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NCT Number: NCT04667273

Effectiveness of Neuromuscular Electrical Stimulation in Patients With Subacromial Impingement Syndrome

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.

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Key information

Conditions

Subacromial Impingement Syndrome Joint Diseases Musculoskeletal Diseases Shoulder Impingement Syndrome Shoulder Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University

Istanbul, 34555, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular Electrical Stimulation (NMES)

Procedure

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

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 outcomes

  1. 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.

Secondary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 8 weeks

    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.

  2. Goniometer

    Time frame: 8 weeks

    Shoulder flexion, abduction, internal rotation, and external rotation, ROM will be measured by a universal goniometer.

  3. Digital hand-held dynamometer

    Time frame: 8 weeks

    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.

  4. Neck Disability Index

    Time frame: 8 weeks

    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".

  5. Pittsburgh Sleep Quality Scale

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 14, 2020
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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