Predicting the outcome of conservative treatment with physiotherapy for shoulder pain in the presence of atraumatic partial-thickness tears of the rotator cuff
Organizational Data
- DRKS-ID:
- DRKS00004462
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2014-04-08
- Last update in DRKS:
- 2018-09-13
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The primary aim of this study is to investigate potential factors that may predict the outcome of conservative treatment with physiotherapy for patients with shoulder pain and degenerative partial-thickness rotator cuff tears as diagnosed by ultrasonography. The rotator cuff, a deep cuff of four tendons around the shoulder, is often involved in a degenerative process that may culminate in tears. These tears may be partial-thickness or full-thickness. Rotator cuff tears can significantly affect shoulder function and quality of life. The precise indications for different treatment approaches for patients with shoulder-pain and partial-thickness rotator cuff tears are yet unclear: whereas some patients respond very well to conservative treatment including physiotherapy, others respond less well, or respond to surgical treatment. Early identification of likely responders and, by corollary, non-responders to a defined treatment approach could save unneccessary effort and suffering and could help to find the best treatment for the individual patient. This study is an observational study, meaning that we just follow the conservative treatment that is usually receommended to patients with shoulder pain and partial-thickness rotator cuff tears. We expect to find out about a set of factors that are likely to predict response to treatment.
Brief summary in scientific language
The primary aim of this study is to develop a predictive model for the outcome of conservative treatment with physiotherapy for patients with shoulder pain and ultrasonographically diagnosed atraumatic partial-thickness rotator cuff tears. The rotator cuff, a deep cuff of four tendons around the shoulder, is often involved in a degenerative continuum culminating in tears. These tears may be partial-thickness or full-thickness. Rotator cuff tears can significantly affect shoulder function and quality of life. The available research reflects the current uncertainty as to precise indications for different treatment approaches: some patients with PTTs respond well to conservative treatment including physiotherapy, while others respond less well, or respond to surgical treatment. Early identification of likely responders and, by corollary, non-responders to a defined treatment approach could save effort and suffering and could promote the optimal distribution of available resources. This study is a non-interventional prognostic cohort study. We aim to generate a hypothesis and determine a predictive model that represents a set of likely predictors of response to treatment.
Health condition or problem studied
- ICD10:
- M75.1 - Rotator cuff syndrome
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Patients are observed over a three-month period of conservative treatment including physiotherapy (with or without adjunctive medical treatment, e.g. analgetics, injections).
Endpoints
- Primary outcome:
- Patient-reported Health-related Quality of Life (HrQoL)/disability as measured through the validated German version of the Western Ontario Rotator Cuff Index (WORC; Huber et al. 2005); assessment: end of observation period (regular follow-up assessment).
- Secondary outcome:
- - Patient-reported perception of perceived change as measured by a Likert-type "Global perceiced change" scale - Progression of the rotator cuff tear from partial to full-thickness as assessed by ultrasonography; assessment: end of observation period.
Study Design
- Purpose:
- Prognosis
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Doctor's practice Hamburg
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2012-12-05
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2015-01-16
- Target Sample Size:
- 152
- Final Sample Size:
- 70
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Inclusion: • Patients with (local) shoulder pain in the presence of an atraumatic (ultrasonographically detected) partial thickness rotator cuff tear (PTT) • Clinical signs of shoulder impingement (e.g. painful arc, positive impingement signs (e.g. Hawkins-Kennedy)) • Adults ( ≥ 18 years) • No restrictions on gender • Agreement on conservative (i.e. non-surgical) treatment • Ability to speak and comprehend the German language • Agreement to participate (signed informed consent) • Anticipated availability for follow-up (living in area of Hamburg) • Agreement to physiotherapy in one of the collaborating practices.
Exclusion Criteria
Exclusion: • Presence of a full thickness rotator cuff tear (FTT) at the affected shoulder • Previous substantial shoulder trauma (e.g. shoulder dislocation) • Previous surgery for the affected shoulder • Previous surgery in the shoulder area that may be causal of or contributory to the current problem (e.g. surgery for breast cancer) • Clinical or (if available) radiological evidence of structural joint pathology • Significantly restricted passive range of movement (ROM) at the affected shoulder (‘capsulitis-type disorders’); current shoulder infection • Clinical signs of symptomatic acromioclavicular arthritis (e.g. local tenderness, positive provocation tests, e.g. ‘Cross-Body Adduction Stress’ test) • Calcific tendinitis • Ultrasonographic evidence of Long Head of Biceps (LHB) tendon subluxation/ dislocation • Referred pain from the cervical spine region • ‘Multisite musculoskeletal pain’ • Systemic diseases or comorbidities as potential sources of (the current) shoulder pain (e.g. breast cancer, rheumatoid disease), or as impairing treatment (e.g. cancer, cardiac insufficiencies) • Neurological disorders or deficits as potential sources of (the current) shoulder pain or impairing assessment and treatment (e.g. hemiplegic shoulder) • Worker’s compensation claims • Unwillingness or inability to give informed consent (e.g. cognitive or intellectual impairments)
Addresses
Primary Sponsor
- Address:
- Teesside University, School of Health and Social CareProf Paul Keane, Dean, als verantwortliche/betreuende Ins...Centuria BuildingTS1 3BA MiddlesbroughUnited Kingdom
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.tees.ac.uk/schools/soh/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Schulter-Zentrum.comDr. med. Andreas Betthäuserc/o Ev. Krankenhaus Alsterdorf22337 HamburgGermany
- Telephone:
- 04046073550
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://schulter-zentrum.com/
Contact for Public Queries
- Address:
- Schulter-Zentrum.comDr. med. Andreas Betthäuserc/o Ev. Krankenhaus Alsterdorf22337 HamburgGermany
- Telephone:
- 040 460 735 50
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://schulter-zentrum.com/
Principal Investigator
- Address:
- Schulter-Zentrum.comDr. med. Andreas Betthäuserc/o Ev. Krankenhaus Alsterdorf22337 HamburgGermany
- Telephone:
- 04046073550
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://schulter-zentrum.com/
Other contact for public queries
- Address:
- Korrespondenzadresse: c/o Dr. med. Andreas Betthäuser, Schulter-Zentrum.com, Ev. Krankenhaus AlsterdorfCordula BraunElisabeth-Flügge-Str. 122337 HamburgGermany
- Telephone:
- (0049) 0176 999 628 68
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Schulter-Zentrum.comc/o Ev. Krankenhaus Alsterdorf22337 HamburgGermany
- Telephone:
- 040 460 735 50
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Kontaktadresse D: hochschule 21Harburger Str. 622146 BuxtehudeGermany
- Telephone:
- (0049) 0176 999 628 68
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Ärztekammer HamburgWeidestraße 122 b22083 HamburgGermany
- Telephone:
- +49-40-2022990
- Fax:
- +40-40-202299410
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2012-05-20
- Ethics committee number:
- PV4154
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2012-11-09
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Braun et al. 2018, Studienbericht, BMC Musculoskeletal Disorders
- Braun & Handoll 2018 Bericht MID-Analyse, Musculoskeletal Science and Practice
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry