Four randomized controlled trials o

Four randomized controlled trials on deep proliferant injection in subjects with chronic low back pain have been reported.One was egregiously flawed.36 The lead author in that study had neither performed prolotherapy nor learned typical radiation patterns of ligaments. The lead author assigned patients on the basis of incorrect referral pattern assumptions and required the injector to treat areas that had nothing to do with the pain the patient was having without allowing any examination to take place. This was with a strong proliferant and naturally led to pain flare in the proliferant group with a worse outcome than in the control group. The other three studies showed long-term and substantial reductions in disability in both active and control groups.
The best-designed study among the group of four studies enrolled 110 subjects with an average of 14 years of low back pain and failure of conservative treatment. Data capture was 96% at 1 year, and injections were with 20% dextrose/0.2% lidocaine or normal saline solution given every 2 weeks for 6 weeks and then as needed with clear improvement. Oneyear and 2-year data outcomes showing percentage improvement in VAS for pain and a standard disability questionnaire (Roland-Morris) are shown in Fig. 139.10e. No significant difference was found between groups. However, given the substantial sustainable change in both groups, it is strongly suggested that injection with saline was not a control. The same general pattern was seen in other studies, although Ongley et al34 found phenol-dextrose-glycerine to be superior to normal saline solution (P = .001) and Klein et al found phenol-dextrose glycerine to be nearly significantly superior to lidocaine (P = .056). In addition to randomized controlled trial, other consecutive case series of patients with chronic low back pain have also confirmed substantial and sustained improvements in pain and function with injection of connective tissue with proliferant. No other modality of treatment has more evidence of long-term benefit for low back pain than prolotherapy in such chronic cases.