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

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thoracic Spine Thrust in Seated Position
Thoracic Spine Thrust in Supine Position
Sponsored by
A.T. Still University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck Pain, Thoracic spine thrust manipulation, Osteopathic Manipulation, Dentistry, Range of Motion

Eligibility Criteria

22 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • A. T. Still University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Thoracic Spine Thrust in Seated Position

Thoracic Spine Thrust in Supine Position

Arm Description

Thoracic spine thrust manipulation will be applied two times at each of two treatment sessions while the participant is in a seated position.

Thoracic spine thrust manipulation will be applied two times at each of two treatment sessions while the participant is in the supine position.

Outcomes

Primary Outcome Measures

Change in Neck Pain Intensity
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)
Neck range of motion will be measured by a licensed Physical Therapist
Change in Neck Disability Index (NDI)
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)
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

Secondary Outcome Measures

Full Information

First Posted
October 9, 2013
Last Updated
November 8, 2018
Sponsor
A.T. Still University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01962090
Brief Title
Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain in Dentistry Students
Official Title
A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain in Dentistry Students: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
A.T. Still University of Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck Pain, Thoracic spine thrust manipulation, Osteopathic Manipulation, Dentistry, Range of Motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thoracic Spine Thrust in Seated Position
Arm Type
Experimental
Arm Description
Thoracic spine thrust manipulation will be applied two times at each of two treatment sessions while the participant is in a seated position.
Arm Title
Thoracic Spine Thrust in Supine Position
Arm Type
Experimental
Arm Description
Thoracic spine thrust manipulation will be applied two times at each of two treatment sessions while the participant is in the supine position.
Intervention Type
Other
Intervention Name(s)
Thoracic Spine Thrust in Seated Position
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Thoracic Spine Thrust in Supine Position
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Neck Pain Intensity
Description
Each participant's neck pain intensity will be assessed by use of the Numeric Pain Rating Scale (NPRS of 0-10)
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
Title
Change in Neck Range of Motion (ROM)
Description
Neck range of motion will be measured by a licensed Physical Therapist
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
Title
Change in Neck Disability Index (NDI)
Description
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
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
Title
Change in Shortened version of the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire (QuickDASH)
Description
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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 serious pathologies or conditions (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, history of prolonged steroid use) hyperreflexia unsteadiness during gait Nystagmus Loss of visual acuity Impaired sensation of the face Altered taste The presence of pathological reflexes pregnancy or considering pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Heick, PT, DPT
Organizational Affiliation
A.T. Still University
Official's Role
Principal Investigator
Facility Information:
Facility Name
A. T. Still University
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States

12. IPD Sharing Statement

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

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