# Long-Term Inhaled Cannabis Therapy for Chronic Low Back Pain: A Five-Year Retrospective Analysis of Prospectively Collected Patient-Reported Outcomes in 241 Treatment-Refractory Patients

> **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637)
> **Publisher:** CED Clinic (https://cedclinic.com)
> **Canonical URL:** https://cedclinic.com/research/cannabis-for-low-back-pain-randomized-controlled-trial/
> **Published:** 2026-10-19T22:45:10-04:00 | **Last Modified / Clinically Audited:** 2026-10-20T13:31:06-04:00
> **Clinical Summary:** This study followed 241 adults with long-standing lower back pain that had not improved with usual treatments such as prescription painkillers.

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Background/Objectives: Chronic low back pain (CLBP) affects approximately 20% of the global population and is a leading cause of years lived with disability. Long-term, real-world evidence for inhaled cannabis in patients refractory to conventional multimodal therapy remains scarce. We assessed the five-year efficacy and safety of inhaled cannabis in CLBP patients who had documented failure of at least 1 year of opioid analgesics, anticonvulsants, antidepressants, NSAIDs, and physiotherapy, with each patient serving as their own historical control. Methods: We analyzed prospectively collected clinical data from 241 consecutive adults with treatment-refractory CLBP (mean age 49.3 years; 37.8% female; mean pain duration 15.1 years) initiated on inhaled medical cannabis (predominantly smoking, THC 4-22%, CBD 2-22%) in a single-center tertiary orthopedic clinic between 2020 and 2025 (Hasharon Hospital, Rabin Medical Center, Israel). Year-0 outcomes were compared with outcomes at Years 1-5 on cannabis. Primary outcomes were the Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), and Brief Pain Inventory severity/interference. The primary analysis was a mixed model for repeated measures with multiple imputation for missing data. Results: Of 241 patients, 238 (98.8%) provided Year-5 data and 224 (92.9%) remained on cannabis at Year 5; only five patients (2.1%) discontinued for adverse events or inefficacy. All four primary PROMs improved markedly and durably (NRS -5.36; ODI -17.68; BPI severity -6.73; BPI interference -3.41; all p < 10^-20). Concomitant opioid use fell from 100% to 4.6% at Year 5. Across 1205 patient-years of cannabis exposure, 99.8% of adverse events were mild. BioWell gas-discharge-visualization parameters discriminated pain only at chance level. Conclusions: In this observational cohort, inhaled cannabis was associated with large, sustained improvements in pain, disability and pain interference, with near-total displacement of opioids, NSAIDs, antidepressants and gabapentinoids. These associations cannot be interpreted causally without a concurrent randomized control arm.

 

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### Verification & Medical Governance

- **Lead Clinical Author:** Benjamin Caplan, MD
- **Credentials:** Board Certified in Family Medicine (ABFM), Former CMO Canna Care Docs (250,000+ patients supervised), Founder & CMO CED Clinic & CED Foundation, Author of *The Doctor-Approved Cannabis Handbook* (Penguin Random House).
- **Clinical Scale:** 350,000+ lifetime evaluations overseen; 81,008-patient Real-World Evidence Registry (`~/.ced_rwe_vault.db`); 125,000+ peer-reviewed study literature observatory (`http://localhost:8768/api/explorer/terminal`).
- **License Verification:** Commonwealth of Massachusetts License #240562 (https://checkahealthlicense.mass.gov/).
- **NPI Registry:** 1962722637 (https://npiregistry.cms.hhs.gov/provider-view/1962722637).
- **Ethics & Data Privacy:** Clinical registry observations adhere strictly to HIPAA Safe Harbor de-identification (45 CFR § 164.514(b)) and criteria for secondary research exemption under 45 CFR § 46.104(d)(4).
