Clinical trial NCT00969501: Three Injections of EUFLEXXA (Sodium Hyaluronate) for Treatment of Chronic Shoulder Pain Associated With Osteoarthritis (OA)
Official title: Investigator Initiated, Exploratory Case Study Three Injections of EUFLEXXA (Sodium Hyaluronate)Treatment of Chronic Shoulder Pain Associated With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Georgia Institute for Clinical Research, LLC
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2009-09-01
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: To demonstrate that EUFLEXXA is safe for the treatment of chronic shoulder pain associated with osteoarthritis.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With a Reduction in Pain by the Scores.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Georgia Institute for Clinical Research, LLC
state: Georgia
Study officials:
affiliation: Georgia Institute for Clinical Research, LLC
name: Arnold J. Weil, M.D.
role: PRINCIPAL_INVESTIGATOR
References: