Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT02610504
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of glenohumeral osteoarthritis
* SPOM score greater than or equal to 50 in study shoulder
* Willing to discontinue oral and topical analgesia other than rescue acetaminophen
* abstinence from any other IA or per-articular injections for the shoulder during the course of the trial
* patients with chronic shoulder pain lasting more than 6 months without clinically significant improvement in pain over the past one month
* pain at least 50% of the days during previous month
* patients who have failed conventional therapy of NSAIDs or steroid injections
* patients with a retained active range of motion of at least 30% in all directions to rule out frozen shoulder
* cooperative and able to communicate effectively
* agree not to participate in any other studies during trial
Exclusion Criteria:
* significant pain from other joints requiring chronic analgesic therapy
* presence of one or more conditions besides OA that could confound pain and functional assessments
* clinically apparent tense effusion, malalignment or instability in study shoulder
* shoulder x-rays of acute fractures, sever loss of bone density, avascular necrosis or severe deformity
* inability to abstain from analgesic use other than rescue acetaminophen
* IA injections of steroids to the study shoulder within 3 months or any other joint within the prior month
* IA injection of hyaluronic acid in the study shoulder within 9 months of baseline
* allergic reaction to HA
* any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion or may compromise pain assessments of shoulder
* uncontrolled hypothyroidism
* pregnant or breastfeeding women
* planned surgical procedure
* history or presence of septic arthritis of study joint or active skin disease or infection in the area of the injection site
* treatment with glucosamine/chondroitin initiated or unstable within 3 months of baseline or change in physical therapy for the study shoulder within 1 month of baseline
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
85 Years
Study:
NCT02610504
Study Brief:
Protocol Section:
NCT02610504