Table 4. Description of Study Characteristics of Randomized Epidural Trials Assessing the Efficacy of Percutaneous Adhesiolysis in Lumbar Post-Surgery Syndrome a.
Study Characteristics Methodological Quality Scoring | Participants/Interventions | Outcome Measures | Pain Relief and Function | Results | Comment(s) | |||
---|---|---|---|---|---|---|---|---|
3 mo | 6 mo | 12 mo | 2 y | |||||
Manchikanti et al. ( 52 ) RA, AC; quality scores: cochrane = 9/12; IPM-QRB = _41/48 | 120; 60 adhesiolysis; 60 caudal epidural; steroid | NRS, ODI, employment status, opioid intake. A significant reduction was 50% for NRS and 40% for ODI. | Caudal = 23%; Adhesiolysis = 78% | Caudal = 7%; Adhesiolysis = 73% | Caudal = 5%; Adhesiolysis = 70% | Caudal = 5%; Adhesiolysis = 82% | 73% of adhesiolysis group had > 50% relief at 12 months; 12% of caudal group did. 3 - 4 adhesiolysis procedures/year | High quality trial showing good evidence of effectiveness. |
Heavner et al. ( 54 ); RA, AC ; quality scores: Cochrane = 9/12; IPM-QRB = 37/48 | 59; 17 Group A: hyaluronidase and hypertonic saline; 15 Group B: hypertonic saline; 17 Group C: isotonic saline; 10 Group D: hyaluronidase and isotonic saline | VAS, MPQ; VAS rated mild (0 - 29), moderate (30 - 54) or severe (55 - 100); Improvement was a 10-point change in VAS. | 40% - 50% of patients improved | 50 - 70% improvement in 3 groups with 20% in normal saline | NA | NA | Significant improvement was seen in 49% at 3 months, 43% at 6 months, and 49% at 12 months. | High quality trial with effectiveness demonstrated with adhesiolysis. |
Manchikanti et al. ( 55 ); RA, AC; quality scores: Cochrane = 9/12; IPM-QRB = 40/48 | 75; 25 caudal epidural steroid injection; 25 1-day adhesiolysis with normal saline; 25 1-day adhesiolysis with hypertonic saline | VAS, ODI, work status, opioid intake, ROM, and psychological evaluation using P-3. Significant pain relief was > 50% relief. | 0%; 64%; 72% | 0%; 60%; 72% | 0%; 60%; 72% | NA | 72% of hypertonic saline and 60% of normal saline patients had > 50% relief at 12 months, versus 0% of caudal injections. | High quality large trial demonstrating efficacy of adhesiolysis with 2-year follow-up and cost utility [57]. |
a Abbreviations: AC = Active Control; MPQ = McGill Pain Questionnaire; NRS = Numeric Rating Scale; ODI = Oswestry Disability Index; P-3 = Pain Patient Profile; RA = Randomized; ROM = range of motion.