Three Injections of EUFLEXXA (Sodium Hyaluronate) for Treatment of Chronic Shoulder Pain Associated With Osteoarthritis (OA)
Investigator Initiated, Exploratory Case Study Three Injections of EUFLEXXA (Sodium Hyaluronate)Treatment of Chronic Shoulder Pain Associated With Osteoarthritis
  • Phase

  • Study Type

  • Study Participants

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.
To demonstrate that EUFLEXXA is safe for the treatment of chronic shoulder pain associated with osteoarthritis.
Study Started
Aug 31
Primary Completion
Aug 31
Study Completion
Aug 31
Results Posted
May 07
Last Update
May 07


2.5 mL of EUFLEXXA (per injection) x 3 injections

EUFLEXXA Experimental



Inclusion Criteria:

Be age 30 to 79
Give written informed consent for trial participation
Must have shoulder pain for a minimum of 6 months but less than 5 years
Must have a Pain Intensity Score of > 5
Must be willing to discontinue all pain medications 24 hours prior to each clinic visit
Must have a stable pain medication regime 1 month prior to treatment
Agrees to maintain pain medication doses within 30% (increase or decrease) of the Baseline dose

Exclusion Criteria:

Any history of full thickness rotator cuff tear or joint effusion
A diagnosis of chronic acromioclavical disease, active epicondylitis, or active Carpal Tunnel Disease
Has had more than 2 corticosteroid injections in the previous 3 months
Has an infection or an inflammatory condition of the trial shoulder
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
Has severe joint effusion of the trial shoulder
Has a diagnosis of cancer within the past 5 years (basal cell carcinoma is not excluded)
Has had any hyaluronate agent or other chondroprotective agents in the trial shoulder
Has a hypersensitivity to HA products, eggs, birds or feathers
Has a history of substance abuse, alcohol abuse or psychiatric condition, that in the opinion of the Investigator, will potentially interfere with participation
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
Is actively involved in a litigation involving Workers' Compensation
Is a female that is pregnant, planning to become pregnant or is lactating
Has participated in a clinical trial within the past four weeks



All Events

Event Type Organ System Event Term

Number of Participants With a Reduction in Pain by the Scores.

Greater than 50 percent reduction in pain scores from baseline.



Age Continuous

years (Mean)
Standard Deviation: 1

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study