NCT04777370

Brief Summary

Interventions including glenohumeral mobilization, sleeper stretches, and thoracic manipulation have been proposed for individuals with loss of shoulder range of motion (ROM). However, the effect of these interventions on shoulder ROM, joint translation, and muscular activity have not been studied in combination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

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

February 22, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

March 31, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

February 22, 2021

Last Update Submit

July 6, 2021

Conditions

Keywords

shoulderGlenohumeral Internal Rotation Deficit (GIRD)joint playmuscular activity

Outcome Measures

Primary Outcomes (3)

  • Change in shoulder IR ROM

    Shoulder IR ROM measured with a goniometer

    Pre intervention to immediate (within 5 minutes) post intervention

  • Change in posterior shoulder translation (mm)

    maximum posterior translation of the humeral head assessed with ultrasound imaging (mm)

    Pre intervention to immediate (within 5 minutes) post intervention

  • Change in infraspinatus electromyographic activity (%MVIC)

    activity of the infraspinatus muscle during posterior translation, assessed as a percentage of the maximal voluntary isometric contraction (MVIC)

    Pre intervention to immediate (within 5 minutes) post intervention

Study Arms (2)

sleeper stretch + thoracic manipulation

EXPERIMENTAL

The group will receive the sleeper stretch at session #1, and a thoracic manipulation followed by the sleeper stretch at session #2.

Other: Sleeper stretchOther: thoracic manipulation

posterior glenohumeral (PG) mobilization + thoracic manipulation

EXPERIMENTAL

The group will receive a posterior glide mobilization at session #1, and a thoracic manipulation followed by posterior glide mobilization at session #2.

Other: posterior glide mobilizationOther: thoracic manipulation

Interventions

The participant will be positioned supine on a plinth, with their scapula stabilized against a firm wedge on the table, and the shoulder joint in the resting position (approx. 55 degrees abduction, 30 degrees horizontal adduction, and slight external rotation). With the extremity held in the same position, the researcher will then apply a grade III (into tissue stretch) PG mobilization. This will consist of five 30-second bouts of sustained gr III posterior glide mobilizations.

posterior glenohumeral (PG) mobilization + thoracic manipulation

All participants randomized to the stretching group will perform five 30-second holds of the sleeper stretch. This is performed by lying on the side to be stretched, elevating the upper arm to 90° on the support surface with the elbow bent 90°, then passively internally rotating the shoulder with force provided by with the opposite arm.

sleeper stretch + thoracic manipulation

Individuals will then undergo a single supine grade V thrust manipulation. All manipulations will take place at the T3-4 segment. If a cavitation ("pop") is not heard or felt by either the subject or examiner, a second thrust will be performed.

posterior glenohumeral (PG) mobilization + thoracic manipulationsleeper stretch + thoracic manipulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • loss of IR of 15 degrees of greater compared to contralateral shoulder

You may not qualify if:

  • currently neck/upper back pain,
  • history of spinal fractures,
  • numbness/altered sensation of the arms or legs,
  • whiplash injury within the prior 6 weeks,
  • infections of the spine,
  • currently pregnant/possibly pregnant,
  • known osteoporosis,
  • Rheumatoid arthritis,
  • previous spine surgery,
  • currently receiving Workman's Compensation,
  • any pending litigation regarding a neck or shoulder injury,
  • history of oral corticosteroids in the prior 6 months,
  • history of shoulder fractures,
  • Current treatment for cancer,
  • Prior history of cancer involving the spine/shoulder,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hartford

West Hartford, Connecticut, 06117, United States

Location

Study Officials

  • Brian Swanson, PT, DSc

    University of Hartford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessment of electromyographic (EMG) activity, IR ROM pre-post intervention, and glenohumeral translation via ultrasound will be performed by a blinded assessor.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: All participants will undergo a single intervention during the first session, and then combined thoracic manipulation and a repeat of the prior intervention at the second session.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2021

First Posted

March 2, 2021

Study Start

March 31, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

July 7, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations