Background Low-level laser treatment (LLLT) is used to treat low back pain (LBP) however, its effects on lumbar disc herniation (LDH) remain unclear. The safety and effectiveness of LLLT for LDH was determined using a systematic review of randomized clinical trials.
Methods Studies on LLLT in adults with LDH were identified from 12 worldwide databases. A risk of bias assessment and a meta-analysis with categorization according to the type of control used (inactive, active, or add-on) was performed. The quality of evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation.
Results The quantitative analyses included five studies. LLLT was significantly more effective at treating LDH [leg pain visual analog scale (VAS) mean difference (MD): -1.90, 95% confidence interval (CI): -2.01, -1.80, I2 80%; LBP VAS MD: -0.79, 95% CI: -0.87, -0.71, I2 80%] than inactive controls (placebo or sham). The quality of the evidence ranged from “low” to “very low.” As an add-on to usual care, LLLT significantly improved pain intensity and disability compared with usual care (leg pain VAS MD: -2.52, 95% CI: -2.65, -2.40, I2 97%; LBP VAS MD: -1.47, 95% CI: -1.58, -1.36; Oswestry Disability Index MD: -4.10, 95% CI: -4.55, -3.65, I2 6%). However, the quality of the evidence ranged from “moderate” to “low.”
Conclusion LLLT significantly improved outcomes compared with the inactive controls, but was not more effective than usual care for LDH. In combination with usual care, LLLT was significantly more effective than usual care alone highlighting the potential of LLLT.
Background This study was the development of a protocol for the comparison between the efficacy of non-pharmacological and pharmacological treatment approaches for lumbar disc herniation in a pragmatic environment to obtain real-world based study data.
Methods The protocol sets out a two-armed, parallel, multicenter pragmatic, randomized-controlled trial (RCT) which will be conducted in four spine specialist hospitals in Korea to determine cost-efficiency.
Results The study will enroll 36 participants and allocate patients into either the non-pharmacological treatment group or the pharmacological treatment group in a 1:2 ratio. Patients must have evidence of disc-related disease diagnosed using MRI, as well as having lower back pain or radiating leg pain (numeric rating scale score ≥ 5). The treatment will last for 8 weeks with a 26-week follow-up. The primary outcome will be measured using the Oswestry Disability Index score from Week 9. Secondary outcomes related to lower back pain and radiating leg pain will be measured using the scores from the numeric rating scale, the visual analogue scale, the European Quality of Life 5 Dimensions 5 Level Version), the 12-item Short Form Survey, and the patient global impression of change.
Conclusion This is the first protocol for a pragmatic RCT evaluating the efficacy, safety, and cost-efficiency of non-pharmacological and pharmacological treatment strategies in a clinical setting. Following the basis of this protocol, RCTs may play an important role in establishing guidelines for treating radiating leg pain and lower back pain and provide effective information to clinicians in practical settings.
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Comparative Effectiveness of Non-Pharmacological and Pharmacological Treatments for Non-Acute Lumbar Disc Herniation: A Multicenter, Pragmatic, Randomized Controlled, Parallel-Grouped Pilot Study Doori Kim, Jee Young Lee, Yoon Jae Lee, Chang Sop Yang, Chang-Hyun Han, In-Hyuk Ha Journal of Clinical Medicine.2025; 14(4): 1204. CrossRef