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Cervical Spine Manipulation Affects on Balance and Proprioception

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Emilio, University of Nevada
ClinicalTrials.gov Identifier:
NCT01745705
First received: December 5, 2012
Last updated: December 7, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Neck Pain
Headache
 Other: Cervical Spine Manipulation
Other: Manual Contact

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Immediate Effects of Cervical Spine Manipulation on Balance and Joint Proprioception in Healthy Individuals

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nevada, Las Vegas:

Primary Outcome Measures:
  • Cervical joint proprioception [ Time Frame: 1 day (Immediately after the intervention) ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • SMART Neurocom Balance Master [ Time Frame: 1 day (Immediately after the intervention) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervical Spine Manipulation
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
Sham Comparator: Manual Contact
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745705

Locations
United States, Nevada
Department of Physical Therapy, University of Nevada Las Vegas
Las Vegas, Nevada, United States, 89154
Sponsors and Collaborators
University of Nevada, Las Vegas
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Emilio, Assistant Professor, University of Nevada
ClinicalTrials.gov Identifier: NCT01745705     History of Changes
Other Study ID Numbers: 1105-3780
Study First Received: December 5, 2012
Last Updated: December 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nevada, Las Vegas:
Manipulation
Balance
Proprioception

Additional relevant MeSH terms:
Neck Pain
Headache
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013