Efficacy of Myofascial Trigger Point Pressure Release on Tinnitus Patients

NCT ID: NCT00999648

Last Updated: 2009-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tinnitus Myofascial Trigger Points

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Manual therapy

Myofascial trigger point pressure release

Group Type EXPERIMENTAL

Myofascial trigger point pressure release (deactivation)

Intervention Type 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.

Control

Placebo myofascial trigger point pressure release

Group Type PLACEBO_COMPARATOR

Placebo myofascial trigger point pressure release

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Manual therapy, pressure release, digital pressure of MTP. Placebo manual therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tinnitus Research Initiative

OTHER

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Departament of Otorhinolaryngology -University of Sao Paulo Medical School

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carina B. Rocha, PT, MA

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17956784 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18075244 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TRI Grant /0704

Identifier Type: -

Identifier Source: secondary_id

CAPPesq 138306

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.