Clinical trial NCT06712329: Chronic Plantar Fasciitis: Which is More Effective? Prolotherapy/Extracorporeal Shock Wave Therapy?
Official title: Chronic Plantar Fasciitis: Which is More Effective? Prolotherapy/Extracorporeal Shock Wave Therapy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Plantar Fasciitis
Keywords: prolotherapy
extracorporeal shock wave therapy
plantar pressure distribution
plantar fascia thickness
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Inceler Medical, Modus Focused ESWT
2. 15% dextrose solution injection
Primary purpose: TREATMENT

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?

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Scale(VAS)
timeFrame: baseline - 6th week-12th week
Secondary outcomes:
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: baseline - 6th week-12th week
measure: Thickness of the plantar fascia
timeFrame: baseline - 6th week-12th week
measure: Plantar pressure distribution
timeFrame: baseline - 6th week-12th week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Şehir Hastanesi Bilkent
state: Çankaya
Study officials:
affiliation: Ankara Şehir Hastanesi Bilkent
name: Ayşe U Baykut
role: PRINCIPAL_INVESTIGATOR
References: