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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).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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,
Show all 12Show fewer
  • 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.

Onur Öksüz, Research Assistant contact

05445401384

oksz.onur@gmail.com

Turkey (Türkiye)1 site
  • Hitit Univercity

    Çorum, 19040

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07918157
Study groupRoleWhat they receive
Laser therapy GroupActive comparatorThe 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 stimulationActive comparatorThe 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 GroupActive comparatorThe 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted5 Nov 2026
  2. Study start15 Nov 2026 (estimated)
  3. Primary completion15 Sep 2028 (estimated)
  4. Study completion15 Sep 2028 (estimated)

Resources

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)
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.

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.

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