Is ESWT Better in Plantar Fasciitis Treatment?

NCT ID: NCT05647291

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-07-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

It was aimed to compare the pain and functional results of ESWT, kinesiotherapy and corticosteroid injection in patients with treatment-resistant plantar fasciitis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The groups were randomized in patients with chronic plantar fasciitis who did not benefit from conservative treatment. A questionnaire study was conducted at the first visit, sixth week, third month, and sixth month. Visual analog scale (VAS) and The American Orthopedic Foot and Ankle Society (AOFAS) score were applied as a questionnaire at each control visit of the patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Plantar Fascitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ESWT Kinesiotaping corticosteroid injection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

extracorporeal Shock wave therapy (ESWT)

ESWT was performed by the same physician. The applicator was placed at the point of maximum sensitivity. Two thousand pulses with a frequency of 6 Hz and a pressure of 3 bar were applied to patients with an Auto Wave 695 (Mettler electronics, USA) brand device. Patients underwent two sessions of ESWT per week for two weeks, adding up to a total of 4 sessions. Local or regional anesthesia was not administered to any patient during ESWT.

Group Type EXPERIMENTAL

extracorporeal Shock wave therapy

Intervention Type DEVICE

Two thousand pulses with a frequency of 6 Hz and a pressure of 3 bar were applied to patients with an Auto Wave 695 (Mettler electronics, USA) brand device. Patients underwent two sessions of ESWT per week, for two weeks, adding up to a total of 4 sessions.

Kinesiotaping

Kinesio tape (KinesioTex, KinesioTaping, US) was applied to the relevant extremity of the patient by the physical therapy and rehabilitation physician once a week, three times in total. During KT, the patient was positioned with the knee and ankle joints in the neutral position. The first strip was adhered along the plantar fascia from the calcaneus to the toes using maximum stretch. The other four strips of tape were attached medially and laterally to support the medial longitudinal arch with a 45° inclination. While maximum stretching was applied to the middle 1/3 of all bands, no stretching was applied to the ends.

Group Type ACTIVE_COMPARATOR

Kinesiotaping

Intervention Type DEVICE

The first strip was adhered along the plantar fascia from the calcaneus to the toes using maximum stretch. The other four strips of tape were attached medially and laterally to support the medial longitudinal arch with a 45° inclination. While maximum stretching was applied to the middle 1/3 of all bands, no stretching was applied to the ends. Once a week, three times

Corticosteroid injection

In the CI group, 40mg/1ml methylprednisolone was applied from the inferior-medial side of the heel to the most sensitive area of the calcaneus medial tubercle of the plantar fascia. The same physician performed a total of two sessions once a week.

Group Type ACTIVE_COMPARATOR

Corticosteroid injection

Intervention Type DRUG

40mg/1ml methylprednisolone, two sessions once a week

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

extracorporeal Shock wave therapy

Two thousand pulses with a frequency of 6 Hz and a pressure of 3 bar were applied to patients with an Auto Wave 695 (Mettler electronics, USA) brand device. Patients underwent two sessions of ESWT per week, for two weeks, adding up to a total of 4 sessions.

Intervention Type DEVICE

Corticosteroid injection

40mg/1ml methylprednisolone, two sessions once a week

Intervention Type DRUG

Kinesiotaping

The first strip was adhered along the plantar fascia from the calcaneus to the toes using maximum stretch. The other four strips of tape were attached medially and laterally to support the medial longitudinal arch with a 45° inclination. While maximum stretching was applied to the middle 1/3 of all bands, no stretching was applied to the ends. Once a week, three times

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

an Auto Wave 695 (Mettler electronics, USA) brand device methylprednisolone KinesioTex, KinesioTaping, US

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* previously diagnosed with PF,
* did not benefit from conservative treatment for at least six months,
* did not use anticoagulants,
* did not have bleeding disorders,
* did not have a psychiatric disease

Exclusion Criteria

* previous ESWT or CI treatment
* obesity,
* seronegative spondyloarthropathy,
* tarsal tunnel syndrome,
* peripheral neuropathy,
* foot-ankle deformity (pes cavus, pes planus, etc.),
* history of mass around foot and ankle,
* previous foot or ankle surgery
* degenerative arthritis around this region
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanliurfa Education and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Harran University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ozlem Orhan

Assistant prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Özlem Orhan

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics and Traumatology, Harran University Medicine Faculty, Şanlıurfa, Turkey

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Harran University Medicine Faculty

Sanliurfa, Outside of the US, Turkey (Türkiye)

Site Status

Sanliurfa Regional Training and Research Hospital

Sanliurfa, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Tang M, Wang L, You Y, Li J, Hu X. Effects of taping techniques on arch deformation in adults with pes planus: A meta-analysis. PLoS One. 2021 Jul 2;16(7):e0253567. doi: 10.1371/journal.pone.0253567. eCollection 2021.

Reference Type RESULT
PMID: 34214104 (View on PubMed)

Chang KV, Chen SY, Chen WS, Tu YK, Chien KL. Comparative effectiveness of focused shock wave therapy of different intensity levels and radial shock wave therapy for treating plantar fasciitis: a systematic review and network meta-analysis. Arch Phys Med Rehabil. 2012 Jul;93(7):1259-68. doi: 10.1016/j.apmr.2012.02.023. Epub 2012 Mar 12.

Reference Type RESULT
PMID: 22421623 (View on PubMed)

Mishra BN, Poudel RR, Banskota B, Shrestha BK, Banskota AK. Effectiveness of extra-corporeal shock wave therapy (ESWT) vs methylprednisolone injections in plantar fasciitis. J Clin Orthop Trauma. 2019 Mar-Apr;10(2):401-405. doi: 10.1016/j.jcot.2018.02.011. Epub 2018 Feb 23.

Reference Type RESULT
PMID: 30828215 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HRU/21.17.30

Identifier Type: -

Identifier Source: org_study_id