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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01962090
Other study ID # 10000350
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2013
Est. completion date May 2015

Study information

Verified date November 2018
Source A.T. Still University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender All
Age group 22 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States A. T. Still University Mesa Arizona

Sponsors (1)

Lead Sponsor Collaborator
A.T. Still University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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