Hemiplegic Shoulder PainNCT07918157
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
A study testing Laser therapy and Transcutaneus electirical nerve stimulation in people with Hemiplegic Shoulder Pain, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate whether laser and Transcutaneous Electirical Nerve Stimulationapplied in addition to conventional physical therapy exercises in hemiplegic shoulder pain seen in patients with stroke provides an additional contribution to pain, range of motion, spasticity, upper extremity functions and… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hemiplegic Shoulder Pain
- What is being tested?
- Laser therapy and Transcutaneus electirical nerve stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2026to 15 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with unilateral ischemic stroke for the first time
- 18-85 years old,
- patients with shoulder pain
Who cannot join
- another disease that will affect the central nervous system
- injections or physical therapy to the same shoulder in the last 3 months,
- history of shoulder surgery,
- cervical radiculopathy,
- inflammatory rheumatic disease or infection,
- serious cardiovascular disease such as heart failure, arrhythmia, myocardial infarction that will affect functional status,
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- disease that will cause cognitive dysfunction,
- Alzheimer's disease, dementia,
- severe visual loss,
- pregnancy and lactation,
- malignancy,
- psychiatric diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Low-Dose Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain and Upper Extremity Functions
This study aimed to investigate whether laser and Transcutaneous Electirical Nerve Stimulationapplied in addition to conventional physical therapy exercises in hemiplegic shoulder pain seen in patients with stroke provides an additional contribution to pain, range of motion, spasticity, upper extremity functions and whether the two treatment types are superior to each other.
Read the detailed description
Stroke is one of the most devastating neurological disorders, affecting approximately 9 million people worldwide annually. With increasing life expectancy, stroke remains a major cause of morbidity and mortality. The introduction of effective treatment strategies in the acute phase has led to increased expectations regarding prognosis. Nevertheless, secondary complications following stroke are frequently encountered and may significantly hinder the rehabilitation process.
The upper extremity is affected more frequently than the lower extremity, and functional recovery of the upper extremity is generally more challenging and slower. Shoulder problems account for a substantial proportion of upper extremity functional impairments. One of the major contributing factors to these problems is impaired shoulder biomechanics. Shoulder pain may develop within the first two weeks following stroke, although it typically occurs between one and three months after stroke.
The etiology of hemiplegic shoulder pain (HSP) is multifactorial and may involve several contributing factors, including shoulder subluxation, complex regional pain syndrome type I, biceps tendinopathy, rotator cuff abnormalities, adhesive capsulitis, and increased muscle tone. Stroke survivors frequently experience impairments in upper extremity motor function and manual dexterity, which may subsequently lead to difficulties in performing activities of daily living. Effective pain management can reduce pain intensity, enhance patients' participation in rehabilitation, and contribute to improvements in joint range of motion and functional capacity.
Various physical therapy modalities are used in the management of HSP. One such modality is laser therapy, an acronym for Light Amplification by Stimulated Emission of Radiation. The fundamental principles of laser technology are based on quantum theory and the concept of stimulated emission. The first functional laser device was developed by Theodore Maiman in 1960. Laser devices generate and amplify light through stimulated emission of radiation within a specific active medium. Laser therapy is thought to exert beneficial effects on pain reduction, joint range of motion, and upper extremity function. In clinical practice, laser therapy is used to exploit its potential regenerative, biostimulatory, analgesic, anti-inflammatory, and anti-edematous effects. Its efficacy has previously been investigated in musculoskeletal conditions such as knee osteoarthritis and adhesive capsulitis of the shoulder, as well as in patients with hemiplegia.
Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological intervention used in the management of acute and chronic pain. TENS devices deliver pulsed electrical currents through electrodes placed on the skin and are generally considered safe and relatively inexpensive. Stimulation parameters, including pulse frequency and intensity, can be adjusted according to clinical requirements and may influence the therapeutic response to TENS.
The aim of this study is to investigate whether laser therapy and TENS, when administered in addition to conventional physical therapy exercises in patients with HSP following stroke, provide additional benefits in terms of pain, joint range of motion, spasticity, and upper extremity function. The study also aims to compare the efficacy of these two treatment modalities and determine whether either modality is superior to the other.
Materials and Methods
Study Design and Participants
This prospective, randomized controlled study is planned to include 60 patients aged 18-85 years who will present to the Physical Medicine and Rehabilitation Outpatient Clinic between November 2026 and September 2028. Eligible participants will have a first-ever ischemic stroke and shoulder pain.
Randomization and Blinding
Eligible participants will be randomly allocated to three groups using the sealed-envelope method, with the allocation process conducted by the same physiotherapist. Owing to the nature of the interventions, the physiotherapist administering the treatments will be aware of the participants' group assignments. However, all outcome assessments are planned to be performed by the same researcher, who will be blinded to treatment allocation.
Rehabilitation Protocol
All participants will undergo a multidisciplinary rehabilitation program consisting of 20 sessions over four weeks, with treatment administered five days per week. Conventional physical therapy exercises will be tailored to each patient's individual needs and neurological status.
The exercise program will be determined by the physiotherapist according to each patient's functional status and will include passive, active-assisted, and active range-of-motion exercises, stretching and strengthening exercises, and mobilization techniques.
Treatment Groups
Group 1: Laser therapy group (n = 20)
Participants in this group will receive laser therapy for five minutes per session, three days per week, in addition to conventional physical therapy.
Group 2: TENS group (n = 20)
Participants in this group will receive TENS for 20 minutes per session, five days per week, in addition to conventional physical therapy.
Group 3: Control group (n = 20)
Participants in this group will receive conventional physical therapy exercises alone.
- Conditions
- Hemiplegic Shoulder Pain
- Being tested
- Laser therapy, Transcutaneus electirical nerve stimulation, control
- Keywords
- hemiplegic shoulder pain, electrical nerve stimulation, laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser therapyOther
In addition to conventional physical therapy, laser therapy was planned to be applied to the shoulder muscle group for 5 minutes per day, 3 days a week, over a period of 4 weeks
Transcutaneus electirical nerve stimulationOther
In the transcutaneous electrical nerve stimulation (TENS) group, in addition to these exercises, TENS was planned to be applied to the shoulder flexor and abductor muscle groups for 20 minutes per day, 5 days a week, for a total duration of 4 weeks.
controlOther
The implementation of conventional physical therapy exercises tailored to the patient's individual needs and neurological level was planned. These exercises are determined by the physiotherapist based on the patient's functional status and comprise passive, active-assisted, and active range of motion (ROM) exercises, stretching and strengthening exercises, and mobilization exercises.
| Study group | Role | What they receive |
|---|---|---|
| Laser therapy Group | Active comparator | The implementation of conventional physical therapy exercises was planned in accordance with the patient's individual needs and neurological level. These exercises were determined by the physiotherapist based on the patient's functional status and were planned to comprise range of motion (ROM) exercises-including passive, active-assisted, and active exercises-as well as stretching, strengthening, and mobilization exercises. Group 1 was designated as the laser therapy group (n=20); in addition to conventional physical therapy, laser therapy was applied to the shoulder muscle group for 5 minutes per day, 3 days a week, over a period of 4 weeks. Receives: Other: Laser therapy |
| Transcutaneus electirical nerve stimulation | Active comparator | The implementation of conventional physical therapy exercises tailored to the patient's individual needs and neurological level was planned. These exercises are determined by the physiotherapist based on the patient's functional status and were planned to comprise passive, active-assisted, and active range of motion (ROM) exercises, stretching and strengthening exercises, and mobilization exercises. In the transcutaneous electrical nerve stimulation (TENS) group, in addition to these exercises, TENS was applied to the shoulder flexor and abductor muscle groups for 20 minutes per day, 5 days a week, for a total duration of 4 weeks. Receives: Other: Transcutaneus electirical nerve stimulation |
| Control Group | Active comparator | The implementation of conventional physical therapy exercises tailored to the patient's individual needs and neurological level was planned. These exercises are determined by the physiotherapist based on the patient's functional status and were planned to comprise passive, active-assisted, and active range of motion (ROM) exercises, stretching and strengthening exercises, and mobilization exercises. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
The pain level of the patients will be measured with a scale given to the patient; visual pain scale. Patients rate their pain on a scale of 0-10. It consists of scores ranging from 0 (no pain) to 10 (most severe pain). Higher scores indicate more severe pain.
Measured: baseline and through study completion, an average of 4 weeks
Secondary outcomes (3)
Disability
The Shoulder Pain and Disability Index is a patient-completed scale consisting of 5 items on pain and 8 items on disability. Each item is marked by the patient on a 0-10 cm scale. High scores indicate high pain and disability.
Measured: baseline and through study completion, an average of 4 weeks
Spasticity
The Modified Ashworth Scale, the most widely used scale for tonus assessment, was used to evaluate spasticity. In this scale, muscle tone is evaluated between 0 normal and 4 being rigid. In our study, spasticity in shoulder adductors and internal rotators, forearm flexors, wrist flexors and finger flexors were recorded by the same investigator.
Measured: baseline and through study completion, an average of 4 weeks
Recovery Stage
Brunnstrom Recovery Stage is a 6-step scale that includes movement patterns with progressively increasing recovery evaluated separately for upper extremity, hand and lower extremity. 0: no movement, 6: full movement. Higher values indicate better motor recovery and were recorded by the same investigator.
Measured: baseline and through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Sep 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
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.
- 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
- Model description
- 1. Laser therapy 2. Transcutaneus electrical nerve stimulation therapy (TENS) 3. Control: classical physical therapy exercises
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Öksüz, Hitit University
- Investigators
- Pınar Ö Başaran, Study chair, Hitit Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918157
- Sponsor's protocol ID
- 2026-14
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The sharing of changes in patients' pain levels is planned.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Low-Dose Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain and Upper Extremity Functions
- ClinicalTrials.gov ID
- NCT07918157
- Acronym / sponsor ID
- 2026-14
- Conditions
- Hemiplegic Shoulder Pain
- Keywords
- hemiplegic shoulder pain, electrical nerve stimulation, laser
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 5 Nov 2026 (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.
This study aimed to investigate whether laser and Transcutaneous Electirical Nerve Stimulationapplied in addition to conventional physical therapy exercises in hemiplegic shoulder pain seen in patients with stroke provides an additional contribution to pain, range of motion, spasticity, upper extremity functions and whether the two treatment types are superior to each other.
Detailed description
Stroke is one of the most devastating neurological disorders, affecting approximately 9 million people worldwide annually. With increasing life expectancy, stroke remains a major cause of morbidity and mortality. The introduction of effective treatment strategies in the acute phase has led to increased expectations regarding prognosis. Nevertheless, secondary complications following stroke are frequently encountered and may significantly hinder the rehabilitation process.
The upper extremity is affected more frequently than the lower extremity, and functional recovery of the upper extremity is generally more challenging and slower. Shoulder problems account for a substantial proportion of upper extremity functional impairments. One of the major contributing factors to these problems is impaired shoulder biomechanics. Shoulder pain may develop within the first two weeks following stroke, although it typically occurs between one and three months after stroke.
The etiology of hemiplegic shoulder pain (HSP) is multifactorial and may involve several contributing factors, including shoulder subluxation, complex regional pain syndrome type I, biceps tendinopathy, rotator cuff abnormalities, adhesive capsulitis, and increased muscle tone. Stroke survivors frequently experience impairments in upper extremity motor function and manual dexterity, which may subsequently lead to difficulties in performing activities of daily living. Effective pain management can reduce pain intensity, enhance patients' participation in rehabilitation, and contribute to improvements in joint range of motion and functional capacity.
Various physical therapy modalities are used in the management of HSP. One such modality is laser therapy, an acronym for Light Amplification by Stimulated Emission of Radiation. The fundamental principles of laser technology are based on quantum theory and the concept of stimulated emission. The first functional laser device was developed by Theodore Maiman in 1960. Laser devices generate and amplify light through stimulated emission of radiation within a specific active medium. Laser therapy is thought to exert beneficial effects on pain reduction, joint range of motion, and upper extremity function. In clinical practice, laser therapy is used to exploit its potential regenerative, biostimulatory, analgesic, anti-inflammatory, and anti-edematous effects. Its efficacy has previously been investigated in musculoskeletal conditions such as knee osteoarthritis and adhesive capsulitis of the shoulder, as well as in patients with hemiplegia.
Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological intervention used in the management of acute and chronic pain. TENS devices deliver pulsed electrical currents through electrodes placed on the skin and are generally considered safe and relatively inexpensive. Stimulation parameters, including pulse frequency and intensity, can be adjusted according to clinical requirements and may influence the therapeutic response to TENS.
The aim of this study is to investigate whether laser therapy and TENS, when administered in addition to conventional physical therapy exercises in patients with HSP following stroke, provide additional benefits in terms of pain, joint range of motion, spasticity, and upper extremity function. The study also aims to compare the efficacy of these two treatment modalities and determine whether either modality is superior to the other.
Materials and Methods
Study Design and Participants
This prospective, randomized controlled study is planned to include 60 patients aged 18-85 years who will present to the Physical Medicine and Rehabilitation Outpatient Clinic between November 2026 and September 2028. Eligible participants will have a first-ever ischemic stroke and shoulder pain.
Randomization and Blinding
Eligible participants will be randomly allocated to three groups using the sealed-envelope method, with the allocation process conducted by the same physiotherapist. Owing to the nature of the interventions, the physiotherapist administering the treatments will be aware of the participants' group assignments. However, all outcome assessments are planned to be performed by the same researcher, who will be blinded to treatment allocation.
Rehabilitation Protocol
All participants will undergo a multidisciplinary rehabilitation program consisting of 20 sessions over four weeks, with treatment administered five days per week. Conventional physical therapy exercises will be tailored to each patient's individual needs and neurological status.
The exercise program will be determined by the physiotherapist according to each patient's functional status and will include passive, active-assisted, and active range-of-motion exercises, stretching and strengthening exercises, and mobilization techniques.
Treatment Groups
Group 1: Laser therapy group (n = 20)
Participants in this group will receive laser therapy for five minutes per session, three days per week, in addition to conventional physical therapy.
Group 2: TENS group (n = 20)
Participants in this group will receive TENS for 20 minutes per session, five days per week, in addition to conventional physical therapy.
Group 3: Control group (n = 20)
Participants in this group will receive conventional physical therapy exercises alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 1. Laser therapy 2. Transcutaneus electrical nerve stimulation therapy (TENS) 3. Control: classical physical therapy exercises
| Arm | Type | Receives |
|---|---|---|
| Laser therapy Group | Active comparator | Other: Laser therapyThe implementation of conventional physical therapy exercises was planned in accordance with the patient's individual needs and neurological level. These exercises were determined by the physiotherapist based on the patient's functional status and were planned to comprise range of motion (ROM) exercises-including passive, active-assisted, and active exercises-as well as stretching, strengthening, and mobilization exercises. Group 1 was designated as the laser therapy group (n=20); in addition to conventional physical therapy, laser therapy was applied to the shoulder muscle group for 5 minutes per day, 3 days a week, over a period of 4 weeks. |
| Transcutaneus electirical nerve stimulation | Active comparator | Other: Transcutaneus electirical nerve stimulationThe implementation of conventional physical therapy exercises tailored to the patient's individual needs and neurological level was planned. These exercises are determined by the physiotherapist based on the patient's functional status and were planned to comprise passive, active-assisted, and active range of motion (ROM) exercises, stretching and strengthening exercises, and mobilization exercises. In the transcutaneous electrical nerve stimulation (TENS) group, in addition to these exercises, TENS was applied to the shoulder flexor and abductor muscle groups for 20 minutes per day, 5 days a week, for a total duration of 4 weeks. |
| Control Group | Active comparator | Other: controlThe implementation of conventional physical therapy exercises tailored to the patient's individual needs and neurological level was planned. These exercises are determined by the physiotherapist based on the patient's functional status and were planned to comprise passive, active-assisted, and active range of motion (ROM) exercises, stretching and strengthening exercises, and mobilization exercises. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with unilateral ischemic stroke for the first time
- 18-85 years old,
- patients with shoulder pain
Key exclusion criteria (12 listed)
- another disease that will affect the central nervous system
- injections or physical therapy to the same shoulder in the last 3 months,
- history of shoulder surgery,
- cervical radiculopathy,
- inflammatory rheumatic disease or infection,
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 |
|---|---|---|
| Laser therapyIn addition to conventional physical therapy, laser therapy was planned to be applied to the shoulder muscle group for 5 minutes per day, 3 days a week, over a period of 4 weeks | Other | Laser therapy Group |
| Transcutaneus electirical nerve stimulationIn the transcutaneous electrical nerve stimulation (TENS) group, in addition to these exercises, TENS was planned to be applied to the shoulder flexor and abductor muscle groups for 20 minutes per day, 5 days a week, for a total duration of 4 weeks. | Other | Transcutaneus electirical nerve stimulation |
| controlThe implementation of conventional physical therapy exercises tailored to the patient's individual needs and neurological level was planned. These exercises are determined by the physiotherapist based on the patient's functional status and comprise passive, active-assisted, and active range of motion (ROM) exercises, stretching and strengthening exercises, and mobilization exercises. | Other | Control Group |
Primary outcome
Pain Level
Time frame: baseline and through study completion, an average of 4 weeks
The pain level of the patients will be measured with a scale given to the patient; visual pain scale. Patients rate their pain on a scale of 0-10. It consists of scores ranging from 0 (no pain) to 10 (most severe pain). Higher scores indicate more severe pain.
3 secondary outcomes
Disability
Time frame: baseline and through study completion, an average of 4 weeks
Spasticity
Time frame: baseline and through study completion, an average of 4 weeks
Recovery Stage
Time frame: baseline and through study completion, an average of 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. The sharing of changes in patients' pain levels is planned.
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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.
Pınar Ö Başaran study chair
Hitit Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser therapy and Transcutaneus electirical nerve stimulation in people with Hemiplegic Shoulder Pain, run by Hitit University 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 3 inclusion and 12 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: opening soon, as of the sponsor's last update on 5 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Onur Öksüz, Research Assistant (05445401384, oksz.onur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: baseline and through study completion, an average of 4 weeks). 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 5 Nov 2026.