Comparison of Ultrasonographic and Clinical Features of Different Energy Levels Extracorporeal Shock Wave Therapy in Plantar Fasciitis

NCT04989530 | Unknown

• 1 other identifier: E-94603339-604.01.02-46403
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Plantar fasciitis is the most common cause of heel pain in adults. It received FDA approval in 2000 for ESWT in the treatment of plantar fasciitis in adults whose pain did not resolve with conservative treatment. ESWT energy levels are categorized as high, medium and low. It is not yet clear which energy level is most effective in the clinical recovery and pain relief of plantar fasciitis after ESWT treatment. Although there are studies in the literature evaluating the effect of different energy densities in the treatment of plantar fasciitis with ESWT, there are very few studies comparing different treatment doses of ESWT. The aim of this study was to evaluate and compare the therapeutic effects of low, medium and high energy ESWT in patients with plantar fasciitis, and also to examine the correlation between plantar fascia thickness changes ultrasonographically and clinical outcomes.

Conditions

Extracorporeal Shock Wave Therapy

Keywords

Extracorporeal Shock Wave Therapy; ultrasonography; plantar fasiit

Outcome Measures

Primary Outcomes (1)

• Foot Function index

  1 months

Secondary Outcomes (1)

• Plantar fasia thickness

  1 months

Other Outcomes (1)

• visual analogue scale

  1 months

Study Arms (3)

Low energy level of ESWT

ACTIVE COMPARATOR

Device: Extracorporeal Shock Wave Therapy

medium energy level of ESWT

ACTIVE COMPARATOR

Device: Extracorporeal Shock Wave Therapy

high energy level of ESWT

ACTIVE COMPARATOR

Device: Extracorporeal Shock Wave Therapy

Interventions

Extracorporeal Shock Wave Therapy DEVICE

different energy levels of ESWT

Low energy level of ESWT; high energy level of ESWT; medium energy level of ESWT

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of heel pain, tenderness at the insertion site of the plantar fascia on the anteromedial aspect of the calcaneal tubercle elicited by palpation, and unresponsiveness to medical treatment.

You may not qualify if:

• history of inflammatory rheumatic disease, trauma of the foot or foot surgery, local dermatological lesion or infection, impaired peripheral circulation, a neurological disorder such as radiculopathy and neuropathy, patients with sequelae of lower extremity fracture, a congenital or acquired deformity, malignancy, cardiac pacemaker, metal implant at the application site, pregnancy, anticoagulant use for coagulopathy

Sponsors & Collaborators

• Baskent University Ankara Hospital: lead

Study Sites (1)

Baskent University Ankara Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 4, 2021
• Study Start: July 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-07

Locations

TU (1)