NCT07196267

Shockwave and Cryoflow for Shoulder Pain After Stroke

Combination Effect of Extracorporeal Shockwave and Cryoflow Therapy on Rotator Cuff Tendonitis in Stroke Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: MTI University · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-stroke Shoulder Pain,Rotator Cuff Tendonitis,Shoulder Spasticity

Interventions

Type	Name	Description
DEVICE	Extracorporeal Shockwave Therapy	Delivered using Shock Master (Master Plus MP200, STORZ Medical AG, Switzerland). Applied at 7 Hz frequency, 2.5-3 bar pressure, for 15 minutes per session, 3 times per week for 8 weeks. Target: supraspinatus tendon region. Applied after Cryoflow therapy in experimental group.
DEVICE	Cryoflow Therapy	Delivered using Cryoflow 1000IR (Model ICE-CT, EC). Applied at 14°C for 15 minutes per session, 3 times per week for 8 weeks. Applied directly over rotator cuff tendon region before ESWT in experimental group.
BEHAVIORAL	Traditional Physical Therapy Program	tretching of shoulder flexors/adductors/internal rotators Strengthening of shoulder extensors/external rotators Weight-bearing exercises (sitting \& quadruped) Neuromuscular Facilitation (PNF) for upper limb Hand dexterity training using Purdue Pegboard
DEVICE	Placebo ESWT and Cryoflow	Identical device setup as active ESWT and Cryoflow, but with energy delivery disabled (no acoustic pulses, no cold air output). Applied for 15 min each, mimicking active treatment to maintain blinding where possible. Used in control group alongside traditional PT.

Timeline

• Start date: 2025-10-10
• Primary completion: 2025-10-30
• Completion: 2025-11-30
• First posted: 2025-09-29
• Last updated: 2026-01-05

Locations

1 site across 1 country: Egypt