NCT01745705

Brief Summary

Cervical spine manipulation (CSM) is utilized by many health care practitioners in the management of patients with neck pain and headache. How CSM works is not understood however, most researchers agree that there is likely a combination of mechanical, neurophysiological and placebo effects. This study will test for possible neurophysiological effects by examining for changes in a person's ability to reposition their head and neck in space, and maintain their balance following CSM.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

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

April 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

2.2 years

First QC Date

December 5, 2012

Last Update Submit

June 17, 2013

Conditions

Keywords

ManipulationBalanceProprioception

Outcome Measures

Primary Outcomes (1)

  • Cervical joint proprioception

    Subjects wear a headband with a mounted laser pointer and sit 1 meter away from a wall. They assume their comfortable neutral cervical posture and then close their eyes and extend their cervical spine and return to their neutral posture with eyes closed. The laser pointer marks the point of return and we measure the difference between start and end points for error.

    1 day (Immediately after the intervention)

Other Outcomes (1)

  • SMART Neurocom Balance Master

    1 day (Immediately after the intervention)

Study Arms (2)

Cervical Spine Manipulation

EXPERIMENTAL

Subjects will lie supine on a treatment table and receive a high velocity low amplitude thrust joint manipulation to their cervical spine in rotation to each side of the neck.

Other: Cervical Spine Manipulation

Manual Contact

SHAM COMPARATOR

Subjects will lie supine on a treatment table and have their suboccipital region gently cupped by the therapist for 30 seconds. No movement or force will be applied, just simple manual contact.

Other: Manual Contact

Interventions

Cervical Spine Manipulation
Manual Contact

Eligibility Criteria

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

You may qualify if:

  • healthy individuals between the ages of 18 and 60

You may not qualify if:

  • current neck pain/symptoms; neck pain symptoms within the last 6 months; confirmation or possibility of pregnancy; dizziness; vertigo, or nausea; history of cervical spine surgery; rheumatoid arthritis; osteoporosis; osteopenia; ankylosing spondylitis; cancer; or vertebral artery insufficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy, University of Nevada Las Vegas

Las Vegas, Nevada, 89154, United States

Location

Related Links

MeSH Terms

Conditions

Neck PainHeadache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 5, 2012

First Posted

December 10, 2012

Study Start

April 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations