Efficacy Evaluation of Red Stove Tendon - Regulating Therapy Combined with Diclofenac Sodium in the Treatment of Lumbar Muscle Strain

Abstract

Objective: This randomized controlled trial aimed to assess whether combining Red Stove Tendon - Regulating Therapy with oral diclofenac sodium yields superior pain relief and functional recovery compared to either monotherapy in patients with lumbar muscle strain. Methods: In this randomized, parallel-group trial, 120 patients with lumbar muscle strain were enrolled and assigned (1:1:1) to receive either Red Stove Tendon - Regulating Therapy alone (RC group, n=40), oral diclofenac sodium alone (DS group, n=40), or their combination (Combination group, n=40) for 7 consecutive days. The primary outcomes were changes in Visual Analog Scale (VAS) for pain, Oswestry Disability Index (ODI), and Quebec Back Pain Disability Scale (QBPDS) scores, assessed at baseline, and at 1 week, 1 month, and 3 months post-treatment. Adverse events were monitored throughout the study eriod. Results: All three groups showed significant improvements over time (all P < 0.05). However, the Combination group demonstrated consistently superior outcomes at all follow-up time points. At 3 months, the mean VAS score in the Combination group was 1.5±0.4, compared to 2.8±0.5 in the RS group and 3.0±0.6 in the DS group (P < 0.05 for both). Similarly, ODI and QBPDS scores were significantly lower in the Combination group (P < 0.05). The overall patient satisfaction rate was highest in the Combination group (92.8% vs. 80.5% in RS group and 75.3% in DS group, P < 0.05). No severe adverse events were reported in any group. Conclusion: The combination of Red Stove Tendon - Regulating Therapy and diclofenac sodium provides rapid and sustained analgesia, along with superior functional restoration in lumbar muscle strain, without significant additional adverse events. These findings support this integrated approach as an effective and safe alternative for managing this condition.