Shoulder ImpingementNCT02035618
Exercises Associated or Not With Manual Therapy Shoulder Impingement
A study testing Exercises and Exercises + Manual Therapy in people with Shoulder Impingement, run by Universidade Federal de Sao Carlos.
Trial summary
Manual therapy combined with a protocol of therapeutic exercises will increase the beneficial effects on scapular kinematics, myofascial pain and function in subjects with shoulder impingement when compared to exercises only. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shoulder Impingement
- What is being tested?
- Exercises and Exercises + Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Jul 2012
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- history of non-traumatic onset of shoulder pain;
- painful arc during active elevation of the arm;
- one or more positive shoulder impingement tests (Neer, Hawkins and Jobe), or pain during passive or resisted external rotation of the arm at 90° of abduction;
- pain with palpation of the rotator cuff tendons;
- all subjects need also to be able to reach 150° of arm elevation as evaluated by visual observation.
Who cannot join
- limitation of glenohumeral internal and external rotation as indicative of adhesive capsulitis;
- body mass index > 28kg/m2 as the amount of subcutaneous tissue can compromise the quality of the signal increasing soft tissue artifact;
- numbness or tingling of the upper limb reproduced by cervical compression test;
- history of clavicle, scapula or humerus fracture;
- history of rotator cuff surgery;
- systemic illnesses;
Show all 11Show fewer
- positive sulcus or apprehension tests as indicative of instability;
- positive drop arm test as indicative of full thickness tear;
- corticosteroid injection within 3 months prior to intervention, or physiotherapy within 6 months prior to intervention;
- depressive symptoms as evaluated by the Beck Depression Inventory score ( > 9 points) due to its influence on myofascial pain;
- allergy to tape.
About this study
Manual therapy combined with a protocol of therapeutic exercises will increase the beneficial effects on scapular kinematics, myofascial pain and function in subjects with shoulder impingement when compared to exercises only.
- Conditions
- Shoulder Impingement
- Being tested
- Exercises, Exercises + Manual Therapy
- 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.
ExercisesOther
Strengthening and stretching
Exercises + Manual TherapyOther
Mobilization; massage; post-isometric relaxation; strengthening; stretching
| Study group | Role | What they receive |
|---|---|---|
| Exercises and manual therapy | Experimental | Not described Receives: Other: Exercises; Other: Exercises + Manual Therapy |
| Exercises | Active comparator | Not described Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scapular kinematics
Measured: up to 3 months from the initial interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startSep 2010
- Primary completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder ImpingementStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Rezende Camargo, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035618
- Sponsor's protocol ID
- UFSCar/CEP 270/2010
- Status last verified
- Jan 2014
- First submitted
- 10 Jan 2014
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Camargo PR, Alburquerque-Sendin F, Avila MA, Haik MN, Vieira A, Salvini TF. Effects of Stretching and Strengthening Exercises, With and Without Manual Therapy, on Scapular Kinematics, Function, and Pain in Individuals With Shoulder Impingement: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2015 Dec;45(12):984-97. doi: 10.2519/jospt.2015.5939. Epub 2015 Oct 15.
PubMed 26471852
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercises Associated or Not With Manual Therapy Shoulder Impingement
- ClinicalTrials.gov ID
- NCT02035618
- Acronym / sponsor ID
- UFSCar/CEP 270/2010
- Conditions
- Shoulder Impingement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2012 (actual)
- First posted
- 14 Jan 2014 (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.
Manual therapy combined with a protocol of therapeutic exercises will increase the beneficial effects on scapular kinematics, myofascial pain and function in subjects with shoulder impingement when compared to exercises only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercises and manual therapy | Experimental | Other: Exercises, Other: Exercises + Manual Therapy |
| Exercises | Active comparator | Other: Exercises |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- history of non-traumatic onset of shoulder pain;
- painful arc during active elevation of the arm;
- one or more positive shoulder impingement tests (Neer, Hawkins and Jobe), or pain during passive or resisted external rotation of the arm at 90° of abduction;
- pain with palpation of the rotator cuff tendons;
- all subjects need also to be able to reach 150° of arm elevation as evaluated by visual observation.
Key exclusion criteria (11 listed)
- limitation of glenohumeral internal and external rotation as indicative of adhesive capsulitis;
- body mass index > 28kg/m2 as the amount of subcutaneous tissue can compromise the quality of the signal increasing soft tissue artifact;
- numbness or tingling of the upper limb reproduced by cervical compression test;
- history of clavicle, scapula or humerus fracture;
- history of rotator cuff surgery;
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 |
|---|---|---|
| ExercisesStrengthening and stretching | Other | Exercises, Exercises and manual therapy |
| Exercises + Manual TherapyMobilization; massage; post-isometric relaxation; strengthening; stretching | Other | Exercises and manual therapy |
Primary outcome
Scapular kinematics
Time frame: up to 3 months from the initial interview
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 15 Jan 2014.
- Derived from this study: PubMed 26471852Camargo PR, Alburquerque-Sendin F, Avila MA, Haik MN, Vieira A, Salvini TF. Effects of Stretching and Strengthening Exercises, With and Without Manual Therapy, on Scapular Kinematics, Function, and Pain in Individuals With Shoulder Impingement: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2015 Dec;45(12):984-97. doi: 10.2519/jospt.2015.5939. Epub 2015 Oct 15.
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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 Exercises and Exercises + Manual Therapy in people with Shoulder Impingement, run by Universidade Federal de Sao Carlos.
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 5 inclusion and 11 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 15 Jan 2014. 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?
Scapular kinematics (time frame: up to 3 months from the initial interview). 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 NCT02035618, which also lists 1 linked publication.
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 15 Jan 2014.