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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by A.T. Still University of Health Sciences
Sponsor:
Information provided by (Responsible Party):
A.T. Still University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01962090
First received: October 9, 2013
Last updated: October 10, 2013
Last verified: September 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: October 2014
Estimated Primary Completion Date: October 2014 (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

Ages Eligible for Study:   22 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: A.T. Still University of Health Sciences
ClinicalTrials.gov Identifier: NCT01962090     History of Changes
Other Study ID Numbers: 10000350
Study First Received: October 9, 2013
Last Updated: October 10, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2014