Comparison of the Effectiveness of Dextrose Prolotherapy and Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKanuni Sultan Suleyman Training and Research Hospital

About this trial

Plantar fasciitis is a degeneration of the plantar aponeurosis and is the most common cause of heel pain (11-15%). Although seen in both sexes, plantar fasciitis is more common in women, usually unilateral and bilateral in 30% of cases . The most widely accepted view regarding the formation of plantar fasciitis is that it is a degenerative process caused by myxoid degeneration, microtears, collagen necrosis, and angiofibroblastic hyperplasia, resulting from repetitive microtrauma to the plantar fascia, particularly at the calcaneal insertion site. It is not inflammatory . The purpose of this study was to compare the effectiveness of prolotherapy, a regenerative treatment, and ESWT in the treatment of plantar fasciitis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of plantar fasciitis

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dextrose Prolotherapy

    Procedure/Surgery

    Participants in this group will receive dextrose prolotherapy twice, at two-week intervals. A 5 mL syringe containing 2.5 mL of 30% dextrose, 2 mL isotonic saline, and 0.5 mL 2% lidocaine (final 15% dextrose solution) will be injected into seven points around the plantar fascia origin under aseptic conditions.

  • Extracorporeal Shock Wave Therapy (ESWT)

    Device

    Participants in this group will receive extracorporeal shock wave therapy (ESWT) twice per week for a total of four sessions. The treatment will be applied to the plantar fascia insertion area using a standard clinical shock wave therapy device. Energy level, frequency, and pulse count will be set according to manufacturer recommendations and standard clinical protocols.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Dextrose ProlotherapyExperimental treatment 1 intervention
Group B: Extracorporeal Shock Wave Therapy (ESWT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Heel Pain Intensity (VAS Score)

Heel pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) at baseline, 6 weeks, and 12 weeks. The primary outcome is the change in VAS score from baseline to week 12 in each treatment group.

Time frame
Baseline, 6 weeks, 12 weeks

Secondary outcomes

1

Change in Foot Function Index (FFI) Total Score

Functional status will be assessed using the Foot Function Index (FFI), which evaluates pain, disability, and activity limitation related to foot function. The total FFI score will be recorded at baseline, 6 weeks, and 12 weeks. The secondary outcome is the change in FFI total score over time.

Time frame
Baseline, 6 weeks, 12 weeks
2

Change in Roles and Maudsley Score

The Roles and Maudsley functional pain score will be used to evaluate treatment response. Patients grade their condition on a 4-point scale from "excellent" to "poor." Scores will be obtained at baseline, 6 weeks, and 12 weeks. Improvement in score indicates better clinical outcome.

Time frame
Baseline, 6 weeks, 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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