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

NCT ID: NCT02304003

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2022-06-30

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.

Conditions

Tendinopathy; Shoulder Impingement Syndrome; Shoulder Pain; Subacromial Impingement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Structured Physiotherapy regimen

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

Group Type: EXPERIMENTAL

Structured Physiotherapy Regimen

Intervention Type: OTHER

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.

Standard care

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.

Group Type: OTHER

Standard Care

Intervention Type: OTHER

Standard follow up in primary care.

Interventions

Structured Physiotherapy Regimen

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.

Intervention Type: OTHER

Standard Care

Standard follow up in primary care.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

Bergen University College

OTHER

Sponsor Role: lead

Responsible Party

Sturla Haslerud

Sturla Haslerud , PT , Msc Orthopedics & Reumatology , PhD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Magnus Bjordal, Professor

Role: STUDY_CHAIR

University of Bergen , Dep. of Global Public Health and Primary Care, Physiotherapy Research Group, Norway.

Locations

Department of Physiotherapy, Hillevaag General Practitioner Practice

Stavanger, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Jan Magnus Bjordal, Professor

Role: CONTACT

Jan.Bjordal@igs.uib.no

55 58 60 37 ext. 0047

Sturla Haslerud, Msc

Role: CONTACT

shas@hib.no

93424347 ext. 0047

Facility Contacts

Sturla Haslerud, Msc

Role: primary

shas@hib.no

93424347 ext. 0047

Jon Joensen, PhD

Role: backup

jon.joensen@hib.no

55 58 72 31 ext. 0047

Other Identifiers

2012/2134

Identifier Type: OTHER

Identifier Source: secondary_id

BergenUC

Identifier Type: -

Identifier Source: org_study_id