NCT02882061

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

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Status
completed

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

9 months

First QC Date

August 24, 2016

Last Update Submit

December 19, 2018

Conditions

Keywords

neck painphysical examinationthoracic manipulation

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

EXPERIMENTAL

All 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.

Procedure: Thoracic spinal manipulation

CTDT negative

ACTIVE COMPARATOR

All 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.

Procedure: Thoracic spinal manipulation

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.

Also known as: HVLA thrust manipulation
CTDT negativeCTDT positive

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brian T Swanson, PT, DSc

    University of New England

    PRINCIPAL INVESTIGATOR

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