PURPOSE:Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis. METHODS:Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used. RESULTS: No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P <.01) at 52 weeks. Adjusted for sex, age, and body mass index, WOMAC scores for patients receiving dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events. CONCLUSIONS:Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises.
RCT Entities:
PURPOSE:Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis. METHODS: Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used. RESULTS: No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P <.01) at 52 weeks. Adjusted for sex, age, and body mass index, WOMAC scores for patients receiving dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events. CONCLUSIONS: Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises.
Authors: Brian M Berman; Lixing Lao; Patricia Langenberg; Wen Lin Lee; Adele M K Gilpin; Marc C Hochberg Journal: Ann Intern Med Date: 2004-12-21 Impact factor: 25.391
Authors: D T Felson; R C Lawrence; P A Dieppe; R Hirsch; C G Helmick; J M Jordan; R S Kington; N E Lane; M C Nevitt; Y Zhang; M Sowers; T McAlindon; T D Spector; A R Poole; S Z Yanovski; G Ateshian; L Sharma; J A Buckwalter; K D Brandt; J F Fries Journal: Ann Intern Med Date: 2000-10-17 Impact factor: 25.391
Authors: David Rabago; Richard Kijowski; Michael Woods; Jeffrey J Patterson; Marlon Mundt; Aleksandra Zgierska; Jessica Grettie; John Lyftogt; Luke Fortney Journal: Arch Phys Med Rehabil Date: 2013-07-10 Impact factor: 3.966
Authors: David Rabago; Laura van Leuven; Lane Benes; Luke Fortney; Andrew Slattengren; Jessica Grettie; Marlon Mundt Journal: J Altern Complement Med Date: 2016-09-07 Impact factor: 2.579
Authors: Regina Wing Shan Sit; Ricky Wing Keung Wu; David Rabago; Kenneth Dean Reeves; Dicken Cheong Chun Chan; Benjamin Hon Kei Yip; Vincent Chi Ho Chung; Samuel Yeung Shan Wong Journal: Ann Fam Med Date: 2020-05 Impact factor: 5.166