Ignite Creation Date:
2024-07-17 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466616
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-10
Brief Title:
Shock Waves Therapy Combined With Leg Stretching in Patients With Plantar Fasciitis
Sponsor:
University of Alcala
Organization:
University of Alcala
Study Overview
Official Title:
Efficacy of Applying Shock Waves Combined With Leg Stretching in Patients With Plantar Fasciitis A Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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 aim of this study is to evaluate the efficacy of a combination treatment consisting of ESWT and stretching of different muscles in the lower body compared to ESWT treatment alone in patients with plantar fasciitis
Detailed Description:
Background Plantar fasciitis is the most common cause of pain in the heel of the foot manifested by the presence of pain in the antero-internal part of the calcaneus Currently there is ample evidence of the efficacy of both shock waves and stretching in their treatment however no study has proven what results are obtained by combining the application of shock waves with stretching in different leg muscles
Objectives The main objective of the study is to compare the effects of OC treatment in conjunction with leg-length stretches against shock waves alone in reducing pain in patients with PF The secondary objectives will be to observe the effects of both treatments on disability and activity limitation in both the short and medium term
Materials and Methods A double-blind randomized clinical trial will be conducted A total of 52 subjects 26 in each group will participate in the study divided into one group that will undergo shockwave therapy plus real stretching experimental group and another that will undergo shockwave therapy plus placebo stretching control group The primary variable of the study will be pain and secondary variables will include changes in disability and activity limitation
Objectives The main objective of the study is to compare the effects of OC treatment in conjunction with leg-length stretches against shock waves alone in reducing pain in patients with PF The secondary objectives will be to observe the effects of both treatments on disability and activity limitation in both the short and medium term
Materials and Methods A double-blind randomized clinical trial will be conducted A total of 52 subjects 26 in each group will participate in the study divided into one group that will undergo shockwave therapy plus real stretching experimental group and another that will undergo shockwave therapy plus placebo stretching control group The primary variable of the study will be pain and secondary variables will include changes in disability and activity limitation
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