Clinical trial NCT06428851: Laser Therapy Versus Neuromuscular Electrical Nerve Stimulation at Hemiplegic Shoulder Pain
Official title: Comparison of Laser Therapy Versus Neuromuscular Electrical Nerve Stimulation at Hemiplegic Shoulder Pain and Upper Extremity Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Shoulder Pain
Keywords: hemiplegic shoulder pain
electrical nerve stimulation
laser
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Laser therapy
2. Neuromuscular electrical nerve stimulation therapy (NMES)
3. Control: classical physical therapy exercises

3)
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate whether laser and neuromuscular electrical nerve stimulation applied 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: Cerebrovascular events, which are estimated to affect approximately 9 million people worldwide, have emerged as a serious cause of morbidity and mortality due to prolonged human lifespan. With the use of effective treatment methods in acute treatment, the level of expectation regarding prognosis has increased. Secondary complications that develop after stroke are frequently encountered. These complications cause serious disruptions in the rehabilitation process. The upper extremity is affected more frequently than the lower extremity and recovery is more difficult and slower. Most of the functional impairments related to the upper extremity are shoulder problems. The most important reason is impaired shoulder biomechanics. Pain may occur in the first 2 weeks after stroke or typically occurs 1 to 3 months after stroke. Pain in the hemiplegic shoulder significantly reduces patients' function and rehabilitation capacity. Reducing pain with effective methods applied for pain increases participation in rehabilitation and increases the range of motion measurements and functional capacity.

There are many physical therapy approaches in the treatment of hemiplegic shoulder pain. Light amplification by stimulated emission of radiation (laser) is one of these treatment approaches and briefly means intensified light. Laser principles are based on the quantum concept introduced by Einstein in 1927. Theodore Maiman developed the first laser device in 1960. According to the basic working principle of laser devices; the photon energy emitted from a light source is passed through a specific medium and it is thought to be effective in reducing pain in the tissue, increasing the range of motion, and improving upper extremity functions. As a result of all these mechanisms of action, laser beams are used in medicine to utilize their regenerative, biostimulating, analgesic, anti-inflammatory, and anti-edematous effects. These laser methods have been previously studied in knee osteoarthritis and shoulder adhesive capsulitis. Laser has also been investigated in hemiplegia.

Neuromuscular electrical nerve stimulation (NMES) produces muscle contractions using electrical pulses. These electrical pulses are delivered to the current muscles through superficial electrodes. The action potential from the central nervous system is mimicked with NMES and contraction is produced in the muscle.

There is no study in the literature comparing laser and neuromuscular electrical nerve stimulation in the hemiplegic shoulder.

This study aimed to investigate whether laser and neuromuscular electrical nerve stimulation applied 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. In this prospective randomized controlled study, 75 stroke patients aged 18-85 years with shoulder pain who were diagnosed with ischemic stroke for the first time and who applied to the Physical Therapy and Rehabilitation Outpatient Clinic between December 2023 and May 2024 were included in the study. The patients included in the study were divided into 3 groups by the same physiotherapist by envelope drawing method. Due to the nature of the study, the physiotherapist administering the treatment was aware of the groups of the patients. On the other hand, all evaluations were performed by the same researcher who was blinded to the type of treatment. All patients underwent a multidisciplinary rehabilitation program 5 days a week for 4 weeks for a total of 20 sessions. Classical physical therapy exercises were applied according to the patient's needs and neurologic level. These exercises are determined by the physiotherapist according to the functional status of the patient and consist of passive, passive assisted, active range of motion exercises, stretching and strengthening exercises, mobilization exercises. 1st group laser group (n:25) received laser for 5 minutes a day 3 days a week in addition to classical physical therapy, 2nd group ES group (n:25) received Neuromuscular electrical nerve stimulation for 20 minutes a day 5 days a week in addition to classical physical therapy. 3. Group, control group (n:25), classical physical therapy exercises were applied.

Eligibility criteria: Inclusion Criteria

* diagnosed with unilateral ischemic stroke for the first time
* 18-85 years old,
* patients with shoulder pain

Exclusion Criteria:

* 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,
* disease that will cause cognitive dysfunction,
* Alzheimer's disease, dementia,
* severe visual loss,
* pregnancy and lactation,
* malignancy,
* psychiatric diseases

Primary outcomes:
measure: Pain Level
timeFrame: baseline and through study completion, an average of 4 weeks
Secondary outcomes:
measure: upper extremity functions
timeFrame: baseline and through study completion, an average of 4 weeks
measure: Disability
timeFrame: baseline and through study completion, an average of 4 weeks
measure: Daily living activities
timeFrame: baseline and through study completion, an average of 4 weeks
measure: Spasticity
timeFrame: baseline and through study completion, an average of 4 weeks
measure: Recovery Stage
timeFrame: baseline and through study completion, an average of 4 weeks
Other outcomes:
Locations:
city: Corum
country: Turkey
facility: Hitit University
Study officials:
affiliation: HİTİT UNİVERSİTY EROL OLÇOK RESEARCH HOSPİTAL
name: MUSTAFA KESER, Ass Prof
role: STUDY_CHAIR
References: