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

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ClinicalTrials.gov Identifier: NCT01885377
Recruitment Status : Recruiting
First Posted : June 25, 2013
Last Update Posted : November 5, 2018
Sponsor:
Collaborators:
University Hospital, Linkoeping
Ostergotland County Council, Sweden
Information provided by (Responsible Party):
Kajsa Johansson, Linkoeping University

Tracking Information
First Submitted Date  ICMJE June 18, 2013
First Posted Date  ICMJE June 25, 2013
Last Update Posted Date November 5, 2018
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01885377 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 20, 2013)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain
Official Title  ICMJE SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain - a Randomized Clinical Trial
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 continues during 2019 and data Collection for all follow ups is anticipated to be completed during the year of 2020.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Shoulder Pain
  • Shoulder Impingement Syndrome
  • Disorder of Rotator Cuff
  • Subacromial Bursitis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Other: Specific exercise group
  • 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.
    Intervention: Other: Control exercise group
Publications * PMID: 22349588

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
167
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2013)
100
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 67 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jenny Nordqvist, MSc, RPT +46 10 103 78 22 jenny.nordqvist@liu.se
Contact: Kajsa Johansson, PhD, RPT +46 10 103 74 89 kajsa.johansson@liu.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01885377
Other Study ID Numbers  ICMJE 8820 PV-JN-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kajsa Johansson, Linkoeping University
Study Sponsor  ICMJE Linkoeping University
Collaborators  ICMJE
  • University Hospital, Linkoeping
  • Ostergotland County Council, Sweden
Investigators  ICMJE
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
PRS Account Linkoeping University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP