Subacromial Impingement SyndromeNCT04667273
Effectiveness of Neuromuscular Electrical Stimulation in Patients With Subacromial Impingement Syndrome
A study testing Neuromuscular Electrical Stimulation (NMES) and Exercise Training (ET) in people with Subacromial Impingement Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Subacromial Impingement Syndrome (SIS) is one of the musculoskeletal system problems. SIS, which is the most common cause of shoulder pain, constitutes 44-65% of complaints of shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Neuromuscular Electrical Stimulation (NMES) and Exercise Training (ET)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2020to 1 Jun 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a diagnosis of subacute / chronic extrinsic SIS
- 18 to 65 years of age
- Being volunteer
Who cannot join
- Fracture or surgical history in the shoulder region
- Another diagnosis that can affect shoulder function
- Having received local corticosteroid injection / treatment in the shoulder joint within the last 3 months
- Neuromuscular disease
- Pregnancy
- Cancer
Show all 11Show fewer
- Unstabil angina
- Communication problems
- Systemic inflammatory joint disease
- Situations where electrical stimulation and exercise are contraindicated
- Orthopedic, rheumatologic or congenital disease of the affected upper extremity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Neuromuscular Electrical Stimulation in Patients With Subacromial Impingement Syndrome: Randomized Controlled Study
Subacromial Impingement Syndrome (SIS) is one of the musculoskeletal system problems. SIS, which is the most common cause of shoulder pain, constitutes 44-65% of complaints of shoulder pain. Studies have shown that exercise is effective in treating patients with SIS, but the effectiveness and superiority of Neuromuscular Electrical Stimulation (NMES) to each other is uncertain. NMES is widely applied in physiotherapy. In the SIS, the lower trapezius and serratus anterior muscle are affected. Therefore, our aim is to determine the effects of exercises and NMES used in patients with SIS on pain, range of motion (ROM), muscle strength and functional status, neck pain and sleep quality.
Read the detailed description
The aim of this study investigate exercise training (ET) and ET combined with Neuromuscular Electrical Stimulation (NMES) on pain, range of motion (ROM), functional capacity, neck pain, sleep quality. The study will be included 48 volunteers with Subacromial Impingement Syndrome (SIS). The study's inclusion criteria are as follows: Having a diagnosis of subacute / chronic extrinsic SIS, 18 to 65 years of age and being volunteer. The exclusion criteria are as follows: Fracture or surgical history in the shoulder region, another diagnosis that can affect shoulder function, having received local corticosteroid injection / treatment in the shoulder joint within the last 3 months, neuromuscular disease, pregnancy, cancer, unstabil angina, communication problems, systemic inflammatory joint disease, situations where electrical stimulation and exercise are contraindicated, orthopedic, rheumatologic or congenital disease of the affected upper extremity. The sociodemographic data of the patients will be questioned. ET will be applied daily and NMES will be applied 2 days a week for 8 weeks. In addition, both groups will apply these exercises as a home program 3 times a day, 10 repetitions of each exercise. Pain intensity with Visual Analog Scale (VAS), range of motion (ROM) with goniometer, muscle strength with Hand-held Dynamometer, upper extremity function evaluation with Quick Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire, disability of neck level with Neck Disability Index, sleep quality with Pittsburgh Sleep Quality Index will be evaluated before and after treatment. All parameters will be compared between ET and ET+NMES group.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Neuromuscular Electrical Stimulation (NMES), Exercise Training (ET)
- Keywords
- Shoulder impingement syndrome, Visual Analog Scale, Range of motion, Muscle strength, Sleep
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical Stimulation (NMES)Procedure or surgery
In Neuromuscular Electrical Stimulation (NMES) application, 4 surface electrodes will be placed in the swollen part of the lower trapezius and serratus anterior muscles of each patient.
NMES will be applied for 20 minutes in rehabilitation mode with a 4-channel device.
Frequency: 80 Hz Amplitude: 0-100 mA (0-0.01 V) Current time-Pulse: 200 μsec Wave form: Biphasic Cycle time: 8 seconds of tetanic muscle stimulation for all patients, with a 2 second rise and fall time and stimulation It will be set as 3 seconds between. It is important to visually observe the contraction to determine the intensity of stimulation.
Exercise Training (ET)Procedure or surgery
Patients will do Wand exercises under the supervision of a physiotherapist. Wand exercises will include shoulder flexion, external rotation and abduction in the scaption position. In the first and second week, these exercises will be performed on the back, and from the third week on standing exercises.
Exercises with the Theraband will be done in 3 sets, each set will consist of 10 repetitions. There will be a 1 minute rest period between sets. When the three sets are easily completed and there is no reported fatigue by the patient, the resistance will be increased by moving from yellow to red, from red to green, respectively, after 4 weeks.
*For shoulder external rotators and serratus anterior muscles are strengthened without weight for the first 2 weeks, then 0.5 kg of dumbbells, in the supine position.
While standing, the lower trapezius, upper trapezius and shoulder external rotators will be strengthened with theraband.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training (ET) + Neuromuscular Electrical Stimulation (NMES) group | Experimental | volunteer patients with Subacromial Impingement Syndrome Receives: Procedure: Neuromuscular Electrical Stimulation (NMES); Procedure: Exercise Training (ET) |
| Exercise Training (ET) group | Other | volunteer patients with Subacromial Impingement Syndrome Receives: Procedure: Exercise Training (ET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability Arm Shoulder Hand Questionnaire (DASH)
The DASH questionnaire is a region-specific, self-report scale to evaluate health status of upper extremity disabilities.
Measured: 8 weeks
Secondary outcomes (5)
Visual Analog Scale (VAS)
The VAS is used for which a patient is asked to indicate his/her perceived pain during the rest, activity and night times. Respondents will mark the location on the 10-centimeter (cm) line corresponding to the amount of pain they experienced.
Measured: 8 weeks
Goniometer
Shoulder flexion, abduction, internal rotation, and external rotation, ROM will be measured by a universal goniometer.
Measured: 8 weeks
Digital hand-held dynamometer
Shoulder flexion, extension, abduction, adduction, internal and external muscle strength measurements will be evaluated with a digital hand-held dynamometer called "Lafayette-Manual Muscle Tester". Before taking measurements, a few trials will be made by informing. Then the individual will be positioned according to the muscle to be tested, the device will be placed in the appropriate area of the muscle whose strength is to be measured, and the individual will be asked to maintain the specified position for each muscle. The evaluation is repeated twice and the value when the position starts to deteriorate will be recorded in newton as the result measurement.
Measured: 8 weeks
Neck Disability Index
Pain related disability will be evaluated using the Turkish version of the Neck Disability Index. This questionnaire consists of 10 questions, each scored between 0 and 5. The final score of the questionnaire is obtained by adding the scores from each question. Disability levels of the patients are as follows: "no disability" (0-4), "mild disability" (5 14), "moderate disability" (15-24), "severe disability" (25 -34) and "complete disability".
Measured: 8 weeks
Pittsburgh Sleep Quality Scale
The Pittsburgh Sleep Quality Scale will be applied to evaluate the sleep quality of the patients. With this scale, both the sleep quality of the patient is evaluated and whether there is a problem with daytime sleepiness is reviewed. In this evaluation; Subjective sleep quality, time to fall asleep, sleep duration, sleep quality, conditions that affect sleep, sleep substance use and daytime sleepiness are evaluated. Each area of the scale is calculated with scores ranging from 0 to 3, high scores indicate poor sleep quality. The total value in this test is a score between 0-21. Its Turkish validity and reliability were made in 1996 by Ağargün et al.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start20 Dec 2020
- Primary completion23 Mar 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- The sample of the study will consist of patients with subacromial impingement syndrome (SIS) who were referred to Istanbul University Cerrahpaşa Physical Therapy and Rehabilitation Department by an orthopedist. Forty eight SIS patients will be included in the study. Patients who meet the inclusion criteria will be divided into two groups. Group 1: Exercise Training+ Neuromuscular Electrical Stimulation Group 2: Exercise Training
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Kaya Mutlu, PT, Istanbul University - Cerrahpasa
- Investigators
- Ebru Kaya Mutlu, Assoc. Prof., Principal investigator, İstanbul Üniversitesi- Cerrahpaşa İstanbul, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667273
- Sponsor's protocol ID
- 2020/11
- Status last verified
- Aug 2021
- First submitted
- 11 Dec 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bdaiwi AH, Mackenzie TA, Herrington L, Horsley I, Cools AM. Acromiohumeral Distance During Neuromuscular Electrical Stimulation of the Lower Trapezius and Serratus Anterior Muscles in Healthy Participants. J Athl Train. 2015 Jul;50(7):713-8. doi: 10.4085/1062-6050-50.4.03. Epub 2015 May 1.
PubMed 25933249Camargo PR, Alburquerque-Sendin F, Avila MA, Haik MN, Vieira A, Salvini TF. Effects of Stretching and Strengthening Exercises, With and Without Manual Therapy, on Scapular Kinematics, Function, and Pain in Individuals With Shoulder Impingement: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2015 Dec;45(12):984-97. doi: 10.2519/jospt.2015.5939. Epub 2015 Oct 15.
PubMed 26471852
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Neuromuscular Electrical Stimulation in Patients With Subacromial Impingement Syndrome: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04667273
- Acronym / sponsor ID
- 2020/11
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- Shoulder impingement syndrome, Visual Analog Scale, Range of motion, Muscle strength, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 14 Dec 2020 (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.
Subacromial Impingement Syndrome (SIS) is one of the musculoskeletal system problems. SIS, which is the most common cause of shoulder pain, constitutes 44-65% of complaints of shoulder pain. Studies have shown that exercise is effective in treating patients with SIS, but the effectiveness and superiority of Neuromuscular Electrical Stimulation (NMES) to each other is uncertain. NMES is widely applied in physiotherapy. In the SIS, the lower trapezius and serratus anterior muscle are affected. Therefore, our aim is to determine the effects of exercises and NMES used in patients with SIS on pain, range of motion (ROM), muscle strength and functional status, neck pain and sleep quality.
Detailed description
The aim of this study investigate exercise training (ET) and ET combined with Neuromuscular Electrical Stimulation (NMES) on pain, range of motion (ROM), functional capacity, neck pain, sleep quality. The study will be included 48 volunteers with Subacromial Impingement Syndrome (SIS). The study's inclusion criteria are as follows: Having a diagnosis of subacute / chronic extrinsic SIS, 18 to 65 years of age and being volunteer. The exclusion criteria are as follows: Fracture or surgical history in the shoulder region, another diagnosis that can affect shoulder function, having received local corticosteroid injection / treatment in the shoulder joint within the last 3 months, neuromuscular disease, pregnancy, cancer, unstabil angina, communication problems, systemic inflammatory joint disease, situations where electrical stimulation and exercise are contraindicated, orthopedic, rheumatologic or congenital disease of the affected upper extremity. The sociodemographic data of the patients will be questioned. ET will be applied daily and NMES will be applied 2 days a week for 8 weeks. In addition, both groups will apply these exercises as a home program 3 times a day, 10 repetitions of each exercise. Pain intensity with Visual Analog Scale (VAS), range of motion (ROM) with goniometer, muscle strength with Hand-held Dynamometer, upper extremity function evaluation with Quick Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire, disability of neck level with Neck Disability Index, sleep quality with Pittsburgh Sleep Quality Index will be evaluated before and after treatment. All parameters will be compared between ET and ET+NMES group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The sample of the study will consist of patients with subacromial impingement syndrome (SIS) who were referred to Istanbul University Cerrahpaşa Physical Therapy and Rehabilitation Department by an orthopedist. Forty eight SIS patients will be included in the study. Patients who meet the inclusion criteria will be divided into two groups. Group 1: Exercise Training+ Neuromuscular Electrical Stimulation Group 2: Exercise Training
| Arm | Type | Receives |
|---|---|---|
| Exercise Training (ET) + Neuromuscular Electrical Stimulation (NMES) group | Experimental | Procedure: Neuromuscular Electrical Stimulation (NMES), Procedure: Exercise Training (ET)volunteer patients with Subacromial Impingement Syndrome |
| Exercise Training (ET) group | Other | Procedure: Exercise Training (ET)volunteer patients with Subacromial Impingement Syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having a diagnosis of subacute / chronic extrinsic SIS
- 18 to 65 years of age
- Being volunteer
Key exclusion criteria (11 listed)
- Fracture or surgical history in the shoulder region
- Another diagnosis that can affect shoulder function
- Having received local corticosteroid injection / treatment in the shoulder joint within the last 3 months
- Neuromuscular disease
- Pregnancy
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 |
|---|---|---|
| Neuromuscular Electrical Stimulation (NMES)In Neuromuscular Electrical Stimulation (NMES) application, 4 surface electrodes will be placed in the swollen part of the lower trapezius and serratus anterior muscles of each patient. NMES will be applied for 20 minutes in rehabilitation mode with a 4-channel device. Frequency: 80 Hz Amplitude: 0-100 mA (0-0.01 V) Current time-Pulse: 200 μsec Wave form: Biphasic Cycle time: 8 seconds of tetanic muscle stimulation for all patients, with a 2 second rise and fall time and stimulation It will be set as 3 seconds between. It is important to visually observe the contraction to determine the intensity of stimulation. | Procedure or surgery | Exercise Training (ET) + Neuromuscular Electrical Stimulation (NMES) group |
| Exercise Training (ET)Patients will do Wand exercises under the supervision of a physiotherapist. Wand exercises will include shoulder flexion, external rotation and abduction in the scaption position. In the first and second week, these exercises will be performed on the back, and from the third week on standing exercises. Exercises with the Theraband will be done in 3 sets, each set will consist of 10 repetitions. There will be a 1 minute rest period between sets. When the three sets are easily completed and there is no reported fatigue by the patient, the resistance will be increased by moving from yellow to red, from red to green, respectively, after 4 weeks. *For shoulder external rotators and serratus anterior muscles are strengthened without weight for the first 2 weeks, then 0.5 kg of dumbbells, in the supine position. While standing, the lower trapezius, upper trapezius and shoulder external rotators will be strengthened with theraband. | Procedure or surgery | Exercise Training (ET) + Neuromuscular Electrical Stimulation (NMES) group, Exercise Training (ET) group |
Primary outcome
Disability Arm Shoulder Hand Questionnaire (DASH)
Time frame: 8 weeks
The DASH questionnaire is a region-specific, self-report scale to evaluate health status of upper extremity disabilities.
5 secondary outcomes
Visual Analog Scale (VAS)
Time frame: 8 weeks
Goniometer
Time frame: 8 weeks
Digital hand-held dynamometer
Time frame: 8 weeks
Neck Disability Index
Time frame: 8 weeks
Pittsburgh Sleep Quality Scale
Time frame: 8 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 25 Aug 2021.
- Results publication: PubMed 25933249Bdaiwi AH, Mackenzie TA, Herrington L, Horsley I, Cools AM. Acromiohumeral Distance During Neuromuscular Electrical Stimulation of the Lower Trapezius and Serratus Anterior Muscles in Healthy Participants. J Athl Train. 2015 Jul;50(7):713-8. doi: 10.4085/1062-6050-50.4.03. Epub 2015 May 1.
- Results publication: PubMed 26471852Camargo PR, Alburquerque-Sendin F, Avila MA, Haik MN, Vieira A, Salvini TF. Effects of Stretching and Strengthening Exercises, With and Without Manual Therapy, on Scapular Kinematics, Function, and Pain in Individuals With Shoulder Impingement: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2015 Dec;45(12):984-97. doi: 10.2519/jospt.2015.5939. Epub 2015 Oct 15.
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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.
Ebru Kaya Mutlu, Assoc. Prof. principal investigator
İstanbul Üniversitesi- Cerrahpaşa İstanbul, Türkiye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation (NMES) and Exercise Training (ET) in people with Subacromial Impingement Syndrome, run by Istanbul University - Cerrahpasa 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 11 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 25 Aug 2021. 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?
Disability Arm Shoulder Hand Questionnaire (DASH) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04667273, which also lists 2 linked publications.
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 25 Aug 2021.