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

Not Applicable

• Conditions: Shoulder Pain; Subacromial Impingement; Tendinopathy; Shoulder Impingement Syndrome

• Registration Number: NCT02304003
• Lead Sponsor: Bergen University College

Brief Summary

Primary aim of this study is to investigate wether an evidence-based physiotherapy regimen is more effective than standard care in patients referred for arthroscopic surgery of the shoulder. It is hypothesized that a multimodal physiotherapy regimen will relieve pain, improve shoulder function and reduce the need for subacromial decompression surgery of the shoulder compared to standard care/wait and see controls.

Detailed Description

There has been a fourfold increase in surgery rates for non-traumatic shoulder disorders , despite increasing evidence demonstrating that there is no difference in effect between physiotherapy based- and surgical interventions. The target population for this study is patients suffering from rotator cuff tendinopathy waiting for subacromial decompression surgery at a university hospital in Norway. During this waiting period , study participants will be randomly assigned to standard follow up or a physiotherapy regimen in primary care. We want to compare the effect of a structured physiotherapy regimen consisting of heavy slow resistance exercises, stretching, manual mobilization and low level laser therapy to standard follow up.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-11-26
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-12-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-23
• Primary Completion: 2021-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Need for surgery	12 weeks (end of treatment) and 6 months post treatment	Dichotomised questionnaire yes or no
Shoulder function	4 weeks , 12 weeks and 6 months	Shoulder Pain and Disability Index. 13 questions. To answer the questions, patients place a mark on a 10 point numerical scale for each question. Verbal anchors for the pain dimension are 'no pain at all' and 'worst pain imaginable', and those for the functional activities are 'no difficulty' and 'so difficult it required help'.
Shoulder Pain	4 weeks , 12 weeks and 6 months	Night pain assessed on a 10 point numerical scale . Pain now and this week measured on a 10 point numerical scale .
Generic health status	12 weeks and 6 months	EQ-5D questionaire. The system comprises the following 5 dimensions: mobility, self-care, usual activities,pain and anxiety/depression. he respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.

Secondary Outcome Measures

Name	Time	Method
Rotator cuff force	12 weeks ( end of treatment)	Maximal painfree isometric force measurements of rotator cuff muscles using handheld dynamometry .
Tendon thickness	12 weeks ( end of treatment )	Ultrasonography measurements of rotator cuff tendon thickness ( subscapularis , supraspinatus , infraspinatus , biceps )
Analgesics and corticosteroid injections	4 weeks , 12 weeks and 6 months	Analgesics consumption and corticosteroids injections registered on questionaire.
Patient global impression of change	4 weeks, 12 weeks & 6 months	To assess global improvement a 7 point categorical scale ranging from " much better to much worse" is used.
Tendon pain pressure threshold	12 weeks ( end of treatment )	Tendon pressure applied over individual rotator cuff tendons with analogue algometer. Pain threshold registered in kilograms.

Trial Locations

Locations (1)

Department of Physiotherapy, Hillevaag General Practitioner Practice; 🇳🇴 Stavanger, Norway