Walter Reed National Military Medical Center
The purpose of this randomized, single-blind comparative-effectiveness pilot study is to compare the effectiveness of two types of injections on pain and function over 6 months in patients with chronic discogenic (originating from the intervertebral discs) low back pain (LBP). Eligible participants will have failed an adequate trial of previous conservative treatments, had no prior surgery, and had no prior injections within the preceding 12 months of study participation. One of the treatments in this study is called platelet-rich plasma (PRP). It uses a sample of a participant's own blood, which is spun in a machine to concentrate the platelets. These platelets are then injected into the participant's back to help healing and reduce pain and swelling. The other treatment available in this study uses donor tissue from the center of a spinal disc, called the nucleus pulposus (NP). This gel-like material normally helps absorb shock in the spine. In this therapy, NP tissue from a donor is injected into the damaged disc to help restore its cushioning function and replace lost tissue. In this study, participants will be randomly assigned to receive one of the two injections (either PRP or NP) to treat chronic discogenic LBP. In order to limit bias in outcome data, participants will not know what injection they received until 6 months post-procedure. Participants will be asked to complete between 5-6 in-person visits with the study team. Beyond procedure-related activities including a blood draw and injection, participants will also complete questionnaires and physical examinations at the respective study visits.
Inclusion Criteria: * Can read and understand English * DEERS eligible * Ages 18-100 * Low back pain duration \> 3 months * Failed an adequate trial of previous conservative treatments for \> 3 months including PT, and oral analgesics, anti-inflammatory medications, or injection therapy within the past 12 months * Average pain score ≥ 4/10 over the past week * Presumed clinical diagnosis of discogenic LBP (such as central, midline back pain exacerbated with flexion and loading; non-radiating; normal sensorimotor exam) * Lumbar MRI within the last 12 months showing disc degeneration in ≤ 2 lum…
Participants will receive up to a 2 mL intradiscal injection of autologous leukocyte-poor PRP in up to two discs
Participants will receive up to a 2 mL intradiscal injection containing a single dose of allogenic NP tissue graft in saline in up to two discs