Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04640337
Status:
RECRUITING
Last Update Posted:
2023-05-09
First Post:
2020-11-10
Brief Title:
Influence of Placebo on Intratissue Percutaneous Electrolysis in Patellar Tendinopathy
Sponsor:
University of Valencia
Organization:
University of Valencia
Study Overview
Official Title:
Influence of Placebo on Intratissue Percutaneous Electrolysis IPE Treatment in Patients With Patellar Tendinopathy
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main aim of this study is to verify the influence of placebo on the effectiveness of Intratissue Percutaneous Electrolysis IPE in patients suffering from with chronic patellar tendinopathy PT
The secondary aim is to investigate the possible influence of the IPE on pain perception and conditioned pain modulation CPM in patients with chronic PT
The secondary aim is to investigate the possible influence of the IPE on pain perception and conditioned pain modulation CPM in patients with chronic PT
Detailed Description:
The aim of this study is to investigate the influence of placebo on the effectiveness of Intratissue Percutaneous Electrolysis IPE in patients with chronic PT For this purpose a randomized clinical trial will be carried out with a sample of patients diagnosed of chronic PT based on signs symptoms and clinical examination Subjects will be randomly allocated to four different groups group E1 IPE will be applied participants will believe they are receiving IPE group E2 IPE will be applied participants will believe they are receiving placebo group P1 IPE will not be applied participants will believe they are receiving IPE and group P2 IPE will not be applied participants will believe they are receiving placebo
IPE treatment will consist of a total of 3 sessions with a time interval of one week between the 1st and 2nd sessions and 2 weeks between the 2nd and 3rd sessions
To evaluate the effect of intervention the subjects will be assessed at baseline V0 one week after the end of the intervention V1 and 3 weeks after the intervention V2
In V0 sociodemographic sex age profession height body mass index BMI sport activity hours of sport per week and clinical data associated pathologies affected lower limb dominant lower limb duration of symptoms will be registered In each assessment time information regarding BMI sports activity hours of sport per week and location of pain will be obtained Moreover in all assessments participants were evaluated for four physical performance tests pain and functional scales ultrasound examination pressure pain thresholds conditioned pain modulation and expectations questionnaires
IPE treatment will consist of a total of 3 sessions with a time interval of one week between the 1st and 2nd sessions and 2 weeks between the 2nd and 3rd sessions
To evaluate the effect of intervention the subjects will be assessed at baseline V0 one week after the end of the intervention V1 and 3 weeks after the intervention V2
In V0 sociodemographic sex age profession height body mass index BMI sport activity hours of sport per week and clinical data associated pathologies affected lower limb dominant lower limb duration of symptoms will be registered In each assessment time information regarding BMI sports activity hours of sport per week and location of pain will be obtained Moreover in all assessments participants were evaluated for four physical performance tests pain and functional scales ultrasound examination pressure pain thresholds conditioned pain modulation and expectations questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None