Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05771220
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2023-02-09
Brief Title:
Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis
Sponsor:
Taif University
Organization:
Taif University
Study Overview
Official Title:
Effectiveness of Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis Shoulder A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-07
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 goal of this clinical trial is to evaluate the combined effects of radial extracorporeal shockwave therapy rESWT and evidence-based physical therapy EBPT interventions for patients with adhesive capsulitis The main questions it aims to answer are
What is the effectiveness of combining rESWT with EBPT interventions for the management of adhesive capsulitis compared to EBPT alone How does the combination of rESWT and EBPT affect pain range of motion and functional outcomes in patients with adhesive capsulitis
Researchers will compare rESWT plus EBPT to a sham rESWT plus EBPT to see if rESWT provides better results for subjects with adhesive capsulitis
The study will randomly assign participants to receive either rESWT plus EBPT or sham rESWT plus EBPT over a 6-week intervention period The primary outcomes will be pain and disability while secondary outcomes will include shoulder range of motion psychological distress and health-related quality of life These outcomes will be assessed at baseline post-intervention and 12 weeks post-randomization
What is the effectiveness of combining rESWT with EBPT interventions for the management of adhesive capsulitis compared to EBPT alone How does the combination of rESWT and EBPT affect pain range of motion and functional outcomes in patients with adhesive capsulitis
Researchers will compare rESWT plus EBPT to a sham rESWT plus EBPT to see if rESWT provides better results for subjects with adhesive capsulitis
The study will randomly assign participants to receive either rESWT plus EBPT or sham rESWT plus EBPT over a 6-week intervention period The primary outcomes will be pain and disability while secondary outcomes will include shoulder range of motion psychological distress and health-related quality of life These outcomes will be assessed at baseline post-intervention and 12 weeks post-randomization
Detailed Description:
Methods Experiment Group patients were given shockwave therapy for 6 weeks as a one session per week follow up after 12 weeks Control Group patients received shame shockwave therapy inaddition to traditional treatment the same period of the experiment groupImportance Till date only a few studies have reported the efficacy and clinical improvements obtained by extracorporeal shockwave therapy ESWT on frozen shoulder Limited by asmall number of studies and insufficient outcomes it is important and necessary to conduct a new randomized controlled trial
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