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

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00004462
• Date of registration: 08/04/2014
• Prospective Registration: No
• Primary sponsor: Teesside University, School of Health and Social Care
• Public title: Predicting the outcome of conservative treatment with physiotherapy for shoulder pain in the presence of atraumatic partial-thickness tears of the rotator cuff
• Scientific title: Predicting the outcome of conservative treatment with physiotherapy for shoulder pain in the presence of atraumatic partial-thickness tears of the rotator cuff
• Date of first enrolment: 05/12/2012
• Target sample size: 152
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00004462
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: Prognosis

Countries of recruitment

Germany

Contacts

• Name: Andreas Betthäuser
• Affiliation: Schulter-Zentrum.com

• Name: Cordula Braun
• Affiliation: Korrespondenzadresse: c/o Dr. med. Andreas Betthäuser, Schulter-Zentrum.com, Ev. Krankenhaus Alsterdorf

Key inclusion & exclusion criteria

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)

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

M75.1

M75.1

Rotator cuff syndrome

Intervention(s)

Group 1: Patients are observed over a three-month period of conservative treatment including physiotherapy (with or without adjunctive medical treatment, e.g. analgetics, injections).

Primary Outcome(s)

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(s)

- 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.

Secondary ID(s)

U1111-1155-3740

Source(s) of Monetary Support

Schulter-Zentrum.com

Kontaktadresse D: hochschule 21

Ethics review

Status: Approved
Approval date: 09/11/2012
Contact:

[e-mail]

Ethik-Kommission der Ärztekammer Hamburg

[phone]

[e-mail]

Results

• Date Completed: 16/01/2015
• URL: http://drks.de/search/en/trial/DRKS00004462#studyResults