Efficiency Of High Power Laser Versus Pulsed Electromagnetic Therapy On Hemiplegic Shoulder Pain

NCT06825832 | Completed

• 1 other identifier: laser + electromagnetic field
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to determine the effectiveness of high-power laser and pulsed electromagnetic field on hemiplegic shoulder pain

Conditions

Hemiplegic Shoulder Pain; Laser Therapy; Pulsed Electromagnetic Therapy

Outcome Measures

Primary Outcomes (3)

• shoulder range of motion

  BY DIGITAL GONIOMETER

  4 weeks

• shoulder pain by visual analogue scale (VAS)

  It will be used to measure pain intensity for each participant in 3 groups (A, B and C). The VAS is usually presented as a 10 cm horizontal line on which the participants' pain intensity is represented by a point between the extremes of "no pain at all "and "worst pain imaginable . zero means no pain ,ten means worst pain.

  4 weeks

• shoulder pain and disability

  by Shoulder Pain and Disability Index (SPADI)

  4 weeks

Study Arms (3)

INTERVENTION 1 LASER

ACTIVE COMPARATOR

The MLS® Laser Therapy device used in this study is M6 (ASA srl -Arcugnano, Italy), equipped with both a robotized multidiode head (up to 3,3W), able to perform automatic scanning treatments, and an MLS® handpiece (up to 1,1W), aimed to perform manual point to point or scanning treatments. Each treatment includes two stages: the scanning of the frontal and dorsal shoulder area of 93 cm2 each with a robotized multidiode head and a point-by-point process with the manual handpiece with 7 points of 3,14 cm2 area. 3 sessions per week for 4 weeks

Device: high power laser therapy

INTERVENTION 2 PEMFT

ACTIVE COMPARATOR

the PEMF application, with application of low intensity and frequency pulsed electromagnetic fields (PEMF), the portable device PMT QS (ASA Srl, Arcugnano) is used, equipped with Flexa applicators (36 x 21 x 2 cm (L x P x H) - 1.2 kg), programmable frequency from 0.5 to 100 Hz and variable magnetic field intensity from 5% to 100% (from \~2.5 to \~40 Gauss)), two solenoid applicators are placed at the anterior and posterior positions in the patient's shoulders and applied for 25 min at 25 G intensity at a frequency of 50 Hz.3 sessions per week for 4 weeks

Device: pulsed electromagnetic field therapy

INTERVENTION 3 EXERCISE

ACTIVE COMPARATOR

The conventional exercise program for hemiplegic shoulder pain (HSP) is stretching exercise therapy, joint stabilization exercise therapy.3 sessions per week for 4 weeks

Other: Exercise

Interventions

high power laser therapy DEVICE

The MLS® Laser Therapy device used in this study is M6 (ASA srl -Arcugnano, Italy), equipped with both a robotized multidiode head (up to 3,3W), able to perform automatic scanning treatments, and an MLS® handpiece (up to 1,1W), aimed to perform manual point to point or scanning treatments. Each treatment includes two stages: the scanning of the frontal and dorsal shoulder area of 93 cm2 each with a robotized multidiode head and a point-by-point process with the manual handpiece with 7 points of 3,14 cm2 area.

INTERVENTION 1 LASER

pulsed electromagnetic field therapy DEVICE

the PEMF application, with application of low intensity and frequency pulsed electromagnetic fields (PEMF), the portable device PMT QS (ASA Srl, Arcugnano) is used, equipped with Flexa applicators (36 x 21 x 2 cm (L x P x H) - 1.2 kg), programmable frequency from 0.5 to 100 Hz and variable magnetic field intensity from 5% to 100% (from \~2.5 to \~40 Gauss)), two solenoid applicators are placed at the anterior and posterior positions in the patient's shoulders and applied for 25 min at 25 G intensity at a frequency of 50 Hz.

INTERVENTION 2 PEMFT

Exercise OTHER

The conventional exercise program for hemiplegic shoulder pain (HSP) is stretching exercise therapy, joint stabilization exercise therapy.

INTERVENTION 3 EXERCISE

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HSP patients aged 40-65 years.
• unilateral hemiplegia for the first time.
• duration of stroke of more than 6 months.
• Visual Analogue Scale (VAS) of more than 4.
• patients with 1-3 degrees of spasticity according to Modified Ashworth Scale (MAS).

You may not qualify if:

• Patients with a history of inflammation-related rheumatic disease
• cervical radiculopathy
• cardiovascular disease or cardiac pacemakers
• uncontrolled siezures or sever arrthymia
• shoulder operations, or shoulder injection during the previous three months were excluded.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Uni

Giza, Ad Doqi, 11432, Egypt

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eman Samir Fayez, PHD

  faculty of physical therapy cairo uni

  STUDY CHAIR

• Ahmed Karmallaah Mohamed, PHD

  faculty of medicine cairo uni

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPLE INVESTIGATOR

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 13, 2025
• Study Start: December 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 15, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-03

Locations

EG (1)