Shoulder Impingement SyndromeNCT01785745
Study of Neurocognitive Therapeutic Exercise in the Shoulder Impingement Syndrome in Comparison With Traditional Therapeutic Exercise
A study testing Neurocognitive therapeutic exercise and Traditional therapeutic exercise in people with Shoulder Impingement Syndrome, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
It is a single-blind randomized controlled clinical trial to evaluate the effectiveness of neurocognitive therapeutic exercise in subjects affected by shoulder impingement syndrome in comparison with traditional therapeutic exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Neurocognitive therapeutic exercise and Traditional therapeutic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2012to Jan 2013
- 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
- Subjects with shoulder impingement syndrome established by clinical examination, X-ray in anteroposterior, axillary and outlet views, and magnetic resonance imaging (MRI) or echography.
Who cannot join
- Rotator cuff and/or subscapularis tendon partial/full-thickness tears,
- capsulolabral pathology responsive to surgical repair,
- congenital abnormalities of the acromion,
- previous surgery on the affected shoulder,
- inflammatory or neurological (systemic or local) diseases involving shoulder girdles,
- cognitive or psychiatric disorders,
- local tumor metastasis or application of radiotherapy,
- acute infections or osseous tuberculosis.
Trial locations and contacts
1 site in 1 country.
Italy1 site
University Hospital "A. Gemelli", Catholic University of the Sacred Heart
Rome, Italy
About this study
Official title: Evaluation of the Effectiveness of Neurocognitive Therapeutic Exercise in Pain Control and Functional Recovery of the Shoulder Impingement Syndrome in Comparison With Traditional Therapeutic Exercise
It is a single-blind randomized controlled clinical trial to evaluate the effectiveness of neurocognitive therapeutic exercise in subjects affected by shoulder impingement syndrome in comparison with traditional therapeutic exercise. The traditional exercise protocol contains mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance. The neurocognitive exercise protocol contains ten exercises involving specific instruments (e.g., table inclined with a board with five concentric circles, sponges of various texture). Each subject, randomly assigned to either neurocognitive therapeutic exercise (group 1) or traditional therapeutic exercise (group 2), will be submitted to one-hour session for three times a week for five weeks. The outcome measures used will be the Quick-DASH questionnaire, the Constant-Murley shoulder outcome score, the ASES score, a visual analogic scale (VAS) and the assessment will be performed at baseline (T0), at the end of treatment protocol (T1), at 3 months (T2) and 6 months (T3) from the end of treatment.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Neurocognitive therapeutic exercise, Traditional therapeutic exercise
- Keywords
- conservative treatment, shoulder, neurocognitive therapeutic exercise, traditional therapeutic exercise, pain
- Medical subject headings
- Shoulder Impingement Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive therapeutic exerciseOther
Ten exercises involving specific instruments (e.g., table inclined with a board with five concentric circles, sponges of various texture). One-hour session for three times a week for five weeks.
Traditional therapeutic exerciseOther
Different exercises as strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance. One-hour session for three times a week for five weeks
| Study group | Role | What they receive |
|---|---|---|
| Traditional therapeutic exercise | Active comparator | The traditional exercise protocol contains mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance. Receives: Other: Traditional therapeutic exercise |
| Neurocognitive therapeutic exercise | Experimental | The neurocognitive exercise protocol contains ten exercises involving specific instruments (e.g., table inclined with a board with five concentric circles, sponges of various texture). Receives: Other: Neurocognitive therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
changing of the Quick-DASH, the short form of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Assessment of changing of the physical ability and symptoms of the upper extremity
Measured: baseline (T0), five weeks (T1), three months (T2), six months (T3)
Secondary outcomes (5)
changing of the Constant-Murley shoulder outcome score
assessment of changing in shoulder range of motion, pain and strength
Measured: baseline (T0), five weeks (T1), three months (T2), six months (T3)
changing of the American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form (ASES) score
Assessment of changing of the physical ability on daily-living tasks
Measured: baseline (T0), five weeks (T1), three months (T2), six months (T3)
changing of the visual analogic scale (VAS)
assessment of changing of shoulder Pain at rest
Measured: baseline (T0), five weeks (T1), three months (T2), six months (T3)
changing of the visual analogic scale (VAS)
assessment of changing of shoulder Pain during movements
Measured: baseline (T0), five weeks (T1), three months (T2), six months (T3)
changing of the Likert score
assessment of changing in participant satisfaction
Measured: baseline (T0), five weeks (T1), three months (T2), six months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startJul 2012
- Primary completionAug 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Bertolini, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785745
- Sponsor's protocol ID
- 486/2012
- Status last verified
- Feb 2013
- First submitted
- 1 Feb 2013
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Neurocognitive Therapeutic Exercise in Pain Control and Functional Recovery of the Shoulder Impingement Syndrome in Comparison With Traditional Therapeutic Exercise
- ClinicalTrials.gov ID
- NCT01785745
- Acronym / sponsor ID
- 486/2012
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- conservative treatment, shoulder, neurocognitive therapeutic exercise, traditional therapeutic exercise, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 7 Feb 2013 (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.
It is a single-blind randomized controlled clinical trial to evaluate the effectiveness of neurocognitive therapeutic exercise in subjects affected by shoulder impingement syndrome in comparison with traditional therapeutic exercise. The traditional exercise protocol contains mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance. The neurocognitive exercise protocol contains ten exercises involving specific instruments (e.g., table inclined with a board with five concentric circles, sponges of various texture). Each subject, randomly assigned to either neurocognitive therapeutic exercise (group 1) or traditional therapeutic exercise (group 2), will be submitted to one-hour session for three times a week for five weeks. The outcome measures used will be the Quick-DASH questionnaire, the Constant-Murley shoulder outcome score, the ASES score, a visual analogic scale (VAS) and the assessment will be performed at baseline (T0), at the end of treatment protocol (T1), at 3 months (T2) and 6 months (T3) from the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional therapeutic exercise | Active comparator | Other: Traditional therapeutic exerciseThe traditional exercise protocol contains mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance. |
| Neurocognitive therapeutic exercise | Experimental | Other: Neurocognitive therapeutic exerciseThe neurocognitive exercise protocol contains ten exercises involving specific instruments (e.g., table inclined with a board with five concentric circles, sponges of various texture). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with shoulder impingement syndrome established by clinical examination, X-ray in anteroposterior, axillary and outlet views, and magnetic resonance imaging (MRI) or echography.
Key exclusion criteria (8 listed)
- Rotator cuff and/or subscapularis tendon partial/full-thickness tears,
- capsulolabral pathology responsive to surgical repair,
- congenital abnormalities of the acromion,
- previous surgery on the affected shoulder,
- inflammatory or neurological (systemic or local) diseases involving shoulder girdles,
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 |
|---|---|---|
| Neurocognitive therapeutic exerciseTen exercises involving specific instruments (e.g., table inclined with a board with five concentric circles, sponges of various texture). One-hour session for three times a week for five weeks. | Other | Neurocognitive therapeutic exercise |
| Traditional therapeutic exerciseDifferent exercises as strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance. One-hour session for three times a week for five weeks | Other | Traditional therapeutic exercise |
Primary outcome
changing of the Quick-DASH, the short form of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: baseline (T0), five weeks (T1), three months (T2), six months (T3)
Assessment of changing of the physical ability and symptoms of the upper extremity
5 secondary outcomes
changing of the Constant-Murley shoulder outcome score
Time frame: baseline (T0), five weeks (T1), three months (T2), six months (T3)
changing of the American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form (ASES) score
Time frame: baseline (T0), five weeks (T1), three months (T2), six months (T3)
changing of the visual analogic scale (VAS)
Time frame: baseline (T0), five weeks (T1), three months (T2), six months (T3)
changing of the visual analogic scale (VAS)
Time frame: baseline (T0), five weeks (T1), three months (T2), six months (T3)
changing of the Likert score
Time frame: baseline (T0), five weeks (T1), three months (T2), six months (T3)
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 7 Feb 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurocognitive therapeutic exercise and Traditional therapeutic exercise in people with Shoulder Impingement Syndrome, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 1 inclusion and 8 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 7 Feb 2013. 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 Italy. 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?
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?
changing of the Quick-DASH, the short form of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire (time frame: baseline (T0), five weeks (T1), three months (T2), six months (T3)). 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 7 Feb 2013.