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Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain in Dentistry Students

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by A.T. Still University of Health Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01962090
First Posted: October 14, 2013
Last Update Posted: February 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
A.T. Still University of Health Sciences
  Purpose

This study is designed to compare the short term effects of two different thoracic spine thrust manipulation techniques on neck range of motion, pain, and self-reported disability in a sample of dental students experiencing neck pain.

The hypothesis of the study is that there will be a difference between the two thoracic spine thrust manipulation techniques for short term effects on neck range of motion, pain, and self-reported disability in a sample of dental students experiencing neck pain.


Condition Intervention
Neck Pain Other: Thoracic Spine Thrust in Seated Position Other: Thoracic Spine Thrust in Supine Position

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain in Dentistry Students: a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by A.T. Still University of Health Sciences:

Primary Outcome Measures:
  • Change in Neck Pain Intensity [ Time Frame: Collected at baseline assessment during initial visit before 1st treatment, one week later before 2nd treatment, and one week later at follow-up appointment - total of 2- 3 weeks anticipated ]
    Each participant's neck pain intensity will be assessed by use of the Numeric Pain Rating Scale (NPRS of 0-10)

  • Change in Neck Range of Motion (ROM) [ Time Frame: Collected at baseline assessment during initial visit before 1st treatment, one week later before 2nd treatment, and one week later at follow-up appointment - total of 2- 3 weeks anticipated ]
    Neck range of motion will be measured by a licensed Physical Therapist

  • Change in Neck Disability Index (NDI) [ Time Frame: Collected at baseline assessment during initial visit before 1st treatment, one week later before 2nd treatment, and one week later at follow-up appointment - total of 2- 3 weeks anticipated ]
    The Neck Disability Index (NDI) is a self-reported measure of disability consisting of a 0-50 point scale where higher scores indicate higher levels of disability

  • Change in Shortened version of the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire (QuickDASH) [ Time Frame: Collected at baseline assessment during initial visit before 1st treatment, one week later before 2nd treatment, and one week later at follow-up appointment - total of 2- 3 weeks anticipated ]
    The shortened version of the Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire is a self-report measure of function that can assess how neck pain may be impacting daily activities that require use of the upper limb


Estimated Enrollment: 50
Study Start Date: October 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thoracic Spine Thrust in Seated Position
Thoracic spine thrust manipulation will be applied two times at each of two treatment sessions while the participant is in a seated position.
Other: Thoracic Spine Thrust in Seated Position
The thoracic spine manipulation used here is a manipulation technique that involves positioning the patient so that a small amplitude quick stretch can be applied to the least mobile area of the thoracic spine as identified by the licensed physical therapist during spinal segmental mobility testing.
Experimental: Thoracic Spine Thrust in Supine Position
Thoracic spine thrust manipulation will be applied two times at each of two treatment sessions while the participant is in the supine position.
Other: Thoracic Spine Thrust in Supine Position
The thoracic spine manipulation used here is a manipulation technique that involves positioning the patient so that a small amplitude quick stretch can be applied to the least mobile area of the thoracic spine as identified by the licensed physical therapist during spinal segmental mobility testing.

  Eligibility

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Ages Eligible for Study:   22 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current student at the Arizona School of Dentistry and Oral Health (ASDOH) at A. T. Still University
  • Primary complaint of neck pain with or without symptoms that spread down into one arm
  • Overall rating of neck pain intensity is at least 3/10; the overall rating is the overall average of the participant's rating of current, least, and worst pain experienced over the previous 24 hours on separate numeric pain rating scales where 0 corresponds to "no pain" and 10 corresponds to "worst pain possible".
  • Neck Disability Index (NDI) score > 10 points (measure of self-reported disability with a 0 to 50 point scale where higher scores indicate higher levels of disability.
  • Proficient in speaking and reading English to complete outcome questionnaires

Exclusion Criteria:

  • Neck pain related to a motor vehicle accident or other trauma within the previous 6 weeks
  • Neck pain that spreads down into both arms
  • Low back pain or thoracic origin of pain
  • Nerve root involvement; defined as the presence of two or more neurological findings (e.g. decreased strength, diminished deep tendon reflex, or decreased sensation) at the same nerve root level
  • Diagnosis of cervical spine stenosis (narrowing of the central canal that contains the spinal cord)
  • History of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery
  • Pending legal action related to current episode of neck pain
  • Contraindications to thoracic spine thrust manipulation

    1. serious pathologies or conditions (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, history of prolonged steroid use)
    2. hyperreflexia
    3. unsteadiness during gait
    4. Nystagmus
    5. Loss of visual acuity
    6. Impaired sensation of the face
    7. Altered taste
    8. The presence of pathological reflexes
    9. pregnancy or considering pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962090


Locations
United States, Arizona
A. T. Still University Recruiting
Mesa, Arizona, United States, 85206
Contact: John Heick, PT, DPT    480-219-6065    jheick@atsu.edu   
Principal Investigator: John Heick, PT, DPT         
Sub-Investigator: Robert Nee, PT, PhD         
Sub-Investigator: Sean Flanigan, PT, DPT         
Sub-Investigator: Cory McKinnon, PT, DPT         
Sub-Investigator: Calvin Noonan, PT, DPT, ATC         
Sub-Investigator: Leah Weinstein, SPT         
Sub-Investigator: Duyan M Tran, SPT         
Sub-Investigator: Sarah Rachwalski, SPT         
Sponsors and Collaborators
A.T. Still University of Health Sciences
  More Information

Responsible Party: A.T. Still University of Health Sciences
ClinicalTrials.gov Identifier: NCT01962090     History of Changes
Other Study ID Numbers: 10000350
First Submitted: October 9, 2013
First Posted: October 14, 2013
Last Update Posted: February 20, 2015
Last Verified: September 2013

Keywords provided by A.T. Still University of Health Sciences:
Neck Pain
Thoracic spine thrust manipulation
Osteopathic Manipulation
Dentistry
Range of Motion

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