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NCT Number: NCT05584046

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

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.

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Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female with age 18-70
  • Unilateral
  • 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

Treatment and study plan

CDAM

Other

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.

2% Ketoprofen Patch

Other

MOHRUS patch is the transdermal analgesic anti-inflammatory patch and is a standard treatment prescribed by doctor. Each patch contains 2% Ketoprofen and it is for the relief of pain and inflammation.

Primary outcomes

  1. Foot Function Index (FFI) questionnaire

    Time frame: Change from baseline FFI at 3 weeks

    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.

  2. Foot Function Index (FFI) questionnaire

    Time frame: Change from baseline FFI at 6 weeks

    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.

  3. Foot Function Index (FFI) questionnaire

    Time frame: Change from baseline FFI at 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick Shu-hang YUNG

CONTACT

[email protected]

+852 3505 2728

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 18, 2022
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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