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

NCT07203222 | Recruiting

• 1 other identifier: AEŞH-EK-2025-066
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegic Shoulder Pain

Keywords

Hemiplegic shoulder pain; Low Dose Laser; TENS; Ultrasonographic evaluation; Upper extremity function; stroke

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  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

  patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months

Secondary Outcomes (7)

• 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

• 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

Study Arms (3)

Low Dose Laser Group

EXPERIMENTAL

Patients who will undergo low laser therapy

Device: Low Dose Laser; Other: Conventional physical therapy

TENS group

ACTIVE COMPARATOR

Patients who will undergo TENS therapy

Device: TENS; Other: Conventional physical therapy

Conventional Therapy

ACTIVE COMPARATOR

Patients who will undergo conventional therapy

Other: Conventional physical therapy

Interventions

Low Dose Laser DEVICE

Patients with subacromial-subdeltoid bursa, m. deltoideus, m. biceps longus, m. infraspinatus, and m. supraspinatus muscles (at the most painful point of the muscles) with a 13-diode Gallium-Aluminium-Arsenide laser device (Intelect Mobile Laser) with a wavelength of 850 nm and 50 mW, 4 Joules per day, 20 seconds, for a total of 15 laser sessions.

Low Dose Laser Group

TENS DEVICE

TENS therapy will be administered using the TENS device (Intelect Advanced Therapy System) for a total of 15 sessions, 5 days a week, 20 minutes per day, at a dose of 20-40 mA.

TENS group

Conventional physical therapy OTHER

Only conventional physiotherapy is planned to be administered to patients.

Conventional Therapy; Low Dose Laser Group; TENS group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Lasers; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• nihal tezel, associate professor

  Ankara Etlik City Hospital

  STUDY DIRECTOR

Central Study Contacts

Aliye Aygün, specialist

CONTACT

+90 0312 797 00 00; aliyeaygunn@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PM&R Specialist

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: September 24, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)