Effect of Radial Extracorpeal Shock Wave on Pain and Function

Sponsor

Delta University for Science and Technology (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04894097

Collaborator

(none)

Enrollment

Arms

3.4

Anticipated Duration (Months)

Study Details

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.

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

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.

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

Primary Purpose:

Treatment

Official Title:

Effect of Radial Extracorpeal Shock Wave on Pain and Function in Hemplegic Shoulder Pain Patients

Anticipated Study Start Date :

May 20, 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	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

Device: radial extracorpeal shock wave

Outcome Measures

Primary Outcome Measures

The pain pressure threshold (PPT) assessment by using pressure algometer procedures [Baseline]
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 [Baseline]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
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.

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.
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:

NCT04894097

Other Study ID Numbers:

Cairo University

First Posted:

May 20, 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

pain thrshold

ROM

Additional relevant MeSH terms:

Hemiplegia

Study Results

No Results Posted as of May 20, 2021