Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT07196267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shockwave and Cryoflow for Shoulder Pain After Stroke
Sponsor:
MTI University
Organization:
Study Overview
Official Title:
Combination Effect of Extracorporeal Shockwave and Cryoflow Therapy on Rotator Cuff Tendonitis in Stroke Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
SW-CF-STROKE
Brief Summary:
This study aims to find out whether combining two physical therapy treatments - Extracorporeal Shockwave Therapy and Cryoflow Therapy - can help reduce shoulder pain and improve function in patients who have developed rotator cuff tendonitis after a stroke. Participants will be divided into groups to receive either one therapy alone or both therapies together. Researchers will measure pain levels, shoulder movement, and daily function before and after treatment to see which approach works best. The goal is to find a more effective, non-drug way to manage shoulder pain in stroke survivors and help them regain better use of their arm.
Detailed Description:
This study will test whether combining Extracorporeal Shockwave Therapy (ESWT) and Cryoflow Therapy with traditional physical therapy is more effective than traditional therapy alone for reducing shoulder pain and improving arm function in stroke patients with rotator cuff tendonitis. Thirty stroke patients (ages 50-70) with moderate-to-severe shoulder spasticity (MAS grade 3) will be randomly assigned to one of two groups:
Group 1 (Control): Receives traditional physical therapy (stretching, strengthening, PNF, hand function training) + placebo ESWT/Cryoflow.
Group 2 (Experimental): Receives the same traditional therapy + real ESWT (7Hz, 15 min) and Cryoflow (14°C, 15 min).
All patients will be treated 3 times per week for 8 weeks. Before and after treatment, researchers will measure: shoulder muscle tone (Modified Ashworth Scale), range of motion (digital goniometer), muscle strength (tensiometer), hand dexterity (Purdue Pegboard), and muscle activity (electromyography). The goal is to find a better, non-drug way to relieve shoulder pain and restore function after stroke.
Group 1 (Control): Receives traditional physical therapy (stretching, strengthening, PNF, hand function training) + placebo ESWT/Cryoflow.
Group 2 (Experimental): Receives the same traditional therapy + real ESWT (7Hz, 15 min) and Cryoflow (14°C, 15 min).
All patients will be treated 3 times per week for 8 weeks. Before and after treatment, researchers will measure: shoulder muscle tone (Modified Ashworth Scale), range of motion (digital goniometer), muscle strength (tensiometer), hand dexterity (Purdue Pegboard), and muscle activity (electromyography). The goal is to find a better, non-drug way to relieve shoulder pain and restore function after stroke.
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?: