Subacromial Impingement SyndromeNCT02374073
Functional Massage of Teres Major Muscle
A study testing Functional Massage and Protocolized physiotherapy in people with Subacromial Impingement Syndrome and Trigger Points, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
Trial summary
Purpose: Subacromial impingement syndrome is the most common shoulder condition. Myofascial trigger points in teres major muscle can be associated with this syndrome. The investigators objective is to find out if adding manual therapy specifically for teres major trigger points can produce better results in these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Impingement Syndrome, Trigger Points
- What is being tested?
- Functional Massage and Protocolized physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Mar 2014
- 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
- Presence of wounds or cutaneous alterations in the shoulder region
- Previous surgery in the shoulder
- Presence of acute inflammatory process in the shoulder (< 7 days),
- Being involved in litigation or compensation processes
- Not having a domain of the language that could make the informed consent not understandable.
About this study
Official title: Effectiveness of Functional Massage of the Teres Major Muscle in Patients With Subacromial Impingement Syndrome. A Randomized Controlled Pilot Study
Purpose: Subacromial impingement syndrome is the most common shoulder condition. Myofascial trigger points in teres major muscle can be associated with this syndrome. The investigators objective is to find out if adding manual therapy specifically for teres major trigger points can produce better results in these patients.
Method: A randomized controlled pilot study was carried out. Fifty people were randomly assigned to one of two groups: intervention group or control group. Both groups received a protocolized physical therapy treatment while the intervention group additionally received manual therapy for teres major trigger points.
- Conditions
- Subacromial Impingement Syndrome, Trigger Points
- Being tested
- Functional Massage, 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.
Functional MassageOther
The functional massage is a manual therapy technique, indicated in cases of painful muscle tightness that combines a rhythmical and non painful passive joint mobilization in the direction of muscle stretching together with compression/decompression of the muscle to be treated.
Protocolized physiotherapyOther
therapeutic exercises, analgesic electrotherapy and cryotherapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Treated with protocolized physiotherapy and functional massage Receives: Other: Functional Massage; Other: Protocolized physiotherapy |
| Control group | Experimental | Treated with 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 (visual analogue scale)
Using a Visual analogue scale
Measured: Change from baseline to 3 weeks
Secondary outcomes (2)
Change in Function (Abbreviated Constant-Murley score)
Using the Abbreviated Constant-Murley score
Measured: Change from baseline to 3 weeks
Change in Active Range of Motion
Flexion, extension, abduction, external rotation and internal rotation
Measured: Change from baseline to 3 weeks
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 startJan 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374073
- Sponsor's protocol ID
- P13/082
- Status last verified
- Feb 2015
- First submitted
- 12 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 Functional Massage of the Teres Major Muscle in Patients With Subacromial Impingement Syndrome. A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02374073
- Acronym / sponsor ID
- P13/082
- Conditions
- Subacromial Impingement Syndrome, Trigger Points
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- 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.
Purpose: Subacromial impingement syndrome is the most common shoulder condition. Myofascial trigger points in teres major muscle can be associated with this syndrome. The investigators objective is to find out if adding manual therapy specifically for teres major trigger points can produce better results in these patients.
Method: A randomized controlled pilot study was carried out. Fifty people were randomly assigned to one of two groups: intervention group or control group. Both groups received a protocolized physical therapy treatment while the intervention group additionally received manual therapy for teres major trigger points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Functional Massage, Other: Protocolized physiotherapyTreated with protocolized physiotherapy and functional massage |
| Control group | Experimental | Other: Protocolized physiotherapyTreated with protocolized 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 (5 listed)
- Presence of wounds or cutaneous alterations in the shoulder region
- Previous surgery in the shoulder
- Presence of acute inflammatory process in the shoulder (< 7 days),
- Being involved in litigation or compensation processes
- Not having a domain of the language that could make the informed consent not understandable.
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 |
|---|---|---|
| Functional MassageThe functional massage is a manual therapy technique, indicated in cases of painful muscle tightness that combines a rhythmical and non painful passive joint mobilization in the direction of muscle stretching together with compression/decompression of the muscle to be treated. | Other | Intervention group |
| Protocolized physiotherapytherapeutic exercises, analgesic electrotherapy and cryotherapy | Other | Control group, Intervention group |
Primary outcome
Change in Pain Intensity (visual analogue scale)
Time frame: Change from baseline to 3 weeks
Using a Visual analogue scale
2 secondary outcomes
Change in Function (Abbreviated Constant-Murley score)
Time frame: Change from baseline to 3 weeks
Change in Active Range of Motion
Time frame: Change from baseline to 3 weeks
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 27 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Massage and Protocolized physiotherapy in people with Subacromial Impingement Syndrome and Trigger Points, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
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 5 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 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in Pain Intensity (visual analogue scale) (time frame: Change from baseline to 3 weeks). 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.