Effectiveness and Safety of Pharmacopuncture Therapy Compared to Standard Physical Therapy in Patients with Chronic Knee Pain: A Pilot Study for a Pragmatic Randomized Controlled Trial.

: There have been a limited number of randomized controlled trials (RCTs) comparing pharmacopuncture therapy (PPT) and physical therapy (PT) for chronic knee pain. In this study, we assess the feasibility, safety, and preliminary effectiveness of PPT compared to PT in patients with chronic knee pain. : This pilot study was designed as a two-arm, parallel RCT. Patients were recruited through in-hospital advertisements. Forty patients aged 19 to 70 with knee pain with a numeric rating scale (NRS) score of 5, persisting for >3 months, were randomized into the PPT or PT group. The type of PT solution or PT method was not determined in advance, leaving it to the clinician's judgment. Treatment was administered twice weekly for 3 weeks with a 6-week follow-up. The primary outcome was the NRS score for knee pain, whereas the secondary outcomes were the visual analog scale (VAS), knee range of motion, Korean Western Ontario and McMaster (K-WOMAC), Patient Global Impression of Change, and five-level EuroQol five-dimension scores. Additionally, adherence, acceptability, dropout rate, and adverse events were measured to assess the feasibility of a follow-up main study. The protocol was registered at ClinicalTrials.gov (NCT06505681). : The PPT group showed significantly superior improvement compared with the PT group in the NRS (difference = -2.05, 95% confidence interval [CI]: -2.76 to -1.34), VAS (difference = -21.58, 95% CI: -29.42 to -13.74), and K-WOMAC scores (difference = -13.17, 95% CI: -21.67 to -4.67). Of the 55 patients who initially expressed interest in participation, 8 declined after receiving detailed information about this study. Among the forty enrolled participants, one patient in the PPT group dropped out, and one missed a single treatment session. Apart from these cases, all participants completed the assigned treatments and follow-up assessments, demonstrating high adherence. No serious adverse events were reported. : PPT demonstrated excellent effectiveness in pain relief and functional improvement in these patients.