Pain Relief and Functional Improvement Provided by ESWT in Plantar Fasciitis is Better Than Corticosteroid Injection and Kinesiotherapy: A Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Harran University
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Change from baseline pain outcomes in visual analog scale (VAS) scores at three months in the corticosteroid injection group.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
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.
Intervention: extracorporeal Shock wave therapy (Device)
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.
Intervention: Kinesiotaping (Device)
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.
Intervention: Corticosteroid injection (Drug)
Outcomes
Primary Outcomes
Change from baseline pain outcomes in visual analog scale (VAS) scores at three months in the corticosteroid injection group.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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 pain in visual analog scale (VAS) score at three months in the kinesiotherapy group.
Time Frame: 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 functional outcomes in the American Orthopedic Foot and Ankle Score at three months in the corticosteroid injection group.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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 Outcomes
- Comparison of visual analog scale results of sixth-week extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.(sixth week)
- Comparison of visual analog scale results of sixth months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.(sixth month)
- Comparison of visual analog scale results of third months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.(third month)
- 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)
- 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)
- 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)
Investigators
Ozlem Orhan
Assistant prof
Harran University