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NCT Number: NCT07203222

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

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.

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Key information

Conditions

Hemiplegic Shoulder Pain Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Conventional physical therapy

Other

Only conventional physiotherapy is planned to be administered to patients.

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 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 outcomes

  1. Fugl Meyer Upper Extremity Motor Function Scale

    Time frame: 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.

  2. Joint Range of Motion (ROM) Measurement

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

  3. Stroke-Specific Quality of Life Scale

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

  4. Barthel Index

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

  5. Beck Depression Scale

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

  6. Pittsburgh Sleep Quality Index

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

  7. Ultrasonographic findings

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aliye Aygün, specialist

CONTACT

[email protected]

+90 0312 797 00 00 ext. +903122911000

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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