Shockwave and Cryoflow for Shoulder Pain After Stroke

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07196267
• Lead Sponsor: MTI University

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.

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 Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-19
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study Start: 2025-09-20
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Primary Completion: 2025-10-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Shoulder Muscle Tone (Spasticity)	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 Outcome Measures

Name	Time	Method
Change in Shoulder Range of Motion	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.
Change in Supraspinatus Muscle Strength	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.
Change in Hand Dexterity and Fine Motor Function	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.
Change in Supraspinatus Muscle Electromyographic Activity	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.