Shoulder PainPhase 4PMISPNCT01956240
Effects of a Pectoralis Minor Muscle Stretching Protocol
A Phase 4 study testing Stretching-Asymptomatic subjects and Stretching-Subjects with shoulder pain in people with Shoulder Pain, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The purpose of this study is to verify the effects of a stretching protocol for the pectoralis minor muscle on its resting length and on the 3D kinematics of the scapula during arm flexion in asymptomatic subjects and patients with impingement syndrome with shortened pectoralis minor. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Stretching-Asymptomatic subjects and Stretching-Subjects with shoulder pain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2013to Jan 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asymptomatic subjects were included if they did not have any positive test for SIS.
- The subjects with shoulder pain were included if:
- they had history of shoulder, at least one week;
- 18 - 45 years;
- range of motion > 150° evaluated with digital inclinometer;
- one or more impingement tests positive - Neer (Neer, 1972), Hawkins (Hawkins and Kennedy, 1980) and Jobe (Jobe and Moynes, 1982) - associated with painful arc during arm elevation, or during external rotation with 90° of arm elevation;
- Individuals from both groups also had to present with shortened PM muscle length.
Who cannot join
- Individuals from both groups were excluded if they:
- BMI (body mass index) > 28kg/m2;
- irradiated shoulder pain;
- scoliosis;
- history of shoulder pain with beginning traumatic;
- history of fracture or surgery in upper limb and rotator cuff;
Show all 10Show fewer
- systemic illnesses;
- tape allergy;
- were pregnant;
- physiotherapy at least 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Effects of a Stretching Protocol for the Pectoralis Minor Muscle on This Resting Length and on the 3D Kinematics of the Scapula During Arm Flexion in Asymptomatic Subjects and Patients With Impingement Syndrome
The purpose of this study is to verify the effects of a stretching protocol for the pectoralis minor muscle on its resting length and on the 3D kinematics of the scapula during arm flexion in asymptomatic subjects and patients with impingement syndrome with shortened pectoralis minor.
Read the detailed description
Fifty subjects (25 symptomatic and 25 asymptomatic for shoulder pain) will be recruited. All of them will be initially assessed twice with one week between the assessments. On each day, they will complete two questionnaires (DASH and SPADI) to assess pain and shoulder function. The resting length of the pectoralis minor muscle and scapular kinematics data during arm flexion will also be measured using an electromagnetic tracking system. Initially, the resting length of the pectoralis minor will be measured, and then 3 repetitions of arm elevation in the sagittal plane will be completed. The stretching protocol will be performed daily for 6 weeks. The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions. After the 6 weeks, the subject will have the same variables from the initial assessments reassessed. For the questionnaires and length of pectoralis minor a two-way ANOVA for repeated measures will be used to check the main effects of group and evaluation and whether there is interaction between them. For scapular internal/external rotation, upward/downward rotation, and tilt anterior/posterior a three-way ANOVA for repeated measures will use to analyze the main effects of group (symptomatic and asymptomatic), elevation angle of the arm (30°, 60°, 90° and 120°) and evaluation (1, 2 and 3) and whether there is evaluation x group x angle interaction. A p value less than 0.05 will be considered significant.
- Conditions
- Shoulder Pain
- Being tested
- Stretching-Asymptomatic subjects, Stretching-Subjects with shoulder pain
- Keywords
- shoulder, pectoralis minor, stretching, scapular kinematics
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching-Asymptomatic subjectsProcedure or surgery
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
Stretching-Subjects with shoulder painProcedure or surgery
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Stretching-Asymptomatic subjects | Experimental | The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions. Receives: Procedure: Stretching-Asymptomatic subjects |
| Stretching-Subjects with shoulder pain | Experimental | The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions. Receives: Procedure: Stretching-Subjects with shoulder pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pectoralis Minor Length After Pectoralis Minor Stretching Protocol
The change of the pectoralis minor muscle will be evaluated with a tape measure and electromagnetic device. The length of the muscle will be recorded in centimeters.
Measured: 6 weeks after stretching
Secondary outcomes (1)
Scapular Kinematics After Pectoralis Minor Stretching Protocol
The scapular kinematics will be evaluated with electromagnetic device. The changes in the scapular kinematics will be described in degrees.
Measured: 6 weeks of stretching
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shoulder PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Metodista de Piracicaba
- Responsible party
- Principal investigator, Dayana Patricia Rosa, Universidade Federal de Sao Carlos
- Investigators
- Dayana Rosa, PT, Principal investigator, UNIMEP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956240
- Sponsor's protocol ID
- 100/12
- Acronym
- PMISP
- Status last verified
- May 2015
- First submitted
- 21 Sep 2013
- Last updated
- 19 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Effects of a Stretching Protocol for the Pectoralis Minor Muscle on This Resting Length and on the 3D Kinematics of the Scapula During Arm Flexion in Asymptomatic Subjects and Patients With Impingement Syndrome
- ClinicalTrials.gov ID
- NCT01956240
- Acronym / sponsor ID
- PMISP / 100/12
- Conditions
- Shoulder Pain
- Keywords
- shoulder, pectoralis minor, stretching, scapular kinematics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Universidade Metodista de Piracicaba
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 12 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to verify the effects of a stretching protocol for the pectoralis minor muscle on its resting length and on the 3D kinematics of the scapula during arm flexion in asymptomatic subjects and patients with impingement syndrome with shortened pectoralis minor.
Detailed description
Fifty subjects (25 symptomatic and 25 asymptomatic for shoulder pain) will be recruited. All of them will be initially assessed twice with one week between the assessments. On each day, they will complete two questionnaires (DASH and SPADI) to assess pain and shoulder function. The resting length of the pectoralis minor muscle and scapular kinematics data during arm flexion will also be measured using an electromagnetic tracking system. Initially, the resting length of the pectoralis minor will be measured, and then 3 repetitions of arm elevation in the sagittal plane will be completed. The stretching protocol will be performed daily for 6 weeks. The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions. After the 6 weeks, the subject will have the same variables from the initial assessments reassessed. For the questionnaires and length of pectoralis minor a two-way ANOVA for repeated measures will be used to check the main effects of group and evaluation and whether there is interaction between them. For scapular internal/external rotation, upward/downward rotation, and tilt anterior/posterior a three-way ANOVA for repeated measures will use to analyze the main effects of group (symptomatic and asymptomatic), elevation angle of the arm (30°, 60°, 90° and 120°) and evaluation (1, 2 and 3) and whether there is evaluation x group x angle interaction. A p value less than 0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretching-Asymptomatic subjects | Experimental | Procedure: Stretching-Asymptomatic subjectsThe stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions. |
| Stretching-Subjects with shoulder pain | Experimental | Procedure: Stretching-Subjects with shoulder painThe stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Asymptomatic subjects were included if they did not have any positive test for SIS.
- they had history of shoulder, at least one week;
- 18 - 45 years;
- range of motion > 150° evaluated with digital inclinometer;
- one or more impingement tests positive - Neer (Neer, 1972), Hawkins (Hawkins and Kennedy, 1980) and Jobe (Jobe and Moynes, 1982) - associated with painful arc during arm elevation, or during external rotation with 90° of arm elevation;
Key exclusion criteria (10 listed)
- BMI (body mass index) > 28kg/m2;
- irradiated shoulder pain;
- scoliosis;
- history of shoulder pain with beginning traumatic;
- history of fracture or surgery in upper limb and rotator cuff;
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 |
|---|---|---|
| Stretching-Asymptomatic subjectsThe stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions. | Procedure or surgery | Stretching-Asymptomatic subjects |
| Stretching-Subjects with shoulder painThe stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions. | Procedure or surgery | Stretching-Subjects with shoulder pain |
Primary outcome
Pectoralis Minor Length After Pectoralis Minor Stretching Protocol
Time frame: 6 weeks after stretching
The change of the pectoralis minor muscle will be evaluated with a tape measure and electromagnetic device. The length of the muscle will be recorded in centimeters.
1 secondary outcome
Scapular Kinematics After Pectoralis Minor Stretching Protocol
Time frame: 6 weeks of stretching
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dayana Rosa, PT principal investigator
UNIMEP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stretching-Asymptomatic subjects and Stretching-Subjects with shoulder pain in people with Shoulder Pain, run by Universidade Federal de Sao Carlos 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 7 inclusion and 10 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 19 May 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pectoralis Minor Length After Pectoralis Minor Stretching Protocol (time frame: 6 weeks after stretching). 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 19 May 2015.