Table 1 Systematic review: summary of characteristics of included studies
Study | Population | ||||
|---|---|---|---|---|---|
Lead author (year), reference, country, type and recruitment dates | Study design | Implanted N (tested N) | Description (as stated by authors) and indication | Age, gender, post back surgery | Baseline VAS/NRSa |
Burgher [17] USA, single center, August 2009 to December 2010 | Retrospective case series | 6 (10) | ‘Axial back and neck pain’ | Mean 53 years, 20% male, not reported | Not reported |
‘All patients had failed more conservative treatment…’ | |||||
All predominantly axial pain | |||||
Campbell [12] USA, single center, July 1974 to August 1975 | Case series | 10 (NR) | ‘Low back pain syndrome with sciatica’ | Mean 48 years, 20% male, not reported | Not reported |
‘Persistent disabling pain despite all traditional medical and surgery’ | |||||
Falco [16] USA, single center, August 2008 to April 2009 | Case series | 18b (28) | ‘Chronic [non-appendicular] pain that had not responded to conservative or surgical treatment and whose pain significantly impacted their quality of life’ | Mean 56 years, 28% male, not reported | Mean 9.1 |
‘Many of the patients had multiple sources and areas of chronic pain for years’ | |||||
‘…in several cases, [failed] lumbar spine surgery.’ | |||||
Paicius [13] USA, single center. May 2005 to September 2006 | Case series | 6 (NR) | ‘History of chronic low back pain’ | Mean 63 years, 50% male, 83% | Mean 9.1 |
Majority of patients followed lumbar surgery | |||||
Sator-Katzenchlager [14] Austria, multicenter June 1999 to February 2007 | Retrospective case series | 66c (NR) | ‘Failed back surgery syndrome’ and ‘low back pain’ | Mean 59 years, 48% male, 56% | Mean 8.2 |
‘Prior failure of systemic or less invasive \treatments….and no indication for further surgery’ | |||||
Verrills [15, 19] Australia, single center, dates not reported | Retrospective case series | 23b (NR) | ‘Failure to respond to conservative treatment….almost all patients had also failed surgical procedures’ | Mean 58 years, 39% male, not reported | Not reported |
‘Low back pain’ | |||||
Verrills [18, 19] Australia, single center, dates not reported | Prospective case series | 44d (NR) | ‘Lumbrosacral pain’ | Range 27 to 88 years, 43% male, not reported | Mean 8.1 |
‘Failure to respond to other conservative therapy’ | |||||
Yakovlev [20] USA, single center August 2007 to July 2009 | Retrospective case series | 18 (NR) | ‘Chronic low back and lower extremity pain associated with PLS after multilevel spinal surgical procedures’ | Mean 62 years, 61% male, 100% | 12 |