An observational study in Rotator Cuff Tear, sponsored by Vanderbilt University. Completed at 9 sites in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-16.
Sponsored by Vanderbilt University · Observational
The goal of this study is to find which patients will improve with the nonsurgical treatment of physical therapy for the treatment of rotator cuff tears.
Rotator cuff tears are found in up to 40% of people over the age of 50 with the prevalence increasing with age. While most people remain asymptomatic, it is unknown why some develop symptoms. In symptomatic patients, surgical repair of a torn rotator cuff fails in 30-50% of patients, yet the majority of patients have a significant reduction pain despite failure of the repair. Nonoperative treatment has reported successful outcomes in 25-82% of patients yet it is not known which patient-related features predict success with nonoperative treatment. The general aim of this research effort is to identify patient features (historical information, physical examination findings, and MRI-based pathology) that would predict success (defined by reduction in visual analog pain scale, and patient satisfaction) with the nonoperative treatment of rotator cuff tears. The proposed study design is a prospective cohort study of patients with rotator cuff tears who will follow a standard physical therapy program derived from an evidence based medicine (EBM) systematic review of Level 1 and Level 2 studies.
Study the effect of historical information on predicting success (as determined by pain relief and patient satisfaction) of nonoperative treatment using the EBM based physical therapy program in treating patients with rotator cuff tears.
Study the effect of physical examination findings on predicting success of a nonoperative treatment using the EBM-based physical therapy program in treating patients with rotator cuff tears.
Study the effect of the severity of the rotator cuff pathology (using standardized magnetic resonance imaging protocols) on predicting success of nonoperative treatment for patients with rotator cuff tears using the EBM-based physical therapy program.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's enrollment of 452 is above the median of 67 across 162 observational studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults between the ages of 18-100 with full thickness rotator cuff tears.
Note: Criteria to obtain a shoulder MRI to evaluate for rotator cuff tear [Appendix D]:
Exclusion Criteria:
Glenohumeral arthritis (meets ≥ 1 of below criteria)
Patients with full thickness rotator cuff tears being treated with physical therapy
Predict successful outcome with an evidence-based, non-operative treatment program by collecting VAS Pain Scale and SANE score.
Time frame: One year
Predict success of non-operative treatment outcomes with other patient related validated instruments (SF-12, ASES, WORC, Marx Activity Scale)
Time frame: One Year
Plan to share: Yes — De Identified data from this cohort is only available to members of the MOON Shoulder Consortium. The member must provide a description of the use of the data to the research coordinator. The data request is then presented to the MOON consortium. A unanimous agreement of the plan by the consortium must be received prior to receiving the data.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt University