Clinical trial NCT02304003: The Effect of an Evidence-based Physiotherapy Regimen for Patients With Rotator Cuff Tendinopathy
Official 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tendinopathy
Shoulder Impingement Syndrome
Shoulder Pain
Subacromial Impingement
Keywords: Shoulder tendinopathy
Subacromial impingement syndrome
Rotator cuff tendinopathy
Supraspinatus tendinopathy
Lead sponsor: Bergen University College
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2014-12-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Need for surgery
timeFrame: 12 weeks (end of treatment) and 6 months post treatment
measure: Shoulder function
timeFrame: 4 weeks , 12 weeks and 6 months
measure: Shoulder Pain
timeFrame: 4 weeks , 12 weeks and 6 months
measure: Generic health status
timeFrame: 12 weeks and 6 months
Secondary outcomes:
measure: Rotator cuff force
timeFrame: 12 weeks ( end of treatment)
measure: Tendon pain pressure threshold
timeFrame: 12 weeks ( end of treatment )
measure: Analgesics and corticosteroid injections
timeFrame: 4 weeks , 12 weeks and 6 months
measure: Tendon thickness
timeFrame: 12 weeks ( end of treatment )
measure: Patient global impression of change
timeFrame: 4 weeks, 12 weeks & 6 months
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Department of Physiotherapy, Hillevaag General Practitioner Practice
Study officials:
affiliation: University of Bergen , Dep. of Global Public Health and Primary Care, Physiotherapy Research Group, Norway.
name: Jan Magnus Bjordal, Professor
role: STUDY_CHAIR
References: