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

Date Published: January 27, 2017

Publisher: Public Library of Science

Author(s): Jinho Lee, Joon-Shik Shin, Yoon Jae Lee, Me-riong Kim, Areum Choi, Jun-Hwan Lee, Kyung-Min Shin, Byung-Cheul Shin, Jae-Heung Cho, In-Hyuk Ha, Gabriel Agbor.

http://doi.org/10.1371/journal.pone.0170972

Abstract

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.

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).

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.

Despite limitations as an observational study, integrative Korean medicine treatment showed positive results in pain, function, and quality of life of FBSS patients.

Partial Text

Low back pain (LBP) and radiating leg pain have heavier impact on time off work and disability than any other medical condition [1]. Although natural progress of LBP is known to be favorable, surgery rates are high. It was reported that 317,000 lumbar surgeries were conducted in the U.S. in 1997 [2], and numbers climbed to 1 million in 2002 [3]. Also, despite lack of clear evidence for spinal fusion, rates have increased 220% between 1990 and 2000 [3,4]. Operation results are not always successful, and cases where LBP and/or leg pain persists or relapses are commonly referred to as failed back surgery syndrome (FBSS) [5,6].

This study is a prospective, multicenter, observational study. Patients with unremitting or recurrent LBP or leg pain after lumbar surgery were recruited at 2 sites of Jaseng Hospital of Korean Medicine (Gangnam branch in Seoul, and Bucheon branch) in Korea from November 2011 to September 2014. The majority of participants were not recruited by advertisements but were patients approached upon visiting the hospital for treatment. Jaseng Hospital of Korean Medicine is a spine specialty hospital certified by the Korean Minister of Health and Welfare that pursues an integrative treatment model of conventional and Korean medicine based on conventional diagnostic technology in diagnosis and Korean medicine treatment for the main treatment modality [23,24]. This study is a report of the 1 year observation results of effect and safety of integrative Korean medicine treatment in FBSS patients.

A total 1,912 patients with history of spine surgery were screened, and the greater majority was excluded from reasons of pain onset, duration or pain level not meeting inclusion criteria. A total 120 patients were enrolled, of which 106 patients (88%) completed the predetermined 16 week integrative Korean medicine treatment program, and 96 patients (80%) attended the 6 month follow-up visit. The 1 year follow-up was conducted by phone in a total 102 patients (85%) out of the initially enrolled 120 patients including drop-out patients (Fig 1).

The lumbar FBSS patients included in our study were chronic pain patients with moderate or higher pain levels, and displayed substantial improvement in LBP and leg pain, disability, and quality of life following 16 weeks of integrative Korean medicine treatment of which pain and disability maintained favorable state at 1 year follow-up. A total 89.4% of participants replied that their current state was improved at 6 months, and 79.2% at 1 year (Fig 2). Recently, several SCS studies of FBSS patients measured primary outcome as 50% or greater decrease in VAS of main pain site at 6 months [14–16,38], and 66.7% of patients displayed a 50% or greater decrease in main pain VAS at 6 months in this study. Also, although many patients had initially received conventional medicine (e.g. analgesics, ESI) prior to study participation, medication use decreased considerably after Korean medicine treatment and patients displayed preference for Korean medicine treatment. In subgroup analysis, patients with pain duration of <6 months displayed faster functional improvement, the region with greater pain out of low back and leg swifter pain alleviation, and men faster pain and functional improvement which may be partly explained through pain sensation difference between men and women [39].   Source: http://doi.org/10.1371/journal.pone.0170972