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

November 8, 2018 updated by: A.T. Still University of Health Sciences

A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain in Dentistry Students: a Randomized Controlled Trial.

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Mesa, Arizona, United States, 85206
        • A. T. Still University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John Heick, PT, DPT, A.T. Still University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

October 10, 2013

First Posted (Estimate)

October 14, 2013

Study Record Updates

Last Update Posted (Actual)

November 13, 2018

Last Update Submitted That Met QC Criteria

November 8, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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