NCT04667273

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

December 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

December 11, 2020

Last Update Submit

August 24, 2021

Conditions

Keywords

Shoulder impingement syndromeVisual Analog ScaleRange of motionMuscle strengthSleep

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

EXPERIMENTAL

volunteer patients with Subacromial Impingement Syndrome

Procedure: Neuromuscular Electrical Stimulation (NMES)Procedure: Exercise Training (ET)

Exercise Training (ET) group

OTHER

volunteer patients with Subacromial Impingement Syndrome

Procedure: Exercise Training (ET)

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.

Exercise Training (ET) + Neuromuscular Electrical Stimulation (NMES) group

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.

Exercise Training (ET) + Neuromuscular Electrical Stimulation (NMES) groupExercise Training (ET) group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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.

  • 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.

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ebru Kaya Mutlu, Assoc. Prof.

    İstanbul Üniversitesi- Cerrahpaşa İstanbul, Türkiye

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
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

Locations