Efficacy of Myofascial Trigger Point Pressure Release on Tinnitus Patients

Tinnitus Clinical Trial

— MTP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999648
• Other study ID #: CAPPesq 138306
• Secondary ID: TRI Grant /0704
• Status: Completed
• Phase: N/A
• First received: October 21, 2009
• Last updated: October 21, 2009
• Start date: March 2008
• Est. completion date: September 2009

Study information

• Verified date: October 2009
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myofascial Trigger Points
• Tinnitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Clinics Hospital of University of Sao Paulo Medical School - Department of Otorhinolaryngology	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Tinnitus Research Initiative

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Bezerra Rocha CA, Sanchez TG, Tesseroli de Siqueira JT. Myofascial trigger point:a possible way of modulating tinnitus. Audiol Neurootol. 2008;13(3):153-60. Epub 2007 Dec 13. — View Citation

Rocha CA, Sanchez TG. Myofascial trigger points: another way of modulating tinnitus. Prog Brain Res. 2007;166:209-14. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Handicap Inventory, tinnitus visual analogue scale (0 to 10), changes of numbers of sounds and frequency		first, fifth and tenth session of treatment	Yes
Secondary	Intensity and frequency of pain; number of active trigger point		first, fifth and tenth session of treatment	Yes

External Links

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