Miofascial Release and Exercises Therapy in the Treatment of Temporomandibular Disorders

NCT02540863 | Completed

• 1 other identifier: UAL-427
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

myofascial pain syndrome; exercise therapy; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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).

  Changes from baseline in intensity of pain at twelve weeks

Secondary Outcomes (8)

• Quality of Sleep (Pittsburgh Sleep Quality Index - PSQI)

  Changes from baseline in quality of sleep at twelve weeks

• State and trait anxiety (state anxiety questionnaire and trait - STAI)

  Changes from baseline in state and trait anxiety at twelve weeks

• Physical parameters of active and passive mouth opening

  Changes from baseline in active and passive mouth opening at twelve weeks

• Physical parameters of pain in temporalis muscles

  Changes from baseline in pain in temporalis muscles at twelve weeks

• Physical parameters of lateral condyle pole and temporal tendon insertion pain

  Changes from baseline in Lateral condyle pole and temporal tendon insertion pain at twelve weeks

Study Arms (2)

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.

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.

Other: exercise therapy

Interventions

myofascial release protocol and Rocabado exercise therapy OTHER

myofascial release protocol and Rocabado exercise therapy

exercise therapy OTHER

exercise therapy

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead

Related Publications (12)

• 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.

  PMID: 21178593 BACKGROUND

• 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.

  PMID: 16202043 BACKGROUND

• 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.

  PMID: 1298767 BACKGROUND

• 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.

  PMID: 17096090 BACKGROUND

• 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.

  PMID: 15894939 BACKGROUND

• 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.

  PMID: 10647761 BACKGROUND

• 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.

  PMID: 17482850 BACKGROUND

• 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.

  PMID: 22446432 BACKGROUND

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

  PMID: 12913944 BACKGROUND

• 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.

  PMID: 22935970 BACKGROUND

• 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.

  PMID: 18314857 BACKGROUND

• 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.

  PMID: 17508633 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Myofascial Pain Syndromes

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD (Lecturer)

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: September 4, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 16, 2015

Record last verified: 2015-09