Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain

August 6, 2024 updated by: APM Spine and Sports Physicians

Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain: A Double-Blind, Placebo Controlled Trial

A double-blind, placebo-controlled study to determine the efficacy of intradiscal injection of bone marrow concentrate on discogenic low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized, double-blind, placebo-controlled study to determine the efficacy of intradiscal injection of bone marrow concentrate on discogenic low back pain. The treatment will be a single injection of autologous bone marrow concentrate into suspected painful disc(s) based upon either prior discography or combination of imaging and exclusion of other anatomic structural sources of pain. The placebo treatment will be an intramuscular injection of normal saline directly dorsal to the transverse process at each suspected level. Outcomes will be measured using VAS and ODI. The primary outcome will be the percentage of patients in the treatment group vs control group at 6 months post-procedure, categorized as a clinical success defined by at least 50% relief of pain. Secondary outcomes will be comparison of success rates at 3 and 12 months, percentage of patients in the two groups with greater than 30% improvement in ODI at 3, 6 and 12 months, Global perceived index at 3, 6, 12 months. Medication log and adjunctive treatments will be recorded and analyzed.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Jordan Young Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Chronic low back pain for more than 6 months w/ low back component greater than leg pain.
  • Average pain of at lest 40/100 on VAS pre-procedure.
  • Inadequate response to at least 6 months of conservative care including medication, physical therapy and/or spinal injection
  • Advanced imaging of MRI or CT demonstrating abnormal disc pathology
  • Presumed lumbar disc pain based on either positive discogram or patient must have MRi findings of either high intensity zone and/or Type 1 or 2 Modic endplate changes, or exclusion of other sources of pain.
  • Having provided informed consent

Exclusion Criteria:

  • Active moderate to severe lumbar radiculopathy
  • Negative discogram
  • Very severe decrease in disc height at planned injection level (disc height of less than 1/3 expected)
  • Active infection
  • Moderate to severe anemia, thrombocytopenia or leukopenia
  • Spinal fracture within the past 6 months
  • Severe psychological illness
  • Inability to consent to the procedure due to cognitive issues
  • Prior surgery at a level considered to be the source of pain
  • Lumbar surgery within the past 6 months
  • Women who are pregnant or breast feeding
  • Prior intradiscal therapeutic injection or procedure
  • Severe uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease or any medical condition which would make the subject unsuitable for this study.
  • Inflammatory arthritis
  • Any cancer within the past 5 years, except basal cell or squamous cell skin cancer
  • Intradural disc herniation
  • Coagulopathy preventing spinal injection
  • Inability to stop anticoagulants other than aspirin due to other medical issues
  • Exceeds 30 mg morphine equivalent per day of opioid use.
  • A history of alcohol or drug abuse within the past 5 years.
  • Use of any investigational drug within the past 30 days.
  • Steroid injection in the spine within the past 30 days.
  • Discography within the last 21 days
  • A known allergy or sensitivity to heparin or citrate (used for processing BMC)
  • Pending litigation involving the subject's back pain.
  • Active worker's compensation claim
  • Central stenosis at a level to be injected with an AP diameter less than or equal to 5 mm
  • Severe anaphylactic/anaphylactoid reaction to any of the medications used. (If a patient does have a mild or moderate allergy to any of the medications used in the procedure or prior anaphylactic/anaphylactoid reaction to any food or drug, they will be given prednisone 50 mg PO 13, 7, and 1 hour prior to the procedure and diphenhydramine 50mg PO 1 hour prior to the procedure.)
  • In order to mitigate any economic risk, a patient without adequate medical insurance coverage for any subsequent tests or procedures deemed clinically necessary will be excluded. BMC is an autologous blood product with multiple clinical uses. Intradiscal administration should not preclude insurance coverage for any subsequent medical issues that might develop pertaining to the intradiscal injection itself or the BMC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bone Marrow Concentrate
Patients in this group will receive injection of autologous bone marrow concentrate into the suspected painful intervertebral discs.
Other: Bone Marrow Concentrate
Bone marrow concentrate is bone marrow harvested from the iliac crest and minimally processed in a centrifuge. It is then injected into the suspected painful disc (s) using fluoroscopic guidance
Sham Comparator: Placebo Group
Patients in this group will receive an injection of normal saline dorsal to the transverse process. The bone marrow aspiration will be simulated for these patients.
Other: Placebo
Injection of normal saline dorsal to the transverse process after sham bone marrow aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief treatment vs placebo group 50%
Time Frame: 6 months
Pain reduction of at least 50% at 6 months post-procedure using Visual Analog Scale (VAS) as indicators of pain relief. A reduction in the VAS of at least 50% from baseline is considered successful. VAS of 10 is considered "worst pain imaginable" and VAS of 0 is no pain at all.
6 months
Functional improvement vs Placebo group 50%
Time Frame: 6 months
Functional improvement of at least 50% at 6 months post-procedure using the Oswestry Disability Index (ODI). A reduction of at least 50% in the Oswestry Disability Index is considered successful. The lower the ODI score, the less impact the pain has on a patients daily functioning.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief treatment vs placebo group 50%
Time Frame: 3 months, 12 months
Pain reduction of at least 50% will be assessed at 3 and 12 months post-procedure using the Visual Analog Scale (VAS). A reduction of VAS score at 3 and 12 months of at least 50% of baseline will be considered successful. A score of 10 is the "worst pain imaginable" and a score of 0 is no pain at all.
3 months, 12 months
Pain relief treatment vs placebo 30%
Time Frame: 3, 6, 12 months
Pain reduction of at least 30% at 3, 6, 12 months post-procedure using the Visual Analog Scale (VAS). A decrease in score of at least 30% will be considered successful. A score of 10 is "the worst pain imaginable" and a score of 0 is no pain at all.
3, 6, 12 months
Functional improvement treatment vs placebo 50%
Time Frame: 3 months, 12 months
Improvement in daily functioning of at least 50% from baseline using the Oswestry Disability Index (ODI). A decrease in score of ODI of at least 50% will be considered successful.
3 months, 12 months
Functional improvement treatment vs placebo 30%
Time Frame: 3 months, 12 months
Improvement in daily functioning of at least 30% from baseline using the Oswestry Disability Index (ODI). A reduction in score by 30% is considered successful
3 months, 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication usage
Time Frame: 12 months
Medication log of use of pain medications pre-procedure vs post-procedure will be assessed to determine if less medication has been taken since the procedure when compared with pre-procedure.
12 months
Adjunct therapy
Time Frame: 12 months
Log of any adjunctive therapies post procedure
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

APM Spine and Sports Physicians

Investigators

  • Principal Investigator: David S Levi, MD, Jordan Young Institute
  • Study Chair: Scott I Horn, DO, Jordan Young Institute
  • Study Chair: Josh Levin, MD, Stanford University
  • Study Chair: Sara A Tyszko, PA-C, Jordan Young Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

August 7, 2024

Study Completion (Actual)

August 7, 2024

Study Registration Dates

First Submitted

November 2, 2017

First Submitted That Met QC Criteria

November 13, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMC-1788

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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