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Stem Cells vs. Steroids for Discogenic Back Pain

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ClinicalTrials.gov Identifier: NCT04735185
Recruitment Status : Not yet recruiting
First Posted : February 3, 2021
Last Update Posted : May 10, 2021
Sponsor:
Collaborators:
The Geneva Foundation
United States Department of Defense
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This is a randomized, comparative-effectiveness study comparing intradiscal autologous stem cells (from bone marrow aspirate) to intradiscal corticosteroid for the treatment of chronic discogenic low back pain (LBP). The primary objective of this study is to determine whether intradiscal autologous stem cells (from bone marrow aspirate) is more effective than intradiscal steroids for the treatment of chronic discogenic low back pain (LBP). Participants in this study will be randomized to receive up to intradiscal stem cell injections at 1 or 2 discs with cells harvested from a bone marrow aspirate drawn from participants' iliac crest, or an equal volume (2 mL) of intradiscal steroids and local anesthetic injected into the discs. In order to identify the painful disc(s), discography may be used at the discretion of the provider. Both treatments are frequently used as part of clinical care (i.e. there is no placebo group).

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Degenerative Disc Disease Other: Autologous stem cells Drug: Corticosteroid Drug: Local anesthetic Not Applicable

Detailed Description:

In this study, the investigators are attempting to determine if intradiscal injection of autologous bone marrow-derived mesenchymal stem cells (BMC) will decrease pain and improve function compared with intradiscal steroids.

Up to 106 patients with a clinical diagnosis of chronic discogenic low back pain for greater than 6 months, MRI evidence of lumbar disc degeneration limited to one or two discs with <50% disc height loss, and positive provocative discography (if clinically indicated) will be randomized to receive intradiscal BMC or steroid and long-acting local anesthetic (bupivacaine).

Those randomized to group I will receive a 2 mL intradiscal injection of autologous bone marrow-derived mesenchymal stem cells from bone marrow aspirate of the posterior ilium, while those randomized to group II will receive an intradiscal injection of the steroid methylprednisolone and the local anesthetic bupivacaine. The first follow-up will occur at 4-weeks post-treatment at which time rescue medications may be prescribed or adjusted but no other analgesic interventions should occur. The primary outcome measure will be pain relief at 3 months post-treatment, while a positive categorical outcome will be a 2-point or greater decrease in average LBP coupled with either a score > 5/7 on the PGIC (indicating noticeable improvement) or a 10-point decrease in ODI (indicating a clinically meaningful benefit). At 3 months, a repeat MRI will be obtained in selected patients at military treatment facilities (i.e. every 5th patient). Those who fail to experience a positive categorical outcome will be withdrawn from the study to receive alternate care, including an option for intradiscal BMC in those who received corticosteroid. For those who continue to experience a positive outcome, there will be 6- and 12-month follow up visits. At all follow-up visits, histories and physical exams will be performed and questionnaires assessing sleep, function, and anxiety and depression will be administered.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We are trying to determine whether intradiscal injection of autologous BMC (bone marrow-derived mesenchymal stem cells) will decrease pain and improve function compared with intradiscal steroid.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Comparative-effectiveness Study of Intradiscal Autologous Bone Marrow Concentrate Versus Intradiscal Corticosteroid for Chronic Discogenic Low Back Pain
Estimated Study Start Date : November 30, 2021
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : November 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Steroids

Arm Intervention/treatment
Active Comparator: Intradiscal autologous stem cells
Participants in this arm will have autologous stem cells harvested through bone marrow aspiration. The stem cells that were harvested will be processed and injected into affected intradiscal spaces in the lumber spine.
Other: Autologous stem cells
In this intervention participants will receive a 2 mL intradiscal injection into each affected disc of autologous bone marrow-derived mesenchymal stem cells from bone marrow aspirate of the posterior ilium.

Active Comparator: Intradiscal corticosteroid and local anesthetic
Participants in this arm will receive an intradiscal injection of the steroid methylprednisolone and the local anesthetic bupivacaine into affected intradiscal spaces in the lumber spine.
Drug: Corticosteroid
In this intervention participants will receive a 1 mL intradiscal injection of the steroid methylprednisolone (40 mg/mL) into each affected disc.

Drug: Local anesthetic
In this intervention participants will receive a 1 mL intradiscal injection of the local anesthetic bupivacaine 0.5% into each affected disc.




Primary Outcome Measures :
  1. Mean change in average low back pain score on 0-10 numerical rating scale [ Time Frame: Baseline and 3 months ]
    Mean change in average low back pain score over the past week at 3 months compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain)


Secondary Outcome Measures :
  1. Hospital Anxiety and Depression Scale score [ Time Frame: 4 weeks ]
    14-question scale measuring anxiety and depression, with each question scored as 0-3 (higher numbers represent greater anxiety or depression).

  2. Hospital Anxiety and Depression Scale score [ Time Frame: 3 months ]
    14-question scale measuring anxiety and depression, with each question scored as 0-3 (higher numbers represent greater anxiety or depression).

  3. Hospital Anxiety and Depression Scale score [ Time Frame: 6 months ]
    14-question scale measuring anxiety and depression, with each question scored as 0-3 (higher numbers represent greater anxiety or depression).

  4. Hospital Anxiety and Depression Scale score [ Time Frame: 1 year ]
    14-question scale measuring anxiety and depression, with each question scored as 0-3 (higher numbers represent greater anxiety or depression).

  5. Athens Insomnia Scale score [ Time Frame: 4 weeks ]
    Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.

  6. Athens Insomnia Scale score [ Time Frame: 3 months ]
    Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.

  7. Athens Insomnia Scale score [ Time Frame: 6 months ]
    Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.

  8. Athens Insomnia Scale score [ Time Frame: 1 year ]
    Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.

  9. Patient global impression of change (PGIC) score [ Time Frame: 4 weeks ]
    1-7 scale evaluating, with higher scores indicating greater improvement.

  10. Patient global impression of change (PGIC) score [ Time Frame: 3 months ]
    1-7 scale evaluating, with higher scores indicating greater improvement.

  11. Patient global impression of change (PGIC) score [ Time Frame: 6 months ]
    1-7 scale evaluating, with higher scores indicating greater improvement.

  12. Patient global impression of change (PGIC) score [ Time Frame: 1 year ]
    1-7 scale evaluating, with higher scores indicating greater improvement.

  13. Oswestry disability index score [ Time Frame: 4 weeks ]
    0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)

  14. Oswestry disability index score [ Time Frame: 3 months ]
    0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)

  15. Oswestry disability index score [ Time Frame: 6 months ]
    0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)

  16. Oswestry disability index score [ Time Frame: 1 year ]
    0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)

  17. Disc Degeneration based on MRI [ Time Frame: 3 months ]
    Disc degeneration on MRI (graded as significantly improved, slightly improved, no change, and worsening degeneration, based on Pfirmann's scale).

  18. Average low back pain score on 0-10 numerical rating scale [ Time Frame: 4 weeks ]
    Average low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).

  19. Average low back pain score on 0-10 numerical rating scale [ Time Frame: 3 months ]
    Average low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).

  20. Average low back pain score on 0-10 numerical rating scale [ Time Frame: 6 months ]
    Average low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).

  21. Average low back pain score on 0-10 numerical rating scale [ Time Frame: 1 year ]
    Average low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).

  22. Mean change in worst low back pain score on 0-10 numerical rating scale [ Time Frame: Baseline and 4 weeks ]
    Mean change in worst low back pain score over the past week at week 4 compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain).

  23. Mean change in worst low back pain score on 0-10 numerical rating scale [ Time Frame: Baseline and 3 months ]
    Mean change in worst low back pain score over the past week at week 3 months compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain).

  24. Mean change in worst low back pain score on 0-10 numerical rating scale [ Time Frame: Baseline and 6 months ]
    Mean change in worst low back pain score over the past week at week 6 months compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain).

  25. Mean change in worst low back pain score on 0-10 numerical rating scale [ Time Frame: Baseline and 1 year ]
    Mean change in worst low back pain score over the past week at week 1 year compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain).

  26. Worst low back pain score on 0-10 numerical rating scale [ Time Frame: 4 weeks ]
    Worst low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).

  27. Worst low back pain score on 0-10 numerical rating scale [ Time Frame: 3 months ]
    Worst low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).

  28. Worst low back pain score on 0-10 numerical rating scale [ Time Frame: 6 months ]
    Worst low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).

  29. Worst low back pain score on 0-10 numerical rating scale [ Time Frame: 12 months ]
    Worst low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).

  30. Positive categorical outcome [ Time Frame: 4 weeks ]
    Greater or equal to 2-point decrease in average low back pain score coupled with a PGIC score of 5 or higher or a decrease on Oswestry disability score of 10 or greater

  31. Positive categorical outcome [ Time Frame: 3 months ]
    Greater or equal to 2-point decrease in average low back pain score coupled with a PGIC score of 5 or higher or a decrease on Oswestry disability score of 10 or greater

  32. Positive categorical outcome [ Time Frame: 6 months ]
    Greater or equal to 2-point decrease in average low back pain score coupled with a PGIC score of 5 or higher or a decrease on Oswestry disability score of 10 or greater

  33. Positive categorical outcome [ Time Frame: 12 months ]
    Greater or equal to 2-point decrease in average low back pain score coupled with a PGIC score of 5 or higher or a decrease on Oswestry disability score of 10 or greater



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18
  2. Pain duration > 6 months
  3. Failure of non-operative treatment > 3 months
  4. Average pain score > 4/10 over the past week
  5. Presumed clinical diagnosis of discogenic low back pain (such as back>leg pain, no or minimal radiation of pain past knee level, no significant improvement with epidural steroid injection, facet injections, sacroiliac joint injections and/or trigger point injections
  6. Lumbar MRI within the last 18 months showing disc degeneration in <= 2 lumbar discs; <50% disc height loss in each disc
  7. Patient agrees to have disc injection(s) and no other low back interventional or pharmacological treatments for at least 3 months
  8. Patient agrees to be off all NSAIDs and corticosteroids from 2 weeks prior to and 3 months after the injection.
  9. Stable dose of analgesic medications for at least 2 weeks

Exclusion Criteria:

  1. Previous disc directed therapy involving heat (e.g. Intradiscal electrothermal therapy (IDET), biacuplasty)
  2. Previous disc injection therapy in the last 3 months (e.g. corticosteroid, platelet rich plasma, stem cells)
  3. 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)
  4. Disc extrusion or symptomatic disc protrusion at affected level
  5. Untreated coagulopathy
  6. Allergy to contrast dye or local anesthetics
  7. Negative discography or discography showing > 2 positive discs
  8. Pain > 15 years in duration
  9. Opioid dose > 30 mg oral morphine equivalents per day (patients may be tapered down or off opioids)
  10. Diffuse pain phenotype (e.g. diagnosis of fibromyalgia)
  11. Secondary gain (e.g. ongoing medical board or litigation related to injury)
  12. Pregnancy (study subject report of negative pregnancy status will be sufficient to participate. Testing will be provided if subject is unsure or requests a test to confirm.
  13. Cannot read or understand English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735185


Contacts
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Contact: Mirinda Anderson White, RN 410-955-6488 mander47@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
The Geneva Foundation
United States Department of Defense
Investigators
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Principal Investigator: Steven Cohen, MD Johns Hopkins University
Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04735185    
Other Study ID Numbers: IRB00250806
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will be available upon request per approval of the U.S. Department of Defense (DoD).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: For up to 3 years
Access Criteria: Per approval by the funding organization (U.S. Department of Defense)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents