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Cannabinoid

Active Comparator: Start with control (Shea butter) for Musculoskeletal Pain

Phase 2 & 3
Waitlist Available
Led By Brent DeGeorge, MD, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged 18 years or older.
Presence of physician-diagnosed musculoskeletal pain in a discrete body region, including bone or joint-related pain, tendon or ligament-related pain, muscle-related pain, or fibromyalgia or physician-diagnosed postoperative pain in a discrete body region.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up [time frame: every 1 week during intervention and 1 week washout, up to 7 weeks.]
Awards & highlights

Study Summary

This trial will explore whether CBD is more effective than a placebo for relieving musculoskeletal pain and improving patient-reported outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~[time frame: every 1 week during intervention and 1 week washout, up to 7 weeks.]
This trial's timeline: 3 weeks for screening, Varies for treatment, and [time frame: every 1 week during intervention and 1 week washout, up to 7 weeks.] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Single Assessment Numerical Evaluation (SANE)
Change from baseline in Visual Analog Pain (VAS) Score during intervention and at follow-up.
Number of participants with change in The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) during intervention and at follow-up.
Secondary outcome measures
Rate of side effects using novel CBD cream.

Trial Design

2Treatment groups
Active Control
Group I: Active Comparator: Start with control (Shea butter)Active Control2 Interventions
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 Shea butter and then crossover to the other condition (CBD) for 2 additional weeks. Patients will apply the topical cream to the affected body region or joint two times daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.
Group II: Active Comparator: Start with CBDActive Control2 Interventions
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 and then crossover to the other condition (Shea butter only) for 2 additional weeks. Patients will apply the topical cream to the affected body region or joint two times daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
748 Previous Clinical Trials
1,236,003 Total Patients Enrolled
Brent DeGeorge, MD, PhDPrincipal InvestigatorUniversity of Virginia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study with CBD compare to other similar research?

"As of now, 83 clinical trials that involve an active comparator starting with CBD are ongoing. Out of those, 18 are in phase 3. Additionally, while some of the research for Active Comparator: Start with CBD is based in Ribeirao Preto, Sao Paulo, there are a total of 311 locations running these sorts of studies."

Answered by AI

Are there any available slots for new participants in this trial?

"The information available on clinicaltrials.gov suggests that this trial is not presently recruiting patients. Although the study was last updated on December 10th, 2021, it was originally posted January 1st, 2022. There are, however, 141 other trials which are recruiting patients."

Answered by AI
~0 spots leftby Mar 2025