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Cervical Spine Manipulation Affects on Balance and Proprioception

Primary Purpose

Neck Pain, Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cervical Spine Manipulation
Manual Contact
Sponsored by
University of Nevada, Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neck Pain focused on measuring Manipulation, Balance, Proprioception

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy individuals between the ages of 18 and 60

Exclusion Criteria:

  • 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.

Sites / Locations

  • Department of Physical Therapy, University of Nevada Las Vegas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Cervical Spine Manipulation

Manual Contact

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2012
Last Updated
June 17, 2013
Sponsor
University of Nevada, Las Vegas
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1. Study Identification

Unique Protocol Identification Number
NCT01745705
Brief Title
Cervical Spine Manipulation Affects on Balance and Proprioception
Official Title
Immediate Effects of Cervical Spine Manipulation on Balance and Joint Proprioception in Healthy Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Consenting participants will have their proprioception tested through a joint repositioning error test for their cervical spine, and also have their balance tested through a Neurocom Balancemaster. Following these pre-intervention measures, they will receive in a random order, either a cervical spine manipulation (CSM) or a sham manipulation, and then have tests repeated to analyze for changes and differences between interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Headache
Keywords
Manipulation, Balance, Proprioception

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cervical Spine Manipulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Manual Contact
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cervical Spine Manipulation
Intervention Type
Other
Intervention Name(s)
Manual Contact
Primary Outcome Measure Information:
Title
Cervical joint proprioception
Description
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.
Time Frame
1 day (Immediately after the intervention)
Other Pre-specified Outcome Measures:
Title
SMART Neurocom Balance Master
Description
Subjects stand on a force plate on a SMART Neurocom Balance Master and complete a Sensory Organization Test (SOT) program which assesses somatosensory, visual and vestobular systems used in maintaining balance.
Time Frame
1 day (Immediately after the intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy individuals between the ages of 18 and 60 Exclusion Criteria: 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.
Facility Information:
Facility Name
Department of Physical Therapy, University of Nevada Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States

12. IPD Sharing Statement

Links:
URL
http://pt.unlv.edu/louie.htm
Description
Related Info

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Cervical Spine Manipulation Affects on Balance and Proprioception

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