NCT01962090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 13, 2018

Status Verified

November 1, 2018

Enrollment Period

1.6 years

First QC Date

October 9, 2013

Last Update Submit

November 8, 2018

Conditions

Neck Pain

Keywords

Neck PainThoracic spine thrust manipulationOsteopathic ManipulationDentistryRange of Motion

Outcome Measures

Primary Outcomes (4)

  • 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)

    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)

    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)

    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)

    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

Study Arms (2)

Thoracic Spine Thrust in Seated Position

EXPERIMENTAL

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

Thoracic Spine Thrust in Supine Position

EXPERIMENTAL

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

Interventions

Thoracic Spine Thrust in Seated PositionOTHER

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.

Thoracic Spine Thrust in Seated Position
Thoracic Spine Thrust in Supine PositionOTHER

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.

Thoracic Spine Thrust in Supine Position

Eligibility Criteria

Age22 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A. T. Still University

Mesa, Arizona, 85206, United States

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Sitting PositionSupine Position

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • John Heick, PT, DPT

    A.T. Still University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2013

First Posted

October 14, 2013

Study Start

October 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

November 13, 2018

Record last verified: 2018-11

Locations

US(1)