Chronic Plantar Fasciitis: Which is More Effective? Prolotherapy/Extracorporeal Shock Wave Therapy?
NCT ID: NCT06712329
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2023-10-01
2024-12-19
Brief Summary
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The fundamental questions that investigators want to answer are as follows:
\[question 1\]:Do ESWT and prolotherapy improve pain and foot function in patients with chronic plantar fasciitis? \[question 2\]:Do ESWT and prolotherapy change plantar pressure distribution and plantar fascia thickness in patients with chronic plantar fasciitis?
Detailed Description
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A total of 70 patients who did not respond to conservative treatment were included in this prospective, randomised controlled study. Following a clinical and ultrasonographic evaluation, the patients were randomly assigned to one of two groups. The study population was divided into two groups: the ESWT group (n = 36) and the prolotherapy group (n = 34). In the ESWT group, a total of 1800 to 2000 focused shock waves (0.15-0.25 mJ/mm² sessions with a frequency of 3-4 Hz) were applied. The prolotherapy group was administered a 3-ml injection of a 15% dextrose solution. The ESWT and prolotherapy treatments were administered in a total of three sessions, with two-week intervals between each session. The efficacy of the treatment was evaluated using a number of different measures, including the Visual Analogue Scale (VAS), the Foot and Ankle Ability Measurement (FAAM), the thickness of the plantar fascia and the distribution of plantar pressure. The evaluations were conducted at the outset of the study, at the six-week mark, and at the 12-week mark following the final intervention.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
2. 15% dextrose solution injection
TREATMENT
TRIPLE
Study Groups
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extracorporeal shock wave therapy group
In the ESWT group, a total of 1800 to 2000 focused shock waves (0.15-0.25 mJ/mm² sessions with a frequency of 3-4 Hz) were applied
extracorporeal shock wave therapy
ESWT (Inceler Medical, Modus Focused ESWT, Turkey) was conducted by a single investigator in accordance with a standardised protocol. The patients were positioned prone on the examination table, with the affected limb placed in a supported position. The focused shockwave was applied in a circular motion along the insertion site of the plantar fascia and over the plantar fascia itself. The participants received 1,800 to 2,000 focused shock waves (0.15-0.25 mJ/mm² session with a frequency of 3-4 Hz). The frequency of the pulses was increased in a gradual manner, in accordance with the maximum tolerable degree of pain for each patient. A minimum dose of 1,000 mJ/mm² was administered. The ESWT was conducted in three sessions, with a two-week interval between each session.
Prolotherapy Group
The prolotherapy group was administered a 3-ml injection of a 15% dextrose solution.
Prolotherapy
The solution employed for dextrose prolotherapy comprised 1.5 ml of 30% dextrose and 1.5 ml of 0.9% isotonic sodium chloride solution, resulting in a total of 3 ml of 15% dextrose solution. . All procedures were conducted by the same investigator. A dextrose solution was infused into the centre and around the damaged area using a peppering technique. Following the procedure, patients were advised to remain in a supine position with their feet restrained for a period of 15 minutes.. Prolotherapy was repeated on three occasions, with each session occurring at a two-week interval
Interventions
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extracorporeal shock wave therapy
ESWT (Inceler Medical, Modus Focused ESWT, Turkey) was conducted by a single investigator in accordance with a standardised protocol. The patients were positioned prone on the examination table, with the affected limb placed in a supported position. The focused shockwave was applied in a circular motion along the insertion site of the plantar fascia and over the plantar fascia itself. The participants received 1,800 to 2,000 focused shock waves (0.15-0.25 mJ/mm² session with a frequency of 3-4 Hz). The frequency of the pulses was increased in a gradual manner, in accordance with the maximum tolerable degree of pain for each patient. A minimum dose of 1,000 mJ/mm² was administered. The ESWT was conducted in three sessions, with a two-week interval between each session.
Prolotherapy
The solution employed for dextrose prolotherapy comprised 1.5 ml of 30% dextrose and 1.5 ml of 0.9% isotonic sodium chloride solution, resulting in a total of 3 ml of 15% dextrose solution. . All procedures were conducted by the same investigator. A dextrose solution was infused into the centre and around the damaged area using a peppering technique. Following the procedure, patients were advised to remain in a supine position with their feet restrained for a period of 15 minutes.. Prolotherapy was repeated on three occasions, with each session occurring at a two-week interval
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. they must have experienced heel pain for a period of at least three months
3. they must exhibit pain and tenderness upon palpation of the medial aspect of the calcaneal tuberosity with the ankle in full dorsiflexion
4. they must have demonstrated no response to conservative treatment for a minimum of three months.
In cases where symptoms were present on both sides, the more prominent side was included.
Exclusion Criteria
2. Dermatological lesion on the heel
3. Pregnancy
4. Infection
5. Malignancy
6. Coagulopathy
7. Pacemaker
8. Peripheral circulatory disorder
9. A neurological disorder, such as radiculopathy or polyneuropathy
10. Previous ESWT, dextrose prolotherapy, or surgical procedure to the heel region
11. A local corticosteroid injection or oral corticosteroids in the last six weeks.
18 Years
75 Years
ALL
No
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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Ayşe Ukbe Baykut
Medical Doctor
Principal Investigators
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Ayşe U Baykut
Role: PRINCIPAL_INVESTIGATOR
Ankara Şehir Hastanesi Bilkent
Locations
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Ankara Şehir Hastanesi Bilkent
Ankara, çankaya, Turkey (Türkiye)
Countries
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Related Links
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Pub Med
Other Identifiers
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ACHBİLKENTAUBAYKUT001
Identifier Type: -
Identifier Source: org_study_id