A Single-blind RCT to Investigate the Effect of a Novel Herbal Patch for the Treatment of PF

Effect of a Novel Herbal Patch for the Treatment of Plantar Fasciitis - A Single-blind Randomized Controlled Trial

Disorders and injuries of tendons and ligaments are some of the most diagnosed musculoskeletal (MS) disorders clinically. Nearly half of the 33 million MS disorders reported in the United States each year are tendon and ligament injuries. Although most of such injuries are non-fatal, they are severely debilitating, resulting in significant reduction in patient's quality of life, loss of productivity, and considerable costs to the healthcare system.

Among all tendon and ligament disorders and injuries, tendon and ligament overuse disorders are the most common and incapacitating ones. Tendinopathy is a painful tendon overuse disorder, which increases with population aging. It has been estimated that about 30% of consultations for MS complaints in a general practice were related to tendinopathy. The affected tendon is presented with local tenderness, swelling and pain, causing physical disability of the affected individual. The affected tendon degenerates and finally ruptures. Common sites of tendinopathy include supraspinatus, common wrist extensor, flexor tendon, patellar tendon, and Achilles tendon. The outcomes of both conservative treatments and surgeries are not satisfactory, with recurrent pain and tendon retear after surgery.

Plantar fasciitis is a chronic painful, degenerative condition of the plantar fascia. It is caused by repetitive traumas at its origin on the calcaneus. Plantar fascia is a thick, ribbon-like fibrous ligament that connects the medial calcaneal tubercle to the heads of the metatarsal bones. It contributes to the support of the foot arch by acting as a tie-rod, where it undergoes tension when the foot bears weight. Therefore, although plantar fascia is anatomically defined as a ligament, it functions similar to a tendon.

This study aims to conduct a randomized controlled study to test the efficacy of CDAM patch for the treatment of plantar fasciitis in patients.

Study Overview

• Status: Recruiting
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Other: CDAM

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Shu-hang YUNG; Phone Number: +852 3505 2728; Email: patrickyung@cuhk.edu.hk

Study Locations

• Hong Kong
  • Sha Tin, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Pauline LUI, PhD; Phone Number: +852 3505 2730; Email: paulinelui@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and female with age 18-65
• Unilateral or bilateral
• Heel pain for more than 6 weeks' duration
• VAS score ≥ 5
• Signed informed consent.

Exclusion Criteria:

• Known chronic disease or receiving long-term medications affecting bone metabolism including BPs
• Contraindication to alendronate therapy such as poor dental fitness
• ACL injury less than 6 weeks
• Injury on duty cases
• Patients who have undergone arthroscopy or open surgery in the index knee in the last 12 months
• Other associated injuries (fractures and other ligament involvement such as neurovascular bundles injury)
• Chondral lesion with concomitant intervention
• Presence of X-ray features of osteoarthritis including decrease in joint space, presence of osteophytes and subchondral cysts
• Neurological deficit
• Pregnant or breastfeeding
• Inability to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CDAM group; Patients receive the CDAM patch and a standard home stretching exercise program	Other: CDAM; Novel drugs such as Traditional Chinese Medicine (TCM) formula that can suppress inflammation may augment tissue healing and reduce activity-related pain in patients suffering from plantar fasciitis. Our team has experiences of using TCM for the treatment of plantar fasciitis. Based on our previous experience, our group has developed a new proprietary topical TCM herbal formula, CDAM, containing Carthami Flos , Dipsaci Radix , Aconiti Lateralis Radix Praeparata and Herba Menthae for the treatment of plantar fasciitis.
No Intervention: Untreated group; Patients receive a standard home stretching exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot Function Index (FFI) questionnaire	The FFI consists of 23 self-reported items divided into three subscales: limitation, pain and disability. The items are scored on a 10-point Likert scale. For each subscale, the raw score is transformed to a 100-point score, with higher score indicating worse limitation / pain / disability. The total score of FFI is the mean of the subscale scores. The Taiwan Chinese version of FFI has been validated.	Change from baseline FFI at 3 weeks
Foot Function Index (FFI) questionnaire	The FFI consists of 23 self-reported items divided into three subscales: limitation, pain and disability. The items are scored on a 10-point Likert scale. For each subscale, the raw score is transformed to a 100-point score, with higher score indicating worse limitation / pain / disability. The total score of FFI is the mean of the subscale scores. The Taiwan Chinese version of FFI has been validated.	Change from baseline FFI at 6 weeks
Foot Function Index (FFI) questionnaire	The FFI consists of 23 self-reported items divided into three subscales: limitation, pain and disability. The items are scored on a 10-point Likert scale. For each subscale, the raw score is transformed to a 100-point score, with higher score indicating worse limitation / pain / disability. The total score of FFI is the mean of the subscale scores. The Taiwan Chinese version of FFI has been validated.	Change from baseline FFI at 8 weeks

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Plantar Fasciitis; Herbal Patch
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: 2022.426

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No