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Effect of Radial Extracorpeal Shock Wave on Pain and Function

Primary Purpose

Hemiplegia

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 pain thrshold, ROM

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:

  • 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

Outcomes

Primary Outcome Measures

The pain pressure threshold (PPT) assessment by using pressure algometer procedures
Pain pressure threshold measurement will be obtained in the same order for all patients.The pressure will be applied with 0.785 cm2 rubber tip at a rate of 1 kg/cm2/sec 27 at the site of measurement. The measurement will at the mid-belly of the deltoid of the painful shoulder. The tip of the algometer will be positioned on this specific point. By pushing the algometer, the force will be applied to the mid belly of deltoid gradually increased. The patients will not allowed to see the algometer display in any moment, and, as soon as the volunteers experience a painful sensation, they say "stop", the algometer will immediately release and the force (in Kpa) will be read from the display. Pain pressure threshold will be measured three times per patient on each site and the average will be calculated and will be used for analysis.

Secondary Outcome Measures

Shoulder range of motion assessment by using magnetic inclinometer
Total shoulder flexion will be measured with full elbow extension and leading with the thumb to ensure consistent rotation. The inclinometer will placed along the shaft of the humerus perpendicular to the plane of motion. Total shoulder abduction will be measured with full elbow extension and leading with the thumb to ensure consistent rotation. The inclinometer will placed along the shaft of the humerus perpendicular to the plane of motion.

Full Information

First Posted
May 16, 2021
Last Updated
February 15, 2023
Sponsor
Delta University for Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04894097
Brief Title
Effect of Radial Extracorpeal Shock Wave on Pain and Function
Official Title
Effect of Radial Extracorpeal Shock Wave on Pain and Function in Hemplegic Shoulder Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 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 purpose of the current study will be focused on the following issues. Evaluation of the effect of radial extracorporeal shock wave on the pressure pain threshold and disability in stroke hemiplegic shoulder.
Detailed Description
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 extra-corporeal 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia
Keywords
pain thrshold, ROM

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
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
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
The pain pressure threshold (PPT) assessment by using pressure algometer procedures
Description
Pain pressure threshold measurement will be obtained in the same order for all patients.The pressure will be applied with 0.785 cm2 rubber tip at a rate of 1 kg/cm2/sec 27 at the site of measurement. The measurement will at the mid-belly of the deltoid of the painful shoulder. The tip of the algometer will be positioned on this specific point. By pushing the algometer, the force will be applied to the mid belly of deltoid gradually increased. The patients will not allowed to see the algometer display in any moment, and, as soon as the volunteers experience a painful sensation, they say "stop", the algometer will immediately release and the force (in Kpa) will be read from the display. Pain pressure threshold will be measured three times per patient on each site and the average will be calculated and will be used for analysis.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Shoulder range of motion assessment by using magnetic inclinometer
Description
Total shoulder flexion will be measured with full elbow extension and leading with the thumb to ensure consistent rotation. The inclinometer will placed along the shaft of the humerus perpendicular to the plane of motion. Total shoulder abduction will be measured with full elbow extension and leading with the thumb to ensure consistent rotation. The inclinometer will placed along the shaft of the humerus perpendicular to the plane of motion.
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: Patient's age ranges from 40 to 60 years. 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: 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.
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
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Effect of Radial Extracorpeal Shock Wave on Pain and Function

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