Long-Term Course of Failed Back Surgery Syndrome (FBSS) Patients Receiving Integrative Korean Medicine Treatment: A 1 Year Prospective Observational Multicenter Study

BACKGROUND: With increase of spine surgeries, failed back surgery syndrome (FBSS) prevalence is also rising. While complementary and alternative medicine (CAM) is commonly used for low back pain (LBP), there are no studies reporting use of integrative Korean medicine in FBSS patients. METHODS: Patients with pain continuing after back surgery or recurring within 1 year and visual analogue scale (VAS) of LBP or leg pain of ≥6 (total n = 120) were recruited at 2 hospital sites from November 2011 to September 2014. Weekly sessions of integrative Korean medicine treatment were conducted for 16 weeks (herbal medicine, acupuncture/electroacupuncture, pharmacopuncture/bee venom pharmacopuncture, and Chuna manual therapy) with additional follow-ups at 24 weeks and 1 year. Outcome measures included VAS of LBP and leg pain (primary outcome), Oswestry Disability Index (ODI), Short-Form 36 (SF-36), medical use, and patient global impression of change (PGIC). RESULTS: VAS of LBP and leg pain improved at 6 months (LBP from 6.1±2.0 at baseline to 2.9±2.3; and leg pain from 5.4±2.6 to 2.4±2.5, respectively). Eighty patients (66.7%) showed improvement of 50% or more in main pain of LBP or leg pain from baseline. Disability and quality of life also improved at 6 months (ODI from 41.3±12.3 at baseline to 23.6±13.6; and SF-36 from 42.8±14.5 to 62.7±16.8). At 1 year follow-up, conventional medical management use decreased, improvement in pain and disability was maintained, and 79.2% reported improvement of PGIC. CONCLUSIONS: Despite limitations as an observational study, integrative Korean medicine treatment showed positive results in pain, function, and quality of life of FBSS patients.