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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07203222
Enrollment
45
Registered
2025-10-02
Start date
2025-09-24
Completion date
2026-08-31
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegic Shoulder Pain

Keywords

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

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)

Interventions

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.

DEVICETENS

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.

OTHERConventional physical therapy

Only conventional physiotherapy is planned to be administered to patients.

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale (VAS)patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 monthsIt 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

MeasureTime frameDescription
Fugl Meyer Upper Extremity Motor Function Scalepatients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 monthsIt 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.
Joint Range of Motion (ROM) Measurementpatients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
Stroke-Specific Quality of Life Scalepatients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
Barthel Indexpatients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
Beck Depression Scalepatients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
Pittsburgh Sleep Quality Indexpatients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
Ultrasonographic findingspatients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 monthsSonographic criteria have been defined based on previous studies.

Countries

Turkey (Türkiye)

Contacts

CONTACTAliye Aygün, specialist
aliyeaygunn@hotmail.com+90 0312 797 00 00
STUDY_DIRECTORnihal tezel, associate professor

Ankara Etlik City Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026