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Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain

Primary Purpose

Discogenic Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bone Marrow Concentrate
Placebo
Sponsored by
APM Spine and Sports Physicians
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Discogenic Pain focused on measuring Low back pain, bone marrow concentrate, disc degeneration

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jordan Young InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Bone Marrow Concentrate

Placebo Group

Arm Description

Patients in this group will receive injection of autologous bone marrow concentrate into the suspected painful intervertebral discs.

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.

Outcomes

Primary Outcome Measures

Pain relief treatment vs placebo group 50%
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.
Functional improvement vs Placebo group 50%
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

Pain relief treatment vs placebo group 50%
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.
Pain relief treatment vs placebo 30%
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.
Functional improvement treatment vs placebo 50%
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.
Functional improvement treatment vs placebo 30%
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

Full Information

First Posted
November 2, 2017
Last Updated
January 14, 2020
Sponsor
APM Spine and Sports Physicians
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1. Study Identification

Unique Protocol Identification Number
NCT03340818
Brief Title
Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain
Official Title
Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain: A Double-Blind, Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
APM Spine and Sports Physicians

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discogenic Pain
Keywords
Low back pain, bone marrow concentrate, disc degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind placebo controlled
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bone Marrow Concentrate
Arm Type
Experimental
Arm Description
Patients in this group will receive injection of autologous bone marrow concentrate into the suspected painful intervertebral discs.
Arm Title
Placebo Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Bone Marrow Concentrate
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Injection of normal saline dorsal to the transverse process after sham bone marrow aspiration
Primary Outcome Measure Information:
Title
Pain relief treatment vs placebo group 50%
Description
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.
Time Frame
6 months
Title
Functional improvement vs Placebo group 50%
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain relief treatment vs placebo group 50%
Description
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.
Time Frame
3 months, 12 months
Title
Pain relief treatment vs placebo 30%
Description
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.
Time Frame
3, 6, 12 months
Title
Functional improvement treatment vs placebo 50%
Description
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.
Time Frame
3 months, 12 months
Title
Functional improvement treatment vs placebo 30%
Description
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
Time Frame
3 months, 12 months
Other Pre-specified Outcome Measures:
Title
Medication usage
Description
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.
Time Frame
12 months
Title
Adjunct therapy
Description
Log of any adjunctive therapies post procedure
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara A Tyszko, PA-C
Phone
757-490-4802
Email
styszko@jordan-younginstitute.com
First Name & Middle Initial & Last Name or Official Title & Degree
David S Levi, MD
Phone
757-490-4802
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Levi, MD
Organizational Affiliation
Jordan Young Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott I Horn, DO
Organizational Affiliation
Jordan Young Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Josh Levin, MD
Organizational Affiliation
Stanford University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sara A Tyszko, PA-C
Organizational Affiliation
Jordan Young Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Jordan Young Institute
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara A Tyszko, PA-C
Phone
757-490-4802
Email
styszko@jordan-younginstitute.com
First Name & Middle Initial & Last Name & Degree
David S Levi, MD
Phone
757-490-4802
First Name & Middle Initial & Last Name & Degree
David S Levi, MD
First Name & Middle Initial & Last Name & Degree
Scott I Horn, DO
First Name & Middle Initial & Last Name & Degree
Josh Levin, MD
First Name & Middle Initial & Last Name & Degree
Sara A Tyszko, PA-C

12. IPD Sharing Statement

Plan to Share IPD
No
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Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain

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