Clinical trial NCT05647291: Is ESWT Better in Plantar Fasciitis Treatment?
Official title: Pain Relief and Functional Improvement Provided by ESWT in Plantar Fasciitis is Better Than Corticosteroid Injection and Kinesiotherapy: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Keywords: ESWT
Kinesiotaping
corticosteroid injection
Lead sponsor: Harran University
Sponsor class: OTHER
Collaborators: name: Sanliurfa Education and Research Hospital
First posted: 2022-12-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline pain outcomes in visual analog scale (VAS) scores at six weeks in the extracorporeal shock wave therapy (ESWT) group.
timeFrame: Baseline and six weeks
measure: Change from baseline pain outcomes in visual analog scale (VAS) scores at three months in the extracorporeal shock wave therapy (ESWT) group
timeFrame: Baseline and three months
measure: Change from baseline pain in visual analog scale (VAS) score at six months in the extracorporeal shock wave therapy (ESWT) group.
timeFrame: Baseline and six months
measure: Change from baseline pain outcomes in visual analog scale (VAS) score at six weeks in the corticosteroid injection group.
timeFrame: Baseline and six weeks
measure: Change from baseline pain outcomes in visual analog scale (VAS) scores at three months in the corticosteroid injection group.
timeFrame: Baseline and three months
measure: Change from baseline pain outcomes in visual analog scale (VAS) scores at six months in the corticosteroid injection group.
timeFrame: Baseline and six months
measure: 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.
timeFrame: Baseline and six weeks
measure: 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.
timeFrame: Baseline and three months
measure: 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.
timeFrame: Baseline and six months
measure: Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score (AOFAS) score at six weeks in the corticosteroid injection group.
timeFrame: Baseline and six weeks
measure: Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score at three months in the corticosteroid injection group.
timeFrame: Baseline and three months
measure: Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score at six months in the corticosteroid injection group.
timeFrame: Baseline and six months
measure: Change from baseline pain in visual analog scale (VAS) score at six weeks in the kinesiotherapy group.
timeFrame: Baseline and six weeks
measure: Change from baseline pain in visual analog scale (VAS) score at three months in the kinesiotherapy group.
timeFrame: Baseline and three months
measure: Change from baseline pain outcomes in visual analog scale (VAS) score at six months in the kinesiotherapy group.
timeFrame: Baseline and six months
measure: Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score (AOFAS) at six weeks in the kinesiotherapy group.
timeFrame: Baseline and six weeks
measure: Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score (AOFAS) at three months in the kinesiotherapy group.
timeFrame: Baseline and three months
measure: Change from baseline functional outcomes in the American Orthopedic Foot and Ankle Score (AOFAS) at six months in the kinesiotherapy group.
timeFrame: Baseline and six months
Secondary outcomes:
measure: Comparison of visual analog scale results of sixth-week extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.
timeFrame: sixth week
measure: Comparison of visual analog scale results of third months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.
timeFrame: third month
measure: Comparison of visual analog scale results of sixth months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.
timeFrame: sixth month
measure: Comparison of American Orthopedic Foot and Ankle Score (AOFAS) scores results of sixth weeks extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.
timeFrame: sixth weeks
measure: Comparison of American Orthopedic Foot and Ankle Score (AOFAS) scores results of three months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.
timeFrame: three month
measure: Comparison of American Orthopedic Foot and Ankle Score (AOFAS) scores results of sixth months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.
timeFrame: sixth month
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Harran University Medicine Faculty
state: Outside Of The US
city: Şanlıurfa
country: Turkey
facility: Sanliurfa Regional Training and Research Hospital
Study officials:
affiliation: Department of Orthopaedics and Traumatology, Harran University Medicine Faculty, Şanlıurfa, Turkey
name: Özlem Orhan
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. Epub 2018 Feb 23.