Chronic Plantar Fasciitis: Which is More Effective? Prolotherapy/Extracorporeal Shock Wave Therapy?

NCT06712329 | Completed

• 1 other identifier: ACHBİLKENTAUBAYKUT001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this prospective study was to compare the effects of ESWT (extracorporeal shock wave therapy ) and prolotherapy on pain and foot function in patients with chronic plantar fasciitis. In addition, the study was to investigate the changes in plantar pressure distribution and plantar fascia thickness measured by ultrasonography after ESWT and prolotherapy. 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?

Conditions

Chronic Plantar Fasciitis

Keywords

prolotherapy; extracorporeal shock wave therapy; plantar pressure distribution; plantar fascia thickness

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale(VAS)

  The Visual Analogue Scale (VAS) was employed to evaluate the general perception of pain and the pain experienced at the first step upon rising. The scale ranges from 0 to 10, with a score of 0 indicating no pain and a score of 10 indicating the most severe pain imaginable

  baseline - 6th week-12th week

Secondary Outcomes (3)

• Foot and Ankle Ability Measure (FAAM)

  baseline - 6th week-12th week

• Thickness of the plantar fascia

  baseline - 6th week-12th week

• Plantar pressure distribution

  baseline - 6th week-12th week

Study Arms (2)

extracorporeal shock wave therapy group

EXPERIMENTAL

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

Other: extracorporeal shock wave therapy

Prolotherapy Group

EXPERIMENTAL

The prolotherapy group was administered a 3-ml injection of a 15% dextrose solution.

Other: Prolotherapy

Interventions

extracorporeal shock wave therapy OTHER

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.

Also known as: eswt

extracorporeal shock wave therapy group

Prolotherapy OTHER

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

Also known as: dextrose prolotherapy

Prolotherapy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants must be aged between 18 and 75 years
• they must have experienced heel pain for a period of at least three months
• they must exhibit pain and tenderness upon palpation of the medial aspect of the calcaneal tuberosity with the ankle in full dorsiflexion
• 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.

You may not qualify if:

• Inflammatory rheumatic disease
• Dermatological lesion on the heel
• Pregnancy
• Infection
• Malignancy
• Coagulopathy
• Pacemaker
• Peripheral circulatory disorder
• A neurological disorder, such as radiculopathy or polyneuropathy
• Previous ESWT, dextrose prolotherapy, or surgical procedure to the heel region
• A local corticosteroid injection or oral corticosteroids in the last six weeks.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Şehir Hastanesi Bilkent

Ankara, çankaya, 06530, Turkey (Türkiye)

Location

Related Links

• Pub Med

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Extracorporeal Shockwave Therapy; Prolotherapy

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Complementary Therapies

Study Officials

• Ayşe U Baykut

  Ankara Şehir Hastanesi Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 1. Inceler Medical, Modus Focused ESWT 2. 15% dextrose solution injection

Study Record Dates

• First Submitted: November 16, 2024
• First Posted: December 2, 2024
• Study Start: October 1, 2023
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)