Effectiveness of Neuromuscular Electrical Stimulation in Patients With Subacromial Impingement Syndrome
Primary Purpose
Subacromial Impingement Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulation (NMES)
Exercise Training (ET)
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring Shoulder impingement syndrome, Visual Analog Scale, Range of motion, Muscle strength, Sleep
Eligibility Criteria
Inclusion Criteria:
- Having a diagnosis of subacute / chronic extrinsic SIS
- 18 to 65 years of age
- Being volunteer
Exclusion Criteria:
- 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
Sites / Locations
- Istanbul University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Exercise Training (ET) + Neuromuscular Electrical Stimulation (NMES) group
Exercise Training (ET) group
Arm Description
volunteer patients with Subacromial Impingement Syndrome
volunteer patients with Subacromial Impingement Syndrome
Outcomes
Primary Outcome Measures
Disability Arm Shoulder Hand Questionnaire (DASH)
The DASH questionnaire is a region-specific, self-report scale to evaluate health status of upper extremity disabilities.
Secondary Outcome Measures
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.
Goniometer
Shoulder flexion, abduction, internal rotation, and external rotation, ROM will be measured by a universal goniometer.
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.
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".
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.
Full Information
NCT ID
NCT04667273
First Posted
December 11, 2020
Last Updated
August 24, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT04667273
Brief Title
Effectiveness of Neuromuscular Electrical Stimulation in Patients With Subacromial Impingement Syndrome
Official Title
Effectiveness of Neuromuscular Electrical Stimulation in Patients With Subacromial Impingement Syndrome: Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 20, 2020 (Actual)
Primary Completion Date
March 23, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
Keywords
Shoulder impingement syndrome, Visual Analog Scale, Range of motion, Muscle strength, Sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Training (ET) + Neuromuscular Electrical Stimulation (NMES) group
Arm Type
Experimental
Arm Description
volunteer patients with Subacromial Impingement Syndrome
Arm Title
Exercise Training (ET) group
Arm Type
Other
Arm Description
volunteer patients with Subacromial Impingement Syndrome
Intervention Type
Procedure
Intervention Name(s)
Neuromuscular Electrical Stimulation (NMES)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Exercise Training (ET)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disability Arm Shoulder Hand Questionnaire (DASH)
Description
The DASH questionnaire is a region-specific, self-report scale to evaluate health status of upper extremity disabilities.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
8 weeks
Title
Goniometer
Description
Shoulder flexion, abduction, internal rotation, and external rotation, ROM will be measured by a universal goniometer.
Time Frame
8 weeks
Title
Digital hand-held dynamometer
Description
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.
Time Frame
8 weeks
Title
Neck Disability Index
Description
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".
Time Frame
8 weeks
Title
Pittsburgh Sleep Quality Scale
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having a diagnosis of subacute / chronic extrinsic SIS
18 to 65 years of age
Being volunteer
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Kaya Mutlu, Assoc. Prof.
Organizational Affiliation
İstanbul Üniversitesi- Cerrahpaşa İstanbul, Türkiye
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University
City
Istanbul
ZIP/Postal Code
34555
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
25933249
Citation
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.
Results Reference
result
PubMed Identifier
26471852
Citation
Camargo 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.
Results Reference
result
Learn more about this trial
Effectiveness of Neuromuscular Electrical Stimulation in Patients With Subacromial Impingement Syndrome
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