跳至主要内容
临床试验/NCT05584046
NCT05584046招募中不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Foot Function Index (FFI) questionnaire

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Single

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Male and female with age 18-70
  • •Unilateral
  • •Heel pain for more than 6 weeks' duration
  • •VAS score ≥ 5
  • •Signed informed consent.

排除标准

  • •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

研究组 & 干预措施

CDAM group

Experimental

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

干预措施: CDAM (Other)

Active Control Group

Active Comparator

Patients receive 2% Ketoprofen patch and a standard home stretching exercise program

干预措施: 2% Ketoprofen Patch (Other)

结局指标

主要结局

Foot Function Index (FFI) questionnaire

时间窗: 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.

Foot Function Index (FFI) questionnaire

时间窗: 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.

Foot Function Index (FFI) questionnaire

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pauline Lui

Professor

Chinese University of Hong Kong

研究点 (1)

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