NCT03252444

Brief Summary

The investigators will test whether conscious control with manual guides and video or EMG biofeedback will enhance 3-D kinematics of scapula in shoulder dysfunction subjects with different type of scapula dyskinesis. The investigators will also examine how correction of scapular orientation may affect the activation of associated muscles during various dynamic movements in these subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration 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

Study Start

First participant enrolled

March 25, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
Last Updated

June 25, 2019

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

August 9, 2017

Last Update Submit

June 24, 2019

Conditions

Keywords

Shoulder dyskinesisEMG biofeedback trainingIntensive Scapula-focused intervention

Outcome Measures

Primary Outcomes (2)

  • Shoulder complex kinematics

    Scapular orientation relative to the thorax is described using a Euler angle sequence of rotation about Zs (protraction/retraction), rotation about Y's (downward /upward rotation), and rotation about X"s (posterior/anterior tipping). Scapular elevation is defined as the vertical displacement of the scapular sensor during arm elevation. Humeral orientation relative to the scapula is described using a Euler angle sequence in which the first rotation represents the plane of elevation, the second rotation defines the amount of elevation, and the third rotation describes the amount of axial rotation.

    The scapular kinematics will be measured before scapular control and immediately after scapular control

  • Shoulder associated muscular activities

    Full bandwidth sEMG data, captured by data acquisition software (AcqKnowledge, Biopac systems Inc., CA, USA)

    The muscle activation will be measured before scapular control and immediately after scapular control

Secondary Outcomes (2)

  • Forward shoulder posture

    After subjects are included in the study, the forward shoulder posture will be measured before scapular control, and be done within 2 hours.

  • Pectoralis minor muscle length

    After subjects are included in the study, the muscle length will be measured before scapular control, and be done within 2 hours.

Study Arms (2)

Biofeedback group

EXPERIMENTAL

After 1 minute of rest, participants will perform 6 trials of bilateral, active, weighted arm elevation in the scapular plane and a therapist classifies the scapular motion into specific patterns of scapular dyskinesis. After the evaluation of scapular dyskinesis, the kinematics and surface EMG (sEMG) data will be collected during 5 trials of the same arm movements and 3 selected exercises.

Other: Conscious control+biofeedback

Conscious control group

ACTIVE COMPARATOR

Conscious correction of scapular orientation will be taught to the subjects in the manner described in previous studies. The starting position is determined in each individual by actively positioning the scapula between maximal upward and downward rotation, external and internal rotation, and posterior and anterior tilt. Scapular assistance test (SAT) is also conducted by passively assisting patients' scapula into appropriate position to correct scapula dyskinesis

Other: Conscious control

Interventions

Conscious control of the scapula is important and can correct neuromuscular coordination as well as strength deficits. The strategy in learning control of scapula into normal orientation can be facilitated by manual guides and/or external cues

Conscious control group

In electromyography (EMG) biofeedback training, electronic equipment is used to reveal instantaneously certain physiological events.

Biofeedback group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • At least three positive of five tests, including Neer's test, Hawkin's test, Empty can test, tenderness in tendon of rotator cuff and resisted external test.
  • Each patient will need a prescription of the physician or orthopedic surgeon for diagnosing impingement symptoms

You may not qualify if:

  • \- Shoulder pain onset due to trauma, a history of shoulder fractures or dislocation, cervical radiculopathy, degenerative joint disease of the shoulder, surgical interventions on the shoulder, or inflammatory arthropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

  • Du WY, Huang TS, Chiu YC, Mao SJ, Hung LW, Liu MF, Yang JL, Lin JJ. Single-Session Video and Electromyography Feedback in Overhead Athletes With Scapular Dyskinesis and Impingement Syndrome. J Athl Train. 2020 Mar;55(3):265-273. doi: 10.4085/1062-6050-490-18. Epub 2019 Dec 26.

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Jiu- Jenq Lin, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2017

First Posted

August 17, 2017

Study Start

March 25, 2015

Primary Completion

May 21, 2017

Study Completion

May 21, 2017

Last Updated

June 25, 2019

Record last verified: 2017-08

Locations