Trigger Points in Teres Major MuscleNCT02374125
Teres Major Muscle and Subacromial Impingement Syndrome
A study testing Diacutaneous Fibrolysis, Trigger Point Pressure Release and Protocolized physiotherapy in people with Trigger Points in Teres Major Muscle and Subacromial Impingement Syndrome, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
There is not a clear understanding of the origin of symptoms perceived by patients with impingement of the soft tissue structures of the subacromial space. Tendinopathy, tendon rupture or other pathologies, are present in asymptomatic subjects and subjects with symptoms and structural integrity can also be found. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigger Points in Teres Major Muscle, Subacromial Impingement Syndrome
- What is being tested?
- Diacutaneous Fibrolysis, Trigger Point Pressure Release and Protocolized physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2014to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and over
- Clinical diagnosis of Subacromial Impingement Syndrome.
- Detectable trigger points in teres major muscle.
- Sign informed consent form.
Who cannot join
- Diacutaneous Fibrolysis contraindications
- Previous shoulder surgery (<1year)
- Language barriers or cognitive issues that limit their ability to provide informed consent and participate in research.
- Patients with a pending litigation or court claim.
Trial locations and contacts
1 site in 1 country.
Martin Barra contact
Spain1 site, 1 recruiting
- Recruiting
Catalan Health Institut. Sant Ildefons Rehabilitation Service
Cornellà de Llobregat, Barcelona, 08840
Martín Barra, martinbarra@gmail.com
About this study
Official title: Effectiveness of Teres Major Muscle Specific Treatment in Patients Diagnosed With Subacromial Impingement Syndrome
There is not a clear understanding of the origin of symptoms perceived by patients with impingement of the soft tissue structures of the subacromial space. Tendinopathy, tendon rupture or other pathologies, are present in asymptomatic subjects and subjects with symptoms and structural integrity can also be found.
Patients diagnosed with subacromial impingement syndrome frequently have myofascial trigger points in the teres major muscle. Travell and Simons reported that the symptoms caused by trigger points in this muscle are similar to those experienced by patients diagnosed with impingement syndrome, but a literature search provides few results regarding relationship between subacromial impingement syndrome and presence of myofascial trigger points in the teres major muscle.
This study aims to provide evidence of the results that can be obtained with a specific approach of teres mayor muscle by two manual techniques, Trigger Point Pressure Release and Diacutaneous Fibrolysis, in subjects with subacromial impingement syndrome, a condition that still representing both a diagnostic and therapeutic challenge. Secondary objective is to compare the outcomes between both techniques to select for each patient the most appropriate to their needs and characteristics.
- Being tested
- Diacutaneous Fibrolysis, Trigger Point Pressure Release, Protocolized physiotherapy
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diacutaneous FibrolysisDevice
Applied only around teres major muscle.
Trigger Point Pressure ReleaseOther
Applied only in teres major muscle trigger points.
Protocolized physiotherapyOther
Exercises, TENS and cryotherapy
| Study group | Role | What they receive |
|---|---|---|
| Fibrolysis Group | Experimental | Actual Diacutaneous Fibrolysis and protocolized physiotherapy Receives: Device: Diacutaneous Fibrolysis; Other: Protocolized physiotherapy |
| Pressure Group | Experimental | Trigger Point Pressure Release and protocolized physiotherapy Receives: Other: Trigger Point Pressure Release; Other: Protocolized physiotherapy |
| Control Group | Active comparator | Protocolized physiotherapy Receives: Other: Protocolized physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain intensity (Using a VAS)
Using a VAS
Measured: Change from baseline to 3 weeks.
Change in Functional capacity (Abbreviated Constant-Murley score)
Abbreviated Constant-Murley score
Measured: Change from baseline to 3 weeks.
Secondary outcomes (2)
Change in Active Range of Motion
Flexion, extension, abduction, external rotation and internal rotation
Measured: Change from baseline to 3 weeks.
Patient perception of change (Global Rating of Change scale)
Global Rating of Change scale
Measured: 3 weeks after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger Points in Teres Major MuscleStudies of the same condition, open and under way.
- 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martín Barra, Principal investigator, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374125
- Sponsor's protocol ID
- P14/033
- Status last verified
- Feb 2015
- First submitted
- 10 Feb 2015
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Teres Major Muscle Specific Treatment in Patients Diagnosed With Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT02374125
- Acronym / sponsor ID
- P14/033
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 Feb 2015 (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.
There is not a clear understanding of the origin of symptoms perceived by patients with impingement of the soft tissue structures of the subacromial space. Tendinopathy, tendon rupture or other pathologies, are present in asymptomatic subjects and subjects with symptoms and structural integrity can also be found.
Patients diagnosed with subacromial impingement syndrome frequently have myofascial trigger points in the teres major muscle. Travell and Simons reported that the symptoms caused by trigger points in this muscle are similar to those experienced by patients diagnosed with impingement syndrome, but a literature search provides few results regarding relationship between subacromial impingement syndrome and presence of myofascial trigger points in the teres major muscle.
This study aims to provide evidence of the results that can be obtained with a specific approach of teres mayor muscle by two manual techniques, Trigger Point Pressure Release and Diacutaneous Fibrolysis, in subjects with subacromial impingement syndrome, a condition that still representing both a diagnostic and therapeutic challenge. Secondary objective is to compare the outcomes between both techniques to select for each patient the most appropriate to their needs and characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fibrolysis Group | Experimental | Device: Diacutaneous Fibrolysis, Other: Protocolized physiotherapyActual Diacutaneous Fibrolysis and protocolized physiotherapy |
| Pressure Group | Experimental | Other: Trigger Point Pressure Release, Other: Protocolized physiotherapyTrigger Point Pressure Release and protocolized physiotherapy |
| Control Group | Active comparator | Other: Protocolized physiotherapyProtocolized physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years and over
- Clinical diagnosis of Subacromial Impingement Syndrome.
- Detectable trigger points in teres major muscle.
- Sign informed consent form.
Key exclusion criteria (4 listed)
- Diacutaneous Fibrolysis contraindications
- Previous shoulder surgery (<1year)
- Language barriers or cognitive issues that limit their ability to provide informed consent and participate in research.
- Patients with a pending litigation or court claim.
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 |
|---|---|---|
| Diacutaneous FibrolysisApplied only around teres major muscle. | Device | Fibrolysis Group |
| Trigger Point Pressure ReleaseApplied only in teres major muscle trigger points. | Other | Pressure Group |
| Protocolized physiotherapyExercises, TENS and cryotherapy | Other | Control Group, Fibrolysis Group, Pressure Group |
Primary outcome
Change in Pain intensity (Using a VAS)
Time frame: Change from baseline to 3 weeks.
Using a VAS
Change in Functional capacity (Abbreviated Constant-Murley score)
Time frame: Change from baseline to 3 weeks.
Abbreviated Constant-Murley score
2 secondary outcomes
Change in Active Range of Motion
Time frame: Change from baseline to 3 weeks.
Patient perception of change (Global Rating of Change scale)
Time frame: 3 weeks after recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
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.
Martin Barra contact
Martín Barra principal investigator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diacutaneous Fibrolysis, Trigger Point Pressure Release and Protocolized physiotherapy in people with Trigger Points in Teres Major Muscle and Subacromial Impingement Syndrome, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Feb 2015. 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 Spain. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Barra (martinbarra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain intensity (Using a VAS) (time frame: Change from baseline to 3 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2015.