SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain
Condition: Shoulder Pain; Shoulder Impingement Syndrome; Disorder of Rotator Cuff; Subacromial Bursitis
MeSH terms: Shoulder Pain; Shoulder Impingement Syndrome; Bursitis
Study type: Interventional

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.
    

Intervention name(s): Specific exercise group; Control exercise group
Intervention type(s): Other; Other
Intervention description(s): 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.; A program with movements to maintain flexibility in the neck and shoulder muscles. Initially PT-tutored every week and then every other week.
Other intervention name(s): •Strength-endurance exercises; •Rotator cuff; •Scapular stabilization; •Eccentric; •Posture; •Movement exercises; •Stretching; •Posture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Subacromial pain; Impingement; Exercises; Physical therapy; Primary care