Neuromuscular Electrical Stimulation on Humeral Adductors in Subjects With Rotator Cuff Tear: an Observational Study

NCT05879003 | Unknown

• 1 other identifier: 202012082RINB
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The teres major and pectoralis major are adductors and may play a compensatory role for deficit in rotator cuff function. The investigators aim to (1) determine the effects of neuromuscular electrical stimulation (NMES) on the two adductors for the outcomes in symptomatic rotator cuff tear subjects, and (2) evaluate the immediate effect of NMES on the co-contraction of the adductors.Thirty symptomatic rotator cuff tear subjects will have NMES on the two adductors. The investigators will measure the acromiohumeral distance by ultrasonography and scapular kinematics during arm elevation with a three-dimensional motion tracking system. Co-contractions will be calculated by surface electromyography.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (2)

• acromiohumeral distance

  acromiohumeral distance was measured by ultrasonography

  change from baseline to "during the neuromuscular electrical stimulation"

• scapular kinematics

  scapular kinematics during arm elevation with a three-dimensional motion tracking system.

  change from baseline to "immediately after the neuromuscular electrical stimulation"

Study Arms (2)

novel brace with neuromuscular electrical stimulation plus exercise group

EXPERIMENTAL

The experimental group received additional NMES during exercise. According to a previous study, the unit's electronics created electrical impulses with an output frequency of 80 Hz and a duration of 200 ms. The synchronous (S) mode and asymmetrical rectangular wave-pulse were used throughout the experiment. The amplitude was set as muscle motor-level contraction with the self-perception of maximal tolerable intensity. A rise and fall time of 2s with a tetanic muscle stimulation lasting 8 seconds and a 3s duration between stimulations were used for all participants.

Device: novel brace with neuromuscular electrical stimulation

exercise control group

ACTIVE COMPARATOR

The exercise intervention consisted of scapular-focused exercises with theraband, including scapula row, serratus punch, and adduction exercises in a standing position. The scapula row exercise was performed with the arm straight and the shoulder flexed to 30°. Participants retracted their scapula and brought the theraband to the side of the body, then returned; the serratus punch exercise began with elbow flexion at 90° and held the theraband. Participants punched and protracted their scapula; the adduction exercise was conducted with arm straight, shoulder internal rotation, and abduction at 30°. Participants pull the theraband to the side of the body. Each was performed at 10 repetitions per set for 3 sets daily.

Behavioral: scapular and adductor exercise

Interventions

novel brace with neuromuscular electrical stimulation DEVICE

The symptomatic rotator cuff tear subjects had NMES on scapular muscles and adductor muscle

Also known as: neuromuscular electrical stimulation

novel brace with neuromuscular electrical stimulation plus exercise group

scapular and adductor exercise BEHAVIORAL

The symptomatic rotator cuff tear subjects conduct scapular and adductor exercise

Also known as: exercise

exercise control group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 20 to 85 years old
• diagnosed with symptomatic rotator cuff tear based on ultrasonography or magnetic resonance imaging
• pain or discomfort specific to the shoulder.

You may not qualify if:

• a diagnosis of frozen shoulder or adhesion capsulitis
• glenohumeral joint instability
• a history of affected shoulder surgery or traumatic dislocation/fracture over the past year
• symptoms related to the cervical spine in recent 6 months
• neuromuscular diseases, such as polymyositis and myotonic dystrophy
• limited arm elevation less than 90°
• contraindications for NMES.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

School of Physical Therapy, National Taiwan University

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• jiu jenq lin, PhD

  School of Physical Therapy, College of Medicine, National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jiu jenq lin, PhD

CONTACT

33668126; jiujlin@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: May 30, 2023
• Study Start: May 15, 2023
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 9, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)