An interventional study of The radial shock wave device in Plantar Fascitis, sponsored by Bihter Aslanyurek. Completed at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by Bihter Aslanyurek · Not applicable, Interventional, and Treatment
This study is a prospective randomized clinical trial. Radial extracorporeal shock wave therapy (r-ESWT) is accepted as one of the most effective treatment modalities for plantar fasciitis (PF). Kinesio taping (KT) applied to the plantar fascia can provide patients with PF some benefits, but there no enough evidence about this topic. This study analysed the acute effect of adding KT to r-ESWT, on pain, foot function and flexibility when treating PF.
The study was performed on 42 patients with unilateral PF, that were randomly assigned into wo groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises. Patients' pain levels were evaluated via the Visual Analogue Scale (VAS), and foot function via the Foot Function Index (FFI). Flexibility was assessed through gastro-soleus and plantar fascia flexibility tests. The evaluations were done before and one week after the final treatment.
273 studies on the registry are indexed under Fasciitis, Plantar; 71 are open to participants now.
This study's enrollment of 42 is below the median of 56 across 238 interventional studies indexed under Fasciitis, Plantar.
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Exclusion Criteria:
Patients with unilateral PF, that were randomly assigned into two groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises.
Device: The radial shock wave device
Patients with unilateral PF, that were randomly assigned into two groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises.
Device: The radial shock wave device
The r-ESWT+Kinesio Tape Application
Also known as: The r-ESWT+Kinesio taping (KT)
Change from baseline in pain on the Visual Analog Scale (VAS) at week 5
VAS is a tool where patients indicate the level of pain they feel using a 10 cm ruler. VAS pain score "no pain" (score=0) and "worst pain" (score=10).
Time frame: Baseline and week 5
Change from baseline Foot function via the Foot Function Index (FFI) at week 5
FFI is a safe and valid foot-specific assessment measure used to evaluate pain, disability, and activity limitation, filled out by the patient self-reported
Time frame: Baseline and week 5
Change from baseline flexibility was evaluated through gastro-soleus and plantar fascia flexibility tests at week 5
The patient was seated on a flat surface with the knees extended and the soles of the feet touching the wall. The tests were repeated three times and the average of the three measurements was taken.
Time frame: Baseline and week 5
Plan to share: Yes — All collected IPD will be shared
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Once the study is published, data will be shared.
Access criteria: If ethics committee requirements are met in similar studies to be conducted by clinical researchers, data can be shared with the permission of the clinical officer.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Bihter Aslanyurek