NCT Number: NCT07233395
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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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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.
Other names: Prolotherapy Injection
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.
Other names: Shock Wave Therapy
Time frame: 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.
Time frame: Baseline, 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.
Time frame: Baseline, 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.
Contact information is provided by the study sponsor or research team.
Kanuni Sultan Suleyman Training and Research Hospital
Other
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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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