Shockwave and Cryoflow for Shoulder Pain After Stroke (SW-CF-STROKE)

MTI University

Status: Completed

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

Treatments: Device: Placebo ESWT and Cryoflow; Behavioral: Traditional Physical Therapy Program; Device: Cryoflow Therapy; Device: Extracorporeal Shockwave Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07196267

PT. BU. EC. Y

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Control: Traditional PT + Placebo

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Traditional Physical Therapy Program

Device: Placebo ESWT and Cryoflow

Experimental: Traditional PT + ESWT + Cryoflow

Experimental group

Description:

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.

Treatment:

Device: Extracorporeal Shockwave Therapy

Device: Cryoflow Therapy

Behavioral: Traditional Physical Therapy Program