NCT04894097

Brief Summary

The purpose of the current study will be focused on the following issues. Evaluation of the effect of magnetic therapy on the pressure pain threshold and disability in stroke hemiplegic shoulder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

December 11, 2025

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

May 16, 2021

Last Update Submit

December 4, 2025

Conditions

Keywords

pain thrsholdROM

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (1)

  • Shoulder range of motion assessment by using magnetic inclinometer

    Baseline

Study Arms (2)

study group

ACTIVE COMPARATOR

Patients will received low frequency high intensity magnetic therapy

Device: magnetic therapy

control group

SHAM COMPARATOR

The patients in this group will be treated by sham magnetic therapy

Device: magnetic therapy

Interventions

High intensity low frequency magnetic therapy

control groupstudy group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hemiplegia

Interventions

Magnetic Field Therapy

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Ibrahim A Abu-Ella, MSC

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * 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 magnetic therapy in addition to design physical therapy program. * The control group (GII) will be treated by sham magnetic therapy in addition to the same design physical therapy program of (GI).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

May 16, 2021

First Posted

May 20, 2021

Study Start

May 20, 2021

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

December 11, 2025

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations