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NCT Number: NCT07480967

Comparison of Platelet-Rich Plasma and Prolotherapy for Plantar Fasciitis

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

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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with plantar fasciitis not responding to conservative therapy.

Exclusion criteria

  • 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.

Treatment and study plan

platelet-rich plasma injection

Procedure

autologous platelet-rich plasma prepared from the participant's blood and injected into the plantar fascia under aseptic conditions.

Prolotherapy with 25% Dextrose

Procedure

Injection of hypertonic dextrose solution into the plantar fascia at the site of maximal tenderness to stimulate tissue healing.

Primary outcomes

  1. Pain intensity measured by the Visual Analog Scale (VAS)

    Time frame: 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.

Secondary outcomes

  1. Foot function assessed using the Foot Function Index (FFI)

    Time frame: Baseline, 2 weeks, 4 weeks, 3 months, 6 months

    Evaluation of functional limitation and disability related to plantar fasciitis. The total score ranges from 0 to 100, where 0 represents no pain or disability, and 100 represents the worst possible pain and functional limitation. Higher scores indicate worse foot function and greater disability.

  2. Patient satisfaction score by 5-point Likert Scale

    Time frame: 2 weeks, 4 weeks, 3 months, 6 months

    Patient satisfaction will be assessed using a 5-point Likert Satisfaction Scale. The scale ranges from 1 to 5, where 1 represents very dissatisfied, 2 represents dissatisfied, 3 represents neutral, 4 represents satisfied, and 5 represents very satisfied. Higher scores indicate greater patient satisfaction with the treatment.

  3. Plantar fascial thickness measured by ultrasound

    Time frame: Baseline, 2 weeks, 4 weeks, 3 months, 6 months

    Plantar fascial thickness will be measured using diagnostic ultrasound. Plantar fascia thickness will be measured in millimeters (mm) at the point of maximal thickness near the calcaneal insertion using musculoskeletal ultrasound. Increased plantar fascia thickness is associated with greater disease severity, and a reduction in thickness over time indicates improvement.

Study contacts

Contact information is provided by the study sponsor or research team.

AKM Akhtaruzzaman, MD

CONTACT

Kazi Mahzabin Arin, MD

CONTACT

[email protected]

+8801754057689

Sponsors and collaborators

Lead sponsor

Bangladesh Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 18, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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