Efficacy of Myofascial Trigger Point Pressure Release on Tinnitus Patients (MTP)

This study has been completed.
Sponsor:
Collaborators:
Tinnitus Research Initiative
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT00999648
First received: October 21, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

The objective of this study is to evaluate the efficacy of myofascial trigger (MTP) point deactivation for tinnitus control in a population with tinnitus and myofascial pain.


Condition Intervention
Tinnitus
Myofascial Trigger Points
Other: Myofascial trigger point pressure release (deactivation)
Other: Placebo myofascial trigger point pressure release

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Myofascial Trigger Point Pressure Release on Tinnitus Patients With Both Tinnitus and Myofascial Pain: a Double-blind Placebo Controlled Randomized Clinical Trial.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Tinnitus Handicap Inventory, tinnitus visual analogue scale (0 to 10), changes of numbers of sounds and frequency [ Time Frame: first, fifth and tenth session of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intensity and frequency of pain; number of active trigger point [ Time Frame: first, fifth and tenth session of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 57
Study Start Date: March 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manual therapy
Myofascial trigger point pressure release
Other: Myofascial trigger point pressure release (deactivation)
The deactivation of MTP will be performed always by the same physiotherapist researcher using the same technique. Afterwards, a myofascial maneuver is performed in each treated muscle. All patients of the experimental group will be advised to perform complimentary procedures at home during the 10-week period treatment in order to maintain the status of the muscle up to the next session and to avoid losing the obtained result:(1) Stretching of the treated muscles, once a day for 25 seconds each, (2)Superficial heat in each treated muscle, once a day for 20 minutes, (3) Watch the correct postures during daily activities and sleeping.
Other Name: Manual therapy, pressure release, digital pressure of MTP.
Placebo Comparator: Control
Placebo myofascial trigger point pressure release
Other: Placebo myofascial trigger point pressure release
The physiotherapist researcher will press in an adjacent nontender muscle fibers of the same muscle that have MTP about 3cm to the right or to the left of each diagnosed MTP, using just a slight pressure on it, not enough for deactivation.
Other Name: Placebo manual therapy

Detailed Description:

A double blind placebo control randomized clinical trial was made to verify the efficacy of the treatment by deactivation of MTP, after 10 sessions, in tinnitus patients by means of comparison with a placebo treatment in a control group. Patients with tinnitus and frequent regional pain for at least 3 months in the head, neck and shoulder girdle were investigated in the Tinnitus Research Group of University of São Paulo Medical School. All of them underwent an interview with the otolaryngologist ("physician researcher"), an audiologist evaluation ("blind researcher"), another blind researcher evaluation for tinnitus and pain and a physiotherapist evaluation and randomization. Both blind researchers evaluated tinnitus and pain in the first, fifth and tenth session. The real treatment was made by a gradual and persistent digital pressure in each MTP previously diagnosed by the blind researcher (8 possible muscles) and some home orientations that included stretch, superficial heat in each treated muscle and watch the correct postures during daily activities and sleeping. In the control group physiotherapist researcher pressed in an adjacent non-tender muscle fibers of the same muscle that have MTP. No other complementary orientation was done.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult subjects of any gender, age and race with presence of uni or bilateral tinnitus for at least 3 months;
  2. Presence of pain complaint for at least 3 months in head, neck and shoulder girdle areas
  3. Presence of at least one myofascial trigger point (MTP) related with the patient's pain complaint (active MTP).

Exclusion Criteria:

  1. Pain complaint involving three or more quadrants of the body, regardless of its cause
  2. Infiltration and/or specific treatment for deactivation of MTP in the last 6 months;
  3. Use of medications or other techniques to treat tinnitus, pain or muscle disorders during the previous last month;
  4. Impossibility of understanding the orientation and/or giving information during MTP evaluation (neurological or psychiatric diseases, bilateral severe or profound hearing loss, etc);
  5. Absence of tinnitus perception during evaluation;
  6. Pulsatile tinnitus or myoclonus (middle ear muscles or palatal myoclonus).
  7. Tinnitus due to certain etiologies that require other specific types of treatment, determined according to the medical evaluation.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00999648

Locations
Brazil
Clinics Hospital of University of Sao Paulo Medical School - Department of Otorhinolaryngology
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Tinnitus Research Initiative
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Carina B. Rocha, PT, MA University of Sao Paulo General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Tanit Ganz Sanchez< MD, PhD, Departament of Otorhinolaryngology -University of Sao Paulo Medical School
ClinicalTrials.gov Identifier: NCT00999648     History of Changes
Other Study ID Numbers: CAPPesq 138306, TRI Grant /0704
Study First Received: October 21, 2009
Last Updated: October 21, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
Tinnitus
Myofascial Trigger Points
Myofascial Pain Syndrome
Controlled Clinical Trial

Additional relevant MeSH terms:
Tinnitus
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014