Is ESWT Better in Plantar Fasciitis Treatment?

Pain Relief and Functional Improvement Provided by ESWT in Plantar Fasciitis is Better Than Corticosteroid Injection and Kinesiotherapy: A Randomized Trial

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

Study Overview

• Status: Completed
• Conditions: Plantar Fascitis
• Intervention / Treatment: Device: extracorporeal Shock wave therapy; Device: Kinesiotaping; Drug: Corticosteroid injection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Şanlıurfa, Turkey
    • Sanliurfa Regional Training and Research Hospital
  • Outside Of The US
    • Şanlıurfa, Outside Of The US, Turkey
      • Harran University Medicine Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: an Auto Wave 695 (Mettler electronics, USA) brand device
Active Comparator: 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.	Device: 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; Other Names: KinesioTex, KinesioTaping, US
Active Comparator: 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.	Drug: Corticosteroid injection; 40mg/1ml methylprednisolone, two sessions once a week; Other Names: methylprednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline pain outcomes in visual analog scale (VAS) scores at six weeks in the extracorporeal shock wave therapy (ESWT) group.	The visual analog scale (VAS) score is validated, the self-reported tool that assesses the intensity of mean pain outcomes at week six. Scores range from 0 to 10; higher scores indicate greater pain intensity. The VAS score is obtained online for free.	Baseline and six weeks
Change from baseline pain outcomes in visual analog scale (VAS) scores at three months in the extracorporeal shock wave therapy (ESWT) group	The visual analog scale (VAS) score is validated, the self-reported tool that assesses the intensity of mean pain outcomes at three months. Scores range from 0 to 10; higher scores indicate greater pain intensity. The VAS score is obtained online for free.	Baseline and three months
Change from baseline pain in visual analog scale (VAS) score at six months in the extracorporeal shock wave therapy (ESWT) group.	The visual analog scale (VAS) score is validated, the self-reported tool that assesses the intensity of mean pain outcomes at six months. Scores range from 0 to 10; higher scores indicate greater pain intensity. The VAS score is obtained online for free.	Baseline and six months
Change from baseline pain outcomes in visual analog scale (VAS) score at six weeks in the corticosteroid injection group.	The visual analog scale (VAS) score is validated, the self-reported tool that assesses the intensity of mean pain outcomes at six weeks. Scores range from 0 to 10; higher scores indicate greater pain intensity. The VAS score is obtained online for free.	Baseline and six weeks
Change from baseline pain outcomes in visual analog scale (VAS) scores at three months in the corticosteroid injection group.	The visual analog scale (VAS) score is validated, the self-reported tool that assesses the intensity of mean pain outcomes at three months. Scores range from 0 to 10; higher scores indicate greater pain intensity. The VAS score is obtained online for free.	Baseline and three months
Change from baseline pain outcomes in visual analog scale (VAS) scores at six months in the corticosteroid injection group.	The visual analog scale (VAS) score is validated, the self-reported tool that assesses the intensity of mean pain outcomes at six months. Scores range from 0 to 10; higher scores indicate greater pain intensity. The VAS score is obtained online for free.	Baseline and six months
Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score (AOFAS) score at six weeks in the extracorporeal shock wave therapy (ESWT) group.	The American Orthopedic Foot and Ankle Score (AOFAS) scores are validated, self-reported tools that assess the intensity of mean functional outcomes at week six. Scores range from 0 to 100, with healthy ankles receiving 100 points. The AOFAS score is obtained online for free.	Baseline and six weeks
Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score (AOFAS) score at three months in the extracorporeal shock wave therapy (ESWT) group.	The American Orthopedic Foot and Ankle Score (AOFAS) scores are validated, self-reported tools that assess the intensity of mean functional outcomes at three months. Scores range from 0 to 100, with healthy ankles receiving 100 points. The AOFAS score is obtained online for free.	Baseline and three months
Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score (AOFAS) score at six months in the extracorporeal shock wave therapy (ESWT) group.	The American Orthopedic Foot and Ankle Score (AOFAS) scores are validated, self-reported tools that assess the intensity of mean functional outcomes at six months. Scores range from 0 to 100, with healthy ankles receiving 100 points. The AOFAS score is obtained online for free.	Baseline and six months
Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score (AOFAS) score at six weeks in the corticosteroid injection group.	The American Orthopedic Foot and Ankle Score (AOFAS) scores are validated, self-reported tools that assess the intensity of mean functional outcomes at week six. Scores range from 0 to 100, with healthy ankles receiving 100 points. The AOFAS score is obtained online for free.	Baseline and six weeks
Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score at three months in the corticosteroid injection group.	The American Orthopedic Foot and Ankle Score (AOFAS) scores are validated, self-reported tools that assess the intensity of mean functional outcomes at three months. Scores range from 0 to 100, with healthy ankles receiving 100 points. The AOFAS score is obtained online for free.	Baseline and three months
Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score at six months in the corticosteroid injection group.	The American Orthopedic Foot and Ankle Score (AOFAS) scores are validated, self-reported tools that assess the intensity of mean functional outcomes at six months. Scores range from 0 to 100, with healthy ankles receiving 100 points. The AOFAS score is obtained online for free.	Baseline and six months
Change from baseline pain in visual analog scale (VAS) score at six weeks in the kinesiotherapy group.	The visual analog scale (VAS) score is validated, the self-reported tool that assesses the intensity of mean pain at week six. Scores range from 0 to 10; higher scores indicate greater pain intensity. The VAS score is obtained online for free.	Baseline and six weeks
Change from baseline pain in visual analog scale (VAS) score at three months in the kinesiotherapy group.	The visual analog scale (VAS) score is validated, the self-reported tool that assesses the intensity of mean pain outcomes at three months. Scores range from 0 to 10; higher scores indicate greater pain intensity. The VAS score is obtained online for free.	Baseline and three months
Change from baseline pain outcomes in visual analog scale (VAS) score at six months in the kinesiotherapy group.	The visual analog scale (VAS) score is validated, the self-reported tool that assesses the intensity of mean pain outcomes at six months. Scores range from 0 to 10; higher scores indicate greater pain intensity. The VAS score is obtained online for free.	Baseline and six months
Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score (AOFAS) at six weeks in the kinesiotherapy group.	The American Orthopedic Foot and Ankle Score (AOFAS) scores are validated, self-reported tools that assess the intensity of mean functional outcomes at week six. Scores range from 0 to 100, with healthy ankles receiving 100 points. The AOFAS score is obtained online for free.	Baseline and six weeks
Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score (AOFAS) at three months in the kinesiotherapy group.	The American Orthopedic Foot and Ankle Score (AOFAS) scores are validated, self-reported tools that assess the intensity of mean functional outcomes at three months. Scores range from 0 to 100, with healthy ankles receiving 100 points. The AOFAS score is obtained online for free.	Baseline and three months
Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score (AOFAS) at six months in the kinesiotherapy group.	The American Orthopedic Foot and Ankle Score (AOFAS) scores are validated, self-reported tools that assess the intensity of mean functional outcomes at six months. Scores range from 0 to 100, with healthy ankles receiving 100 points. The AOFAS score is obtained online for free.	Baseline and six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection treatment results at the sixth week.	The visual analog scale (VAS) score is validated, the self-reported tool that assesses the intensity of mean pain outcomes at six months. Scores range from 0 to 10; higher scores indicate greater pain intensity. The VAS score is obtained online for free. We compared the VAS scores of three different treatment modalities.	sixth week
Comparison of extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection treatment results in the third month.	The visual analog scale (VAS) score is validated, the self-reported tool that assesses the intensity of mean pain outcomes at three months. Scores range from 0 to 10; higher scores indicate greater pain intensity. The VAS score is obtained online for free. We compared the VAS scores of three different treatment modalities.	third month
Comparison of extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection treatment results in the sixth month.	The visual analog scale (VAS) score is validated, the self-reported tool that assesses the intensity of mean pain outcomes at six months. Scores range from 0 to 10; higher scores indicate greater pain intensity. The VAS score is obtained online for free. We compared the VAS scores of three different treatment modalities.	sixth month
Comparison of extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection treatment results in the sixth weeks.	The American Orthopedic Foot and Ankle Score (AOFAS) scores are validated, self-reported tools that assess the intensity of mean functional outcomes at sixth weeks. Scores range from 0 to 100, with healthy ankles receiving 100 points. The AOFAS score is obtained online for free. We compared the AOFAS scores of three different treatment modalities.	sixth weeks
Comparison of extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection treatment results in the three months.	The American Orthopedic Foot and Ankle Score (AOFAS) scores are validated, self-reported tools that assess the intensity of mean functional outcomes at three months. Scores range from 0 to 100, with healthy ankles receiving 100 points. The AOFAS score is obtained online for free. We compared the AOFAS scores of three different treatment modalities.	three month
Comparison of extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection treatment results in the sixth month.	The American Orthopedic Foot and Ankle Score (AOFAS) scores are validated, self-reported tools that assess the intensity of mean functional outcomes at six months. Scores range from 0 to 100, with healthy ankles receiving 100 points. The AOFAS score is obtained online for free. We compared the AOFAS scores of three different treatment modalities.	sixth month

Collaborators and Investigators

• Sponsor: Harran University
• Collaborators: Sanliurfa Education and Research Hospital
• Investigators: Principal Investigator: Özlem Orhan, Department of Orthopaedics and Traumatology, Harran University Medicine Faculty, Şanlıurfa, Turkey

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): April 17, 2022
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Estimate): December 12, 2022

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Kinesiotaping; corticosteroid injection; ESWT
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuroprotective Agents; Protective Agents; Methylprednisolone
• Other Study ID Numbers: HRU/21.17.30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: for a period of six months, starting three months after publication.
• IPD Sharing Access Criteria: Information can be obtained by medical doctors by contacting the principal investigator via e-mail.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No