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

B

Bergen University College

Status

Unknown

Conditions

Shoulder Pain
Subacromial Impingement
Shoulder Impingement Syndrome
Tendinopathy

Treatments

Other: Structured Physiotherapy Regimen
Other: Standard Care

Study type

Interventional

Funder types

Other

Identifiers

NCT02304003
2012/2134 (Other Identifier)
BergenUC

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Structured Physiotherapy regimen
Experimental group
Description:
Heavy-slow resistance training of rotator cuff . Scapular exercises. Manual mobilisation of glenohumeral joint . Stretching. Low Level Laser therapy
Treatment:
Other: Structured Physiotherapy Regimen
Standard care
Other group
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.
Treatment:
Other: Standard Care

Trial contacts and locations

1

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Central trial contact

Sturla Haslerud, Msc; Jan Magnus Bjordal, Professor

Data sourced from clinicaltrials.gov

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