Slow and Accelerated Rehabilitation Protocols

Condition(s) studied

Investigational drug(s) / intervention(s)

Accelerated (ACCEL) protocol group: After randomization and initial evaluations, patients will be referred to Physiotherapy and Rehabilitation clinics for a 8-week-long Phase 2 and Phase 3 trainings.

Slow (SLOW) protocol group: After randomization and initial evaluations, patients will be referred to Physiotherapy and Rehabilitation clinics for a 14-week-long Phase 2 and Phase 3 trainings.

Study summary

Latissimus dorsi transfer is an established treatment option with favorable results in massive, irreparable rotator cuff tears, however, it is controversial if earlier motion is detrimental or beneficial to the postoperative goal of reduced pain and improved clinical outcomes. Therefore, the aim of this study is to compare the effects of slow and accelerated rehabilitation protocols after latissimus dorsi transfer in massive, irreparable rotator cuff tears.

Eligibility

Primary outcome measure(s)

• Visual analog scale — 14 weeks
  Visual analog scale is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
• The Disabilities of the Arm, Shoulder and Hand Questionnaire — 14 weeks
  The Disabilities of the Arm, Shoulder and Hand Questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. It consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
• American Shoulder and Elbow Surgeons score — 14 weeks
  It is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. Patients can complete the questionnaire in less than five minutes. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
• Western Ontario Rotator Cuff Index — 14 weeks
  It has 21 items in four domains, including physical symptoms (ten questions), sports/recreation/work (four questions), lifestyle (four questions) and emotions (three questions). Raw scores range from 0 to 2100 with a higher score indicating decreased quality of life due to pathological condition of the rotator cuff. Mathematic conversion yields a percentage score; higher percentages indicate proximity to normal function.
• Constant-Murley Shoulder Score — 14 weeks
  Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively. In the original publication, the pain experienced during normal activities of daily living was scored as: no pain = 15 points, mild = 10, moderate = 5 and severe = 0 points.

Trial sites (1)

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