Effectiveness of intradiscal platelet rich plasma for discogenic low back pain without Modic changes: A randomized controlled trial

Objective: To determine if autologous platelet-rich plasma (PRP) injection into a degenerative intervertebral disc, without Modic changes on magnetic resonance imaging (MRI), improve pain and function. Design: Prospective, randomized controlled study. Setting: Outpatient spine practice (Stichting Rugpoli, Netherlands). Participants: Adults with chronic low back pain referred to Stichting Rugpoli, according to the Dutch General Practitioners Guidelines, unresponsive to conservative treatment, without Modic changes on MRI. Methods: Provocation discography was performed to confirm the suspected disc was the source of pain. Participants were randomized to receive 1.0 ​cc intradiscal PRP (intervention) or 1.0 ​cc Saline with 0.2g Kefzol (control). Data on pain (Numeric Rating Scale), physical function (Roland Morris Disabilty Questionnaire, RMDQ), and participants' general perceived health (SF-12) were collected at 1 week, 4 weeks, 2 months, 6 months, 9 months and 1 year. A repeated-measures analysis (mixed model) was used for comparing the outcomes of the groups. Results: Of the initial 98 (49 intervention, 49 control) patients randomized, 89 (91%) (44 intervention, 45 control) with complete outcome data were analyzed. Groups were balanced at baseline. After twelve months no differences between groups were found in the average pain (improved 21/44 in intervention vs 16/45 in control, p ​= ​0.244), the disability scores (RMDQ minimal 3 points improvement 22/44 in intervention vs 24/45 in control, p ​= ​0.753) and the SF-12 (mean difference physical health -1.19, 95% CI -5.39 to 2.99, p ​= ​0.721, and mental health -0.34, 95% CI -3.99 to 3.29, p ​= ​0.834). One serious adverse event occurred (spondylodiscitis) after intervention. Conclusion: Participants who received intradiscal PRP showed no significant improvement in pain or functionality compared to the control group at 1 year follow up.