Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain
NCT ID: NCT03340818
Last Updated: 2024-08-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
66 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-08-01
Study Completion Date
2024-08-07
Brief Summary
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A double-blind, placebo-controlled study to determine the efficacy of intradiscal injection of bone marrow concentrate on discogenic low back pain.
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Detailed Description
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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.
Conditions
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Discogenic Pain
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomized, double-blind placebo controlled
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Participant and PA providing follow up care and assessing data from ODI, VAS etc will be blinded. Physician performing procedure will not be blinded.
Study Groups
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Bone Marrow Concentrate
Patients in this group will receive injection of autologous bone marrow concentrate into the suspected painful intervertebral discs.
Group Type
EXPERIMENTAL
Bone Marrow Concentrate
Intervention Type
OTHER
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
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.
Group Type
SHAM_COMPARATOR
Placebo
Intervention Type
OTHER
Injection of normal saline dorsal to the transverse process after sham bone marrow aspiration
Interventions
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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
Intervention Type
OTHER
Placebo
Injection of normal saline dorsal to the transverse process after sham bone marrow aspiration
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
55 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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APM Spine and Sports Physicians
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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David S Levi, MD
Role: PRINCIPAL_INVESTIGATOR
Jordan Young Institute
Scott I Horn, DO
Role: STUDY_CHAIR
Jordan Young Institute
Josh Levin, MD
Role: STUDY_CHAIR
Stanford University
Sara A Tyszko, PA-C
Role: STUDY_CHAIR
Jordan Young Institute
Locations
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Jordan Young Institute
Virginia Beach, Virginia, United States
Site Status
Countries
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United States
References
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Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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BMC-1788
Identifier Type: -
Identifier Source: org_study_id
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