Comparison of Platelet-Rich Plasma and Prolotherapy for Plantar Fasciitis

Официальное название

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

Обзор

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

Подробное описание

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.

This study is designed as a randomized controlled trial in which eligible participants will be allocated to either PRP therapy or prolotherapy. Clinical outcomes will be assessed during follow-up to determine the effectiveness of each intervention in reducing pain and improving functional status. The findings of this trial may provide evidence to guide treatment decisions for patients with plantar fasciitis who do not respond to conventional conservative management.

Вмешательства

• Процедура platelet-rich plasma injection
  autologous platelet-rich plasma prepared from the participant's blood and injected into the plantar fascia under aseptic conditions.
• Процедура Prolotherapy with 25% Dextrose
  Injection of hypertonic dextrose solution into the plantar fascia at the site of maximal tenderness to stimulate tissue healing.

Первичные конечные точки

• Pain intensity measured by the Visual Analog Scale (VAS) [Срок оценки: Baseline, 2 weeks, 4 weeks, 3 months, 6 months]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• Patient with plantar fasciitis not responding to conservative therapy.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Bangladesh · 1 центр

• Bangladesh Medical University — Dhaka

Публикации

• Dohan Ehrenfest DM, Andia I, Zumstein MA, Zhang CQ, Pinto NR, Bielecki T. Classification of platelet concentrates (Platelet-Rich Plasma-PRP, Platelet-Rich Fibrin-PRF) for topical and infiltrative use in orthopedic and sports medicine: current consensus, clinical implications and perspectives. Muscles Ligaments Tendons J. 2014 May 8;4(1):3-9. eCollection 2014 Jan. PMID 24932440
• Capotosto S, Nazemi AK, Komatsu DE, Penna J. Prolotherapy in the Treatment of Sports-Related Tendinopathies: A Systematic Review of Randomized Controlled Trials. Orthop J Sports Med. 2024 Nov 4;12(11):23259671241275087. doi: 10.1177/23259671241275087. eCollection 2024 Nov. PMID 39502373
• Ahadi T, Cham MB, Mirmoghtadaei M, Raissi GR, Janbazi L, Zoghi G. The effect of dextrose prolotherapy versus placebo/other non-surgical treatments on pain in chronic plantar fasciitis: a systematic review and meta-analysis of clinical trials. J Foot Ankle Res. 2023 Feb 10;16(1):5. doi: 10.1186/s13047-023-00605-3. PMID 36759882
• Michalak N, Banks D, Kane L, Siefferman J. Dextrose Prolotherapy for the Treatment of Chronic Shoulder Pain in Patients With Joint Hypermobility: A Case Series. Clin Med Insights Arthritis Musculoskelet Disord. 2024 Jul 24;17:11795441241264821. doi: 10.1177/11795441241264821. eCollection 2024. PMID 39055287
• Alhakami AM, Babkair RA, Sahely A, Nuhmani S. Effectiveness of therapeutic ultrasound on reducing pain intensity and functional disability in patients with plantar fasciitis: a systematic review of randomised controlled trials. PeerJ. 2024 Mar 22;12:e17147. doi: 10.7717/peerj.17147. eCollection 2024. PMID 38529309
• Tseng WC, Chen YC, Lee TM, Chen WS. Plantar Fasciitis: An Updated Review. J Med Ultrasound. 2023 Oct 6;31(4):268-274. doi: 10.4103/jmu.jmu_2_23. eCollection 2023 Oct-Dec. PMID 38264606
• Ryan MB, Wong AD, Gillies JH, Wong J, Taunton JE. Sonographically guided intratendinous injections of hyperosmolar dextrose/lidocaine: a pilot study for the treatment of chronic plantar fasciitis. Br J Sports Med. 2009 Apr;43(4):303-6. doi: 10.1136/bjsm.2008.050021. Epub 2008 Nov 19. PMID 19019908
• Pretorius J, Habash M, Ghobrial B, Alnajjar R, Ellanti P. Current Status and Advancements in Platelet-Rich Plasma Therapy. Cureus. 2023 Oct 17;15(10):e47176. doi: 10.7759/cureus.47176. eCollection 2023 Oct. PMID 38021947

Идентификаторы

NCT: NCT07480967 · BMU/2026/20/000004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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