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临床试验/NCT07480967
NCT07480967尚未招募不适用

Efficacy Of Platelet Rich Plasma Therapy Versus Prolotherapy In Patients With Plantar Fasciitis: A Randomized Controlled Trial

Bangladesh Medical University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2026年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
Pain intensity measured by the Visual Analog Scale (VAS)

研究概览

简要总结

This randomized controlled trial evaluates the comparative effectiveness of platelet-rich plasma (PRP) therapy and prolotherapy in patients with plantar fasciitis. Both interventions are commonly used regenerative injection therapies intended to improve pain and functional outcomes in patients who do not respond adequately to conventional conservative treatments.

Participants diagnosed with plantar fasciitis will be randomly assigned to receive either PRP injection or prolotherapy. The results of this study aim to identify the more effective injection therapy for improving clinical outcomes in patients with plantar fasciitis

详细描述

Plantar fasciitis is a common musculoskeletal disorder characterized by chronic heel pain resulting from degeneration and microtears of the plantar fascia at its calcaneal insertion. It frequently affects individuals who perform prolonged standing, repetitive walking, or high-impact activities. The condition may lead to persistent discomfort, functional limitation, and reduced quality of life.

Initial management typically includes conservative measures such as rest, stretching exercises, orthotic devices, physiotherapy, and pharmacological pain management. Although many patients respond to these treatments, a subset of patients continues to experience chronic symptoms requiring additional therapeutic options.

Regenerative injection therapies have emerged as alternative treatments for chronic plantar fasciitis. Platelet-rich plasma therapy involves preparing a concentrated platelet suspension from autologous blood and injecting it into the affected region. The platelets release multiple growth factors that may stimulate tissue regeneration, promote collagen synthesis, and enhance healing of the damaged plantar fascia.

Prolotherapy is another injection-based therapy that uses an irritant solution, most commonly hypertonic dextrose, injected at the site of ligament or tendon attachment. The solution induces a controlled inflammatory response that stimulates fibroblast proliferation and connective tissue repair, which may strengthen the affected structures.

Despite the increasing use of PRP therapy and prolotherapy, the comparative effectiveness of these treatments remains uncertain. Evidence comparing the two techniques is limited, and determining their relative benefits may assist clinicians in selecting the most appropriate treatment for patients with persistent plantar fasciitis.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with plantar fasciitis not responding to conservative therapy.

排除标准

  • Patients with uncontrolled diabetes, haematological disorders, hepatitis B or C, HIV, clinical signs of acute inflammation, or septicaemia.
  • Those receiving local steroid injections within one month.
  • Those receiving non-steroidal anti-inflammatory medications within 72 hours.
  • Platelet levels 25% below the normal level.
  • Patient who had acute ankle or foot trauma, a diagnosis of calcaneal fracture, or stress fracture.

结局指标

主要结局

Pain intensity measured by the Visual Analog Scale (VAS)

时间窗: Baseline, 2 weeks, 4 weeks, 3 months, 6 months

Pain intensity will be measured using the Visual Analog Scale (VAS). The Visual Analog Scale is a validated measure of pain intensity consisting of a 10-cm line ranging from 0 to 10, where 0 represents no pain, and 10 represents the worst imaginable pain. Higher scores indicate greater pain intensity.

次要结局

  • Foot function assessed using the Foot Function Index (FFI)(Baseline, 2 weeks, 4 weeks, 3 months, 6 months)
  • Patient satisfaction score by 5-point Likert Scale(2 weeks, 4 weeks, 3 months, 6 months)
  • Plantar fascial thickness measured by ultrasound(Baseline, 2 weeks, 4 weeks, 3 months, 6 months)

研究者

发起方
Bangladesh Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kazi Mahzabin Arin

Assistant Professor

Bangladesh Medical University

研究点 (1)

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