Comparison of Effectiveness of Low Dose Laser and Transcutaneous Electrical Stimulation in Hemiplegic Shoulder

Not Applicable

Recruiting

• Conditions: Hemiplegic Shoulder Pain

• Registration Number: NCT07203222
• Lead Sponsor: Ankara Etlik City Hospital

Brief Summary

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.

Detailed Description

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)

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-24
• Study First Submitted: 2025-09-24
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2026-04-30
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	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

Secondary Outcome Measures

Name	Time	Method
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	Sonographic criteria have been defined based on previous studies.
Modify Ashworth Scale	patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months	It is the most commonly used assessment method for spasticity on an international platform. The joint should be moved passively, repeatedly and rapidly, and resistance should be graded according to the examination findings. It is graded as 0, 1, 1+, 2, 3, 4.
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	It is a scale used to assess sensorimotor impairment in patients with a history of stroke. It is designed to evaluate motor function, balance, sensation, and joint function in patients with hemiplegia. Each task is scored on a scale of 0 to 2. The total score ranges from 0 to 66.

Trial Locations

Locations (1)

Ankara Etlik City Hospital; Ankara, Yenimahalle, Turkey (Türkiye)