Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589037
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
34Comparison of Shockwave Application on the Sole of the Foot Vs the Back of the Leg in the Treatment of Plantar Fasciitis a Clinical Trial34
Sponsor:
None
Organization:
None
Study Overview
Official Title:
34Comparison of Shockwave Application on the Sole of the Foot Vs the Back of the Leg in the Treatment of Plantar Fasciitis a Clinical Trial34
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SW-PF-BL
Brief Summary:
The study focuses on plantar fasciitis one of the most common causes of non-traumatic foot and ankle pain with an estimated prevalence of 10 Its objective is to evaluate the effectiveness of shock wave therapy applied along the course of the sciatic nerve in treating plantar fasciitis comparing its effects on pain foot-ankle functionality and quality of life
Forty-eight subjects will be recruited and randomly assigned to two groups one will receive local shock wave therapy while the other will receive therapy along the sciatic nerve Data will be collected at four points in time before the intervention one week after one month after and three months after with blinded data collection
Pain foot-ankle functionality and quality of life will be measured Data analysis will be performed using SPSS 290 applying ANOVA and other tests depending on the normality of the data Differences will be estimated with a 95 confidence interval and a p-value lt 005
Forty-eight subjects will be recruited and randomly assigned to two groups one will receive local shock wave therapy while the other will receive therapy along the sciatic nerve Data will be collected at four points in time before the intervention one week after one month after and three months after with blinded data collection
Pain foot-ankle functionality and quality of life will be measured Data analysis will be performed using SPSS 290 applying ANOVA and other tests depending on the normality of the data Differences will be estimated with a 95 confidence interval and a p-value lt 005
Detailed Description:
Introduction Plantar fasciitis is one of the most common causes of non-traumatic ankle-foot pain The exact prevalence is unknown but it is estimated to be around 10
Objective To evaluate the efficacy of applying shock waves along the course of the sciatic nerve in the treatment of plantar fasciitis and its effect on pain as well as to assess changes in ankle-foot functionality and quality of life
Material and Methods Forty-eight subjects who meet the inclusion criteria will be recruited and randomly assigned to each intervention group The control group will receive local shock wave therapy while the experimental group will receive shock wave therapy along the course of the sciatic nerve
Data Collection Data will be collected at four different times before the intervention one week after one month after and three months after The data collection will be carried out by a team member who will be blinded to the group to which the subject belongs The dependent variables to be measured are pain VAS scale ankle-foot functionality FFI and quality of life SF12
Data Analysis The data analysis will use SPSS 290 Normality of variables will be assessed and descriptive analyses will be conducted Initial homogeneity between groups will be compared and ANOVA and other tests will be applied according to normality and homoscedasticity Differences and percentage changes will be calculated estimating effect size with a 95 CI and p lt 05
Objective To evaluate the efficacy of applying shock waves along the course of the sciatic nerve in the treatment of plantar fasciitis and its effect on pain as well as to assess changes in ankle-foot functionality and quality of life
Material and Methods Forty-eight subjects who meet the inclusion criteria will be recruited and randomly assigned to each intervention group The control group will receive local shock wave therapy while the experimental group will receive shock wave therapy along the course of the sciatic nerve
Data Collection Data will be collected at four different times before the intervention one week after one month after and three months after The data collection will be carried out by a team member who will be blinded to the group to which the subject belongs The dependent variables to be measured are pain VAS scale ankle-foot functionality FFI and quality of life SF12
Data Analysis The data analysis will use SPSS 290 Normality of variables will be assessed and descriptive analyses will be conducted Initial homogeneity between groups will be compared and ANOVA and other tests will be applied according to normality and homoscedasticity Differences and percentage changes will be calculated estimating effect size with a 95 CI and p lt 05
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None