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

Not Applicable
Not yet recruiting
Conditions
Plantar Fasciitis
Registration Number
NCT07233395
Lead Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
60
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

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in Heel Pain Intensity (VAS Score)Baseline, 6 weeks, 12 weeks

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.

Secondary Outcome Measures
NameTimeMethod
Change in Foot Function Index (FFI) Total ScoreBaseline, 6 weeks, 12 weeks

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.

Change in Roles and Maudsley ScoreBaseline, 6 weeks, 12 weeks

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.

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