SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain (SWESS)

August 9, 2022 updated by: Kajsa Johansson, Linkoeping University

SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain - a Randomized Clinical Trial

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Linköping, Sweden, 581 85
        • Primary Care unit "Rörelse & Hälsa"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Specific exercise group
A progressive program of strength-endurance exercises for the rotator cuff and scapula stabilizing muscles combined with mobilization of the joint capsule when needed
A program where exercise load is individually adjusted and the exercises progressed during a 3 month period. The 'pain monitoring model' were used to find the individual resistance. Several exercises are performed eccentrically in order to load more. Initially the exercises were PT-tutored every week and then every other week.
Other Names:
  • •Strength-endurance exercises
  • •Rotator cuff
  • •Scapular stabilization
  • •Eccentric
  • •Posture
Active Comparator: Control exercise group
General movements for the neck and shoulder and self-stretching. No progression some addition of exercises during the three month period.
A program with movements to maintain flexibility in the neck and shoulder muscles. Initially PT-tutored every week and then every other week.
Other Names:
  • •Posture
  • •Movement exercises
  • •Stretching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Constant-Murley shoulder assessment
Time Frame: Baseline and change 3-, 6- and 12 months

Measure a combination of self assessed and clinician assessed items; pain, range-of-motion (flexion and abduction), functional positions (hand in neck as well as hand in back), abduction strength.

The score is summarized to a maximum of 100 for best available shoulder function.

Baseline and change 3-, 6- and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Euro Qol 5D index (EQ 5D)
Time Frame: Baseline and change 3-, 6- and 12 months
Health Related Quality of Life by EuroQol 5 dimensions and index. Measures different items related to heath related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It results in a health-state where an index of 1 is optimal.
Baseline and change 3-, 6- and 12 months
Disabilities of the arm, shoulder and hand
Time Frame: Baseline and change 3-, 6- and 12 months
Self-assessment of the ability to performed exemplified activities. 0 indicates a non-affected upper extremity.
Baseline and change 3-, 6- and 12 months
VAS for pain
Time Frame: Baseline and change 3-, 6- and 12 months
Self-assessed for pain at rest, in activity and at night if it disturbs sleeping
Baseline and change 3-, 6- and 12 months
Patients Global Impression of Change (PGIC)
Time Frame: At follow-up: 3-, 6- and 12 months
The patients are asked to assess change. A scale ranging from getting worse by the intervention to be recovered.
At follow-up: 3-, 6- and 12 months
The Patient Specific functional Scale
Time Frame: Baseline and change 3-, 6- and 12 months
Self-selected functional activities to relate efficacy to during follow-ups.
Baseline and change 3-, 6- and 12 months
Euro Qol VAS (EQ VAS)
Time Frame: Baseline and change 3-, 6- and 12 months
In EQ VAS the patients assess their health state on a vertical line valued from 0-100.
Baseline and change 3-, 6- and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HAD)
Time Frame: Baseline
To screen mental health (depression and/or anxiety) in all included patients. Maximum score is 21 points for the depression and anxiety part respectively. The higher score, the higher risk of a depression and/or anxiety.
Baseline
Sick-leave and return to work or working status
Time Frame: Baseline, 3-, 6- and 12 months
Patient reported can be double checked by the Swedish Social Insurance Agency.
Baseline, 3-, 6- and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Birgitta Öberg, Professor, Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University
  • Study Director: Lars Adolfsson, Professor, Dept. of Orthopaedics, University Hospital Linköping & Linköping University
  • Principal Investigator: Kajsa Johansson, PhD, Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • PMID: 22349588

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2011

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimate)

June 25, 2013

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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