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Table 1 Schedule of enrolment, interventions, and outcome assessment

From: Effects of adjuvant application of corticosteroid and ozone after ultrasound-guided puncture and lavage for the treatment of rotator cuff calcific tendinitis: study protocol for a non-inferiority randomized controlled trial

 

Study period

Action/timepoint

Enrolment

Intervention phase

Follow- up

1 week

1 month

3 months

6 months

12 months

Eligibility screen

 × 

      

Informed consent

 × 

      

History and physical examination

 × 

      

X-rays

 × 

 

 × 

 

 × 

 

 × 

Randomization

 × 

      

Interventions

 UGPL + steroid injection

 

 × 

     

 UGPL + ozone injection

 

 × 

     

Assessment

 NRS

 × 

 

 × 

 × 

 × 

 × 

 × 

 WORC

 × 

 

 × 

 × 

 × 

 × 

 × 

 UCLASS

 × 

 

 × 

 × 

 × 

 × 

 × 

 DASH

 × 

 

 × 

 × 

 × 

 × 

 × 

 RC-QOL

 × 

 

 × 

 × 

 × 

 × 

 × 

 Calcification absorption

  

 × 

 

 × 

 

 × 

 Multiple treatmentsa

   

 × 

 × 

 × 

 × 

 Adverse events

 

 × 

 × 

 × 

 × 

 × 

 × 

  1. UGPL ultrasound-guided puncture and lavage, NRS numeric rating scale, WORC Western Ontario Rotator Cuff index, UCLASS the University of California at Los Angeles shoulder scale, DASH Disabilities of the Arm, Shoulder and Hand, RC-QOL Rotator Cuff Quality-of-life Messure
  2. aIf required