Study Design.. Prospective observational 1-year study.
Objective.. To determine minimum clinically important difference (MCID) and substantial clinical benefit (SCB) of outcome measures in failed back surgery syndrome (FBSS) patients, as these metrics enable assessment of whether and when an intervention produces clinically meaningful effects in a patient.
Summary of Background Data.. Several methods have been devised to quantify clinically important difference, but MCID and SCB for FBSS patients has yet to be determined.
Methods.. Patients with persisting/recurrent low back pain (LBP) and/or leg pain after lumbar surgery who completed 16 weeks of treatment (n = 105) at two hospitals in Korea from November 2011 to September 2014 were analyzed. Global perceived effect was used to determine receiver operating characteristic curves in visual analogue scale (VAS), Oswestry disability index (ODI), and short form-36 (SF-36) in an anchor-based approach.
Results.. MCIDs for ODI, LBP and leg pain VAS, physical component summary, mental health component summary (MCS), and overall health scores of SF-36 were 9.0, 22.5, 27.5, 10.2, 4.0, and 8.9, and SCBs were 15.0, 32.5, 37.0, 19.7, 19.3, and 21.1, respectively. MCID and SCB area under the curve was ≥0.8, and ≥0.7, respectively.
Conclusion.. LBP and leg pain VAS, ODI, and physical component summary of SF-36 may be used to measure responsiveness in FBSS patients.
Level of Evidence: 3
*Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea
†Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea
‡Korean Medicine Life Science, University of Science and Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon, Republic of Korea
§Spine and Joint Center, Pusan National University Korean Medicine Hospital, Yangsan, Republic of Korea
¶Department of Korean Rehabilitation Medicine, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea
||Department of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, Republic of Korea.
Address correspondence and reprint requests to In-Hyuk Ha, KMD, MSc, Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 858 Eonju-ro, Gangnam-gu, Seoul, Republic of Korea; E-mail: firstname.lastname@example.org
Received 6 May, 2016
Revised 27 July, 2016
Accepted 3 August, 2016
The device(s)/drug(s) is/are FDA-approved or approved by corresponding national agency for this indication.
The Korea Institute of Oriental Medicine (K16123) grant funds were received in support of this work.
Relevant financial activities outside the submitted work: grants.