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

NCT ID: NCT05584046

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-20
• Study Completion Date: 2025-06-30

Brief Summary

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.

Conditions

Plantar Fasciitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CDAM group

Patients receive the CDAM patch and a standard home stretching exercise program

Group Type: EXPERIMENTAL

CDAM

Intervention Type: 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.

Untreated group

Patients receive a standard home stretching exercise program

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Pauline Lui

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prince of Wales Hospital

Shatin, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Patrick Shu-hang YUNG

Role: CONTACT

patrickyung@cuhk.edu.hk

+852 3505 2728

Facility Contacts

Pauline LUI, PhD

Role: primary

paulinelui@cuhk.edu.hk

+852 3505 2730

Other Identifiers

2022.426

Identifier Type: -

Identifier Source: org_study_id