Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-20 @ 8:26 PM
Study NCT ID:
NCT05920369
Status:
UNKNOWN
Last Update Posted:
2023-06-27
First Post:
2023-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
The Combined Effect of Extracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome After Breast Cancer Surgery With Axillary Dissection: A Comparative, Controlled Clinical Trial.
Status:
UNKNOWN
Status Verified Date:
2023-06
Last Known Status:
RECRUITING
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:
A total of 93 suitable patients will be randomly allocated into three groups: Group A will receive both low-energy extracorporeal shock wave therapy and a tailored exercise program, Group B will receive only low-energy extracorporeal shock wave therapy, and Group C will receive only the tailored exercise program.
Detailed Description:
Patients were randomly assigned to one of three groups: Group A, which received a low-energy extracorporeal shockwave treatment and a tailored exercise program; Group B, which received only a low-energy extracorporeal shockwave treatment; and Group C, which received only the tailored exercise program. The randomization process was done using a computer-generated table of random numbers concealed by sealed opaque envelopes. The patients' shoulder range of motion, pain intensity, upper extremity activities, and echogenicity, thickness, and disorganization were assessed using a digital inclinometer, visual analogue scale, quick DASH scale, and diagnostic ultrasound, respectively. The randomization process was overseen by a professional physical therapist who was not involved in the study procedures.
All outcomes were measured at the baseline and four weeks post-intervention. The outcomes were collected by a well-experienced investigator who was blind to the group assignments and considered as part of the research team.
All outcomes were measured at the baseline and four weeks post-intervention. The outcomes were collected by a well-experienced investigator who was blind to the group assignments and considered as part of the research team.
Study Oversight
Has Oversight DMC:
True
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?: