Clinical trial NCT01885377: SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain
Official title: SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Shoulder Impingement Syndrome
Disorder of Rotator Cuff
Subacromial Bursitis
Keywords: Subacromial pain
Impingement
Exercises
Physical therapy
Primary care
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital, Linkoeping
name: Ostergotland County Council, Sweden
First posted: 2013-06-25
Enrollment: 164
Sex: ALL
Minimum age (years): 30
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: A randomized clinical trial in order to evaluate the efficacy of a specific exercise strategy for patients with subacromial pain.

Hypothesis:

H1 - The three month specific exercise strategy has a satisfactory effect improving shoulder function and/or shoulder pain.

H0 - No difference between the two exercise strategies (specific exercise strategy and active control exercises).

Method: Patients attending primary care with subacromial pain are offered participation. If accepted, they will participate in a three month rehabilitation program. The duration of symptoms can vary from 2 weeks and longer. The patients will be randomized to either rehabilitation; the specific exercise strategy or active control exercises. All patients has an equal number of sessions with the physical therapist (PT) to offer similar attention and support with exercise performance. A blinded physical therapist evaluates the following outcomes at baseline and after three-, six and twelve months:

Primary outcomes: Constant-Murley shoulder assessment (CM-score). Secondary outcomes; Disabilities of the Arm Shoulder and Hand questionnaire (DASH), different aspects of pain by Visual Analogue Scale (VAS), EuroQol-5D index (EQ-5D) and EuroQol-VAS (EQ-VAS), The Patient Specific functional Scale, and Patients' global impression of change (PGIC). Also sick-leave and return to work will be recorded. All patients are evaluated with a diagnostic ultrasound to reveal the status of the rotator cuff.

Additional to the analysis of treatment effect on shoulder function and pain, factors influencing and explaining the CM-score at follow-ups will be analyzed.

This study is warranted in order to evaluate if an earlier reported positive effect on shoulder function and pain with the specific exercise strategy, in patients on waiting list for subacromial decompression, can be repeated in the primary care population of patients with subacromial pain. There is no consensus about first-line exercises for patients with subacromial pain, and these positive results on pain and shoulder function need to be reproduced in primary care before they can be recommended and implemented. Further, knowledge about which factors that can be used in prediction rules for patients that will respond to the exercises or needs surgery is lacking.

Detailed description: This study will be reopened and will continue the inclusion due to underpowered results.

A new application to the Ethical committee was submitted. Approval to reopen this RCT-study was received at 27th of September 2018 (dnr 218/445-32).

Additional inclusion of 40 additional patients will start at 1th of November 2018. Data from baseline to 12 months follow-up (as described in protocol) will be collected. Inclusion continued and the last inklusion was completed in February 2020. Data Collection for all follow ups is anticipated to be completed at latest during March the year of 2021.

Eligibility criteria: Inclusion Criteria:

* At least 2 weeks of symptom duration
* Typical history and pain location (C5 dermatome)

Three of these four must be positive:

* Neer impingement sign
* Hawkins-Kennedy impingement sign
* Jobe supraspinatus test
* Patte maneuver

Exclusion Criteria:

* Polyarthritis or fibromyalgia
* Pathological hyper-laxity or dislocation of the any of the shoulder joints
* Cervical spine pathology
* Lack of communication skills that prevent the use of outcome measures
* Signs in ultrasound of bone spurs i.e. Acromio-Clavicular joint, that will affect the subacromial space

Primary outcomes:
measure: The Constant-Murley shoulder assessment
timeFrame: Baseline and change 3-, 6- and 12 months
Secondary outcomes:
measure: Euro Qol 5D index (EQ 5D)
timeFrame: Baseline and change 3-, 6- and 12 months
measure: Disabilities of the arm, shoulder and hand
timeFrame: Baseline and change 3-, 6- and 12 months
measure: VAS for pain
timeFrame: Baseline and change 3-, 6- and 12 months
measure: Patients Global Impression of Change (PGIC)
timeFrame: At follow-up: 3-, 6- and 12 months
measure: The Patient Specific functional Scale
timeFrame: Baseline and change 3-, 6- and 12 months
measure: Euro Qol VAS (EQ VAS)
timeFrame: Baseline and change 3-, 6- and 12 months
Other outcomes:
measure: Hospital Anxiety and Depression Scale (HAD)
timeFrame: Baseline
measure: Sick-leave and return to work or working status
timeFrame: Baseline, 3-, 6- and 12 months
Locations:
city: Linköping
country: Sweden
facility: Primary Care unit "Rörelse & Hälsa"
Study officials:
affiliation: Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University
name: Birgitta Öberg, Professor
role: STUDY_CHAIR
affiliation: Dept. of Orthopaedics, University Hospital Linköping & Linköping University
name: Lars Adolfsson, Professor
role: STUDY_DIRECTOR
affiliation: Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University
name: Kajsa Johansson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: PMID: 22349588