For this study, a patient must be able to voluntarily provide informed consent for him/herself. A guardian or family member cannot give consent on behalf of a patient. If a patient has a legal guardian or a conservator for medical decisions, they should be excluded from the study. In some cases, a physician or family [...]
The patient must be able to complete the study questionnaires in English because the standardized questionnaires are only validated in English. If the patient requires a translator, they should be excluded from the study. Otherwise, you should assess the patient’s language comprehension skills as you speak with them. If you believe the patient can communicate [...]
No, the study will only pay for a research MRI – for patients who meet the criteria above in "Which patients may be offered an initial research MRI."
At enrollment, research MRIs are intended solely/specifically for the purpose of determining if a patient is eligible for the trial. They may be offered at the discretion of the treating physician, as appropriate. Research MRIs (if available at a recruiting site) should only be offered to patients who: (1) meet all pre-MRI eligibility criteria, (2) [...]
Is there an “expiration date” for MRIs used to establish eligibility for the trial? For example, what if a patient comes in with an MRI that was done six months ago or longer?
There is no pre-determined time point at which MRIs are “too old.” This will be a clinical determination made by the treating physician. The key question is whether, in the physician’s judgment, the MRI in question accurately represents the patient’s current symptoms. If so, then that MRI may be used to determine eligibility for the [...]
No, this is a pragmatic trial. So, the standard clinical MRI a patient would normally receive, as read by their treating physician, is sufficient to determine if the patient meets the MRI & post-MRI eligibility criteria for the study.
Do patients need to have been symptomatic (experiencing pain/ reduced function) for a minimum amount of time?
No. There is no minimum amount of time for patients to have been experiencing symptoms in order to be eligible for participation in the study.
No. Patients may only be enrolled in the trial for one shoulder. If a patient has MRI-confirmed tears of ≤ 4cm in both shoulders at the time of enrollment, they should be enrolled for the shoulder with the larger tear (unless MD advises otherwise). Treatment for the enrolled shoulder would be randomly assigned. The patient [...]
It depends on what kind of study the patient is already participating in. If it is not related to their shoulder or does not interfere with their shoulder treatment, then the answer is likely yes. (Use your best judgment.) If you are unsure or have questions on this front, contact ARC coordinating center personnel for [...]
Can a patient who is currently having or has already had physical therapy for the affected shoulder take part in the ARC trial?
Yes. Previous physical therapy for their shoulder does not prevent a patient from participating in the trial (if they have not previously followed the ARC physical therapy protocol). However, they would still have a 50-50 chance of being randomized to either treatment. So long as the patient is ok with receiving more physical therapy (without [...]