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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Florida

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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 Placebos

    Drug

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Participants who receive a transdermal cannabidiol creamExperimental treatment 1 intervention
Group B: Participants who receive a matched placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Daily for one month
2

• One-month changes in average daily pain score compared to baseline.

Time frame
Daily for one month
3

• Global patient satisfaction

measured using a five-point Likert scale assessing overall perceived improvement.

Time frame
Daily for one month.

Secondary outcomes

1

Duration of immediate pain relief following initial application

Time frame
Daily for one month
2

Adherence to protocol measured by patient logs and pump counts

Time frame
Daily for one month
3

Incidence of adverse effects

Occurrence of negative side effects

Time frame
Daily for one month
4

Rescue analgesic use

Time frame
Daily for one month

Other outcomes

Sponsors and contacts

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