NCT04513535

Brief Summary

The purpose of this study is to directly compare the effects of four distinct interventions commonly used in the treatment of shoulder pathology on shoulder range of motion (ROM) and strength in asymptomatic shoulders:

  • grade III oscillatory anterior-posterior glenohumeral joint mobilizations
  • an internal rotation (IR) "sleeper" stretch
  • supine upper-thoracic manipulation
  • cervical spine manipulation

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 Feb 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

Study Start

First participant enrolled

February 7, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

August 11, 2020

Last Update Submit

February 22, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in shoulder ER strength

    pre-test post-test strength test of the infraspinatus with hand held dynamometer

    immediate pre-post intervention

  • Change in shoulder IR ROM

    change pre-post test IR ROM at 90 degrees ABD

    immediate pre-post intervention

  • change in posterior shoulder mobility

    change in pre-post test posterior shoulder mobility assessed in horizontal adduction

    immediate pre-post intervention

  • change in infraspinatus EMG activity

    change in pre-post test EMG peak and mean root squared activity

    immediate pre-post intervention

Study Arms (6)

manual therapy combination 1

EXPERIMENTAL

Cervical manipulation, Thoracic manipulation

Other: Thoracic ManipulationOther: Cervical Manipulation

manual therapy combination 2

EXPERIMENTAL

Cervical manipulation, glenohumeral mobilization

Other: Cervical ManipulationOther: glenohumeral posterior glide mobilization

manual therapy combination 3

EXPERIMENTAL

cervical manipulation, sleeper stretch

Other: Cervical ManipulationOther: Sleeper stretch

manual therapy combination 4

EXPERIMENTAL

thoracic manipulation, glenohumeral mobilization

Other: Thoracic ManipulationOther: glenohumeral posterior glide mobilization

manual therapy combination 5

EXPERIMENTAL

thoracic manipulation, sleeper stretch

Other: Thoracic ManipulationOther: Sleeper stretch

manual therapy combination 6

EXPERIMENTAL

glenohumeral mobilization, sleeper stretch

Other: glenohumeral posterior glide mobilizationOther: Sleeper stretch

Interventions

A supine thoracic manipulation will be utilized. Participants will be lying supine on the plinth with their arms crossed over their chest, making sure the forearms are not crossed. An experienced clinician will place their hand on the inferior segment (T4); the superior segment (T3) will be placed in the midrange of thoracic flexion and extension. The clinician will apply a high velocity, end range, anterior to posterior thrust by using their body weight to deliver the thrust through the participants crossed elbows, thus creating a bilateral gapping of the facet joints. If a cavitation is achieved after the first thrust, the thoracic manipulation intervention is complete. If not, one more attempt will be made to achieve a cavitation. Regardless of if there was a cavitation or not, after the second attempt the intervention is complete.

manual therapy combination 1manual therapy combination 4manual therapy combination 5

Participants will be lying supine on the plinth on the table. A high velocity low amplitude manipulation will be performed to the cervical spine by an experienced clinician.The clinician will place the right proximal phalanx of the index finger over the posterolateral aspect of the articular pillar at the right C4/C5 segment to maximally influence the C5 myotomal distribution. The clinician's left hand will be cradling the participants head. The participant will be brought into midrange flexion-extension, ipsilateral side bend, and contralateral rotation of C4/5. Once a firm end feel is felt the manipulation will be administered into left rotation in an arc toward the left eye. If a cavitation is achieved after the first thrust, the intervention is complete. If not, one more attempt will be made to achieve a cavitation;after the second attempt the intervention is complete.

manual therapy combination 1manual therapy combination 2manual therapy combination 3

Participants will be instructed to lay supine on the plinth and a plastic orthopedic wedge will be placed under their scapula for stabilization on the side that is receiving the mobilization. The experienced clinician will stand on the same side being mobilized and held the participant's arm proximal to the medial and lateral humeral epicondyles. The clinician will hold the participant's arm in the scapular plane, approximately 55 degrees of abduction and slight ER with a grade one long axis distraction applied and sustained throughout the entire mobilization. A grade three oscillatory mobilization will be applied for three sets of 30 seconds with a 30 second rest in between.

manual therapy combination 2manual therapy combination 4manual therapy combination 6

Participants will be positioned in a side lying position with the arm to be stretched on the table. The arm to be tested will then be positioned at a 90-90 shoulder abduction and elbow flexion position. A support will be positioned behind the patient to ensure there is no compensatory trunk movement during the stretch, and an examiner verified the arm is in a 90-90 position. A sleeper stretch will be subsequently completed, in which the participant will internally rotate the arm to stretch the posterior shoulder musculature. Three, thirty second stretches will be completed

manual therapy combination 3manual therapy combination 5manual therapy combination 6

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants will be included in this study if they:
  • are between the ages of 18 and 55
  • have no history of shoulder, neck, or upper back dysfunction.

You may not qualify if:

  • Individuals will be excluded if they report having any of the following conditions:
  • shoulder, neck, or upper back pain;
  • prior shoulder, neck or upper back surgery;
  • previous injury to shoulder, neck, or thoracic area;
  • active inflammatory disease process in treatment area;
  • osteoporosis;
  • signs and symptoms of a nerve root pathology/radiculopathy (dermatomal sensory changes, myotomal weakness, reflex changes);
  • upper motor neuron lesions/spinal cord pathology;
  • local infection;
  • active or history of cancer;
  • long term corticosteroid use;
  • systemically unwell;
  • systemic hyperlaxity;
  • known connective tissue disease;
  • known abnormalities of the spine;
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hartford

West Hartford, Connecticut, 06117, United States

Location

MeSH Terms

Interventions

Manipulation, Spinal

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

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
outcomes assessor blinded to group allocations
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: modified crossover, each group will experience 2/4 interventions
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 14, 2020

Study Start

February 7, 2020

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

February 23, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

IPD will be made available in de-identified form upon request

Locations