Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01885377
Recruitment Status : Recruiting
First Posted : June 25, 2013
Last Update Posted : November 5, 2018
University Hospital, Linkoeping
Ostergotland County Council, Sweden
Information provided by (Responsible Party):
Kajsa Johansson, Linkoeping University

Brief Summary:

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


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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Shoulder Impingement Syndrome Disorder of Rotator Cuff Subacromial Bursitis Other: Specific exercise group Other: Control exercise group Not Applicable

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 continues during 2019 and data Collection for all follow ups is anticipated to be completed during the year of 2020.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain - a Randomized Clinical Trial
Study Start Date : January 2012
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

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
Other: Specific exercise group
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.
Other: Control exercise group
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:
  • •Movement exercises
  • •Stretching
  • •Posture

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

Other Outcome Measures:
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   30 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01885377

Layout table for location contacts
Contact: Jenny Nordqvist, MSc, RPT +46 10 103 78 22
Contact: Kajsa Johansson, PhD, RPT +46 10 103 74 89

Layout table for location information
Primary Care unit "Rörelse & Hälsa" Recruiting
Linköping, Sweden, 581 85
Principal Investigator: Jenny Norqvist, MSc, RPT         
Sponsors and Collaborators
Linkoeping University
University Hospital, Linkoeping
Ostergotland County Council, Sweden
Layout table for investigator information
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

PMID: 22349588

Layout table for additonal information
Responsible Party: Kajsa Johansson, Senior Lecturer, Linkoeping University Identifier: NCT01885377    
Other Study ID Numbers: 8820 PV-JN-1
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: October 2018
Keywords provided by Kajsa Johansson, Linkoeping University:
Subacromial pain
Physical therapy
Primary care
Additional relevant MeSH terms:
Layout table for MeSH terms
Shoulder Pain
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Signs and Symptoms
Shoulder Injuries
Wounds and Injuries