Three Injections of EUFLEXXA (Sodium Hyaluronate) for Treatment of Chronic Shoulder Pain Associated With Osteoarthritis (OA)
CompletedNot applicableNCT00969501
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The hypothesis of this study is that by using 3 injections of EUFLEXXA, there will be an improvement in pain levels and range of motion.
Study details
- Official title
- Investigator Initiated, Exploratory Case Study Three Injections of EUFLEXXA (Sodium Hyaluronate)Treatment of Chronic Shoulder Pain Associated With Osteoarthritis
- Conditions
- Interventions
- Drug: EUFLEXXA
- Sponsor
- Georgia Institute for Clinical Research, LLC
- Collaborators
- Ferring Pharmaceuticals
- Start date
- 2009-08
- Primary completion
- 2010-08
- Sex
- All
- Age range
- from 30 Years to 79 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Be age 30 to 79 2. Give written informed consent for trial participation 3. Must have shoulder pain for a minimum of 6 months but less than 5 years 4. Must have a Pain Intensity Score of \> 5 5. Must be willing to discontinue all pain medications 24 hours prior to each clinic visit 6. Must have a stable pain medication regime 1 month prior to treatment 7. Agrees to maintain pain medication doses within 30% (increase or decrease) of the Baseline dose Exclusion Criteria: 1. Any history of full thickness rotator cuff tear or joint effusion 2. A diagnosis of chronic acromioclavical disease, active epicondylitis, or active Carpal Tunnel Disease 3. Has had more than 2 corticosteroid injections in the previous 3 months 4. Has an infection or an inflammatory condition of the trial shoulder 5. Has acute or inflammatory arthropathy in the trial shoulder, e.g. gouty arthritis, psoriatic arthritis or rheumatoid arthritis. Has a history of systemic inflammatory arthropathies, e.g. polyarthritis, rheumatoid arthritis, psoriatic arthritis or gout 6. Has severe joint effusion of the trial shoulder 7. Has a diagnosis of cancer within the past 5 years (basal cell carcinoma is not excluded) 8. Has had any hyaluronate agent or other chondroprotective agents in the trial shoulder 9. Has a hypersensitivity to HA products, eggs, birds or feathers 10. Has a history of substance abuse, alcohol abuse or psychiatric condition, that in the opinion of the Investigator, will potentially interfere with participation 11. Has any medical condition that may increase the risk associated with intra-articular injections, to include (but are not limited to): thrombocytopenia, blood disorders treated with warfarin or anticoagulants, anemia or other concomitant diseases that, in the opinion of the Investigator, will interfere with the evaluation of the trial treatment, e.g., renal or liver disease, uncontrolled diabetes, significant cardiovascular, immune deficiency, or infectious disease 12. Is actively involved in a litigation involving Workers' Compensation 13. Is a female that is pregnant, planning to become pregnant or is lactating 14. Has participated in a clinical trial within the past four weeks
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00969501