Clinical trial NCT05584046: A Single-blind RCT to Investigate the Effect of a Novel Herbal Patch for the Treatment of PF
Official title: Effect of a Novel Herbal Patch for the Treatment of Plantar Fasciitis - A Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plantar Fasciitis
Keywords: Plantar Fasciitis
Herbal Patch
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Foot Function Index (FFI) questionnaire
timeFrame: Change from baseline FFI at 3 weeks
measure: Foot Function Index (FFI) questionnaire
timeFrame: Change from baseline FFI at 6 weeks
measure: Foot Function Index (FFI) questionnaire
timeFrame: Change from baseline FFI at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: