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TREATMENT OF CHRONIC SHOULDER PAIN: INTRA-ARTICULAR INJECTION (IA) OF SOCIUM HYALURONATE (HYALGAN®, HA)

Authors: RD Altman, RW Moskowitz, S Jacobs, M Daley, J Udell, R Levin

References: Osteoarthritis and Cartilage, Volume 13, Supplement A, page S75

Abstract
HA therapy is indicated for the treatment (Rx) of pain of knee osteoarthritis (OA). Based on results of several small studies, we chose to evaluate the potential benefits of IA HA for shoulder pain. Design: DB, randomized, saline-controlled, 6-mo study in patients with chronic shoulder pain: either sex, ³35 yrs of age, with moderate-to-severe unilateral shoulder pain (>0.5, <5 yrs) due to (exam, x-ray, MRI) glenohumeral joint OA, rotator cuff tear (RCT), and/or adhesive capsulitis. On admission, patients had limited range of motion (ROM) and failed to respond adequately to physical therapy, ³1 steroid injection, and analgesics. Patients were stratified into OA (± additional pathologies) and Non-OA. There were 3 Rx groups: 5 weekly IA saline (PBS); 5 weekly IA HA (HA-5); or 3 weekly IA HA followed by 2 weekly IA PBS (HA-3). Primary efficacy outcome in the intent-to-treat (ITT) population was shoulder pain on movement (100-mm visual analog scale, VAS) at 3 mos. Some secondary endpoints included night pain, ROM, and SF-12. Results: For all groups-average age 63 yrs, 37% BMI >30.5, and 50% male. 61% had OA, 2/3 of whom also had RCT (55% partial). For the ITT population (n=602), the overall Rx effect on pain reduction was significant for HA-3 (p=0.036) and HA-5 (p=0.012) vs control over 6 mos using a mixed-effect model. At individual timepoints, significant improvements were seen for the HA-3 group at Wks 17 (p=0.025) and 26 (p=0.005) and for the HA-5 group at Weeks 7 (p=0.011) and 17 (p=0.001). The HA groups were not statistically different from each other. The majority of benefit was seen in OA patients. In OA patients at 3 mos, pain reduction with HA-3 (p=0.051) and HA-5 (p=0.058) vs control, and the overall treatment effect through 6 mos was statistically significant (HA-3: p=0.003 and HA-5: 0.002). The HA-5 OA group demonstrated significant pain reduction at Wks 7 (p=0.001), 9 (p=0.018), 17 (p=0.006), and 26 (p=0.020), and the HA-3 group exhibited significant pain reduction at Weeks 17 (p=0.012) and 26 (p=<0.001). In contrast, neither Non-OA HA group differed significantly from control at 3 mos or in 6-mos overall Rx effect. Secondary outcome measures tended to support the primary outcome. The safety profile was favorable in all groups, with no significant differences observed between groups in adverse event profile and a low incidence (<1%) of injection-site pain.

Conclusion: The results demonstrate that HA-3 or HA-5 injections are efficacious for the Rx of chronic shoulder pain due to OA alone or associated with multiple etiologies, even in patients refractory to standard-of-care, nonsurgical interventions. HA therapy was well tolerated in this elderly population.

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