An interventional study of Extracorporeal Shockwave Therapy and Cryoflow Therapy in Post-stroke Shoulder Pain,Rotator Cuff Tendonitis,Shoulder Spasticity, sponsored by MTI University. Completed at 1 site in Egypt. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by MTI University · Not applicable, Interventional, and Treatment
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.
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.
MTI University is the lead sponsor of 58 studies on the registry; 11 are open to participants now.
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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:
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
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
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
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
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
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
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
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.
Time frame: Baseline and after 8 weeks of treatment (24 sessions)
Change in Shoulder Range of Motion
Measured using a digital goniometer for active shoulder abduction and adduction. Range of motion recorded in degrees.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and after 8 weeks of treatment (24 sessions)
Plan to share: Undecided
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