Effectiveness of Neuromuscular Electrical Stimulation in Patients With Subacromial Impingement Syndrome

Subacromial Impingement Syndrome Clinical Trial

Official title:

Effectiveness of Neuromuscular Electrical Stimulation in Patients With Subacromial Impingement Syndrome: Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667273
• Other study ID #: 2020/11
• Status: Completed
• Phase: N/A
• Start date: December 20, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: August 2021
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 1, 2021
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome
• Syndrome

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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/ — View Citation

Camargo PR, Alburquerque-Sendín 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 Randomiz — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability Arm Shoulder Hand Questionnaire (DASH)	The DASH questionnaire is a region-specific, self-report scale to evaluate health status of upper extremity disabilities.	8 weeks
Secondary	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.	8 weeks
Secondary	Goniometer	Shoulder flexion, abduction, internal rotation, and external rotation, ROM will be measured by a universal goniometer.	8 weeks
Secondary	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.	8 weeks
Secondary	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".	8 weeks
Secondary	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 Agargün et al.	8 weeks