Post-stroke Shoulder Pain,Rotator Cuff Tendonitis,Shoulder SpasticitySW-CF-STROKENCT07196267
Shockwave and Cryoflow for Shoulder Pain After Stroke
A study testing Extracorporeal Shockwave Therapy, Cryoflow Therapy and Traditional Physical Therapy Program in people with Post-stroke Shoulder Pain,Rotator Cuff Tendonitis,Shoulder Spasticity, run by MTI University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Post-stroke Shoulder Pain,Rotator Cuff Tendonitis,Shoulder Spasticity
- What is being tested?
- Extracorporeal Shockwave Therapy, Cryoflow Therapy and Traditional Physical Therapy Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination Effect of Extracorporeal Shockwave and Cryoflow Therapy on Rotator Cuff Tendonitis in Stroke Patients
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.
Read the 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.
- Being tested
- Extracorporeal Shockwave Therapy, Cryoflow Therapy, Traditional Physical Therapy Program, Placebo ESWT and Cryoflow
- Keywords
- Extracorporeal Shockwave Therapy, Cryoflow Therapy, Stroke Rehabilitation, Modified Ashworth Scale, Electromyography, Purdue Pegboard, Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave TherapyDevice
Also called ESWT
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.
Cryoflow TherapyDevice
Also called Cryoflow 1000IR
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.
Traditional Physical Therapy ProgramBehavioural
Also called Stretching, Strengthening, PNF, Weight-bearing, Hand Function Training
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
Placebo ESWT and CryoflowDevice
Also called Sham Shockwave ,Sham 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Extracorporeal Shockwave Therapy; Device: Cryoflow Therapy; Behavioral: Traditional Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 8 weeks of treatment (24 sessions)
Secondary outcomes (4)
Change in Shoulder Range of Motion
Measured using a digital goniometer for active shoulder abduction and adduction. Range of motion recorded in degrees.
Measured: Baseline and after 8 weeks of treatment (24 sessions)
Change in Supraspinatus Muscle Strength
Measured using a tensiometer (Lafayette, U.S.A.) to quantify isometric strength of the supraspinatus muscle. Force recorded in kilograms or Newtons.
Measured: Baseline and after 8 weeks of treatment (24 sessions)
Change in Hand Dexterity and Fine Motor Function
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.
Measured: Baseline and after 8 weeks of treatment (24 sessions)
Change in Supraspinatus Muscle Electromyographic Activity
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.
Measured: Baseline and after 8 weeks of treatment (24 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start10 Oct 2025
- Primary completion30 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke Shoulder Pain,Rotator Cuff Tendonitis,Shoulder SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, reda abd elrazik, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196267
- Sponsor's protocol ID
- PT. BU. EC. Y
- Acronym
- SW-CF-STROKE
- Status last verified
- Jan 2026
- First submitted
- 19 Sep 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Effect of Extracorporeal Shockwave and Cryoflow Therapy on Rotator Cuff Tendonitis in Stroke Patients
- ClinicalTrials.gov ID
- NCT07196267
- Acronym / sponsor ID
- SW-CF-STROKE / PT. BU. EC. Y
- Keywords
- Extracorporeal Shockwave Therapy, Cryoflow Therapy, Stroke Rehabilitation, Modified Ashworth Scale, Electromyography, Purdue Pegboard, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control: Traditional PT + Placebo | Placebo comparator | Behavioral: Traditional Physical Therapy Program, Device: Placebo ESWT and CryoflowParticipants 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. |
| Experimental: Traditional PT + ESWT + Cryoflow | Experimental | Device: Extracorporeal Shockwave Therapy, Device: Cryoflow Therapy, Behavioral: Traditional Physical Therapy ProgramParticipants 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shockwave TherapyAlso: ESWTDelivered 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 | Experimental: Traditional PT + ESWT + Cryoflow |
| Cryoflow TherapyAlso: Cryoflow 1000IRDelivered 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. | Device | Experimental: Traditional PT + ESWT + Cryoflow |
| Traditional Physical Therapy ProgramAlso: Stretching, Strengthening, PNF, Weight-bearing, Hand Function Trainingtretching 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 | Behavioural | Control: Traditional PT + Placebo, Experimental: Traditional PT + ESWT + Cryoflow |
| Placebo ESWT and CryoflowAlso: Sham Shockwave ,Sham CryoflowIdentical 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. | Device | Control: Traditional PT + Placebo |
Primary outcome
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.
4 secondary outcomes
Change in Shoulder Range of Motion
Time frame: Baseline and after 8 weeks of treatment (24 sessions)
Change in Supraspinatus Muscle Strength
Time frame: Baseline and after 8 weeks of treatment (24 sessions)
Change in Hand Dexterity and Fine Motor Function
Time frame: Baseline and after 8 weeks of treatment (24 sessions)
Change in Supraspinatus Muscle Electromyographic Activity
Time frame: Baseline and after 8 weeks of treatment (24 sessions)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave Therapy, Cryoflow Therapy and Traditional Physical Therapy Program in people with Post-stroke Shoulder Pain,Rotator Cuff Tendonitis,Shoulder Spasticity, run by MTI University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shoulder Muscle Tone (Spasticity) (time frame: Baseline and after 8 weeks of treatment (24 sessions)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.