Shockwave and Cryoflow for Shoulder Pain After Stroke

N/ACompletedNCT07196267

MTI University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Interventions

Extracorporeal Shockwave TherapyDEVICE

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

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 ProgramBEHAVIORAL

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

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.