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

NCT ID: NCT06825832

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

One common problem that often manifests two weeks to two months following a stroke is shoulder pain. It adversely impacts patients' quality of life and hinders their ability to regain motor and sensory function. Psychological alterations and sleep problems, such as depression, anxiety, hypervigilance, fear avoidance, pain catastrophizing, trouble falling asleep, and early awakening, can also occure.

The majority of HSP develop in the first 2 weeks up to 6 months and about 65% of those will continue to experience the problem several months after that .

The actual cause of HSP is uncertain and frequently complex. So far, numerous pathogenic processes have been found that are likely to be associated to HSP: Joint subluxation, adhesive capsulitis, complex regional pain syndrome, rotator cuff injury, spasticity, and other conditions .

In the last few decades, an enormous number of treatment options have been developed due to the multiple etiology of HSP, But there is still a great deal of uncertainty regarding their efficacy because several etiologies probably lead to the same problem .

High power laser therapy is one suggested therapeutic option for shoulder pain HPLT has long been used to treat conditions that low power laser therapy (LPLT) cannot, such as increased microcirculation, accelerated tissue regeneration, decreased swelling, inflammation, and pain, because of its photomechanical, thermal, electrical and bio stimulating effects on deep tissues. Benefits of HPLT over LPLT include higher power, deeper tissue penetration, shorter emission durations, and longer rest intervals that avoid heat buildup.

It is hypothesized that compared to single-wavelength low-level laser therapy (LLLT), Multiwave Locked System (MLS) allows for better penetration and therapeutic efficacy .

Magnetic field therapy enhances local cellular activity, organizes collagen fibers, enhances oxygen use in tissues, and speeds up circulation by enhancing blood vessel vasodilation without raising local temperatures but There is insufficient evidence supporting its efficacy and superiority to physical therapy agents .

To our knowledge this is the first study to determine the efficiency of high-power laser and pulsed electromagnetic field on hemiplegic shoulder pain.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemiplegic Shoulder Pain Laser Therapy Pulsed Electromagnetic Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

INTERVENTION 1 LASER

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

Group Type ACTIVE_COMPARATOR

high power laser therapy

Intervention Type 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 2 PEMFT

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

Group Type ACTIVE_COMPARATOR

pulsed electromagnetic field therapy

Intervention Type 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 3 EXERCISE

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

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

high power laser therapy

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 Type DEVICE

pulsed electromagnetic field therapy

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 Type DEVICE

Exercise

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. Patients with a history of inflammation-related rheumatic disease
2. cervical radiculopathy
3. cardiovascular disease or cardiac pacemakers
4. uncontrolled siezures or sever arrthymia
5. shoulder operations, or shoulder injection during the previous three months were excluded.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Mohamed Elsayed

PRINCIPLE INVESTIGATOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eman Samir Fayez, PHD

Role: STUDY_CHAIR

faculty of physical therapy cairo uni

Ahmed Karmallaah Mohamed, PHD

Role: STUDY_DIRECTOR

faculty of medicine cairo uni

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cairo Uni

Giza, Ad Doqi, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

laser + electromagnetic field

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Graded Motor Imagery in Impingement
NCT06865001 ACTIVE_NOT_RECRUITING NA