Influence of Radial Extracorpeal Shock Wave in Hemiplegic Shoulder Patients

Influence of Radial Extracorpeal Shock Wave Therapy on Sonographic Findings in Patients With Hemiplegic Shoulder Pain

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.

Study Overview

• Status: Completed
• Conditions: Hemiplegia; Spastic
• Intervention / Treatment: Device: radial extracorpeal shock wave

Detailed Description

Painful shoulder is a common complication following hemiplegic stroke. This pain may interfere with functional improvement, the patient's quality of life, and it may impede the process of rehabilitation. Further understanding of rotator cuff tendon impairment and other shoulder soft tissue structural abnormalities in stroke patients may help clinicians in assigning more complete therapeutic plans to hemiplegic patients. The radial extracorporeal shock wave therapy has promising results in patients with musculoskeletal problems and in those with various causes of HSP, including spasticity, rotator cuff problems, adhesive capsulitis, and complex regional pain syndrome .The purposes of this study are to examine sonographic structural changes pre and post the radial extracorporeal shock wave intervention in hemiplegic shoulder pain, as well as to explore the relationships between sonographic structural changes and hemiplegic shoulder pain. This study will be a benefit in the physical therapy field and may guide rehabilitation programs of physical therapy towards better results through decreasing time needed to perform activity of daily living, decreasing dependency and making patient an active member in society.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. 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).

  3. Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental Scale >24).

  4. Patient who understand the study process and signed the informed consent form.

  5. 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.

Exclusion Criteria:

• The following patients will be excluded from the study:

  1. Patients who cannot express their own pain intensity.
  2. Patients with a history of trauma or surgery to the shoulder on the affected side.
  3. Patients with history of oral NSAIDs 3 days before this study or take warfarin medication with an international normalized ratio above 4.0.
  4. Patients with a history of shoulder pain before the stroke.

  6. Patients who have received a previous shoulder intra-articular injection or other interventions on the affected shoulder within one month before rESWT.

  7. Patients with cardiac pacemaker. 8. Patients who have osteoporosis. 9. Patients with psychological problems.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: study group; 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; 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
Sham Comparator: control group; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment by using shoulder pain and disability index (SPADI).	Shoulder pain and disability index is a shoulder specific self-reported questionnaire measuring pain and disability in patients with shoulder pain. It contains 5 items assessing pain and 8 items assessing shoulder function. Each item is scored on visual analogue scale with (Right end) defined as "worst pain imaginable/ so difficult required help", (Left end)"no pain/no difficulty". Scores will be calculated as follow, in part one pain scores in all questions will be added, and the mean value will be chosen. In part two functional scores of all questions will add and the mean value will be chosen for the purpose of data analysis. Final score for each part will be statistically analyzed separately	Baseline

Collaborators and Investigators

• Sponsor: Delta University for Science and Technology
• Investigators: Principal Investigator: Ibrahim A Abu-Ella, MSC, Cairo University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Sonography
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia
• Other Study ID Numbers: P.T.REC/012/002870

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No