A Phase 2/3 interventional study of Platelet-Rich Plasma (PRP) Injection and Nucleus Pulposus (NP) Injection in Discogenic Low Back Pain, sponsored by Walter Reed National Military Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Walter Reed National Military Medical Center · Phase 2/3, Interventional, and Treatment
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.
Walter Reed National Military Medical Center is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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Exclusion Criteria:
Biological: Platelet-Rich Plasma (PRP) Injection
Biological: Nucleus Pulposus (NP) Injection
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
Between-Group Difference in Mean Change in Average LBP (NPRS)
The 11-item NPRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain).
Time frame: Change from Baseline to 1-, 3-, 6-, and 12-months will be assessed. Change from Baseline to 6 months is the primary outcome.
Between-Group Difference in Mean Change in Function (ODI)
The Oswestry Disability Index (ODI) is a 10-item questionnaire that measures the impact of low back pain on an individual's overall function. The ODI is scored on a scale from 0-100%, where a lower percentage reflects better function.
Time frame: Change from Baseline to 1-, 3-, 6-, and 12-months will be assessed. 6 months is the primary timepoint.
Patient Perception of Change/Satisfaction
The Patient Global Impression of Change (PGIC) is a 7-point Likert scale to measure changes in overall clinical status and satisfaction in response to an intervention. The PGIC has the following response options: 1 - No change (or condition has gotten worse); 2 - Almost the same, hardly any change at all; 3 - A little better, but no noticeable change; 4 - Somewhat better, but the change has not made any real difference; 5 - Moderately better, and a slight but noticeable change; 6 - Better and a definite improvement that has made a real and worthwhile difference; 7 - A great deal better and a considerable improvement that has made all the difference.
Time frame: Will capture at 1-, 3-, 6-, and 12-months from Baseline. 6 months is the primary timepoint.
Proportion of Participants with Significant Medication Reduction
Medication use will be assessed at each timepoint. A reduction \> 20% in opioid usage or cessation of a non-opioid analgesic will be considered significant. The proportion of participants with a significant medication reduction will be reported.
Time frame: Change from Baseline to 1-, 3-, 6-, and 12-months will be assessed. 6 months is the primary timepoint.
Proportion of Participants with Positive Categorical Outcome
A positive categorical outcome is defined as a ≥ 2-point decrease in average NPRS score coupled with a PGIC score ≥ 5/7 or ≥ 10-point decrease in ODI, without significant supplemental medication use.
Time frame: Will capture at 1-, 3-, 6-, and 12-months from Baseline. 6 months is the primary timepoint.
Effect on Quality of Life (HADS, AIS)
The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire scored from 0-21, where low scores indicate lower levels of anxiety and depression. The Athens Insomnia Scale (AIS) is an 8-item questionnaire scored from 0-24, where low scores indicate lower levels of insomnia. The HADS and AIS provide additional information on an individual's overall quality of life in terms of mental health and sleep quality.
Time frame: Change from Baseline to 1-, 3-, 6-, and 12-months will be assessed. 6 months is primary timepoint.
Between-Group Difference in Average LBP (DVPRS)
The Defense Veterans Pain Rating Scale (DVPRS) is a 11-point scale measuring pain intensity, where a lower score indicates less pain. 4 additional supplemental questions are included if average pain level is ≥ 4/10.
Time frame: Change from Baseline to 1-, 3-, 6-, and 12-months will be assessed. 6 months is the primary timepoint.
Demographic and Clinical Predictors of Treatment Response
Subgroup exploratory analyses will be performed to determine whether any demographic and clinical variables (e.g., biological sex, baseline pain severity, cell and immunoregulatory profiles) predict treatment response.
Time frame: Will capture at Baseline, 1-, 3-, 6-, and 12-months. 6 months is the primary timepoint.
Plan to share: No
Start is estimated for Dec 2026; primary completion for Jun 2028, 18 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Platelet rich plasma
Walter Reed National Military Medical Center