Clinical trial NCT00999648: Efficacy of Myofascial Trigger Point Pressure Release on Tinnitus Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Myofascial Trigger Points
Keywords: Tinnitus
Myofascial Trigger Points
Myofascial Pain Syndrome
Controlled Clinical Trial
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Tinnitus Research Initiative
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2009-10-22
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Tinnitus Handicap Inventory, tinnitus visual analogue scale (0 to 10), changes of numbers of sounds and frequency
timeFrame: first, fifth and tenth session of treatment
Secondary outcomes:
measure: Intensity and frequency of pain; number of active trigger point
timeFrame: first, fifth and tenth session of treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Clinics Hospital of University of Sao Paulo Medical School - Department of Otorhinolaryngology
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Carina B. Rocha, PT, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rocha CA, Sanchez TG. Myofascial trigger points: another way of modulating tinnitus. Prog Brain Res. 2007;166:209-14. doi: 10.1016/S0079-6123(07)66018-X.
citation: 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. doi: 10.1159/000112423. Epub 2007 Dec 13.