Plantar Fasciitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGtransdermal CBD cream (Tolcylen®, Marlinz Pharma)
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.
DRUGMatched Placebos
The control group will receive a placebo cream identical in appearance, texture, scent, and packaging to the active product but containing no cannabidiol.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • Immediate pain relief, measured by change in numeric rating scale (0-10) from baseline to ten minutes after supervised application. | Daily for one month | — |
| • One-month changes in average daily pain score compared to baseline. | Daily for one month | — |
| • Global patient satisfaction | Daily for one month. | measured using a five-point Likert scale assessing overall perceived improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of immediate pain relief following initial application | Daily for one month | — |
| Adherence to protocol measured by patient logs and pump counts | Daily for one month | — |
| Incidence of adverse effects | Daily for one month | Occurrence of negative side effects |
| Rescue analgesic use | Daily for one month | — |
| Time to perceived improvement in symptoms | Daily for one month | — |
| 6. PROMIS Pain Interference questionnaire | At enrollment and at end of once month | — |
| 7. Foot Function Index questionnaires | At enrollment and at one month | — |
| 8. Return to normal activity - the number of days required for participants to resume full standing or walking tolerance without pain | Once during one month | — |
Countries
United States
Contacts
CONTACTAntony Merendino, DPM
CONTACTShea Herlihy, MS
Outcome results
None listed