Clinical trial NCT03340818: 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
Overall status: COMPLETED
Phase: NA
Conditions: Discogenic Pain
Keywords: Low back pain, bone marrow concentrate, disc degeneration
Lead sponsor: APM Spine and Sports Physicians
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind placebo controlled
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain relief treatment vs placebo group 50%
timeFrame: 6 months
measure: Functional improvement vs Placebo group 50%
timeFrame: 6 months
Secondary outcomes:
measure: Pain relief treatment vs placebo group 50%
timeFrame: 3 months, 12 months
measure: Pain relief treatment vs placebo 30%
timeFrame: 3, 6, 12 months
measure: Functional improvement treatment vs placebo 50%
timeFrame: 3 months, 12 months
measure: Functional improvement treatment vs placebo 30%
timeFrame: 3 months, 12 months
Other outcomes:
measure: Medication usage
timeFrame: 12 months
measure: Adjunct therapy
timeFrame: 12 months
Locations:
city: Virginia Beach
country: United States
facility: Jordan Young Institute
state: Virginia
Study officials:
affiliation: Jordan Young Institute
name: David S Levi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jordan Young Institute
name: Scott I Horn, DO
role: STUDY_CHAIR
affiliation: Stanford University
name: Josh Levin, MD
role: STUDY_CHAIR
affiliation: Jordan Young Institute
name: Sara A Tyszko, PA-C
role: STUDY_CHAIR
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