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

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ClinicalTrials.gov Identifier: NCT02850055
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
MARIA JOSE DIAZ ARRIBAS, Universidad Complutense de Madrid

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.


Condition or disease Intervention/treatment Phase
Tinnitus Other: Conventional Physiotherapy Other: Specific Manual Therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness Specific Manual Therapy in a Multimodal Physical Therapy Treatment in Patients With Tinnitus and Temporomandibular Joint Disorder.
Study Start Date : January 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Specific Manual Therapy Group
Conventional Physiotherapy and Specific manual therapy, six one hour treatment sessions. An hour for week.
Other: Specific Manual Therapy
  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.
Other Name: Manual Therapy

Active Comparator: Multimodal Group
Conventional Physiotherapy, six one hour treatment sessions. An hour for week.
Other: Conventional Physiotherapy
  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.
Other Name: Multimodal Group




Primary Outcome Measures :
  1. Change from baseline Intensity of Temporomandibular Joint pain. [ Time Frame: At baseline, 1 week post-treatment, and 2 and 6 months post-treatment ]
    Intensity of TMJ pain (measured by VAS) at rest. It will be valued three times with 1 min between the three valuations and the average will be recorded.

  2. Change from baseline Intensity of tinnitus. [ Time Frame: At baseline, 1 week post-treatment, and 2 and 6 months post-treatment ]
    Intensity of tinnitus (measured by VAS) at rest. It will be valued three times with 1 min between the three valuations and the average will be recorded.


Secondary Outcome Measures :
  1. Change from baseline degree of disability caused by tinnitus [ Time Frame: At baseline, 1 week post-treatment, and 2 and 6 months post-treatment ]
    Degree of disability caused by tinnitus (measured with the Spanish adaptation of the Tinnitus Handicap Inventory (THI).

  2. Change from baseline degree of disability caused by temporomandibular disorder [ Time Frame: At baseline, 1 week post-treatment, and 2 and 6 months post-treatment ]
    Degree of disability caused by temporomandibular disorder (measured by Craniofacial Pain and Disability Inventory (CF-PDI)).

  3. Change from baseline quality of life. [ Time Frame: At baseline, 1 week post-treatment, and 2 and 6 months post-treatment ]
    Quality of life, measured with a previously validated Spanish version of the SF-12 (Short Form Health Survey).

  4. Change from baseline health condition [ Time Frame: At baseline, 1 week post-treatment, and 2 and 6 months post-treatment ]
    Health condition (measured with a visual scale (VAS) from 0 to 10)

  5. Change from baseline emotional state [ Time Frame: At baseline, 1 week post-treatment, and 2 and 6 months post-treatment ]
    Emotional state of the patient (measured with Beck questionnaire).

  6. Change from baseline pain sensibility [ Time Frame: At baseline, 1 week post-treatment, and 2 and 6 months post-treatment ]
    Pain sensibility by pressure (measured with algometer) in the masseter, temporal and lateral pterygoid muscles.

  7. Change from baseline range of motion [ Time Frame: At baseline, 1 week post-treatment, and 2 and 6 months post-treatment ]
    Range of motion of the temporomandibular joint in the mouth opening and bilateral excursion movements (measured in millimetres by vernier callipers)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850055


Contacts
Contact: María J Díaz, Professor 00 34 913941518 mjdiazar@med.ucm.es

Locations
Spain
María José Díaz Arribas Recruiting
Madrid, Spain, 28040
Contact: María J Díaz, Professor    00343941518    mjdiazar@med.ucm.es   
Principal Investigator: Pablo Delgado de la Serna, Master         
Sponsors and Collaborators
Universidad Complutense de Madrid
Investigators
Study Director: María J Díaz, Professor Physiotherapy Professor

Publications:

Responsible Party: MARIA JOSE DIAZ ARRIBAS, Tenured University Professor, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT02850055     History of Changes
Other Study ID Numbers: MJD_2016
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MARIA JOSE DIAZ ARRIBAS, Universidad Complutense de Madrid:
physiotherapy, Temporomandibular Joint Disorder, tinnitus.

Additional relevant MeSH terms:
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Nervous System Diseases
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Tinnitus
Neurologic Manifestations
Signs and Symptoms
Myofascial Pain Syndromes