A Double-Blinded Study on Rapid and Sustained Pain Relief Topical Cannabidiol for Plantar Fasciitis

Phase 2Not Yet RecruitingNCT07776405

University of Florida50 enrolled

Overview

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.

Plantar fasciitis is one of the most common causes of plantar heel pain, affecting millions of adults annually and accounting for a large proportion of musculoskeletal complaints seen in orthopaedic and sports medicine clinics. The condition is typically caused by repetitive microtrauma and inflammation at the plantar fascia's insertion on the calcaneus, leading to chronic pain, functional impairment, and limitations in daily activities. Despite its prevalence, effective and well-tolerated long-term treatments remain limited. Current management strategies, including stretching, orthotics, corticosteroid injections, and physical therapy, often provide only temporary relief or are associated with adverse effects from repeated use. Cannabidiol (CBD), a non-psychoactive phytocannabinoid derived from hemp, has gained attention for its potential anti-inflammatory and analgesic properties. Preclinical and clinical studies have demonstrated CBD's ability to modulate inflammatory markers, reduce cytokine activity, and improve pain perception in various musculoskeletal and neuropathic conditions. These mechanisms make it a promising candidate for targeting inflammation-driven pain disorders such as plantar fasciitis. Although CBD has been studied for arthritis, tendon injuries, and generalized pain syndromes, no published trials have yet evaluated its efficacy in plantar fasciitis specifically. A recent scoping review on topical CBD interventions confirmed this absence of evidence, highlighting a significant gap in the current literature regarding CBD's role in localized foot and heel pain. This lack of research underscores an unmet clinical need to assess whether transdermal delivery of CBD could provide measurable short- and long-term benefits in patients with plantar fasciitis. This study aims to address that gap by evaluating a 6000 mg transdermal CBD cream (Tolcylen®, Marlinz Pharma) for both immediate and sustained pain reduction in adults with plantar fasciitis. By using a randomized, double-blinded, placebo-controlled design, we intend to determine whether topical CBD can offer a safe, non-invasive, and effective alternative or adjunct to current treatments. The results of this investigation may contribute to the emerging evidence on topical cannabinoids in orthopaedic pain management and inform future clinical practice guidelines.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Plantar Fasciitis

Interventions

transdermal CBD cream (Tolcylen®, Marlinz Pharma)DRUG

The 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 PlacebosDRUG

The control group will receive a placebo cream identical in appearance, texture, scent, and packaging to the active product but containing no cannabidiol.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 (?) * Willing to apply assigned cream once daily and attend needed visits (?) Exclusion Criteria: * 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 * Concurrent therapies that confound pain outcomes. Routine use of systemic opioids, regular use of nonsteroidal anti-inflammatory drugs beyond rescue parameters, new analgesic starts during the study, or use of other topical analgesics on the study area

Locations (1)

University of Florida Department of Orthopaedics

Gainesville, Florida, United States

Outcomes

Primary Outcomes

• Immediate pain relief, measured by change in numeric rating scale (0-10) from baseline to ten minutes after supervised application.