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

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?

Study Overview

• Status: Completed
• Conditions: Chronic Plantar Fasciitis
• Intervention / Treatment: Other: extracorporeal shock wave therapy; Other: Prolotherapy

Detailed Description

Chronic plantar fasciitis is a prevalent musculoskeletal disorder that results in discomfort and impaired functionality within the plantar surface of the foot. In instances where conservative treatment proves ineffective, it can complicate the management of the condition. Two invasive treatment options, namely extracorporeal shock wave therapy (ESWT) and prolotherapy, are available for the management of plantar fasciitis, with the objective of providing pain and functional improvement. The objective of this study was to compare the effects of ESWT and prolotherapy on pain, foot function, plantar fascia thickness and plantar pressure distribution in patients with chronic plantar fasciitis.

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06530
      • Ankara Şehir Hastanesi Bilkent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. participants must be aged between 18 and 75 years
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:

1. Inflammatory rheumatic disease
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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.; Other Names: eswt
Experimental: Prolotherapy Group; The prolotherapy group was administered a 3-ml injection of a 15% dextrose solution.	Other: 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 Names: dextrose prolotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot and Ankle Ability Measure (FAAM)	The Foot and Ankle Ability Measure (FAAM) was developed to assess the physical function of individuals with foot pathology. FAAM is a self-administered questionnaire consisting of 29 items, 21 of which pertain to activities of daily living (ADL) and 8 to sports. Each item of the FAAM is scored on a 5-point Likert scale with 4 points representing no difficulty at all; 3 points, slight difficulty; 2 points, moderate difficulty; 1 point, extreme difficulty; and 0 points, unable to do. The sixth option is not applicable if patients feel that this item does not concern them. If all items are answered, the ADL and sports subscales have a maximum score of 84 and 32, respectively. The obtained scores are transformed to percentages by dividing them with the maximum potential score and then multiplying the result by 100. A high score in both categories is indicative of a high level of physical functioning	baseline - 6th week-12th week
Thickness of the plantar fascia	A high-resolution ultrasound (5-13 MHz linear transducer, LOGIQ 9; GE Healthcare, China) was employed to ascertain the thickness of the plantar fascia. Ultrasonography measurements were conducted by the same individual, who has over five years of experience in this field. The participants were positioned in a prone manner with their ankles maintained in a neutral position. The thickness was measured in a vertical direction, commencing from the hyperechogenic border of the calcaneus bone and continuing until it reached the lower hyperechogenic edge of the plantar fascia. An average of three plantar fascia thickness measurements were taken at each assessment to minimise potential errors. The plantar fascia thickness was evaluated by a physiatrist who was unaware of the treatment groups	baseline - 6th week-12th week
Plantar pressure distribution	All participants underwent a static plantar pressure distribution assessment utilising the Formetric 4D system (DIERS MedicalSystems, Germany). In the test, each participant was required to stand on the platform, barefoot, with their feet side by side and facing forward for a period of five seconds. The parameters subjected to analysis were hindfoot plantar pressure (percent) and forefoot plantar pressure (percent)	baseline - 6th week-12th week

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Ayşe U Baykut, Ankara Şehir Hastanesi Bilkent

Publications and helpful links

Helpful Links

• Pub Med

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): December 19, 2024
• Study Completion (Actual): December 19, 2024

Study Registration Dates

• First Submitted: November 16, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: extracorporeal shock wave therapy; prolotherapy; plantar pressure distribution; plantar fascia thickness
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: ACHBİLKENTAUBAYKUT001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: all collected IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No