).
Measured: Changes from baseline in state and trait anxiety at twelve weeks
Physical parameters of active and passive mouth opening
The subjects were asked to open her/his mouth as much as possible for the measurement of active mouth opening without pain and maximal active mouth opening. Maximal passive mouth opening was measured after the application of downward pressure on the mandible by the second and third finger of the patient. The vertical overlap of the incisors was measured by a ruler (Helios-Preisser, Gammertingen, Germany) and recorded in mm for these parameters.
Measured: Changes from baseline in active and passive mouth opening at twelve weeks
Physical parameters of pain in temporalis muscles
Trigger points were assessed by palpation of temporal muscle (anterior, middle, and origin).
Measured: Changes from baseline in pain in temporalis muscles at twelve weeks
Physical parameters of lateral condyle pole and temporal tendon insertion pain
The muscles, tendon, and lateral condyles were palpated to the finger portion of the examiner´s finger applying a pressure on the muscle (1 Kg) and lateral condyles (0.5 Kg) being studied for 3-6s.
Measured: Changes from baseline in Lateral condyle pole and temporal tendon insertion pain at twelve weeks
Physical parameters of clicking sound when opening / close palpation
Joint sounds during mouth opening and closing were assessed with the examiner's left index finger on the right joint and the right finger on pre-auricular area. The fingertip is placed anterior to the tragus of the ear. The patient is asked to slowly open as much as possible. After each closing, the subject must place the teeth in contact at a maximal intercuspal position. The patient open and close the mouth three times. Total number of sounds was recorded on both sides.
Measured: Changes from baseline in clicking sound when opening / close palpation at twelve weeks
Physical parameters of pain in masseter muscles
Trigger points were assessed by palpation of masseter muscle (anterior, deep, origin).
Measured: Changes from baseline in pain in temporalis muscles at twelve weeks
Physical parameters of pain in lateral pterygoid muscles
Trigger points were assessed by palpation of lateral pterygoid muscle
Measured: Changes from baseline in pain in lateral pterygoid muscles at twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adelaida María Castro-Sánchez, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540863
- Sponsor's protocol ID
- UAL-427
- Status last verified
- Sep 2015
- First submitted
- 25 Aug 2015
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hoffmann RG, Kotchen JM, Kotchen TA, Cowley T, Dasgupta M, Cowley AW Jr. Temporomandibular disorders and associated clinical comorbidities. Clin J Pain. 2011 Mar-Apr;27(3):268-74. doi: 10.1097/AJP.0b013e31820215f5.
PubMed 21178593Venancio Rde A, Camparis CM, Lizarelli Rde F. Low intensity laser therapy in the treatment of temporomandibular disorders: a double-blind study. J Oral Rehabil. 2005 Nov;32(11):800-7. doi: 10.1111/j.1365-2842.2005.01516.x.
PubMed 16202043Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. No abstract available.
PubMed 1298767Leblebici B, Pektas ZO, Ortancil O, Hurcan EC, Bagis S, Akman MN. Coexistence of fibromyalgia, temporomandibular disorder, and masticatory myofascial pain syndromes. Rheumatol Int. 2007 Apr;27(6):541-4. doi: 10.1007/s00296-006-0251-z. Epub 2006 Nov 10.
PubMed 17096090Manfredini D, Tognini F, Montagnani G, Bazzichi L, Bombardieri S, Bosco M. Comparison of masticatory dysfunction in temporomandibular disorders and fibromyalgia. Minerva Stomatol. 2004 Nov-Dec;53(11-12):641-50. English, Italian.
PubMed 15894939Aaron LA, Burke MM, Buchwald D. Overlapping conditions among patients with chronic fatigue syndrome, fibromyalgia, and temporomandibular disorder. Arch Intern Med. 2000 Jan 24;160(2):221-7. doi: 10.1001/archinte.160.2.221.
PubMed 10647761Balasubramaniam R, de Leeuw R, Zhu H, Nickerson RB, Okeson JP, Carlson CR. Prevalence of temporomandibular disorders in fibromyalgia and failed back syndrome patients: a blinded prospective comparison study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Aug;104(2):204-16. doi: 10.1016/j.tripleo.2007.01.012. Epub 2007 May 7.
PubMed 17482850Fraga BP, Santos EB, Farias Neto JP, Macieira JC, Quintans LJ Jr, Onofre AS, De Santana JM, Martins-Filho PR, Bonjardim LR. Signs and symptoms of temporomandibular dysfunction in fibromyalgic patients. J Craniofac Surg. 2012 Mar;23(2):615-8. doi: 10.1097/SCS.0b013e31824cd81a.
PubMed 22446432Rhodus NL, Fricton J, Carlson P, Messner R. Oral symptoms associated with fibromyalgia syndrome. J Rheumatol. 2003 Aug;30(8):1841-5.
PubMed 12913944Alonso-Blanco C, Fernandez-de-Las-Penas C, de-la-Llave-Rincon AI, Zarco-Moreno P, Galan-Del-Rio F, Svensson P. Characteristics of referred muscle pain to the head from active trigger points in women with myofascial temporomandibular pain and fibromyalgia syndrome. J Headache Pain. 2012 Nov;13(8):625-37. doi: 10.1007/s10194-012-0477-y. Epub 2012 Aug 31.
PubMed 22935970Nifosi F, Violato E, Pavan C, Sifari L, Novello G, Guarda Nardini L, Manfredini D, Semenzin M, Pavan L, Marini M. Psychopathology and clinical features in an Italian sample of patients with myofascial and temporomandibular joint pain: preliminary data. Int J Psychiatry Med. 2007;37(3):283-300. doi: 10.2190/PM.37.3.f.
PubMed 18314857Salvetti 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Myofascial Release and Exercises Therapy in the Treatment of Temporomandibular Disorders: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02540863
- Acronym / sponsor ID
- UAL-427
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- myofascial pain syndrome, exercise therapy, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Sep 2015 (estimated)
- 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.
Objectives: The aim of this research is to compare the effectiveness of myofascial release therapy and exercise therapy on pain, quality of sleep, anxiety, trigger points, and joint sounds in individuals with temporomandibular disorders and myofascial pain-dysfunction syndrome.
Material and Methods: A single-blind randomized clinical trial will be conducted in a university research clinic. Sixty-four subjects with temporomandibular disorders and myofascial pain-dysfunction syndrome will be randomly assigned to physical therapy group (myofascial release protocol and Rocabado exercise therapy) and control group (exercise therapy). Intensity of pain, quality of life, quality of sleep, anxiety, trigger points, and joint sounds will be collected at baseline, and forty-eight hours after the intervention phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myofascial release protocol and Rocabado exercise therapy | Experimental | Other: myofascial release protocol and Rocabado exercise therapyMyofascial Release Protocol: * Suboccipital release. * Compression - decompression of temporomandibular joint. * Horizontal release of temporomandibular joint. * Deep fascia release in temporal region. * Masseter deep fascia release. * Pterygoiddeep fascia release. * Intraoral pterygoid deep fascia release. |
| exercise therapy | Active comparator | Other: exercise therapyRocabado´s 6 x 6 exercises program utilizes six exercises six times by day. The patient is in supine position with a loop of 6 cm in the cervical area, and the therapist sits at the head of the bed. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of myofascial pain with or without jaw opening limitation (Ia and Ib) according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD).
- 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.
- Agreement to attend evening therapy sessions.
Key exclusion criteria (7 listed)
- Subjects with dental pain or tender muscles caused by systemic diseases.
- Major psychological disorders.
- A recent history of trauma in the face and neck area.
- Subjects wearing full or partial dentures.
- Edentulism.
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 |
|---|---|---|
| myofascial release protocol and Rocabado exercise therapy | Other | myofascial release protocol and Rocabado exercise therapy |
| exercise therapy | Other | exercise therapy |
Primary outcome
Intensity of pain (100-mm VAS)
Time frame: Changes from baseline in intensity of pain at twelve weeks
A 100-mm VAS was used for determining pain intensity, ranging from 0 (no pain) to 100 (very severe pain).
8 secondary outcomes
Quality of Sleep (Pittsburgh Sleep Quality Index - PSQI)
Time frame: Changes from baseline in quality of sleep at twelve weeks
State and trait anxiety (state anxiety questionnaire and trait - STAI)
Time frame: Changes from baseline in state and trait anxiety at twelve weeks
Physical parameters of active and passive mouth opening
Time frame: Changes from baseline in active and passive mouth opening at twelve weeks
Physical parameters of pain in temporalis muscles
Time frame: Changes from baseline in pain in temporalis muscles at twelve weeks
Physical parameters of lateral condyle pole and temporal tendon insertion pain
Time frame: Changes from baseline in Lateral condyle pole and temporal tendon insertion pain at twelve weeks
Physical parameters of clicking sound when opening / close palpation
Time frame: Changes from baseline in clicking sound when opening / close palpation at twelve weeks
Physical parameters of pain in masseter muscles
Time frame: Changes from baseline in pain in temporalis muscles at twelve weeks
Physical parameters of pain in lateral pterygoid muscles
Time frame: Changes from baseline in pain in lateral pterygoid muscles at twelve weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
- Background: PubMed 21178593Hoffmann RG, Kotchen JM, Kotchen TA, Cowley T, Dasgupta M, Cowley AW Jr. Temporomandibular disorders and associated clinical comorbidities. Clin J Pain. 2011 Mar-Apr;27(3):268-74. doi: 10.1097/AJP.0b013e31820215f5.
- Background: PubMed 16202043Venancio Rde A, Camparis CM, Lizarelli Rde F. Low intensity laser therapy in the treatment of temporomandibular disorders: a double-blind study. J Oral Rehabil. 2005 Nov;32(11):800-7. doi: 10.1111/j.1365-2842.2005.01516.x.
- Background: PubMed 1298767Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. No abstract available.
- Background: PubMed 17096090Leblebici B, Pektas ZO, Ortancil O, Hurcan EC, Bagis S, Akman MN. Coexistence of fibromyalgia, temporomandibular disorder, and masticatory myofascial pain syndromes. Rheumatol Int. 2007 Apr;27(6):541-4. doi: 10.1007/s00296-006-0251-z. Epub 2006 Nov 10.
- Background: PubMed 15894939Manfredini D, Tognini F, Montagnani G, Bazzichi L, Bombardieri S, Bosco M. Comparison of masticatory dysfunction in temporomandibular disorders and fibromyalgia. Minerva Stomatol. 2004 Nov-Dec;53(11-12):641-50. English, Italian.
- Background: PubMed 10647761Aaron LA, Burke MM, Buchwald D. Overlapping conditions among patients with chronic fatigue syndrome, fibromyalgia, and temporomandibular disorder. Arch Intern Med. 2000 Jan 24;160(2):221-7. doi: 10.1001/archinte.160.2.221.
- Background: PubMed 17482850Balasubramaniam R, de Leeuw R, Zhu H, Nickerson RB, Okeson JP, Carlson CR. Prevalence of temporomandibular disorders in fibromyalgia and failed back syndrome patients: a blinded prospective comparison study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Aug;104(2):204-16. doi: 10.1016/j.tripleo.2007.01.012. Epub 2007 May 7.
- Background: PubMed 22446432Fraga BP, Santos EB, Farias Neto JP, Macieira JC, Quintans LJ Jr, Onofre AS, De Santana JM, Martins-Filho PR, Bonjardim LR. Signs and symptoms of temporomandibular dysfunction in fibromyalgic patients. J Craniofac Surg. 2012 Mar;23(2):615-8. doi: 10.1097/SCS.0b013e31824cd81a.
- Background: PubMed 12913944Rhodus NL, Fricton J, Carlson P, Messner R. Oral symptoms associated with fibromyalgia syndrome. J Rheumatol. 2003 Aug;30(8):1841-5.
- Background: PubMed 22935970Alonso-Blanco C, Fernandez-de-Las-Penas C, de-la-Llave-Rincon AI, Zarco-Moreno P, Galan-Del-Rio F, Svensson P. Characteristics of referred muscle pain to the head from active trigger points in women with myofascial temporomandibular pain and fibromyalgia syndrome. J Headache Pain. 2012 Nov;13(8):625-37. doi: 10.1007/s10194-012-0477-y. Epub 2012 Aug 31.
- Background: PubMed 18314857Nifosi F, Violato E, Pavan C, Sifari L, Novello G, Guarda Nardini L, Manfredini D, Semenzin M, Pavan L, Marini M. Psychopathology and clinical features in an Italian sample of patients with myofascial and temporomandibular joint pain: preliminary data. Int J Psychiatry Med. 2007;37(3):283-300. doi: 10.2190/PM.37.3.f.
- Background: PubMed 17508633Salvetti 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing myofascial release protocol and Rocabado exercise therapy and exercise therapy in people with Temporomandibular Joint Disorders, run by Universidad de Almeria.
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 7 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 16 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Intensity of pain (100-mm VAS) (time frame: Changes from baseline in intensity of pain at twelve weeks). 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 NCT02540863, which also lists 12 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 16 Sep 2015; AzTrials last refreshed its copy on 8 Nov 2026.