Degenerative Rotator Cuff Disease With Impingement SyndromePhase 3ADHCISNCT01022775
Dynamic Humeral Centering in Impingement Syndrome
A Phase 3 study testing Dynamic humeral centering and Nonspecific mobilisation in people with Degenerative Rotator Cuff Disease With Impingement Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine wether dynamic humeral centering is effective in patients with impingement syndrome of the shoulder Read more about this study
- Who is it for?
- Ages 31 years and older
- Conditions the study is for
- Degenerative Rotator Cuff Disease With Impingement Syndrome
- What is being tested?
- Dynamic humeral centering and Nonspecific mobilisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2001to Feb 2007
- Phase
- Phase 3
- 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 31 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 30 years
- pain duration > 1 month
- presence of at least 2 positive impingement test results from Neer, Yocum and Hawkins testing
- total Constant score < 80.
Who cannot join
- stiffness
- anteroposterior instability
- tendinous calcification
- corticosteroid injection within the previous 30 days
- previous surgery
- humeral fracture
- inflammatory joint disease
- neoplastic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Dynamic Humeral Centering in Impingement Syndrome: a Randomized Clinical Trial
The purpose of this study is to determine wether dynamic humeral centering is effective in patients with impingement syndrome of the shoulder
Read the detailed description
Clinical trial with randomization for treatment and physiotherapist
- Being tested
- Dynamic humeral centering, Nonspecific mobilisation
- Keywords
- Degenerative rotator cuff disease, Impingement syndrome, Dynamic humeral centering, Randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic humeral centeringProcedure or surgery
Dynamic humeral centering performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months.
Nonspecific mobilisationProcedure or surgery
Nonspecific mobilisation performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| 1: Dynamic humeral centering | Experimental | Dynamic humeral centering performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months. Receives: Procedure: Dynamic humeral centering |
| 2: Nonspecific mobilisation | Active comparator | Nonspecific mobilisation performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months. Receives: Procedure: Nonspecific mobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant total score as a mean and by category
Measured: at 3 months
Secondary outcomes (3)
Constant total score
Measured: at 12 months
Constant subscores for pain, activity, mobility and strength, and self-assessed disability on a 0- to 100-point visual analog scale, and analgesic and nonsteroidal anti-inflammatory drug (NSAID) use
Measured: at 3 months
Constant subscores for pain, activity, mobility and strength, and self-assessed disability on a 0- to 100-point visual analog scale, and analgesic and nonsteroidal anti-inflammatory drug (NSAID) use
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startApr 2001
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Degenerative Rotator Cuff Disease With Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Societe Francaise de Rhumatologie
- Investigators
- Johann BEAUDREUIL, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022775
- Sponsor's protocol ID
- P000203
- Other IDs
- CRC99241
- Acronym
- ADHCIS
- Status last verified
- Nov 2009
- First submitted
- 30 Nov 2009
- Last updated
- 1 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Beaudreuil J, Ostertag A, Lasbleiz S, Vicaut E, Yelnik A, Bardin T, Orcel P. Efficacy of dynamic humeral centering according to Neer test results: a stratified analysis of a randomized-controlled trial. Int J Rehabil Res. 2015 Mar;38(1):81-3. doi: 10.1097/MRR.0000000000000079.
PubMed 25185788Beaudreuil J, Lasbleiz S, Richette P, Seguin G, Rastel C, Aout M, Vicaut E, Cohen-Solal M, Liote F, de Vernejoul MC, Bardin T, Orcel P. Assessment of dynamic humeral centering in shoulder pain with impingement syndrome: a randomised clinical trial. Ann Rheum Dis. 2011 Sep;70(9):1613-8. doi: 10.1136/ard.2010.147694. Epub 2011 May 29.
PubMed 21623001
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dynamic Humeral Centering in Impingement Syndrome: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01022775
- Acronym / sponsor ID
- ADHCIS / P000203
- Keywords
- Degenerative rotator cuff disease, Impingement syndrome, Dynamic humeral centering, Randomized clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Societe Francaise de Rhumatologie
- Study start
- Apr 2001
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 1 Dec 2009 (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.
The purpose of this study is to determine wether dynamic humeral centering is effective in patients with impingement syndrome of the shoulder
Detailed description
Clinical trial with randomization for treatment and physiotherapist
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Dynamic humeral centering | Experimental | Procedure: Dynamic humeral centeringDynamic humeral centering performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months. |
| 2: Nonspecific mobilisation | Active comparator | Procedure: Nonspecific mobilisationNonspecific mobilisation performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months. |
Who may qualify
- Ages
- 31 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 30 years
- pain duration > 1 month
- presence of at least 2 positive impingement test results from Neer, Yocum and Hawkins testing
- total Constant score < 80.
Key exclusion criteria (8 listed)
- stiffness
- anteroposterior instability
- tendinous calcification
- corticosteroid injection within the previous 30 days
- previous 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 |
|---|---|---|
| Dynamic humeral centeringDynamic humeral centering performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months. | Procedure or surgery | 1: Dynamic humeral centering |
| Nonspecific mobilisationNonspecific mobilisation performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months. | Procedure or surgery | 2: Nonspecific mobilisation |
Primary outcome
Constant total score as a mean and by category
Time frame: at 3 months
3 secondary outcomes
Constant total score
Time frame: at 12 months
Constant subscores for pain, activity, mobility and strength, and self-assessed disability on a 0- to 100-point visual analog scale, and analgesic and nonsteroidal anti-inflammatory drug (NSAID) use
Time frame: at 3 months
Constant subscores for pain, activity, mobility and strength, and self-assessed disability on a 0- to 100-point visual analog scale, and analgesic and nonsteroidal anti-inflammatory drug (NSAID) use
Time frame: at 12 months
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 1 Dec 2009.
- Derived from this study: PubMed 25185788Beaudreuil J, Ostertag A, Lasbleiz S, Vicaut E, Yelnik A, Bardin T, Orcel P. Efficacy of dynamic humeral centering according to Neer test results: a stratified analysis of a randomized-controlled trial. Int J Rehabil Res. 2015 Mar;38(1):81-3. doi: 10.1097/MRR.0000000000000079.
- Derived from this study: PubMed 21623001Beaudreuil J, Lasbleiz S, Richette P, Seguin G, Rastel C, Aout M, Vicaut E, Cohen-Solal M, Liote F, de Vernejoul MC, Bardin T, Orcel P. Assessment of dynamic humeral centering in shoulder pain with impingement syndrome: a randomised clinical trial. Ann Rheum Dis. 2011 Sep;70(9):1613-8. doi: 10.1136/ard.2010.147694. Epub 2011 May 29.
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.
Johann BEAUDREUIL, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dynamic humeral centering and Nonspecific mobilisation in people with Degenerative Rotator Cuff Disease With Impingement Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 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 1 Dec 2009. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Constant total score as a mean and by category (time frame: at 3 months). 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 NCT01022775, which also lists 2 linked publications.
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 1 Dec 2009; AzTrials last refreshed its copy on 2 Nov 2026.