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

Ankara City Hospital

Status: Completed

Conditions: Chronic Plantar Fasciitis

Treatments: Other: Prolotherapy; Other: extracorporeal shock wave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06712329

ACHBİLKENTAUBAYKUT001

Details and patient eligibility

About

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?

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

extracorporeal shock wave therapy group

Experimental group

Description:

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

Treatment:

Other: extracorporeal shock wave therapy

Prolotherapy Group

Experimental group

Description:

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

Treatment:

Other: Prolotherapy