Plantar FascitisNCT05647291
Is ESWT Better in Plantar Fasciitis Treatment?
A study testing extracorporeal Shock wave therapy, Corticosteroid injection and Kinesiotaping in people with Plantar Fascitis, run by Harran University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- extracorporeal Shock wave therapy, Corticosteroid injection and Kinesiotaping
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Oct 2021to 28 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- previous ESWT or CI treatment
- obesity,
- seronegative spondyloarthropathy,
- tarsal tunnel syndrome,
- peripheral neuropathy,
- foot-ankle deformity (pes cavus, pes planus, etc.),
Show all 9Show fewer
- history of mass around foot and ankle,
- previous foot or ankle surgery
- degenerative arthritis around this region
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Harran University Medicine Faculty
Sanliurfa, Outside of the US
Sanliurfa Regional Training and Research Hospital
Sanliurfa
About this study
Official title: 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.
Read the 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.
- Conditions
- Plantar Fascitis
- Being tested
- extracorporeal Shock wave therapy, Corticosteroid injection, Kinesiotaping
- Keywords
- ESWT, Kinesiotaping, corticosteroid injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal Shock wave therapyDevice
Also called an Auto Wave 695 (Mettler electronics, USA) brand device
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.
Corticosteroid injectionDrug
Also called methylprednisolone
40mg/1ml methylprednisolone, two sessions once a week
KinesiotapingDevice
Also called KinesioTex, KinesioTaping, US
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
| Study group | Role | What they receive |
|---|---|---|
| extracorporeal Shock wave therapy (ESWT) | Experimental | 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. Receives: Device: extracorporeal Shock wave therapy |
| Kinesiotaping | Active comparator | 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. Receives: Device: Kinesiotaping |
| Corticosteroid injection | Active comparator | 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. Receives: Drug: Corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and six months
Secondary outcomes (6)
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.
Measured: sixth week
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.
Measured: third month
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.
Measured: sixth 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.
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.
Measured: sixth weeks
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.
Measured: three month
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.
Measured: sixth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start15 Oct 2021
- Primary completion17 Apr 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanliurfa Education and Research Hospital
- Responsible party
- Principal investigator, Ozlem Orhan, Harran University
- Investigators
- Özlem Orhan, Principal investigator, Department of Orthopaedics and Traumatology, Harran University Medicine Faculty, Şanlıurfa, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647291
- Sponsor's protocol ID
- HRU/21.17.30
- Status last verified
- Dec 2022
- First submitted
- 23 Nov 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
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.
PubMed 34214104Chang 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.
PubMed 22421623Mishra 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.
PubMed 30828215
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief and Functional Improvement Provided by ESWT in Plantar Fasciitis is Better Than Corticosteroid Injection and Kinesiotherapy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05647291
- Acronym / sponsor ID
- HRU/21.17.30
- Conditions
- Plantar Fascitis
- Keywords
- ESWT, Kinesiotaping, corticosteroid injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Collaborators
- Sanliurfa Education and Research Hospital
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 17 Apr 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| extracorporeal Shock wave therapy (ESWT) | Experimental | Device: extracorporeal Shock wave therapyESWT 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 | Active comparator | Device: KinesiotapingKinesio 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. |
| Corticosteroid injection | Active comparator | Drug: Corticosteroid injectionIn 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- previous ESWT or CI treatment
- obesity,
- seronegative spondyloarthropathy,
- tarsal tunnel syndrome,
- peripheral neuropathy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extracorporeal Shock wave therapyAlso: an Auto Wave 695 (Mettler electronics, USA) brand deviceTwo 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. | Device | extracorporeal Shock wave therapy (ESWT) |
| Corticosteroid injectionAlso: methylprednisolone40mg/1ml methylprednisolone, two sessions once a week | Drug | Corticosteroid injection |
| KinesiotapingAlso: KinesioTex, KinesioTaping, USThe 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 | Device | Kinesiotaping |
Primary outcome
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 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 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 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 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 (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 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 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 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 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 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 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.
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.
6 secondary outcomes
Comparison of visual analog scale results of sixth-week extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.
Time frame: sixth week
Comparison of visual analog scale results of third months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.
Time frame: third month
Comparison of visual analog scale results of sixth months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.
Time frame: sixth 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.
Time frame: sixth weeks
Comparison of American Orthopedic Foot and Ankle Score (AOFAS) scores results of three months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.
Time frame: three month
Comparison of American Orthopedic Foot and Ankle Score (AOFAS) scores results of sixth months extracorporeal shock wave therapy (ESWT), kinesiotherapy, and corticosteroid injection therapy.
Time frame: sixth month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Results publication: PubMed 34214104Tang 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.
- Results publication: PubMed 22421623Chang 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.
- Results publication: PubMed 30828215Mishra 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özlem Orhan principal investigator
Department of Orthopaedics and Traumatology, Harran University Medicine Faculty, Şanlıurfa, Turkey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extracorporeal Shock wave therapy, Corticosteroid injection and Kinesiotaping in people with Plantar Fascitis, run by Harran University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647291, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.