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临床试验/NCT06825832
NCT06825832已完成不适用

Efficiency of High Power Laser Versus Pulsed Electromagnetic Therapy on Hemiplegic Shoulder Pain

Cairo University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
shoulder range of motion

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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
  • •patients with 1-3 degrees of spasticity according to Modified Ashworth Scale (MAS).

排除标准

  • •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.

研究组 & 干预措施

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

干预措施: high power laser therapy (Device)

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

干预措施: pulsed electromagnetic field therapy (Device)

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

干预措施: Exercise (Other)

结局指标

主要结局

shoulder range of motion

时间窗: 4 weeks

BY DIGITAL GONIOMETER

shoulder pain by visual analogue scale (VAS)

时间窗: 4 weeks

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.

shoulder pain and disability

时间窗: 4 weeks

by Shoulder Pain and Disability Index (SPADI)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Elsayed

PRINCIPLE INVESTIGATOR

Cairo University

研究点 (1)

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