Back Pain, Low
Conditions
Brief summary
In this research, the study team will use brain imaging to evaluate the presence of neuroinflammation in the brains and spinal cords of patients with low back pain, and whether CBD effects levels of neuroinflammation. The efficacy of CBD use for low back pain treatment will also be evaluated by observing whether CBD administration will reduce neuroinflammation and low back pain symptoms.
Detailed description
The goal of this research study is to test whether glial cells (the immune cells of the brain and spinal cord) that are active in patients with low back pain can be reduced with CBD. Previous studies have showed that patients with chronic low back pain demonstrated elevations in brain levels of the 18kDa translocator protein (TSPO), a marker of glial activation. To test this hypothesis, the study team will image the brains and spinal cords of patients suffering from low back pain using integrated magnetic resonance- positron emission tomography (MR-PET), and a radiotracer called \[11C\]PBR28, which tracks levels of glial activation. The efficacy of CBD as a treatment for chronic low back pain will be evaluated. The study team will observe whether 4 weeks of CBD treatment may reduce glial activation along with self-reported low back pain symptoms. To this end, patients will be evaluated clinically and/or re-scanned after completing the 4-week trial of minocycline. This study will be enrolling individuals who have been suffering from chronic low back pain.
Interventions
DRUGCannabidiol
Epidiolex, an agent within the anti-epileptic drug class, will be used. Epidiolex, Greenwich Biosciences Inc.'s CBD formulation, is a 100 mg/mL purified oral solution. The recommended starting dosage is 2.5mg/kg taken twice daily (5mg/kg/day). After one week, the dosage will be increased to a maintenance dosage of 10 mg/kg twice daily (20 mg/kg/day). At the end of the first week, the patient will increase the dose to 10 mg/kg twice daily for the following week.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* age ≥ 18 and ≤ 75; * the ability to give written, informed consent; * ongoing pain that averaged at least 4, on a 0-10 scale of pain during a typical week, and present for at least 50% of days during a typical week; * fluency in English; * on a stable pain treatment (pharmacological or otherwise) for the previous four weeks. * Medical records confirming diagnosis of low back pain * Chronic low back pain, ongoing for at least 6 months prior to enrollment.
Exclusion criteria
* outpatient surgery within 2 months and inpatient surgery within 6 months from the time of scanning; * elevated baseline transaminase (ALT and AST) levels above 3 times the Upper Limit of Normal (ULN), accompanied by elevations in bilirubin above 2 times the ULN * any interventional pain procedures within 6 weeks prior to scanning procedure or at any point during study enrollment; * surgical intervention or introduction/change in opioid regimen at any point during study enrollment * contraindications to functional magnetic resonance imaging scanning and positron emission tomography scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia); * current or past history within the last 5 years of major medical illness not affecting the central nervous system, other than chronic pain; * implanted spinal cord stimulator (SCS) for pain treatment; * any history of neurological illness or major medical illness affecting the central nervous system, unless clearly resolved without long-term consequences; * current or past history of major psychiatric illness; * PTSD, depression, and anxiety are
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Brain Positron Emission Tomography Signal | 4 weeks | The investigators will test for the presence of a significant treatment effect in the brain \[11C\]PBR28 signal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Pain Outcomes as Measured by Self Report on a 0-10 Numerical Pain Rating Scale (Worst Pain in the Past 24 Hours). | 4 weeks | The investigators will test for the presence of a significant treatment effect in pain outcomes on a self reported numerical (0-10) pain rating scale. Higher number indicates worse pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CBD Arm Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after a 4-week trial of a liquid formulation of CBD.
Cannabidiol: Epidiolex, an agent within the anti-epileptic drug class, will be used. Epidiolex, Greenwich Biosciences Inc.'s CBD formulation, is a 100 mg/mL purified oral solution. The recommended starting dosage is 2.5mg/kg taken twice daily (5mg/kg/day). After one week, the dosage will be increased to a maintenance dosage of 10 mg/kg twice daily (20 mg/kg/day). At the end of the first week, the patient will increase the dose to 10 mg/kg twice daily for the following week. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | CBD Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 62.5 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 3 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Changes in Brain Positron Emission Tomography Signal
The investigators will test for the presence of a significant treatment effect in the brain \[11C\]PBR28 signal.
Time frame: 4 weeks
Population: Trial ended early because funding was obtained to do a larger, placebo-controlled trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBD Arm | Changes in Brain Positron Emission Tomography Signal | 0.00197 Standardized Uptake Values (SUVs) | Standard Deviation 0.017756865 |
Secondary
Changes in Pain Outcomes as Measured by Self Report on a 0-10 Numerical Pain Rating Scale (Worst Pain in the Past 24 Hours).
The investigators will test for the presence of a significant treatment effect in pain outcomes on a self reported numerical (0-10) pain rating scale. Higher number indicates worse pain.
Time frame: 4 weeks
Population: Trial ended early because funding was obtained to do a larger, placebo-controlled trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBD Arm | Changes in Pain Outcomes as Measured by Self Report on a 0-10 Numerical Pain Rating Scale (Worst Pain in the Past 24 Hours). | 4.5 score on a scale | Standard Deviation 0.707106781 |