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Completed

NCT Number: NCT07196267

Shockwave and Cryoflow for Shoulder Pain After Stroke

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.

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Key information

Conditions

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

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Benha University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: ESWT

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.

Other names: Cryoflow 1000IR

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

Other names: Stretching, Strengthening, PNF, Weight-bearing, Hand Function Training

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.

Other names: Sham Shockwave ,Sham Cryoflow

Primary outcomes

  1. Change in Shoulder Muscle Tone (Spasticity)

    Time frame: Baseline and after 8 weeks of treatment (24 sessions)

    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.

Secondary outcomes

  1. Change in Shoulder Range of Motion

    Time frame: Baseline and after 8 weeks of treatment (24 sessions)

    Measured using a digital goniometer for active shoulder abduction and adduction. Range of motion recorded in degrees.

  2. Change in Supraspinatus Muscle Strength

    Time frame: Baseline and after 8 weeks of treatment (24 sessions)

    Measured using a tensiometer (Lafayette, U.S.A.) to quantify isometric strength of the supraspinatus muscle. Force recorded in kilograms or Newtons.

  3. Change in Hand Dexterity and Fine Motor Function

    Time frame: Baseline and after 8 weeks of treatment (24 sessions)

    Measured using surface electromyography (Neuropac apparatus) to record amplitude of motor unit action potentials (MUAP) of the supraspinatus muscle during standardized contractions. Reflects neuromuscular activation.

  4. Change in Supraspinatus Muscle Electromyographic Activity

    Time frame: Baseline and after 8 weeks of treatment (24 sessions)

    Measured using surface electromyography (Neuropac apparatus) to record amplitude of motor unit action potentials (MUAP) of the supraspinatus muscle during standardized contractions. Reflects neuromuscular activation.

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Official study title

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

Acronym: SW-CF-STROKE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.