Shoulder PainNCT02353442
Changes in Subjects With Posterior Capsule Tightness
A study testing Posterior shoulder mobilizations, External rotators strengthening and Scapular squeezing in people with Shoulder Pain, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
To identify biomechanical and sensibility changes in people with posterior capsule tightness in people with and without shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Posterior shoulder mobilizations, External rotators strengthening and Scapular squeezing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Aug 2016
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria: all subjects should have posterior capsule tightness and shoulder pain. So they should have:
- low flexion test (flexion + internal rotation) > 7°, between arms;
- symptoms consistent to shoulder impingement and arm elevation close to 150° as determined by digital inclinometer. The diagnosis for SIS was made based on a clinical examination and self-reported history. To be classified as having shoulder impingement, subjects had to present with at least 3 of the following: positive Neer test, positive Hawkins test, positive Jobe test, pain with passive or isometric resisted shoulder lateral rotation, pain with active shoulder elevation, and pain in the anterolateral shoulder region.
Exclusion Criteria: Individuals from both groups were excluded if they:
- were pregnant;
- had ligamentous laxity based on positive Sulcus test, Apprehension test or anterior drawer;
- had history of clavicle, scapula or humerus fracture;
- history of shoulder surgery or traumatic lesion; -had adhesive capsulitis or scoliosis; - had systemic illnesses;
- transpore tape allergy;
- body mass index > 28kg/m2;
- physical therapy treatment in the last 6 months;
- bilateral symptoms;
- steroid injection in the last 6 weeks;
- drugs with muscle relaxant in the last 72 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomechanical and Neurophysiological Changes in Subjects With Posterior Capsule Tightness - Evaluation and Treatment
To identify biomechanical and sensibility changes in people with posterior capsule tightness in people with and without shoulder pain.
Read the detailed description
Some studies have shown that posterior capsule tightness can be related with shoulder dysfunctions and kinematics alterations. This study will be divided in two studies. The purpose of study 1 will be to assess the scapular and humeral kinematics, the strength of the shoulder external rotators and the pressure pain threshold in subjects with posterior capsule tightness with and without shoulder pain. Study 2 will verify the effects of two different treatments in subjects with posterior capsule tightness and shoulder pain on the same variables of study 1. One-hundred subjects will participate in the first study and will be divided in 4 groups: Group 1 - 25 subjects with shoulder pain and posterior capsule tightness; Group 2 - 25 subjects with no shoulder pain and no posterior capsule tightness; Group 3 - 25 subjects with shoulder pain and no posterior capsule tightness; and group 4 - 25 subjects with no shoulder pain and no posterior capsule tightness. All subjects will complete the DASH and Shoulder Pain and Disability Index questionnaires. External and internal rotation range of motion, strength of the external rotators, scapular kinematics and humeral translations during arm elevation, and pressure pain threshold will be measured. For the second study 50 subjects with shoulder pain and posterior capsule tightness will be recruited. The subjects will be randomly divided in 2 groups: experimental group or control group. The experimental group will receive glenohumeral posterior mobilization, stretching of posterior capsule and strengthening of the shoulder external rotators. The control group will do ultrasound;, stretching for the upper trapezius and scapular squeezing. Both groups will receive intervention for 3x/week/4 weeks. All subjects will be supervised for one physiotherapist and same variables from study 1 will be analyzed at pre and post-intervention.
- Conditions
- Shoulder Pain
- Being tested
- Posterior shoulder mobilizations, External rotators strengthening, Placebo ultrasound, Scapular squeezing, Upper trapezius stretching
- Keywords
- Pain, Rotator cuff, Stretching, Mobilization, Scapula, Posterior capsule
- Medical subject headings
- Shoulder Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior shoulder mobilizationsOther
A second investigator performed 5min of posterior capsule shoulder mobilization for the experimental group, 3times/week during 4 weeks.
External rotators strengtheningOther
Individuals performed 3x10 repetitions of external rotators strengthening in sidelying position 3times/week during 4 weeks.
Placebo ultrasoundOther
A second investigator performed 5min of placebo ultrassound for the control group, 3times/week during 4 weeks.
Scapular squeezingOther
Individuals performed 3x10 repetitions scapular squeezing exercise 3times/week during 4 weeks.
Upper trapezius stretchingOther
Individuals performed 3x30s of upper trapezius stretching, 3times/week during 4 weeks.
Posterior Capsule StretchingOther
Individuals performed 3x30s of posterior capsule stretching, 3times/week during 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | This group will perform during 4 weeks:
* placebo ultrasound during 5min ;
* scapular squeezing in the sitting position (3x10repetitions);
* upper trapezius stretching (in sitting position, 3x30s and 30s of rest). Receives: Other: Placebo ultrasound; Other: Scapular squeezing; Other: Upper trapezius stretching |
| Experimental group | Active comparator | This group will perform during 4 weeks:
* posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
* external rotators strengthening in sidelying positions with load (3x10repetitions);
* posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest). Receives: Other: Posterior shoulder mobilizations; Other: External rotators strengthening; Other: Posterior Capsule Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scapular Kinematics at 4weeks (Pre and Post Treatment)
It was assessed in degrees with 3D system pre and post treatment.
Measured: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Humeral Translations at 4weeks (Pre and Post Treatment).
It was assessed in millimeters with 3D system pre and post treatment.
Measured: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Secondary outcomes (3)
Strength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).
The strength was evaluated with digital dynamometer in Newton pre and post treatment.
Measured: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
It was measured by a digital algometer in kPa pre and post treatment.
Measured: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Pain and Function at 4weeks (Pre and Post Treatment)
For these measures, the SPADI (Shoulder Pain and Disabilities Index) questionnaire was used, pre and post treatment. The is a self-assessment questionnaire with 5 questions about pain and 8 about functional activities. The final score (0-100) of the questionnaire is provided in percentage and a maximum score of 100 implies the worst possible condition.
Measured: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2016
- Study completionAug 2016
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dayana Patricia Rosa, Universidade Federal de Sao Carlos
- Investigators
- Dayana Rosa, Ms, Principal investigator, UFSCar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353442
- Sponsor's protocol ID
- 860.648
- Status last verified
- Feb 2017
- First submitted
- 18 Jan 2015
- Last updated
- 21 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical and Neurophysiological Changes in Subjects With Posterior Capsule Tightness - Evaluation and Treatment
- ClinicalTrials.gov ID
- NCT02353442
- Acronym / sponsor ID
- 860.648
- Conditions
- Shoulder Pain
- Keywords
- Pain, Rotator cuff, Stretching, Mobilization, Scapula, Posterior capsule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Posted 15 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify biomechanical and sensibility changes in people with posterior capsule tightness in people with and without shoulder pain.
Detailed description
Some studies have shown that posterior capsule tightness can be related with shoulder dysfunctions and kinematics alterations. This study will be divided in two studies. The purpose of study 1 will be to assess the scapular and humeral kinematics, the strength of the shoulder external rotators and the pressure pain threshold in subjects with posterior capsule tightness with and without shoulder pain. Study 2 will verify the effects of two different treatments in subjects with posterior capsule tightness and shoulder pain on the same variables of study 1. One-hundred subjects will participate in the first study and will be divided in 4 groups: Group 1 - 25 subjects with shoulder pain and posterior capsule tightness; Group 2 - 25 subjects with no shoulder pain and no posterior capsule tightness; Group 3 - 25 subjects with shoulder pain and no posterior capsule tightness; and group 4 - 25 subjects with no shoulder pain and no posterior capsule tightness. All subjects will complete the DASH and Shoulder Pain and Disability Index questionnaires. External and internal rotation range of motion, strength of the external rotators, scapular kinematics and humeral translations during arm elevation, and pressure pain threshold will be measured. For the second study 50 subjects with shoulder pain and posterior capsule tightness will be recruited. The subjects will be randomly divided in 2 groups: experimental group or control group. The experimental group will receive glenohumeral posterior mobilization, stretching of posterior capsule and strengthening of the shoulder external rotators. The control group will do ultrasound;, stretching for the upper trapezius and scapular squeezing. Both groups will receive intervention for 3x/week/4 weeks. All subjects will be supervised for one physiotherapist and same variables from study 1 will be analyzed at pre and post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Placebo ultrasound, Other: Scapular squeezing, Other: Upper trapezius stretchingThis group will perform during 4 weeks: * placebo ultrasound during 5min ; * scapular squeezing in the sitting position (3x10repetitions); * upper trapezius stretching (in sitting position, 3x30s and 30s of rest). |
| Experimental group | Active comparator | Other: Posterior shoulder mobilizations, Other: External rotators strengthening, Other: Posterior Capsule StretchingThis group will perform during 4 weeks: * posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest); * external rotators strengthening in sidelying positions with load (3x10repetitions); * posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Posterior shoulder mobilizationsA second investigator performed 5min of posterior capsule shoulder mobilization for the experimental group, 3times/week during 4 weeks. | Other | Experimental group |
| External rotators strengtheningIndividuals performed 3x10 repetitions of external rotators strengthening in sidelying position 3times/week during 4 weeks. | Other | Experimental group |
| Placebo ultrasoundA second investigator performed 5min of placebo ultrassound for the control group, 3times/week during 4 weeks. | Other | Control group |
| Scapular squeezingIndividuals performed 3x10 repetitions scapular squeezing exercise 3times/week during 4 weeks. | Other | Control group |
| Upper trapezius stretchingIndividuals performed 3x30s of upper trapezius stretching, 3times/week during 4 weeks. | Other | Control group |
| Posterior Capsule StretchingIndividuals performed 3x30s of posterior capsule stretching, 3times/week during 4 weeks. | Other | Experimental group |
Primary outcome
Scapular Kinematics at 4weeks (Pre and Post Treatment)
Time frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
It was assessed in degrees with 3D system pre and post treatment.
Humeral Translations at 4weeks (Pre and Post Treatment).
Time frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
It was assessed in millimeters with 3D system pre and post treatment.
3 secondary outcomes
Strength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).
Time frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
Time frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Pain and Function at 4weeks (Pre and Post Treatment)
Time frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Shoulder Pain
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Rotator Cuff Tendinopathy
Not yet recruiting
Effects of Different Kinesio Taping Methods in Subacromial Impingement Syndrome
Subacromial Impingement Syndrome
RecruitingObservational study
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
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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, Ms principal investigator
UFSCar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior shoulder mobilizations, External rotators strengthening and Scapular squeezing 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?
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 21 Mar 2017. 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?
Yes. Results are posted in the registry (first posted 15 Feb 2017). 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?
Scapular Kinematics at 4weeks (Pre and Post Treatment) (time frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)). 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 21 Mar 2017.