Influence of Radial Extracorpeal Shock Wave in Hemiplegic Shoulder Patients

NCT04859673 | Completed DMC

• 1 other identifier: P.T.REC/012/002870
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are to examine sonographic structural changes pre and post the radial extracorporeal shock wave intervention in hemiplegic shoulder pain, and to assess the relationships between sonographic structural changes and hemiplegic shoulder pain.

Conditions

Hemiplegia; Spastic

Keywords

Sonography; Pain

Outcome Measures

Primary Outcomes (1)

• Evaluation of hemiplegic shoulder structural changes by ultrasonography

  Ultrasonography evaluation includes long head of biceps tendon ,subscapularis tendon, supraspinatus tendon, infraspinatus tendon. Each abnormal ultrasound (US) finding will be assigned a score of one (1) if present or zero (0) if absent. Long head of biceps effusion, sub acromial sub deltoid bursa effusion, subluxation, and adhesive capsulitis scored. Tendon tear, tendinosis, and tendon degeneration will be similarly scored for each of the four examined tendons per shoulder. The sum of these scores yielded a raw ultrasound (US) score; such that the minimum score was zero (normal examination) while the maximum score amounted to sixteen .The raw US scores will be further grouped into graded US scores, such that scores of 0, 1-2, 3-4, 5-6, and more than 6 abnormal sonographic findings represented normal shoulder, mild damage, moderate damage, severe damage, and intense damage, respectively

  Baseline

Secondary Outcomes (1)

• Pain assessment by using shoulder pain and disability index (SPADI).

  Baseline

Study Arms (2)

study group

ACTIVE COMPARATOR

Patients will received 3,000 pulses, 1,500 pulses per site at a frequency of 12 Hz per session with the submaximal pressure between 0.39 and 1.95 mJ/mm2 (1.0 and 5.0 bar), depending on the level which the patient can tolerate without local anesthetics.

Device: radial extracorpeal shock wave

control group

SHAM COMPARATOR

The patients in this group will be treated by sham radial extracorporeal shock wave therapy. Stimulation will not deliver as the transmitter head will be removed. The patients will receive the same frequency of air pressure and sound

Device: radial extracorpeal shock wave

Interventions

radial extracorpeal shock wave DEVICE

Swiss DolorClast® Master - Shockwave Therapy System will be used to apply the radial extracorporeal shock wave. It consists of master console, Evo Blue hand-piece, 15mm and 36mm interchangeable contact heads (applicators), contact gel, cart, and external compressor

control group; study group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Patient's age ranges from 40 to 60 years. 2. Spasticity of upper limb ranges from mild to moderate (grade 1+: 2) according to modified aschworth scale (MAS).
• \. Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental Scale \>24).
• \. Patient who understand the study process and signed the informed consent form.
• \. Patient with stroke more than 3 months ago. 8. Patient with shoulder pain and limited range of motion (ROM) or loss of motion in the proximal arm on the hemiplegic side.

You may not qualify if:

• The following patients will be excluded from the study:
• Patients who cannot express their own pain intensity.
• Patients with a history of trauma or surgery to the shoulder on the affected side.
• Patients with history of oral NSAIDs 3 days before this study or take warfarin medication with an international normalized ratio above 4.0.
• Patients with a history of shoulder pain before the stroke.
• \. Patients who have received a previous shoulder intra-articular injection or other interventions on the affected shoulder within one month before rESWT.
• \. Patients with cardiac pacemaker. 8. Patients who have osteoporosis. 9. Patients with psychological problems.

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Related Publications (1)

• Wilson RD, Chae J. Hemiplegic Shoulder Pain. Phys Med Rehabil Clin N Am. 2015 Nov;26(4):641-55. doi: 10.1016/j.pmr.2015.06.007. Epub 2015 Sep 9.

  PMID: 26522903 RESULT

MeSH Terms

Conditions

Hemiplegia; Muscle Spasticity; Pain

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• Ibrahim A Abu-Ella, MSC

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients in control group will be treated by sham radial extracorporeal shock wave therapy in addition to, the same design physical therapy program. Stimulation will not deliver as the transmitter head will be removed. The patients will receive the same frequency of air pressure and sound
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: The selected patients will be randomly assigned to two equal groups (study group (GI), and control group (GII).The study group (GI) will be treated by the radial extracorporeal shock wave in addition to design physical therapy program. • The control group (GII) will be treated by sham radial extracorporeal shock wave in addition to the same design physical therapy program of (GI).

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 26, 2021
• Study Start: June 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)