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Efficacy of Myofascial Trigger Point Pressure Release on Tinnitus Patients (MTP)

Primary Purpose

Tinnitus, Myofascial Trigger Points

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Myofascial trigger point pressure release (deactivation)
Placebo myofascial trigger point pressure release
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Myofascial Trigger Points, Myofascial Pain Syndrome, Controlled Clinical Trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Manual therapy

Control

Arm Description

Myofascial trigger point pressure release

Placebo myofascial trigger point pressure release

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intensity and frequency of pain; number of active trigger point

Full Information

First Posted
October 21, 2009
Last Updated
October 21, 2009
Sponsor
University of Sao Paulo General Hospital
Collaborators
Tinnitus Research Initiative, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT00999648
Brief Title
Efficacy of Myofascial Trigger Point Pressure Release on Tinnitus Patients
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Tinnitus Research Initiative, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Myofascial Trigger Points
Keywords
Tinnitus, Myofascial Trigger Points, Myofascial Pain Syndrome, Controlled Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual therapy
Arm Type
Experimental
Arm Description
Myofascial trigger point pressure release
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo myofascial trigger point pressure release
Intervention Type
Other
Intervention Name(s)
Myofascial trigger point pressure release (deactivation)
Other Intervention Name(s)
Manual therapy, pressure release, digital pressure of MTP.
Intervention Description
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
Intervention Name(s)
Placebo myofascial trigger point pressure release
Other Intervention Name(s)
Placebo manual therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Intensity and frequency of pain; number of active trigger point
Time Frame
first, fifth and tenth session of treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carina B. Rocha, PT, MA
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinics Hospital of University of Sao Paulo Medical School - Department of Otorhinolaryngology
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
17956784
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.
Results Reference
background
PubMed Identifier
18075244
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.
Results Reference
background
Links:
URL
http://www.zumbido.org.br
Description
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Efficacy of Myofascial Trigger Point Pressure Release on Tinnitus Patients

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