Is ESWT Better in Plantar Fasciitis Treatment?

Not Applicable

Completed

• Conditions: Plantar Fascitis
• Interventions: Drug: Corticosteroid injection; Device: extracorporeal Shock wave therapy; Device: Kinesiotaping

• Registration Number: NCT05647291
• Lead Sponsor: Harran University

Brief Summary

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

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 Timeline

• Study Start: 2021-10-15
• Primary Completion: 2022-04-17
• Study Completion: 2022-07-28
• Study First Submitted: 2022-11-23
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-02
• Study First Posted: 2022-12-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Corticosteroid injection	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.
extracorporeal Shock wave therapy (ESWT)	extracorporeal Shock wave therapy	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.
Kinesiotaping	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline pain in visual analog scale (VAS) score at three months in the kinesiotherapy group.	Baseline and three months	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.
Change from baseline pain outcomes in visual analog scale (VAS) scores at three months in the corticosteroid injection group.	Baseline and three months	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.
Change from baseline pain outcomes in visual analog scale (VAS) scores at six months in the corticosteroid injection group.	Baseline and six months	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.
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.	Baseline and six weeks	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.
Change from baseline pain outcomes in visual analog scale (VAS) score at six months in the kinesiotherapy group.	Baseline and six months	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.
Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score (AOFAS) at six weeks in the kinesiotherapy group.	Baseline and six weeks	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.
Change from baseline pain outcomes in visual analog scale (VAS) scores at six weeks in the extracorporeal shock wave therapy (ESWT) group.	Baseline and six weeks	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.
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.	Baseline and 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.
Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score (AOFAS) score at six weeks in the corticosteroid injection group.	Baseline and six weeks	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.
Change from baseline pain in visual analog scale (VAS) score at six weeks in the kinesiotherapy group.	Baseline and six weeks	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.
Change from baseline pain outcomes in visual analog scale (VAS) scores at three months in the extracorporeal shock wave therapy (ESWT) group	Baseline and three months	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.
Change from baseline pain in visual analog scale (VAS) score at six months in the extracorporeal shock wave therapy (ESWT) group.	Baseline and six months	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.
Change from baseline pain outcomes in visual analog scale (VAS) score at six weeks in the corticosteroid injection group.	Baseline and six weeks	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.
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.	Baseline and six months	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.
Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score at six months in the corticosteroid injection group.	Baseline and six months	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.
Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score at three months in the corticosteroid injection group.	Baseline and 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.
Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score (AOFAS) at six months in the kinesiotherapy group.	Baseline and six months	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.
Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score (AOFAS) at three months in the kinesiotherapy group.	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Comparison of visual analog scale results of sixth-week extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.	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.
Comparison of visual analog scale results of sixth months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.	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.
Comparison of visual analog scale results of third months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.	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.
Comparison of American Orthopedic Foot and Ankle Score (AOFAS) scores results of three months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.	three month	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.
Comparison of American Orthopedic Foot and Ankle Score (AOFAS) scores results of sixth weeks extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.	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.
Comparison of American Orthopedic Foot and Ankle Score (AOFAS) scores results of sixth months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.	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.

Trial Locations

Locations (2)

Harran University Medicine Faculty; 🇹🇷 Şanlıurfa, Outside Of The US, Turkey

Sanliurfa Regional Training and Research Hospital; 🇹🇷 Şanlıurfa, Turkey