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

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

Overview

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)

Interventions

• Device 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.
• 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.
• Other Conventional physical therapy
  Only conventional physiotherapy is planned to be administered to patients.

Primary outcome measures

• 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]

Secondary outcome measures (7)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Ankara Etlik City Hospital — Ankara

Identifiers

NCT: NCT07203222 · AEŞH-EK-2025-066

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗