Comparison of Platelet-Rich Plasma and Prolotherapy for Plantar Fasciitis
ConditionPlanter Fasciitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBangladesh Medical University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with plantar fasciitis not responding to conservative therapy.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
platelet-rich plasma injection
Procedure/Surgeryautologous platelet-rich plasma prepared from the participant's blood and injected into the plantar fascia under aseptic conditions.
Prolotherapy with 25% Dextrose
Procedure/SurgeryInjection of hypertonic dextrose solution into the plantar fascia at the site of maximal tenderness to stimulate tissue healing.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Group Platelet Rich Plasma (PRP) TherapyActive comparator 1 intervention
Group B: Group ProlotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain intensity measured by the Visual Analog Scale (VAS)
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.
Time frame
Baseline, 2 weeks, 4 weeks, 3 months, 6 monthsSecondary outcomes
1
Foot function assessed using the Foot Function Index (FFI)
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.
Time frame
Baseline, 2 weeks, 4 weeks, 3 months, 6 months2
Patient satisfaction score by 5-point Likert Scale
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.
Time frame
2 weeks, 4 weeks, 3 months, 6 months3
Plantar fascial thickness measured by ultrasound
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.
Time frame
Baseline, 2 weeks, 4 weeks, 3 months, 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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