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Influence of Radial Extracorpeal Shock Wave in Hemiplegic Shoulder Patients

Primary Purpose

Hemiplegia, Spastic

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
radial extracorpeal shock wave
Sponsored by
Delta University for Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring Sonography, Pain

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

study group

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 13, 2021
Last Updated
February 15, 2023
Sponsor
Delta University for Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04859673
Brief Title
Influence of Radial Extracorpeal Shock Wave in Hemiplegic Shoulder Patients
Official Title
Influence of Radial Extracorpeal Shock Wave Therapy on Sonographic Findings in Patients With Hemiplegic Shoulder Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Delta University for Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Spastic
Keywords
Sonography, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
Participant
Masking Description
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
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
radial extracorpeal shock wave
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluation of hemiplegic shoulder structural changes by ultrasonography
Description
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
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Pain assessment by using shoulder pain and disability index (SPADI).
Description
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
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim A Abu-Ella, MSC
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo university
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26522903
Citation
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.
Results Reference
result

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Influence of Radial Extracorpeal Shock Wave in Hemiplegic Shoulder Patients

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