CompletedNot Applicable

Psychosocial Factors, Lifestyle and Central Pain Processing as Potential Predictors of Outcome for Rotator Cuff Repair

Switzerland142 participantsStarted 2019-01-01

Plain-language summary

The influence of modifiable psychosocial and lifestyle factors and the role of central pain processing (CPP) on outcome after rotator cuff repair (RCR) is not well enough established to formulate holistic prognosis. Modern pain neuroscience emphasises to explain musculoskeletal shoulder pain biopsychosocially, which seems short when looking at the yearly RCR increase. This study will explore modifiable psychosocial and lifestyle factors and CPP as potential predictors for outcome after RCR.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Scheduled for elective arthroscopic RCR; * First time RCR on the target shoulder; * Completed primary and secondary outcome measures (Western Ontario Rotator Cuff Index (WORC), Constant Score, Maximum Pain on Numeric Rating Scale and EQ-5D-5L) from daily routine. Exclusion Criteria: * Changes of intra operative procedure (e.g. anything but RCR) * Re-repair of tendon; * No surgery; * Other pain-related or neurological comorbidities that could interfere with pain measures;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Western Ontario Rotator Cuff Index (WORC) change from preOP to 12 weeks postOP and preOP to 12months postOP

Timeframe: pre operative (T1), 12 Weeks postoperative (T2), 12 months postoperative (T3)

Trial details

NCT IDNCT04946149

SponsorKantonsspital Winterthur KSW

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-05-10

View on ClinicalTrials.gov More Rotator Cuff Tear or Rupture, Not Specified as Traumatic trials