Needling Techniques for Tonifying Kidneys and Dredging Meridians for Knee Osteoarthritis: A Randomized Clinical Trial

Detailed Summary

The thirty-nine-week open-label clinical study investigates the efficacy of acupuncture for Knee Osteoarthritis (KOA) as adjunctive therapy to analgesics compared to analgesics only and assesses the effects after 9 and 24 weeks, with safety assessment provided. The study seeks to find possible additional benefits of acupuncture on Kidney Deficiency (KD) while treating KOA with an acupuncture protocol designed to treat KOA following Traditional Chinese Medicine (TCM) theory, which connects KOA with KD as its root cause. The points prescription uses local and Kidney-related points to treat KOA. The chronic conditions require a higher number of acupuncture treatments. This study will provide acupuncture treatments in three cycles, each three weeks long, with frequency three times weekly. Twenty-seven acupuncture treatments of KOA during fifteen weeks tend to improve KOA and KDS; symptoms are assessed in 10 successive time points, and treatment effects and effect persistence are analysed. 64 patients with symptomatic KOA are randomly allocated into the Acupuncture (A) or Control (C) group according to their permanent, unique, and coincidental Personal Identification Number, which is randomly given to all citizens in Croatia. Before the experiment starts, demographics and disease parameters of all participants are compared. To objectify acupuncture effects, the enrolled physiatrist's measures included knee measures at 3 time points: baseline, at the end of acupuncture (Week 15), and nine weeks later (Week 24). Subjective evaluations of symptoms are assessed by Western Ontario and McMaster University Arthritis Index (WOMAC) total and subscales scores, Numeric Rating Scale (NRS), and Kidney Deficiency Syndrome Questionnaire (KDSQ) every 3 weeks till the 24th week (9 assessments). Analgesics taken by participants (DRUG) in the last three days before the assessments are recorded. Acupuncture treatment was promised to all participants. Therefore, at Week 25, the between-group analysis ended, and the C group crossed over to receive the identical acupuncture protocol. The 10th assessment in Week 39 was used to estimate, by within-group analysis, the immediate effects of the acupuncture in group C and the effect persistence in group A. The Lequesne index was introduced additionally at Week 24 as another measure of the knee's functional state.

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