Efficacy of Myofascial Trigger Point Pressure Release on Tinnitus Patients

NCT00999648 | Completed DMC

• 2 other identifiers: CAPPesq 138306TRI Grant /0704
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus; Myofascial Trigger Points

Keywords

Tinnitus; Myofascial Trigger Points; Myofascial Pain Syndrome; Controlled Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Tinnitus Handicap Inventory, tinnitus visual analogue scale (0 to 10), changes of numbers of sounds and frequency

  first, fifth and tenth session of treatment

Secondary Outcomes (1)

• Intensity and frequency of pain; number of active trigger point

  first, fifth and tenth session of treatment

Study Arms (2)

Manual therapy

EXPERIMENTAL

Myofascial trigger point pressure release

Other: Myofascial trigger point pressure release (deactivation)

Control

PLACEBO COMPARATOR

Placebo myofascial trigger point pressure release

Other: Placebo myofascial trigger point pressure release

Interventions

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.

Also known as: Manual therapy, pressure release, digital pressure of MTP.

Manual therapy

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.

Also known as: Placebo manual therapy

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Tinnitus Research Initiative: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

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

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (2)

• 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.

  PMID: 17956784 BACKGROUND

• 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.

  PMID: 18075244 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Tinnitus; Myofascial Pain Syndromes

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Carina B. Rocha, PT, MA

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: October 22, 2009
• Study Start: March 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 22, 2009

Record last verified: 2009-10

Locations

BR (1)