Shockwave and Cryoflow for Shoulder Pain After Stroke

NCT07196267 | Completed

• 1 other identifier: PT. BU. EC. Y
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Extracorporeal Shockwave Therapy; Cryoflow Therapy; Stroke Rehabilitation; Modified Ashworth Scale; Electromyography; Purdue Pegboard; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Shoulder Muscle Tone (Spasticity)

  Measured using the Modified Ashworth Scale (MAS) for shoulder adductors. MAS is a 6-point ordinal scale (0 = no increase in muscle tone, 5 = affected part rigid) to assess resistance during passive movement. Lower scores indicate reduced spasticity.

  Baseline and after 8 weeks of treatment (24 sessions)

Secondary Outcomes (4)

• Change in Shoulder Range of Motion

  Baseline and after 8 weeks of treatment (24 sessions)

• Change in Supraspinatus Muscle Strength

  Baseline and after 8 weeks of treatment (24 sessions)

• Change in Hand Dexterity and Fine Motor Function

  Baseline and after 8 weeks of treatment (24 sessions)

• Change in Supraspinatus Muscle Electromyographic Activity

  Baseline and after 8 weeks of treatment (24 sessions)

Study Arms (2)

Control: Traditional PT + Placebo

PLACEBO COMPARATOR

Participants receive a traditional physical therapy program including stretching, strengthening, PNF, weight-bearing, and hand function training (Purdue Pegboard) for 40 minutes per session, 3 times per week for 8 weeks. Placebo extracorporeal shockwave and cryoflow therapy (device turned off or mimicked without active energy delivery) are applied to maintain blinding where possible.

Behavioral: Traditional Physical Therapy Program; Device: Placebo ESWT and Cryoflow

Experimental: Traditional PT + ESWT + Cryoflow

EXPERIMENTAL

Participants receive the same traditional physical therapy program as the control group, plus active Extracorporeal Shockwave Therapy (7 Hz, 2.5-3 bar, 15 min) and Cryoflow Therapy (14°C, 15 min) applied sequentially before PT. Treatments are administered 3 times per week for 8 weeks.

Device: Extracorporeal Shockwave Therapy; Device: Cryoflow Therapy; Behavioral: Traditional Physical Therapy Program

Interventions

Extracorporeal Shockwave Therapy DEVICE

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.

Also known as: ESWT

Experimental: Traditional PT + ESWT + Cryoflow

Cryoflow Therapy DEVICE

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.

Also known as: Cryoflow 1000IR

Experimental: Traditional PT + ESWT + Cryoflow

Traditional Physical Therapy Program BEHAVIORAL

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

Also known as: Stretching, Strengthening, PNF, Weight-bearing, Hand Function Training

Control: Traditional PT + Placebo; Experimental: Traditional PT + ESWT + Cryoflow

Placebo ESWT and Cryoflow DEVICE

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.

Also known as: Sham Shockwave ,Sham Cryoflow

Control: Traditional PT + Placebo

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of stroke confirmed by neurologist via physical examination and MRI. Age between 50 and 70 years. Moderate to severe shoulder spasticity, graded as Stage 3 on the Modified Ashworth Scale (MAS) for shoulder adductors.
• Medically stable (vital signs within normal limits). Conscious, cooperative, and able to follow instructions. No orthopedic conditions, surgeries, or injuries affecting the shoulder or upper limb.
• No sensory impairments (visual, auditory, proprioceptive) that would interfere with assessment or treatment.
• Able to provide informed consent.

You may not qualify if:

• History of shoulder surgery or fracture. Presence of shoulder subluxation or dislocation. Severe cognitive impairment or inability to communicate. Uncontrolled hypertension, cardiac disease, or other unstable medical conditions.
• Skin lesions, open wounds, or infection over the shoulder region. Diagnosis of frozen shoulder (adhesive capsulitis), rheumatoid arthritis, or other inflammatory joint diseases.
• Previous treatment with ESWT or cryotherapy for shoulder within the last 6 months.
• Use of botulinum toxin injections in the upper limb within the last 3 months

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

Faculty of Physical Therapy, Benha University

Cairo, Egypt

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy; Weight-Bearing

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Mechanical Phenomena; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Physical Therapy for musculoskeletal disorders and its surgery, Faculty of Physical Therapy, Benha University

Model Details: Participants are randomly assigned to either the Control Group (traditional PT + placebo) or the Experimental Group (traditional PT + real ESWT and Cryoflow). Both groups receive treatment concurrently over 8 weeks, with outcomes compared at baseline and post-intervention.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: October 10, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 5, 2026

Record last verified: 2026-01

Locations

EG (1)