Is ESWT Better in Plantar Fasciitis Treatment?

Plantar Fascitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05647291
• Other study ID #: HRU/21.17.30
• Status: Completed
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: July 28, 2022

Study information

• Verified date: December 2022
• Source: Harran University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 28, 2022
• Est. primary completion date: April 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

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.

Drug:
• Corticosteroid injection
40mg/1ml methylprednisolone, two sessions once a week

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

Locations

Country	Name	City	State
Turkey	Harran University Medicine Faculty	Sanliurfa	Outside Of The US
Turkey	Sanliurfa Regional Training and Research Hospital	Sanliurfa

Sponsors (2)

Lead Sponsor	Collaborator
Harran University	Sanliurfa Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 R — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Comparison of visual analog scale results of sixth-week extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.	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
Secondary	Comparison of visual analog scale results of third months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.	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
Secondary	Comparison of visual analog scale results of sixth months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.	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
Secondary	Comparison of American Orthopedic Foot and Ankle Score (AOFAS) scores results of sixth weeks extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.	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
Secondary	Comparison of American Orthopedic Foot and Ankle Score (AOFAS) scores results of three months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.	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
Secondary	Comparison of American Orthopedic Foot and Ankle Score (AOFAS) scores results of sixth months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.	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