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Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain

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ClinicalTrials.gov Identifier: NCT03340818
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
APM Spine and Sports Physicians

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

Condition or disease Intervention/treatment Phase
Discogenic Pain Other: Bone Marrow Concentrate Other: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind placebo controlled
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participant and PA providing follow up care and assessing data from ODI, VAS etc will be blinded. Physician performing procedure will not be blinded.
Primary Purpose: Treatment
Official Title: Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain: A Double-Blind, Placebo Controlled Trial
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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


Other Outcome Measures:
  1. 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.

  2. Adjunct therapy [ Time Frame: 12 months ]
    Log of any adjunctive therapies post procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT03340818


Contacts
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Contact: Sara A Tyszko, PA-C 757-490-4802 styszko@jordan-younginstitute.com
Contact: David S Levi, MD 757-490-4802

Locations
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United States, Virginia
Jordan Young Institute Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Sara A Tyszko, PA-C    757-490-4802    styszko@jordan-younginstitute.com   
Contact: David S Levi, MD    757-490-4802      
Principal Investigator: David S Levi, MD         
Sub-Investigator: Scott I Horn, DO         
Sub-Investigator: Josh Levin, MD         
Sub-Investigator: Sara A Tyszko, PA-C         
Sponsors and Collaborators
APM Spine and Sports Physicians
Investigators
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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
  Study Documents (Full-Text)

Documents provided by APM Spine and Sports Physicians:
Study Protocol and Statistical Analysis Plan  [PDF] September 21, 2017
Informed Consent Form  [PDF] October 11, 2017

More Information
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Publications:

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Responsible Party: APM Spine and Sports Physicians
ClinicalTrials.gov Identifier: NCT03340818    
Other Study ID Numbers: BMC-1788
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by APM Spine and Sports Physicians:
Low back pain, bone marrow concentrate, disc degeneration
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations