Effectiveness of Manual Therapy in Patients With Tinnitus and Temporomandibular Joint Disorder.

NCT02850055 | Completed

• 1 other identifier: MJD_2016
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Tinnitus is one of the most prevalent symptoms that causes more disability in patients with temporomandibular disorder (TMD). The present study postulates a possible link between temporomandibular joint (TMJ) and inner ear based on their anatomical, biomechanical and physiological relationship, proposing a physiotherapy treatment for the temporomandibular joint to improve tinnitus. The aim of the study is to evaluate the effectiveness of adding specific manual therapy to a multimodal physiotherapy treatment in patients with tinnitus and temporomandibular disorder.

Conditions

Tinnitus

Keywords

physiotherapy, Temporomandibular Joint Disorder, tinnitus.

Outcome Measures

Primary Outcomes (2)

• Change from baseline Intensity of Temporomandibular Joint pain.

  Intensity of TMJ pain (measured by NPRS) at rest.

  At baseline, 1 week post-treatment, and 3 and 6 months post-treatment

• Change from baseline of tinnitus severity.

  Intensity of tinnitus (measured by VAS) at rest. It will be determined by assessing tinnitus annoyance and tinnitus loudness and the average will be recorded.

  At baseline, 1 week post-treatment, and 3 and 6 months post-treatment

Secondary Outcomes (6)

• Change from baseline degree of tinnitus-related handicap

  At baseline, 1 week post-treatment, and 3 and 6 months post-treatment

• Change from baseline degree of disability caused by temporomandibular disorder

  At baseline, 1 week post-treatment, and 3 and 6 months post-treatment

• Change from baseline quality of life.

  At baseline, 1 week post-treatment, and 3 and 6 months post-treatment

• Change from baseline emotional state (depressive symptoms)

  At baseline, 1 week post-treatment, and 3 and 6 months post-treatment

• Change from baseline pressure pain sensibility

  At baseline, 1 week post-treatment, and 3 and 6 months post-treatment

Study Arms (2)

Specific Manual Therapy Group

EXPERIMENTAL

Conventional Physiotherapy and Specific manual therapy, six one hour treatment sessions. An hour for week.

Other: Specific Manual Therapy

Multimodal Group

ACTIVE COMPARATOR

Conventional Physiotherapy, six one hour treatment sessions. An hour for week.

Other: Conventional Physiotherapy

Interventions

Conventional Physiotherapy OTHER

1. Leaflet care and health habits of the temporomandibular joint. 2. Program of cranio-cervical and temporomandibular exercises. 3. Massage of the cervical muscles and self care document for home.

Also known as: Multimodal Group

Multimodal Group

Specific Manual Therapy OTHER

1. Leaflet care and health habits of the temporomandibular joint. 2. Program of cranio-cervical and temporomandibular exercises. 3. Massage of the cervical muscles and self care document for home. 4. Specific manual therapy techniques focusing on the temporomandibular joint and temporomandibular muscles.

Also known as: Manual Therapy

Specific Manual Therapy Group

Eligibility Criteria

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

You may qualify if:

• ≥ 18 and ≤ 65 years old.
• Suffering from tinnitus and temporomandibular dysfunction with a myofascial or joint dysfunction origin: diagnosis of tinnitus attributed to TMD
• In a subacute and chronic phase.

You may not qualify if:

• Non signature of the informed consent.
• Patients with a diagnosis of ENT and / or neurological problems from which could arise tinnitus and / or the temporomandibular pain.
• Inability to read, understand and complete questionnaires, read and understand a brochure, or understand and follow verbal commands (e.g. Illiteracy, dementia or blindness).
• Having received physiotherapy in the last 12 months.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

María José Díaz Arribas

Madrid, 28040, Spain

Location

Related Publications (17)

• Calixtre LB, Moreira RF, Franchini GH, Alburquerque-Sendin F, Oliveira AB. Manual therapy for the management of pain and limited range of motion in subjects with signs and symptoms of temporomandibular disorder: a systematic review of randomised controlled trials. J Oral Rehabil. 2015 Nov;42(11):847-61. doi: 10.1111/joor.12321. Epub 2015 Jun 7.

  PMID: 26059857 BACKGROUND

• Langguth B. Treatment of tinnitus. Curr Opin Otolaryngol Head Neck Surg. 2015 Oct;23(5):361-8. doi: 10.1097/MOO.0000000000000185.

  PMID: 26261868 BACKGROUND

• Plein CT, Harounian J, Floyd E, Irizarry R, Ferzli G, Kidwai S, Rosenfeld RM. A Systematic Review of Eligibility and Outcomes in Tinnitus Trials: Reassessment of Tinnitus Guideline. Otolaryngol Head Neck Surg. 2016 Jan;154(1):24-32. doi: 10.1177/0194599815608160. Epub 2015 Oct 12.

  PMID: 26459245 BACKGROUND

• Sencimen M, Yalcin B, Dogan N, Varol A, Okcu KM, Ozan H, Aydintug YS. Anatomical and functional aspects of ligaments between the malleus and the temporomandibular joint. Int J Oral Maxillofac Surg. 2008 Oct;37(10):943-7. doi: 10.1016/j.ijom.2008.07.003. Epub 2008 Sep 2.

  PMID: 18768297 BACKGROUND

• Al-Ani MZ, Davies SJ, Gray RJ, Sloan P, Glenny AM. WITHDRAWN: Stabilisation splint therapy for temporomandibular pain dysfunction syndrome. Cochrane Database Syst Rev. 2016 Jan 4;2016(1):CD002778. doi: 10.1002/14651858.CD002778.pub3.

  PMID: 26727210 BACKGROUND

• Ebrahim S, Montoya L, Busse JW, Carrasco-Labra A, Guyatt GH; Medically Unexplained Syndromes Research Group. The effectiveness of splint therapy in patients with temporomandibular disorders: a systematic review and meta-analysis. J Am Dent Assoc. 2012 Aug;143(8):847-57. doi: 10.14219/jada.archive.2012.0289.

  PMID: 22855899 BACKGROUND

• La Touche R, Fernandez-de-las-Penas C, Fernandez-Carnero J, Escalante K, Angulo-Diaz-Parreno S, Paris-Alemany A, Cleland JA. The effects of manual therapy and exercise directed at the cervical spine on pain and pressure pain sensitivity in patients with myofascial temporomandibular disorders. J Oral Rehabil. 2009 Sep;36(9):644-52. doi: 10.1111/j.1365-2842.2009.01980.x. Epub 2009 Jul 14.

  PMID: 19627454 BACKGROUND

• La Touche R, Paris-Alemany A, Mannheimer JS, Angulo-Diaz-Parreno S, Bishop MD, Lopez-Valverde-Centeno A, von Piekartz H, Fernandez-Carnero J. Does mobilization of the upper cervical spine affect pain sensitivity and autonomic nervous system function in patients with cervico-craniofacial pain?: A randomized-controlled trial. Clin J Pain. 2013 Mar;29(3):205-15. doi: 10.1097/AJP.0b013e318250f3cd.

  PMID: 22874091 BACKGROUND

• Armijo-Olivo S, Pitance L, Singh V, Neto F, Thie N, Michelotti A. Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jan;96(1):9-25. doi: 10.2522/ptj.20140548. Epub 2015 Aug 20.

  PMID: 26294683 BACKGROUND

• Attanasio G, Leonardi A, Arangio P, Minni A, Covelli E, Pucci R, Russo FY, De Seta E, Di Paolo C, Cascone P. Tinnitus in patients with temporo-mandibular joint disorder: Proposal for a new treatment protocol. J Craniomaxillofac Surg. 2015 Jun;43(5):724-7. doi: 10.1016/j.jcms.2015.02.009. Epub 2015 Mar 12.

  PMID: 25868942 BACKGROUND

• La Touche R, Pardo-Montero J, Gil-Martinez A, Paris-Alemany A, Angulo-Diaz-Parreno S, Suarez-Falcon JC, Lara-Lara M, Fernandez-Carnero J. Craniofacial pain and disability inventory (CF-PDI): development and psychometric validation of a new questionnaire. Pain Physician. 2014 Jan-Feb;17(1):95-108.

  PMID: 24452650 BACKGROUND

• Vilagut G, Valderas JM, Ferrer M, Garin O, Lopez-Garcia E, Alonso J. [Interpretation of SF-36 and SF-12 questionnaires in Spain: physical and mental components]. Med Clin (Barc). 2008 May 24;130(19):726-35. doi: 10.1157/13121076. Spanish.

  PMID: 18570798 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010 Jun 1;152(11):726-32. doi: 10.7326/0003-4819-152-11-201006010-00232. Epub 2010 Mar 24.

  PMID: 20335313 BACKGROUND

• Knol MJ, Groenwold RH, Grobbee DE. P-values in baseline tables of randomised controlled trials are inappropriate but still common in high impact journals. Eur J Prev Cardiol. 2012 Apr;19(2):231-2. doi: 10.1177/1741826711421688. No abstract available.

  PMID: 22512015 BACKGROUND

• Kalamir A, Bonello R, Graham P, Vitiello AL, Pollard H. Intraoral myofascial therapy for chronic myogenous temporomandibular disorder: a randomized controlled trial. J Manipulative Physiol Ther. 2012 Jan;35(1):26-37. doi: 10.1016/j.jmpt.2011.09.004. Epub 2011 Nov 10.

  PMID: 22079052 BACKGROUND

• Gomes CA, Politti F, Andrade DV, de Sousa DF, Herpich CM, Dibai-Filho AV, Gonzalez Tde O, Biasotto-Gonzalez DA. Effects of massage therapy and occlusal splint therapy on mandibular range of motion in individuals with temporomandibular disorder: a randomized clinical trial. J Manipulative Physiol Ther. 2014 Mar-Apr;37(3):164-9. doi: 10.1016/j.jmpt.2013.12.007. Epub 2014 Jan 3.

  PMID: 24387891 BACKGROUND

• Delgado de la Serna P, Plaza-Manzano G, Cleland J, Fernandez-de-Las-Penas C, Martin-Casas P, Diaz-Arribas MJ. Effects of Cervico-Mandibular Manual Therapy in Patients with Temporomandibular Pain Disorders and Associated Somatic Tinnitus: A Randomized Clinical Trial. Pain Med. 2020 Mar 1;21(3):613-624. doi: 10.1093/pm/pnz278.

  PMID: 31665507 DERIVED

MeSH Terms

Conditions

Tinnitus; Temporomandibular Joint Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• María J Díaz, Professor

  Physiotherapy Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenured University Professor

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: July 29, 2016
• Study Start: January 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: June 15, 2018
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)