Hemiplegic Shoulder PainNCT07203222
Comparison of Effectiveness of Low Dose Laser and Transcutaneous Electrical Stimulation in Hemiplegic Shoulder
A study testing Low Dose Laser, TENS and Conventional physical therapy in people with Hemiplegic Shoulder Pain, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemiplegic Shoulder Pain
- What is being tested?
- Low Dose Laser, TENS and Conventional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Sep 2025to 20 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06010
About this study
Official 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
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.
Read the 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)
- Conditions
- Hemiplegic Shoulder Pain
- Being tested
- Low Dose Laser, TENS, Conventional physical therapy
- Keywords
- Hemiplegic shoulder pain, Low Dose Laser, TENS, Ultrasonographic evaluation, Upper extremity function, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose LaserDevice
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.
TENSDevice
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 therapyOther
Only conventional physiotherapy is planned to be administered to patients.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Laser Group | Experimental | Patients who will undergo low laser therapy Receives: Device: Low Dose Laser; Other: Conventional physical therapy |
| TENS group | Active comparator | Patients who will undergo TENS therapy Receives: Device: TENS; Other: Conventional physical therapy |
| Conventional Therapy | Active comparator | Patients who will undergo conventional therapy Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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
Measured: 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
Measured: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
Barthel Index
Measured: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
Beck Depression Scale
Measured: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
Pittsburgh Sleep Quality Index
Measured: 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.
Measured: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start24 Sep 2025
- Primary completion30 Jul 2026
- Study completion20 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Shoulder PainStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Naz Kalem, Ankara Etlik City Hospital
- Investigators
- nihal tezel, associate professor, Study director, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203222
- Sponsor's protocol ID
- AEŞH-EK-2025-066
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07203222
- Acronym / sponsor ID
- AEŞH-EK-2025-066
- Conditions
- Hemiplegic Shoulder Pain
- Keywords
- Hemiplegic shoulder pain, Low Dose Laser, TENS, Ultrasonographic evaluation, Upper extremity function, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 20 Oct 2026 (actual)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose Laser Group | Experimental | Device: Low Dose Laser, Other: Conventional physical therapyPatients who will undergo low laser therapy |
| TENS group | Active comparator | Device: TENS, Other: Conventional physical therapyPatients who will undergo TENS therapy |
| Conventional Therapy | Active comparator | Other: Conventional physical therapyPatients who will undergo conventional therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose LaserPatients 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. | Device | Low Dose Laser Group |
| TENSTENS 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. | Device | TENS group |
| Conventional physical therapyOnly conventional physiotherapy is planned to be administered to patients. | Other | Conventional Therapy, Low Dose Laser Group, TENS group |
Primary outcome
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
7 secondary outcomes
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
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
Time frame: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes
Related trials for Hemiplegic Shoulder Pain
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Not yet recruiting
Effectiveness of High-intensity Peripheral Magnetic Stimulation on Hemiplegic Shoulder Pain After Stroke
Hemiplegic Shoulder Pain
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
Recruiting
High-Intensity Laser Therapy in Hemiplegic Shoulder Pain
Hemiplegia and/or Hemiparesis Following Stroke
RecruitingObservational study
Effects of Hemiplegic Shoulder Pain on Upper Extremity Motor Function, Trunk Control, Fear of Falling, Mobility and Indepence in Activities of Daily Living in Patients With Stroke
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nihal tezel, associate professor study director
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dose Laser, TENS and Conventional physical therapy in people with Hemiplegic Shoulder Pain, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.