Hemiplegic Shoulder PainNCT06428851
Laser Therapy Versus Neuromuscular Electrical Nerve Stimulation at Hemiplegic Shoulder Pain
A study testing Laser therapy and Neuromuscular electrical nerve stimulation in people with Hemiplegic Shoulder Pain, run by Hitit University at 1 site in Turkey (Türkiye).
Trial 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… 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 Neuromuscular electrical nerve stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Dec 2023to 17 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
About this study
Official title: Comparison of Laser Therapy Versus Neuromuscular Electrical Nerve Stimulation at Hemiplegic Shoulder Pain and Upper Extremity Functions
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.
Read the 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.
- Conditions
- Hemiplegic Shoulder Pain
- Being tested
- Laser therapy, Neuromuscular electrical 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
Shoulder girdle muscles were lasered for 5 minutes a day, 3 days a week, total of 4 weeks.
Neuromuscular electrical nerve stimulationOther
Neuromuscular electrical nerve stimulation was applied to the shoulder flexor and abductor muscles for 20 minutes a day 5 days a week, total of 4 weeks.
ControlOther
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 5 days a week for 1 hour, total of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Laser therapy Group | Active comparator | 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. Group 1 Laser therapy group (n:25) in addition to classical physical therapy, laser was applied to the shoulder group muscles for 5 minutes a day, 3 days a week for 4 weeks. Receives: Other: Laser therapy |
| Neuromuscular electrical nerve stimulation Group | Active comparator | 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. In Neuromuscular electrical nerve stimulation group, in addition to these exercises, Neuromuscular electrical nerve stimulation was applied to the shoulder flexor and abductor muscle groups for 20 minutes a day, 5 days a week for a total of 4 weeks. Receives: Other: Neuromuscular electrical nerve stimulation |
| Control Group | Active comparator | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (5)
upper extremity functions
upper extremity functions were evaluated with Fugl-Meyer. Fugl-Meyer is a stroke-specific performance-based scale, fully filled by the same investigator, each parameter is scored between 0-2. The total score is between 0 to 100. 0: unsuccessful, 1: partially successful, 2: completely successful performance. A higher score indicates better performance
Measured: baseline and through study completion, an average of 4 weeks
Disability
he 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
Daily living activities
Barthel index It is filled out after the examination by the same investigator to evaluate the activities of daily living of the patients. Turkish version of the scale has been adapted. The Barthel index consists of 10 items related to activities of daily living and mobility. Nutrition, transition from wheelchair to bed and back, self-care, bathing, walking, climbing up and down stairs, dressing, bladder and bowel continence are evaluated. The items can be divided into two parts related to self-care and mobility. A scoring is based on whether the person is assisted in performing these tasks. The highest total score that can be achieved is 100, which means that the individual is completely independent in their physical functioning. The lowest score is 0, indicating that the individual is completely dependent
Measured: baseline and through study completion, an average of 4 weeks
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
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.
- First posted24 May 2024
- Study start26 Dec 2023
- Primary completion17 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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. Neuromuscular electrical nerve stimulation therapy (NMES) 3. Control: classical physical therapy exercises 3\)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Özge Başaran, Hitit University
- Investigators
- MUSTAFA KESER, Ass Prof, Study chair, HİTİT UNİVERSİTY EROL OLÇOK RESEARCH HOSPİTAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428851
- Sponsor's protocol ID
- 2023-174
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laser Therapy Versus Neuromuscular Electrical Nerve Stimulation at Hemiplegic Shoulder Pain and Upper Extremity Functions
- ClinicalTrials.gov ID
- NCT06428851
- Acronym / sponsor ID
- 2023-174
- Conditions
- Hemiplegic Shoulder Pain
- Keywords
- hemiplegic shoulder pain, electrical nerve stimulation, laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 1. Laser therapy 2. Neuromuscular electrical nerve stimulation therapy (NMES) 3. Control: classical physical therapy exercises 3)
| Arm | Type | Receives |
|---|---|---|
| Laser therapy Group | Active comparator | Other: Laser therapyClassical 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. Group 1 Laser therapy group (n:25) in addition to classical physical therapy, laser was applied to the shoulder group muscles for 5 minutes a day, 3 days a week for 4 weeks. |
| Neuromuscular electrical nerve stimulation Group | Active comparator | Other: Neuromuscular electrical nerve stimulationClassical 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. In Neuromuscular electrical nerve stimulation group, in addition to these exercises, Neuromuscular electrical nerve stimulation was applied to the shoulder flexor and abductor muscle groups for 20 minutes a day, 5 days a week for a total of 4 weeks. |
| Control Group | Active comparator | Other: ControlClassical 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with unilateral ischemic stroke for the first time
- 18-85 years old,
- patients with shoulder pain
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser therapyShoulder girdle muscles were lasered for 5 minutes a day, 3 days a week, total of 4 weeks. | Other | Laser therapy Group |
| Neuromuscular electrical nerve stimulationNeuromuscular electrical nerve stimulation was applied to the shoulder flexor and abductor muscles for 20 minutes a day 5 days a week, total of 4 weeks. | Other | Neuromuscular electrical nerve stimulation Group |
| ControlClassical 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 5 days a week for 1 hour, total of 4 weeks. | Other | Control Group |
Primary outcome
Pain Level
Time frame: baseline and through study completion, an average of 4 weeks
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.
5 secondary outcomes
upper extremity functions
Time frame: baseline and through study completion, an average of 4 weeks
Disability
Time frame: baseline and through study completion, an average of 4 weeks
Daily living activities
Time frame: baseline and through study completion, an average of 4 weeks
Spasticity
Time frame: baseline and through study completion, an average of 4 weeks
Recovery Stage
Time frame: baseline and through study completion, an average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
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Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MUSTAFA KESER, Ass Prof study chair
HİTİT UNİVERSİTY EROL OLÇOK RESEARCH HOSPİTAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser therapy and Neuromuscular electrical 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: finished, as of the sponsor's last update on 24 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 24 May 2024.