A protocol for a randomized clinical trial assessing the efficacy of hypertonic dextrose injection (prolotherapy) in chronic ankle instability

• Published in: Current controlled trials in cardiovascular medicine 2022-12, Vol.23 (1), p.1063-9, Article 1063
• Main Authors: Sit, Regina Wing Shan, Wu, Ricky Wing Keung, Ling, Samuel Ka Kin, Wang, Bo, Chan, Dicken Cheong Chun, Yip, Benjamin Hon Kei, Wong, Samuel Yeung Shan, Reeves, Kenneth Dean, Rabago, David
• Format: Article
• Language: English
• Subjects: Ankle; Ankle Injuries - diagnosis; Ankle Injuries - drug therapy; Ankle Joint; Arthritis; Chronic ankle instability; Chronic Disease; Clinical trials; Data collection; Exercise; Glucose - adverse effects; Humans; Hypertonic dextrose injection; Injuries; Joint Instability - diagnosis; Joint Instability - drug therapy; Ligaments; Osteoarthritis; Physical fitness; Postural Balance; Primary care; Prolotherapy; Quality of life; Randomized Controlled Trials as Topic; Treatment Outcome; Ultrasonic imaging
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-022-07037-7

Lateral ankle sprain (LAS) is a common injury. Conservative care is not uniformly effective. Chronic ankle instability (CAI) results in up to 70% of patients with LAS in the physically active population. LAS, together with subsequent osteochondral lesions and pain in many patients, leads to the development of post-traumatic osteoarthritis, resulting in a substantial direct and indirect personal and societal health burden. Dextrose prolotherapy (DPT) is an injection-based therapy for many chronic musculoskeletal conditions but has not been tested for CAI. This protocol describes a randomized controlled trial to test the efficacy of DPT versus normal saline (NS) injections for chronic ankle instability (CAI). A single-center, parallel-group, randomized controlled trial will be conducted at a university-based primary care clinic in Hong Kong. A total of 114 patients with CAI will be randomly allocated (1:1) to DPT and NS groups. The primary outcome will be the Cumberland Ankle Instability Tool scores at 1 year. The secondary outcomes will be the number of re-sprains in 1 year, the Star Excursion Balance Test, the 5-level of EuroQol 5-dimension questionnaire, and the Foot and Ankle Ability Measure. All outcomes will be evaluated at baseline and at 16, 26, and 52 weeks using a linear mixed model. We hypothesized the DPT is a safe, easily accessible, and effective treatment for patients with CAI. This RCT study will inform whether DPT could be a primary non-surgical treatment for CAI. Chinese Clinical Trial Registry ChiCTR2000040213 . Registered on 25 November 2020.