An interventional study of Low Dose Laser and TENS in Hemiplegic Shoulder Pain, sponsored by Ankara Etlik City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Ankara Etlik City Hospital · Not applicable, Interventional, and Treatment
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.
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)
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 45 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Ankara Etlik City Hospital is the lead sponsor of 166 studies on the registry; 75 are open to participants now.
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Exclusion Criteria:
Patients who have undergone upper extremity botulinum toxin application within the last 6 months
*Pregnant women or those planning to become pregnant
Patients who will undergo low laser therapy
Device: Low Dose Laser · Other: Conventional physical therapy
Patients who will undergo TENS therapy
Device: TENS · Other: Conventional physical therapy
Patients who will undergo conventional therapy
Other: Conventional physical therapy
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 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.
Only conventional physiotherapy is planned to be administered to patients.
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
Time frame: 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
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.
Time frame: 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
Time frame: 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
Time frame: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
Barthel Index
Time frame: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
Beck Depression Scale
Time frame: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
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
Ultrasonographic findings
Sonographic criteria have been defined based on previous studies.
Time frame: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
Plan to share: Yes
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Ankara Etlik City Hospital