NCT05170451

A Randomized Controlled Trial of Topical Cannabidiol for the Treatment of Musculoskeletal Pain

Withdrawn Phase 2/Phase 3 Last updated 23 February 2024

What this trial tests

Phase 2/Phase 3 trial testing CBD in Musculoskeletal Pain. Withdrawn.

Timeline

1 January 2022

Primary endpoint
1 June 2022

1 December 2022

Quick facts

Lead sponsor	University of Virginia
Phase	Phase 2/Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Start date	1 January 2022
Primary completion	1 June 2022
Estimated completion	1 December 2022
Sites	1 location across United States

Drugs / interventions tested

• CBD — full drug profile →
• Control

Conditions studied

• Musculoskeletal Pain — all drugs for Musculoskeletal Pain →

Sponsor

University of Virginia

Who can join

18 and older, any sex, with Musculoskeletal Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of participants with change in The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) during intervention and at follow-up.
  Time frame: [Time Frame: Every 1 week during intervention and 1 week washout, up to 7 weeks.]
  PROMIS-29 will measure health-related quality of life and is a validated, 29 question survey divided into seven sub-domains of function including physical functioning, social function, pain interference, pain intensity, sleep, depression, and anxiety, where a higher score indicates more pain interference.
• Change from baseline in Visual Analog Pain (VAS) Score during intervention and at follow-up.
  Time frame: [Time Frame: Every 1 week during intervention and 1 week washout, up to 7 weeks.]
  The VAS score is a unidimensional measure of pain intensity and is a validated, subjective measure for acute and chronic pain. A patient is asked to indicate his/her perceived pain intensity along a horizontal line (from 0 to 100), and this rating is then measured from the left edge with higher numbers indicating more pain.
• Change from baseline in Single Assessment Numerical Evaluation (SANE)
  Time frame: [Time Frame: Every 1 week during intervention and 1 week washout, up to 7 weeks.]
  The SANE score is a validated metric for musculoskeletal pain which can be applied to any joint or region of interest. The patient is asked to rate his/her pain from 0-100. Patients rate their current illness score in relation to their pre-injury baseline.

Sponsor's own description

Rationale: CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain; however, no clinical trial has been performed to establish efficacy of CBD in humans for musculoskeletal pain.

Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for musculoskeletal pain.

Study Design: The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the CBD or control and then crossover to the other condition for 2 additional weeks. Patients will apply the CBD or control cream to the affected area twice daily (approximately every 12 hours) for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Strategies to Improve Cannabidiol Bioavailability and Drug Delivery.
   O'Sullivan SE, Jensen SS, Kolli AR, Nikolajsen GN, et al · · 2024 · cited 23× · PMID 38399459 · DOI 10.3390/ph17020244