Examination of Cervical Thoracic Differentiation Testing in Individuals With Neck Pain
1 other identifier
interventional
48
0 countries
N/A
Brief Summary
Neck pain is a very common diagnosis and physical therapy, specifically thoracic manipulation, has been shown to be an effective treatment. Thoracic manipulation, which involves a quick thrust type push to a segment of the midback region of the spine, has been shown to decrease pain and improve function in individuals with neck pain. However, it is not known if there is a test that will accurately identify individuals with neck pain who would respond more favorably to thoracic techniques. The Cervical-Thoracic Differentiation Test (CTDT) is a test used clinically to differentiate pain originating from either the cervical (neck) or thoracic (midback) regions of the spine in individuals with neck pain. It has also been speculated that specific unloading tests, where a tester selectively unloads a portion of the weight of the cervical or thoracic spine through manual distraction may help determine who will respond more favorably to thoracic treatment. To the best of our knowledge, despite widespread clinical use, these tests have not been tested for validity or reliability at this time. Therefore, the purposes of this research are to assess the reliability and criterion referenced validity of the CTDT and unloading tests, as well as examine the relationship between tests and baseline subject characteristics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2016
CompletedFirst Posted
Study publicly available on registry
August 29, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedDecember 21, 2018
December 1, 2018
9 months
August 24, 2016
December 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain measured on Visual Analog Pain Scale (VAS) in the provocative position
Immediate pre-post intervention
Secondary Outcomes (1)
Pain at rest on VAS
Immediate pre-post intervention
Study Arms (2)
CTDT positive
EXPERIMENTALAll subjects with a positive cervicothoracic differentiation test will be assigned to this arm. All subjects will then receive thoracic spinal manipulation to a level between T1 and T4.
CTDT negative
ACTIVE COMPARATORAll subjects with a negative cervicothoracic differentiation test will be assigned to this arm. All subjects will then receive thoracic spinal manipulation to a level between T1 and T4.
Interventions
The most hypomobile (stiff) and/or painful segment between T1-T4 will be determined , and this is the segment to which the examiner will apply the thrust. The manipulation will be performed with subjects lying supine. The examiner will use a 'pistol grip' to apply pressure on the articular pillars of the thoracic segment bilaterally in order to block the inferior vertebrae of the hypomobile segment. The subject will cross their arms over their chest to the point where the elbows are aligned. This will allow the examiner to apply pressure through both elbows in an anterior-to-posterior direction. The examiner will assure the direction of force is felt into his/her stabilizing hand. The subject will be asked to take a deep breath in and then exhale completely. A grade V (HVLA) thrust will be applied at the end of the subject's exhalation. If a cavitation is not heard or felt by either the subject or examiner, a second thrust will be performed.
Eligibility Criteria
You may not qualify if:
- Via questionnaire:
- Symptoms of radiculopathy (pain below elbow, altered sensation), a history of a whiplash injury within 6 weeks of the examination, pregnancy or potential pregnancy, active cancer, fracture, spinal infections, rheumatoid arthritis, severe osteoporosis, history of oral corticosteroid use, previous spine surgery, workman's compensation claims or pending legal action for the individuals neck pain
- Via physical exam:
- Identification of any medical signs suggestive of a non-musculoskeletal etiology of symptoms such as inability to change pain with motion, evidence of central nervous system involvement, signs consistent with nerve root compression (at least 2 of the following had to be diminished for nerve root involvement to be considered: myotomal strength, dermatomal sensation, or reflexes).
- Any volunteers receiving current Workman's Compensation or with active/pending litigation for their shoulders will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian T Swanson, PT, DSc
University of New England
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 24, 2016
First Posted
August 29, 2016
Study Start
September 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
December 21, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share