Comparison of Effectiveness of Low Dose Laser and Transcutaneous Electrical Stimulation in Hemiplegic Shoulder

NCT ID: NCT07203222

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-24

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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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

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Hemiplegic Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Low Dose Laser Group

Patients who will undergo low laser therapy

Group Type EXPERIMENTAL

Low Dose Laser

Intervention Type 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.

Conventional physical therapy

Intervention Type OTHER

Only conventional physiotherapy is planned to be administered to patients.

TENS group

Patients who will undergo TENS therapy

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type 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

Intervention Type OTHER

Only conventional physiotherapy is planned to be administered to patients.

Conventional Therapy

Patients who will undergo conventional therapy

Group Type ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type OTHER

Only conventional physiotherapy is planned to be administered to patients.

Interventions

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Low Dose Laser

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.

Intervention Type DEVICE

TENS

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.

Intervention Type DEVICE

Conventional physical therapy

Only conventional physiotherapy is planned to be administered to patients.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ayse Naz Kalem

PM&R Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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nihal tezel, associate professor

Role: STUDY_DIRECTOR

Ankara Etlik City Hospital

Locations

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Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Aliye Aygün, specialist

Role: CONTACT

+90 0312 797 00 00 ext. +903122911000

Facility Contacts

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Aliye Aygün

Role: primary

+90 0312 797 00 00

Other Identifiers

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AEŞH-EK-2025-066

Identifier Type: -

Identifier Source: org_study_id

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