Influence of Radial Extracorpeal Shock Wave in Hemiplegic Shoulder Patients

Sponsor

Delta University for Science and Technology (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04859673

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemiplegia Spastic	Device: radial extracorpeal shock wave	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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:

Single (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

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Evaluation of hemiplegic shoulder structural changes by ultrasonography [Baseline]
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). [Baseline]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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).

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.

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.
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Delta University for Science and Technology

Investigators

Principal Investigator: Ibrahim A Abu-Ella, MSC, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ibrahim Ahmed Ibrahim Abu Ella, assistant lecturer, Delta University for Science and Technology

ClinicalTrials.gov Identifier:

NCT04859673

Other Study ID Numbers:

P.T.REC/012/002870

First Posted:

Apr 26, 2021

Last Update Posted:

May 20, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ibrahim Ahmed Ibrahim Abu Ella, assistant lecturer, Delta University for Science and Technology

Sonography

Pain

Additional relevant MeSH terms:

Hemiplegia

Study Results

No Results Posted as of May 20, 2021