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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07233395
Enrollment
60
Registered
2025-11-18
Start date
2025-11-15
Completion date
2026-03-15
Last updated
2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plantar Fasciitis

Keywords

Dextrose Prolotherapy, Extracorporeal Shock Wave Therapy (ESWT), Physical Medicine and Rehabilitation

Brief summary

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.

Detailed description

Plantar fasciitis is known as the most common cause of heel pain in adults. While its incidence increases between the ages of 40 and 60, it is more common in runners, those who work in positions requiring prolonged standing, overweight individuals, and those with certain biomechanical foot problems. Diagnosis of plantar fasciitis can be easily made through history and physical examination. Conservative methods are the first line of treatment. Local injections and ESWT are used in patients who fail to improve despite conservative treatment. ESWT and Prolotherapy are treatment methods that induce regeneration by creating a controlled inflammation. This prospective study aims to compare the effectiveness of ESWT and Prolotherapy, which have similar mechanisms of action, in the treatment of plantar fasciitis and to identify the more effective method.

Interventions

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.

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.

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome assessor will be blinded to treatment allocation. Participants and care providers will be aware of the intervention due to the nature of the treatments.

Intervention model description

Participants will be randomly assigned to one of two parallel groups. One group will receive dextrose prolotherapy and the other will receive extracorporeal shock wave therapy (ESWT). The study aims to compare the effectiveness of these two regenerative treatment methods in patients with plantar fasciitis.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of plantar fasciitis Ages 18 to 75 years Both male and female participants Heel pain localized to the medial calcaneal tubercle for more than 3 months Morning first-step pain and pain increasing with daily loading Willingness to participate and provide written informed consent Patients presenting to Kanuni Sultan Süleyman Training and Research Hospital

Exclusion criteria

Cardiac pacemaker Type 1 or Type 2 diabetes mellitus History of inflammatory rheumatic disease Bleeding disorders Use of anticoagulant medications other than aspirin Allergy to dextrose Previous foot or ankle surgery Peripheral neuropathy S1 radiculopathy in the same extremity Local corticosteroid injection to the plantar fascia within the last 3 months ESWT applied to the plantar fascia within the last 3 months Physical therapy applied to the foot/ankle in the last 3 months Cognitive dysfunction Active infection at the planned injection site \-

Design outcomes

Primary

MeasureTime frameDescription
Change in Heel Pain Intensity (VAS Score)Baseline, 6 weeks, 12 weeksHeel 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.

Secondary

MeasureTime frameDescription
Change in Foot Function Index (FFI) Total ScoreBaseline, 6 weeks, 12 weeksFunctional 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.
Change in Roles and Maudsley ScoreBaseline, 6 weeks, 12 weeksThe 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.

Contacts

Primary ContactZEYNEP KARAKUZU GÜNGÖR
zeynepkarakuzu@hotmail.com.tr+905077750375

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026