Strengthening Exercises in Shoulder Impingement (SExSI) Trial
Condition: Subacromial Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome
Study type: Interventional

Summary: 
      This study evaluates the addition of a high dose of simple home-based elastic band
      strengthening exercises to usual care in patients with subacromial impingement syndrome. Half
      of the participants receive instructions in simple home-based elastic band strengthening
      exercises in addition to usual care, while the other half receive usual care.
    

Detailed description: 
      The SEXSI trial is a pragmatic, assessor and participant blinded, randomized, controlled,
      superiority trial, with a two-group parallel design. Patients with subacromial impingement
      syndrome will be randomized to either usual care or a home-based intervention consisting of
      progressive high volume resistance training in addition to usual care using a 1:1 allocation.
      The primary end-point will be change in the Shoulder Pain and Disability Index (SPADI) 16
      weeks after baseline.

      The overall frame for the trial is a main clinical effectiveness-part and an embedded
      mechanistic part. The clinical effectiveness-part will be reported in the main trial paper,
      and include the following outcomes: SPADI (primary outcome), Abduction strength, External
      rotation strength, Abduction ROM, Pain last week, QoL-index, QoL-VAS, Global impression of
      change and PASS. Missing outcome data will be imputed using multiple imputations based on the
      following variables: All previous scores in the relevant outcome, Age, Gender and Allocation.

      A full trial protocol will be published and made publicly available. A constrained Linear
      Mixed Model (cLMM) will be applied for all continuous outcomes with Time Frame 16 weeks
      (including the primary outcome), to compare the change from baseline to 16 weeks in the
      intervention group (IG) to that in the control group (CG). The outcome at 16 weeks will be
      included as dependent variable, treatment group (IG or CG) as main effect and both baseline
      score and any additional follow up measurements as repeated measurements. The covariance
      structures will be selected based on the MAICE procedure. Binary outcomes will be reported as
      proportions with corresponding 95% confidence intervals, and will be compared using
      Chi-squared tests, and Odds Ratios computed from random effects logistic regression models.
      All of these analyses will be conducted as intention to treat (ITT) analyses, including all
      randomized participants, regardless of protocol adherence, meaning that all participants will
      be analysed as randomized. In the primary trial report, all collected outcomes will be
      listed, and it will be stated that the below-mentioned variables - belonging to the
      mechanistic part - will be reported in secondary publications.

      The mechanistic part will be reported in secondary papers with a clear reference to the
      primary trial and trial registration, and it will hold the label "secondary analyses from a
      pragmatic randomized controlled trial" in the title. The following outcomes will be reported:

      Outcomes regarding pain sensitization (temporal summation of pain, conditioned pain
      modulation, pain pressure threshold and pain catastrophizing) will be reported in a
      subsequent paper where we also plan to investigate:

        -  the modifying effects of pain sensitization on the effectiveness of the add-on
           intervention

        -  the dose-response relationship between objectively monitored adherence to the add-on
           intervention and change in SPADI, shoulder abduction strength and external rotation
           strength

        -  the dose-response relationship between pain sensitization and change in SPADI, shoulder
           abduction strength and external rotation strength, and to what degree this is mediated
           through adherence to the intervention.

      Outcomes regarding scapula dyskinesia and scapula dysfunction will be reported in another
      subsequent paper, were we also plan to investigate the modifying effects of scapula
      dyskinesia and scapula dysfunction on the effectiveness of the intervention on changes in
      SPADI, abduction strength and external rotation strength.
    

Intervention name(s): Strengthen your Shoulder; Usual Care
Intervention type(s): Other; Other
Intervention description(s): A simple home-based elastic band strengthening exercise intervention. This program consists of progressive high volume resistance training exercises with an elastic band.; Usual care, consisting of a referral to general rehabilitation in the municipal under the Danish Health Act § 140, most often with the alternative option to choose a private physiotherapeutic clinic, partly at their own expense. Also includes any additional treatment the patient receives between baseline and follow-up, except that included in "Strengthen your Shoulder".
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: "Shoulder Impingement Syndrome"[Mesh]; "Rehabilitation"[Mesh]; "Exercise"[Mesh]; "Rotator Cuff"[Mesh]