The Effect of an Evidence-based Physiotherapy Regimen for Patients With Rotator Cuff Tendinopathy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02304003
• Date of registration: 26/11/2014
• Prospective Registration: No
• Primary sponsor: Bergen University College
• Public title: The Effect of an Evidence-based Physiotherapy Regimen for Patients With Rotator Cuff Tendinopathy
• Scientific title: The Effect of an Evidence-based Physiotherapy Regimen for Patients on Need for Subacromial Decompression Surgery Due to Rotator Cuff Tendinopathy : a Randomized Controlled Trial.
• Date of first enrolment: April 2014
• Target sample size: 80
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02304003
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Jan Magnus Bjordal, Professor

• Name: Jan Magnus Bjordal, Professor
• Affiliation: University of Bergen , Dep. of Global Public Health and Primary Care, Physiotherapy Research Group, Norway.

• Name: Sturla Haslerud, Msc

Key inclusion & exclusion criteria

Inclusion Criteria:

Patients on need for surgery ( placed at surgical waiting list at hospital or referred to
surgery by their GP )

1. Typical history with difficulties working with arms elevated over the head, and pain
located in the upper segment of C5 dermatome.

2. Symptom duration of minimum 3 months.

3. Three or more reproducible signs of rotator cuff tendinopathy / subacromial
impingement:

- Positive isometric abduction and/or lateral rotation (Ombregt, Bisschop & Veer,
2003)

- Painful arc during active abduction (Ombregt, Bisschop & Veer, 2003)

- Positive Neers sign (Neer, 1972 ; Tennent, Beach & Meyers, 2003)

- Positive Jobes test (Jobe & Moynes, 1982 ; Tennent, Beach & Meyers, 2003)

- Positive Hawkins-Kennedy impingement test (Hawkins & Kennedy, 1980)

Exclusion Criteria:

1. Shoulder pain due to trauma, e.g. fall.

2. Reduced ROM consistent with adhesive capsulitis/frozen shoulder

3. History in combination with examination and tests (apprehension/relocation), giving
reason to suspect pathological instability

4. Full thickness rupture of rotator cuff tendon

5. OA of the glenohumeral joint, Os acromiale with decreased space of the subacromial
space, previous fractures in the shoulder complex or shoulder surgery on the
symptomatic side.

6. Subjects with other comorbidity: Rheumatological or neurological disease, fibromyalgia
or symptoms from the cervical spine

7. Subjects suffering from serious psychiatric illness.

8. Subjects unable to understand English or Norwegian.

9. Less than 3 positive reproducible sings of rotator cuff pathology / subacromial
disease.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Shoulder Impingement Syndrome

Subacromial Impingement

Tendinopathy

Shoulder Pain

Intervention(s)

Other: Standard Care

Other: Structured Physiotherapy Regimen

Primary Outcome(s)

Shoulder function [Time Frame: 4 weeks , 12 weeks and 6 months]

Need for surgery [Time Frame: 12 weeks (end of treatment) and 6 months post treatment]

Shoulder Pain [Time Frame: 4 weeks , 12 weeks and 6 months]

Generic health status [Time Frame: 12 weeks and 6 months]

Secondary Outcome(s)

Analgesics and corticosteroid injections [Time Frame: 4 weeks , 12 weeks and 6 months]

Patient global impression of change [Time Frame: 4 weeks, 12 weeks & 6 months]

Tendon pain pressure threshold [Time Frame: 12 weeks ( end of treatment )]

Tendon thickness [Time Frame: 12 weeks ( end of treatment )]

Rotator cuff force [Time Frame: 12 weeks ( end of treatment)]

Secondary ID(s)

2012/2134

BergenUC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Bergen