Comparison of the Efficacy of Low-Dose Laser and Transcutaneous Electrical Nerve Stimulation in Subacute Hemiplegic Shoulder Pain, and the Effect of Treatments on Upper Extremity Function and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
The primary aim of this study is to compare the efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) and Low Level Laser Therapy (LLLT), which are analgesic modalities that play an important role in the treatment of this frequently encountered complication. The secondary aim of the study is to evaluate its effectiveness on upper extremity function, quality of life, sleep, and fatigue.
详细描述
Stroke is a leading cause of morbidity and mortality worldwide. (1) Hemiplegic shoulder pain (HSP) is one of the common complications seen in up to 40% of stroke patients and negatively affects the rehabilitation process. (2) It is also a significant complication that prolongs hospital stay. Therefore, developing effective treatment strategies is extremely important.
The primary aim of our study is to compare the efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) and Low Level Laser Therapy (LLLT), which are analgesic modalities that play an important role in the treatment of this frequently encountered complication.
Treatment methods used for hemiplegic shoulder pain: Exercises (joint range of motion, stretching and strengthening exercises), physical therapy agents, kinesiology taping, transcutaneous electrical nerve stimulation (TENS), suprascapular nerve block (SSNB), suprascapular nerve pulsed radiofrequency (PRF), botulinum toxin type A (BoNT-A) intramuscular injections, corticosteroid injections, segmental neuromyotherapy (SNMT), trigger point dry needling (TrPs-DN), robot-assisted shoulder rehabilitation therapy (RSRT), platelet-rich plasma (PrP) injection, repetitive transcranial magnetic stimulation ( rTMS), peripheral nerve stimulation (PNS), neuromuscular electrical stimulation (NMES), functional electrical stimulation (FES), and interferential current stimulation (IFC) play a role in the management of the hemiplegic shoulder pain clinic. (3)
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-75 years
- •Patients with shoulder pain on the hemiplegic side *Mini mental state examination ≥ 25
- •History of stroke within the last 2 weeks to 6 months
- •Patients with shoulder pain scoring 40-100 points on the visual analogue scale (moderate to severe) will be included.
排除标准
- •Patients who refuse to provide written consent or attend follow-up visits
- •Being under 18 years of age
- •Patients with motor aphasia
- •Patients who have had a shoulder injection within the last 3 months
- •Patients who have undergone upper extremity botulinum toxin application within the last 6 months
- •*Pregnant women or those planning to become pregnant
- •Inflammatory rheumatic disease
- •Patients who have undergone shoulder injury and surgery prior to stroke
- •Patients with other conditions that could explain shoulder pain
- •Patients with complex regional pain syndrome
- •Patients with a history of epilepsy, pacemaker, or arrhythmia diagnosis
- •Malignancy
- •Diseases such as Alzheimer's or dementia that cause cognitive impairment -History of psychiatric disorders such as major depression or personality disorders
- •Alcohol and drug addiction
研究组 & 干预措施
Low Dose Laser Group
Patients who will undergo low laser therapy
干预措施: Conventional physical therapy (Other)
Low Dose Laser Group
Patients who will undergo low laser therapy
干预措施: Low Dose Laser (Device)
TENS group
Patients who will undergo TENS therapy
干预措施: TENS (Device)
TENS group
Patients who will undergo TENS therapy
干预措施: Conventional physical therapy (Other)
Conventional Therapy
Patients who will undergo conventional therapy
干预措施: Conventional physical therapy (Other)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
It is a method used to measure a person's level of pain or discomfort. The VAS allows patients to quantitatively express their level of pain or discomfort based on their own perceptions. The VAS is scored on a scale of 0-100. Mild: 10-39, Moderate: 40-79, Severe: 80-100
次要结局
- Joint Range of Motion (ROM) Measurement(patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months)
- Stroke-Specific Quality of Life Scale(patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months)
- Barthel Index(patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months)
- Beck Depression Scale(patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months)
- Caregiver Burden Scale(patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months)
- Fatigue assessment scale(patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months)
- Pittsburgh Sleep Quality Index(patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months)
- Ultrasonographic findings(patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months)
- Modify Ashworth Scale(patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months)
- Fugl Meyer Upper Extremity Motor Function Scale(patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months)
研究者
Ayse Naz Kalem
PM&R Specialist
Ankara Etlik City Hospital