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Table 2 Variables, outcome measures and methods of analysis

From: The Strengthening Exercises in Shoulder Impingement trial (The SExSI-trial) investigating the effectiveness of a simple add-on shoulder strengthening exercise programme in patients with long-lasting subacromial impingement syndrome: Study protocol for a pragmatic, assessor blinded, parallel-group, randomised, controlled trial

Variable/outcome

Hypothesis

Outcome measure

Methods of analysis

Primary outcome

Intervention improved outcome

  

  SPADI change Δt0-t3

 

Score 0–100 (continuous)

cLMM

Secondary outcomes

Intervention improved outcome

  

  Abd. MVC change Δt0-t3

 

Nm/kg (continuous)

cLMM

  Ext. rot. MVC change Δt0-t3

 

Nm/kg (continuous)

cLMM

  Abd. total ROM change Δt0-t3

 

Degrees (continuous)

cLMM

  Pain last week change Δt0-t3

 

NRS 0–10 (continuous)

cLMM

  EQ-5D change Δt0-t3

 

Index value (continuous)

cLMM

  Global impression of change, at t3

 

% much improved/fully recovered (binary)

χ2 test

 Pain sensitisation Δt1-t3

   

  Temporal Summation of Pain

 

VAS increase (continuous)

cLMM

  Conditioned Pain Modulation

 

kPa increase (continuous)

cLMM

  Pain Pressure Threshold

 

kPa (continuous)

cLMM

 Scapular involvement

   

  SAT

 

% positive (binary)

χ2 test

  SDT

 

% positive (binary)

χ2 test

Subgroup analyses

   

  Scapula involvement (SAT and SDT yes/no)

Dysfunction modifies the effect of intervention

SPADI score, abduction MVC and external rotation MVC (continuous)

cLMM with interaction term

  Central sensitisation (TS and CPM high vs. low)

CS modifies the effect of intervention

SPADI score, abduction MVC and external rotation MVC (continuous)

cLMM with interaction term

Sensitivity analyses

Intervention improved outcome

Primary outcome

 

  Per protocol analysis

  

cLMM

  Adjusting for baseline

  

cLMM

  1. cLMM constrained linear mixed model, EQ-5D EuroQol 5D-3 L, MVC maximum voluntary contraction, Nm/kg Newton meter per kilo body weight, ROM range of movement, SAT scapula dysfunction, SDT scapula dyskinesia, SPADI Shoulder Pain and Disability Index, VAS visual analogue scale