Clinical trial NCT06825832: Efficiency Of High Power Laser Versus Pulsed Electromagnetic Therapy On Hemiplegic Shoulder Pain
Official title: Efficiency of High Power Laser Versus Pulsed Electromagnetic Therapy on Hemiplegic Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Shoulder Pain
Laser Therapy
Pulsed Electromagnetic Therapy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: shoulder range of motion
timeFrame: 4 weeks
measure: shoulder pain by visual analogue scale (VAS)
timeFrame: 4 weeks
measure: shoulder pain and disability
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Uni
state: Ad Doqi
Study officials:
affiliation: faculty of physical therapy cairo uni
name: Eman Samir Fayez, PHD
role: STUDY_CHAIR
affiliation: faculty of medicine cairo uni
name: Ahmed Karmallaah Mohamed, PHD
role: STUDY_DIRECTOR
References: