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

October 21, 2009
October 21, 2009
March 2008
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Intensity and frequency of pain; number of active trigger point [ Time Frame: first, fifth and tenth session of treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy of Myofascial Trigger Point Pressure Release on Tinnitus Patients
Efficacy of Myofascial Trigger Point Pressure Release on Tinnitus Patients With Both Tinnitus and Myofascial Pain: a Double-blind Placebo Controlled Randomized Clinical Trial.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Tinnitus
  • Myofascial Trigger Points
  • 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.
  • 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
  • Experimental: Manual therapy
    Myofascial trigger point pressure release
    Intervention: Other: Myofascial trigger point pressure release (deactivation)
  • Placebo Comparator: Control
    Placebo myofascial trigger point pressure release
    Intervention: Other: Placebo myofascial trigger point pressure release

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00999648
CAPPesq 138306, TRI Grant /0704
Yes
Tanit Ganz Sanchez< MD, PhD, Departament of Otorhinolaryngology -University of Sao Paulo Medical School
University of Sao Paulo General Hospital
  • Tinnitus Research Initiative
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
Principal Investigator: Carina B. Rocha, PT, MA University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP