Miofascial Release and Exercises Therapy in the Treatment of Temporomandibular Disorders

NCT ID: NCT02540863

Last Updated: 2015-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Temporomandibular Joint Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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myofascial release protocol and Rocabado exercise therapy

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.

Group Type EXPERIMENTAL

myofascial release protocol and Rocabado exercise therapy

Intervention Type OTHER

exercise therapy

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.

Group Type ACTIVE_COMPARATOR

exercise therapy

Intervention Type OTHER

Interventions

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myofascial release protocol and Rocabado exercise therapy

Intervention Type OTHER

exercise therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Almeria

OTHER

Sponsor Role lead

Responsible Party

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Adelaida María Castro-Sánchez

PhD (Lecturer)

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 21178593 (View on PubMed)

Venancio 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.

Reference Type BACKGROUND
PMID: 16202043 (View on PubMed)

Dworkin 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.

Reference Type BACKGROUND
PMID: 1298767 (View on PubMed)

Leblebici 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.

Reference Type BACKGROUND
PMID: 17096090 (View on PubMed)

Manfredini 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.

Reference Type BACKGROUND
PMID: 15894939 (View on PubMed)

Aaron 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.

Reference Type BACKGROUND
PMID: 10647761 (View on PubMed)

Balasubramaniam 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.

Reference Type BACKGROUND
PMID: 17482850 (View on PubMed)

Fraga 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.

Reference Type BACKGROUND
PMID: 22446432 (View on PubMed)

Rhodus NL, Fricton J, Carlson P, Messner R. Oral symptoms associated with fibromyalgia syndrome. J Rheumatol. 2003 Aug;30(8):1841-5.

Reference Type BACKGROUND
PMID: 12913944 (View on PubMed)

Alonso-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.

Reference Type BACKGROUND
PMID: 22935970 (View on PubMed)

Nifosi 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.

Reference Type BACKGROUND
PMID: 18314857 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17508633 (View on PubMed)

Other Identifiers

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UAL-427

Identifier Type: -

Identifier Source: org_study_id

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