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Discogenic Low Back PainPhase 2/3NCT07895225

PRP Versus NP Injections for Chronic Discogenic Low Back Pain

A Phase 2/3 study testing Platelet-Rich Plasma (PRP) Injection and Nucleus Pulposus (NP) Injection in people with Discogenic Low Back Pain, run by Walter Reed National Military Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Discogenic Low Back Pain
What is being tested?
Platelet-Rich Plasma (PRP) Injection and Nucleus Pulposus (NP) Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Dec 2026to Dec 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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 lumbar discs; Modified Pfirrmann scoring III-VII
  • Agrees to have disc injection(s) and no other low back interventional (e.g., lumbar epidural steroid injections) or new pharmacological treatments (other than permitted supplemental medications which must be stopped 2 weeks prior to each follow-up) outside of the study for at least 6 months [Physical therapy (PT), exercise, or psychotherapy are allowed prior to 6 months]
  • Agrees to be off all NSAIDs (e.g., aspirin, ibuprofen, Aleve, naproxen, Advil, Motrin, Celebrex) from 2 weeks prior to and 3 months after the injection
  • Agrees to be off all corticosteroids (e.g., systemic, other injections) for at least 6 weeks after the injection
  • Stable dose of analgesic medications (excluding NSAIDs) for at least 2 weeks (off schedule 2 opioids for 1 month)

Who cannot join

  • Pregnancy (Women of childbearing capacity will have pregnancy test to confirm status)
  • Actively breastfeeding
  • Low back pain > 15 years in duration
  • Previous disc directed therapy involving heat (e.g., Intradiscal electrothermal therapy (IDET), biacuplasty)
  • Previous disc injection therapy in the last 12 months (e.g., corticosteroid, PRP)
  • Corticosteroid injections of the low back in the 3 months prior to injection and other corticosteroid therapy (e.g., systemic, other injections) in the 6 weeks prior to injection
Show all 17Show fewer
  • Previous lumbar spine surgery (e.g., discectomy, fusion) at the affected levels (i.e., those with relief after surgery in whom adjacent segment discogenic pain is suspected can be considered on a case-by-case basis)
  • Focal neurological deficit attributed to disc pathology (i.e., abnormal sensorimotor exam consistent with disc pathology)
  • Individuals deemed at risk to require systemic steroid over the 6-month study course (e.g., individuals with poorly controlled asthma or COPD, individuals with a poorly controlled autoimmune disease)
  • Individuals with poorly controlled medical or psychiatric co-morbidities, as determined by their specialist or primary care provider (in those not receiving specialty care)
  • Poorly controlled medical (e.g., unstable angina, congestive heart failure, poorly controlled diabetes) or psychiatric condition that has required medication adjustments within the past 2 weeks (severe depression or schizophrenia)
  • Untreated coagulopathy or inability to safely stop anticoagulants
  • Allergy to contrast dye or local anesthetics
  • Inability to stop Schedule 2 opioid use within 1 month of enrollment due to chronic pain
  • Diffuse pain phenotype (e.g., diagnosis of fibromyalgia)
  • Secondary gain (e.g., ongoing medical board or litigation related to injury)
  • Anticipated PCS or deployment within 12 months of enrollment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Edward Dolomisiewicz contact

301-295-8571

edward.a.dolomisiewicz.mil@health.mil

Marin Smith contact

marin.s.smith.ctr@health.mil

United States1 site

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

Other trials in United States

About this study

Official title: Randomized, Comparative-Effectiveness Study of Intradiscal Injections for Chronic Discogenic Low Back Pain (LBP)

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.

Being tested
Platelet-Rich Plasma (PRP) Injection, Nucleus Pulposus (NP) Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Platelet-Rich Plasma (PRP) InjectionBiological

    Participants will receive up to a 2 mL intradiscal injection of autologous leukocyte-poor PRP in up to two discs

  • Nucleus Pulposus (NP) InjectionBiological

    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

Study groups in NCT07895225
Study groupRoleWhat they receive
Intradiscal Autologous Platelet-Rich Plasma (PRP) InjectionActive comparatorNot described
Receives: Biological: Platelet-Rich Plasma (PRP) Injection
Intradiscal Allogeneic Nucleus Pulposus (NP) Tissue Graft InjectionActive comparatorNot described
Receives: Biological: Nucleus Pulposus (NP) Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Change from Baseline to 1-, 3-, 6-, and 12-months will be assessed. Change from Baseline to 6 months is the primary outcome.

Secondary outcomes (7)

  1. 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.

    Measured: Change from Baseline to 1-, 3-, 6-, and 12-months will be assessed. 6 months is the primary timepoint.

  2. 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.

    Measured: Will capture at 1-, 3-, 6-, and 12-months from Baseline. 6 months is the primary timepoint.

  3. 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.

    Measured: Change from Baseline to 1-, 3-, 6-, and 12-months will be assessed. 6 months is the primary timepoint.

  4. 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.

    Measured: Will capture at 1-, 3-, 6-, and 12-months from Baseline. 6 months is the primary timepoint.

  5. 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.

    Measured: Change from Baseline to 1-, 3-, 6-, and 12-months will be assessed. 6 months is primary timepoint.

  6. 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.

    Measured: Change from Baseline to 1-, 3-, 6-, and 12-months will be assessed. 6 months is the primary timepoint.

  7. 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.

    Measured: Will capture at Baseline, 1-, 3-, 6-, and 12-months. 6 months is the primary timepoint.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07895225
Sponsor's protocol ID
WRNMMC-2026-0527
Status last verified
Oct 2026
First submitted
19 Oct 2026
Last updated
26 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tuakli-Wosornu YA, Terry A, Boachie-Adjei K, Harrison JR, Gribbin CK, LaSalle EE, Nguyen JT, Solomon JL, Lutz GE. Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study. PM R. 2016 Jan;8(1):1-10; quiz 10. doi: 10.1016/j.pmrj.2015.08.010. Epub 2015 Aug 24.

    PubMed 26314234

  • Lorio MP, Tate JL, Myers TJ, Block JE, Beall DP. Perspective on Intradiscal Therapies for Lumbar Discogenic Pain: State of the Science, Knowledge Gaps, and Imperatives for Clinical Adoption. J Pain Res. 2024 Mar 18;17:1171-1182. doi: 10.2147/JPR.S441180. eCollection 2024.

    PubMed 38524692

  • Schneider BJ, Hunt C, Conger A, Qu W, Maus TP, Vorobeychik Y, Cheng J, Duszynski B, McCormick ZL. The effectiveness of intradiscal biologic treatments for discogenic low back pain: a systematic review. Spine J. 2022 Feb;22(2):226-237. doi: 10.1016/j.spinee.2021.07.015. Epub 2021 Aug 2.

    PubMed 34352363

  • Manchikanti L, Knezevic E, Knezevic NN, Kaye AD, Atluri S, Sanapati MR, Pampati V, Hirsch JA. Effectiveness of Intradiscal Regenerative Medicine Therapies for Long-Term Relief of Chronic Low Back Pain: A Systematic Review and Meta-Analysis. Pain Physician. 2024 Dec;27(10):E995-E1032.

    PubMed 39688822

  • Beall DP, Davis TT, Amirdelfan K, Naidu RK, DePalma MJ, Costandi S, Fleming JW, Yoon ES, Ganey T, Block JE, Mekhail N. Nucleus Pulposus Allograft Supplementation in Patients with Lumbar Discogenic Pain: Initial 6-month Outcomes from a Prospective Clinical Pilot Study. Pain Physician. 2024 Nov;27(8):E865-E871.

    PubMed 39621986

  • Navani A, Ambach M, Calodney A, Rosenthal R, Li G, Mahoney CB, Everts PA. The Safety and Effectiveness of Orthobiologic Injections for Discogenic Chronic Low Back Pain: A Multicenter Prospective, Crossover, Randomized Controlled Trial with 12 Months Follow-up. Pain Physician. 2024 Jan;27(1):E65-E77.

    PubMed 38285032

  • Navani A, Manchikanti L, Albers SL, Latchaw RE, Sanapati J, Kaye AD, Atluri S, Jordan S, Gupta A, Cedeno D, Vallejo A, Fellows B, Knezevic NN, Pappolla M, Diwan S, Trescot AM, Soin A, Kaye AM, Aydin SM, Calodney AK, Candido KD, Bakshi S, Benyamin RM, Vallejo R, Watanabe A, Beall D, Stitik TP, Foye PM, Helander EM, Hirsch JA. Responsible, Safe, and Effective Use of Biologics in the Management of Low Back Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines. Pain Physician. 2019 Jan;22(1S):S1-S74.

    PubMed 30717500

  • Pettine KA, Murphy MB, Suzuki RK, Sand TT. Percutaneous injection of autologous bone marrow concentrate cells significantly reduces lumbar discogenic pain through 12 months. Stem Cells. 2015 Jan;33(1):146-56. doi: 10.1002/stem.1845.

    PubMed 25187512

  • Cohen SP, Wenzell D, Hurley RW, Kurihara C, Buckenmaier CC 3rd, Griffith S, Larkin TM, Dahl E, Morlando BJ. A double-blind, placebo-controlled, dose-response pilot study evaluating intradiscal etanercept in patients with chronic discogenic low back pain or lumbosacral radiculopathy. Anesthesiology. 2007 Jul;107(1):99-105. doi: 10.1097/01.anes.0000267518.20363.0d.

    PubMed 17585221

  • Cao P, Jiang L, Zhuang C, Yang Y, Zhang Z, Chen W, Zheng T. Intradiscal injection therapy for degenerative chronic discogenic low back pain with end plate Modic changes. Spine J. 2011 Feb;11(2):100-6. doi: 10.1016/j.spinee.2010.07.001. Epub 2010 Sep 20.

    PubMed 20850390

  • Serio MA, Bartolina R, Sudini S, MacDonald EM, Thomassen AS, Shekoohi S, Chami AA, Kaye AD. Clinical Efficacy and Risks of Intradiscal Orthobiological Injections: A Narrative Review. Curr Pain Headache Rep. 2025 Jul 11;29(1):99. doi: 10.1007/s11916-025-01414-y.

    PubMed 40646365

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Platelet-Rich Plasma (PRP) Injection and Nucleus Pulposus (NP) Injection in people with Discogenic Low Back Pain, run by Walter Reed National Military Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Edward Dolomisiewicz (301-295-8571, edward.a.dolomisiewicz.mil@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Between-Group Difference in Mean Change in Average LBP (NPRS) (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07895225, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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