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Completed

NCT Number: NCT00999648

Efficacy of Myofascial Trigger Point Pressure Release on Tinnitus Patients

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinics Hospital of University of Sao Paulo Medical School - Department of Otorhinolaryngology

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Myofascial trigger point pressure release (deactivation)

Other

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 names: Manual therapy, pressure release, digital pressure of MTP.

Placebo myofascial trigger point pressure release

Other

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 names: Placebo manual therapy

Primary outcomes

  1. 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

Secondary outcomes

  1. Intensity and frequency of pain; number of active trigger point

    Time frame: first, fifth and tenth session of treatment

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Tinnitus Research Initiative

Registry information

Official study 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.

Acronym: MTP

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 22, 2009
Registry last updated
Oct 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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