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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Laser Group | Experimental | Patients who will undergo low laser therapy |
|
| TENS group | Active Comparator | Patients who will undergo TENS therapy |
|
| Conventional Therapy | Active Comparator | Patients who will undergo conventional therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aliye Aygün, specialist | Contact | +90 0312 797 00 00 | +903122911000 | aliyeaygunn@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| nihal tezel, associate professor | Ankara Etlik City Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital | Recruiting | Ankara | Yenimahalle | 06010 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D004599 | Electric Stimulation Therapy |
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|
| 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. |
|
| 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 |
| 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 | Sonographic criteria have been defined based on previous studies. | patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |