TinnitusMTPNCT00999648
Efficacy of Myofascial Trigger Point Pressure Release on Tinnitus Patients
A study testing Myofascial trigger point pressure release (deactivation) in people with Tinnitus and Myofascial Trigger Points, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tinnitus, Myofascial Trigger Points
- What is being tested?
- Myofascial trigger point pressure release (deactivation)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinics Hospital of University of Sao Paulo Medical School - Department of Otorhinolaryngology
São Paulo, São Paulo, 05403-000
About this study
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.
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.
Read the 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.
- Conditions
- Tinnitus, Myofascial Trigger Points
- Being tested
- Myofascial trigger point pressure release (deactivation), Placebo myofascial trigger point pressure release
- Keywords
- Tinnitus, Myofascial Trigger Points, Myofascial Pain Syndrome, Controlled Clinical Trial
- Medical subject headings
- Tinnitus, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial trigger point pressure release (deactivation)Other
Also called Manual therapy, pressure release, digital pressure of MTP.
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 releaseOther
Also called Placebo manual therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy | Experimental | Myofascial trigger point pressure release Receives: Other: Myofascial trigger point pressure release (deactivation) |
| Control | Placebo comparator | Placebo myofascial trigger point pressure release Receives: Other: Placebo myofascial trigger point pressure release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Handicap Inventory, tinnitus visual analogue scale (0 to 10), changes of numbers of sounds and frequency
Measured: first, fifth and tenth session of treatment
Secondary outcomes (1)
Intensity and frequency of pain; number of active trigger point
Measured: first, fifth and tenth session of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tinnitus Research Initiative, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Carina B. Rocha, PT, MA, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999648
- Sponsor's protocol ID
- CAPPesq 138306
- Other IDs
- TRI Grant /0704
- Acronym
- MTP
- Status last verified
- Oct 2009
- First submitted
- 21 Oct 2009
- Last updated
- 22 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17956784Bezerra 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.
PubMed 18075244
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00999648
- Acronym / sponsor ID
- MTP / CAPPesq 138306
- Conditions
- Tinnitus, Myofascial Trigger Points
- Keywords
- Tinnitus, Myofascial Trigger Points, Myofascial Pain Syndrome, Controlled Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Tinnitus Research Initiative, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy | Experimental | Other: Myofascial trigger point pressure release (deactivation)Myofascial trigger point pressure release |
| Control | Placebo comparator | Other: Placebo myofascial trigger point pressure releasePlacebo myofascial trigger point pressure release |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofascial trigger point pressure release (deactivation)Also: Manual therapy, pressure release, digital pressure of MTP.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. | Other | Manual therapy |
| Placebo myofascial trigger point pressure releaseAlso: Placebo manual therapyThe 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. | Other | Control |
Primary outcome
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
1 secondary outcome
Intensity and frequency of pain; number of active trigger point
Time frame: first, fifth and tenth session of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2009.
- Background: PubMed 17956784Rocha 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.
- Background: PubMed 18075244Bezerra 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carina B. Rocha, PT, MA principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial trigger point pressure release (deactivation) in people with Tinnitus and Myofascial Trigger Points, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00999648, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2009.