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.

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

Sponsors

Lead sponsor: Bergen University College

Collaborator: University of Bergen

Source 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.

Overall Status Recruiting
Start Date April 2014
Completion Date June 2022
Primary Completion Date June 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Need for surgery 12 weeks (end of treatment) and 6 months post treatment
Shoulder function 4 weeks , 12 weeks and 6 months
Shoulder Pain 4 weeks , 12 weeks and 6 months
Generic health status 12 weeks and 6 months
Secondary Outcome
Measure Time Frame
Rotator cuff force 12 weeks ( end of treatment)
Tendon pain pressure threshold 12 weeks ( end of treatment )
Analgesics and corticosteroid injections 4 weeks , 12 weeks and 6 months
Tendon thickness 12 weeks ( end of treatment )
Patient global impression of change 4 weeks, 12 weeks & 6 months
Enrollment 80
Condition
Intervention

Intervention type: Other

Intervention name: Structured Physiotherapy Regimen

Description: Experimental group will be treated with heavy-slow resistance exercises targeted at the rotator cuff tendons, and exercises to improve scapular stability and strength. Glenohumeral mobilisation techniques and and stretching of glenohumeral capsule and pectoralis minor. Rotator cuff tendons and glenohumeral synovia will be irradiated with low level laser according to WALT dosage recommendations . Intervention period is 12 weeks. Three weekly treatment sessions at 0-3 weeks. 4-12 weeks one treatment session weekly , and two days of home-exercise per week.

Arm group label: Structured Physiotherapy regimen

Intervention type: Other

Intervention name: Standard Care

Description: Standard follow up in primary care.

Arm group label: Standard care

Eligibility

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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jan Magnus Bjordal, Professor Study Chair University of Bergen , Dep. of Global Public Health and Primary Care, Physiotherapy Research Group, Norway.
Overall Contact

Last name: Jan Magnus Bjordal, Professor

Phone: 55 58 60 37

Phone ext: 0047

Email: [email protected]

Location
facility status contact contact_backup
Department of Physiotherapy, Hillevaag General Practitioner Practice Recruiting Sturla Haslerud, Msc 93424347 0047 [email protected]
Location Countries

Norway

Verification Date

August 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Bergen University College

Investigator full name: Sturla Haslerud

Investigator title: Sturla Haslerud , PT , Msc Orthopedics & Reumatology , PhD candidate

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Structured Physiotherapy regimen

Arm group type: Experimental

Description: Heavy-slow resistance training of rotator cuff . Scapular exercises. Manual mobilisation of glenohumeral joint . Stretching. Low Level Laser therapy

Arm group label: Standard care

Arm group type: Other

Description: Standard care offered in primary care while waiting for surgery , this may be but are not limited to : Wait and see, Drugs ( NSAIDS ), Corticosteroid injections, physiotherapy or other conservative treatment options.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov