Health TrialsbyHealthPanel

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

ConditionHemiplegic Shoulder Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAnkara Etlik City Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low Dose Laser

    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.

  • TENS

    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

    Other intervention

    Only conventional physiotherapy is planned to be administered to patients.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Low Dose Laser GroupExperimental treatment 2 interventions
Group B: TENS groupActive comparator 2 interventions
Group C: Conventional TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months

Secondary outcomes

1

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.

Time frame
patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months
2

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
3

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
4

Barthel Index

Time frame
patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ankara Etlik City Hospital

Lead sponsor

Source ClinicalTrials.gov
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