Trial document





This trial has been registered retrospectively.
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  DRKS00004462

Trial Description

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Title

Predicting the outcome of conservative treatment with physiotherapy for shoulder pain in the presence of atraumatic partial-thickness tears of the rotator cuff

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Trial Acronym

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URL of the Trial

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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.

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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.

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Organizational Data

  •   DRKS00004462
  •   2014/04/08
  •   [---]*
  •   yes
  •   Approved
  •   PV4154, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  •   U1111-1155-3740 
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Health Condition or Problem studied

  •   M75.1 -  Rotator cuff syndrome
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Interventions/Observational Groups

  •   Patients are observed over a three-month period of conservative treatment including physiotherapy (with or without adjunctive medical treatment, e.g. analgetics, injections).
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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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).

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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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2012/12/05
  •   152
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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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.

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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)

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Addresses

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    • Teesside University, School of Health and Social Care
    • Mr.  Prof  Paul  Keane, Dean, als verantwortliche/betreuende Institution des PhD von C. Braun (s.u., Studie ist Teil eines PhD (keine finanzielle Förderung)); as responsible/supervising institution of C. Braun's PhD (study is part of a PhD programme (see below, no financial funding)) 
    • Centuria Building
    • TS1 3BA  Middlesbrough
    • United Kingdom
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    • Schulter-Zentrum.com
    • Mr.  Dr. med.  Andreas  Betthäuser 
    • c/o Ev. Krankenhaus Alsterdorf
    • 22337  Hamburg
    • Germany
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    • Schulter-Zentrum.com
    • Mr.  Dr. med.  Andreas  Betthäuser 
    • c/o Ev. Krankenhaus Alsterdorf
    • 22337  Hamburg
    • Germany
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    • Korrespondenzadresse: c/o Dr. med. Andreas Betthäuser, Schulter-Zentrum.com, Ev. Krankenhaus Alsterdorf
    • Ms.  Cordula  Braun 
    • Elisabeth-Flügge-Str. 1
    • 22337   Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Schulter-Zentrum.com
    • Mr.  Dr. med.  Andreas  Betthäuser 
    • c/o Ev. Krankenhaus Alsterdorf
    • 22337  Hamburg
    • Germany
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    •   040 460 735 50
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    • Kontaktadresse D: hochschule 21
    • Ms.  Cordula  Braun 
    • Harburger Str. 6
    • 22146  Buxtehude
    • Germany
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    •   (0049) 0176 999 628 68
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Status

  •   Recruiting complete, follow-up complete
  •   2015/01/16
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Trial Publications, Results and other Documents

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