Effectiveness of Neuromuscular Electrical Stimulation in Patients With Subacromial Impingement Syndrome
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2020
CompletedFirst Posted
Study publicly available on registry
December 14, 2020
CompletedStudy Start
First participant enrolled
December 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedAugust 25, 2021
August 1, 2021
3 months
December 11, 2020
August 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Visual Analog Scale (VAS)
8 weeks
Goniometer
8 weeks
Digital hand-held dynamometer
8 weeks
Neck Disability Index
8 weeks
Pittsburgh Sleep Quality Scale
8 weeks
Study Arms (2)
Exercise Training (ET) + Neuromuscular Electrical Stimulation (NMES) group
EXPERIMENTALvolunteer patients with Subacromial Impingement Syndrome
Exercise Training (ET) group
OTHERvolunteer patients with Subacromial Impingement Syndrome
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Having a diagnosis of subacute / chronic extrinsic SIS
- to 65 years of age
- Being volunteer
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University
Istanbul, 34555, Turkey (Türkiye)
Related 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: 10.4085/1062-6050-50.4.03. Epub 2015 May 1.
PMID: 25933249RESULTCamargo 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.
PMID: 26471852RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ebru Kaya Mutlu, Assoc. Prof.
İstanbul Üniversitesi- Cerrahpaşa İstanbul, Türkiye
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Prof. Dr, PhD
Study Record Dates
First Submitted
December 11, 2020
First Posted
December 14, 2020
Study Start
December 20, 2020
Primary Completion
March 23, 2021
Study Completion
June 1, 2021
Last Updated
August 25, 2021
Record last verified: 2021-08