NCT01518504

Brief Summary

The purpose of this study is to investigate the effect of thoracic spine joint manipulation versus a sham intervention on active and passive shoulder flexion (elevation), external rotation, and internal rotation range of motion.

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 Dec 2011

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 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 21, 2012

Status Verified

November 1, 2012

Enrollment Period

6 months

First QC Date

December 1, 2011

Last Update Submit

November 19, 2012

Conditions

Shoulder Range of Motion in Healthy Individuals

Keywords

ThoracicManipulationManual TherapyMobilizationShoulderRange of Motion

Outcome Measures

Primary Outcomes (1)

  • Changes in Shoulder Range of motion

    To determine changes in shoulder active and passive range of motion following one of two intervention protocols. Changes will be measured by examining shoulder range of motion in three directions: Shoulder flexion, internal rotation and external rotation. We hypothesize that the use of a thoracic spine joint manipulation will increase shoulder range of motion in flexion (elevation) as well as external and internal rotation to a greater degree than a sham mobilization.

    Single Study Visit

Study Arms (2)

Thoracic Mobilization

EXPERIMENTAL

The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will apply a small amplitude, quick thrust at end of range.

Other: Thoracic Mobilization

Sham

SHAM COMPARATOR

The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will not apply any other force than light hand contact.

Other: Sham

Interventions

Thoracic MobilizationOTHER

The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will apply a small amplitude, quick thrust at end of range.

Also known as: manipulation, Grade V joint mobilization, small amplitude, quick thrust mobilization/manipulation
Thoracic Mobilization
ShamOTHER

The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will not apply any other force than light hand contact.

Sham

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults 19-45 years

You may not qualify if:

  • Individuals who are pregnant
  • History of cervical or thoracic surgery
  • Bone or joint disease
  • Current infection or tumor
  • Osteopenia/osteoporosis
  • Spinal fracture
  • Rheumatologic pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

  • Terry L Grindstaff, PHD,PT,ATC

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2011

First Posted

January 26, 2012

Study Start

December 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 21, 2012

Record last verified: 2012-11

Locations

US(1)