About this trial
This prospective, double-blinded, placebo-controlled study evaluates the efficacy of a 6000 mg transdermal CBD cream in adults with plantar fasciitis. Fifty participants will apply either CBD or placebo once daily for one month.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients aged 18-85
Clinical diagnosis of plantar fasciitis by a qualified provider
Symptomatic for at least four weeks with plantar heel pain consistent with plantar fascia involvement
Baseline average pain score that meets eligibility threshold as defined in the protocol (?)
Disqualifiers
Special populations and consent limitations. Pregnancy, breastfeeding, prisoners, inability to provide informed consent, or inability to complete study procedures
Contraindications to topical products or CBD. History of allergy or sensitivity to cannabinoids, excipients, or topical creams used in the study
Confounding dermatologic conditions at the application site. Open wounds, active infection, dermatitis, ulceration, or recent burns on the heel or midfoot
Recent or planned procedures that alter outcomes. Corticosteroid injection, platelet rich plasma, surgery, immobilization, or shockwave therapy within the protocol washout window
Trial design
Parallel
Treatments tested in this trial
transdermal CBD cream (Tolcylen®, Marlinz Pharma)
DrugThe active product is the study CBD cream supplied by the manufacturer. Dosing is three pumps per application which delivers approximately one point five milliliters of cream. Application is once daily to the most tender plantar fascia region for the entire study month. The first dose will be taught and supervised in clinic using a glove. The cream will be massaged into the affected area for at least forty-five seconds. Skin must be clean and dry before application. No other topical agents may be placed on the study area during the study period.
Matched Placebos
DrugThe control group will receive a placebo cream identical in appearance, texture, scent, and packaging to the active product but containing no cannabidiol.
Treatment groups
Trial outcomes
Primary outcomes
• Immediate pain relief, measured by change in numeric rating scale (0-10) from baseline to ten minutes after supervised application.
• One-month changes in average daily pain score compared to baseline.
• Global patient satisfaction
measured using a five-point Likert scale assessing overall perceived improvement.
Secondary outcomes
Duration of immediate pain relief following initial application
Adherence to protocol measured by patient logs and pump counts
Incidence of adverse effects
Occurrence of negative side effects
Rescue analgesic use
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: