Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02882061 |
| Other study ID # |
071316-003 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2016 |
| Est. completion date |
June 1, 2017 |
Study information
| Verified date |
December 2018 |
| Source |
University of New England |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
The research aims and hypotheses are:
Aim 1: Evaluate the inter-tester reliability of the CTDT and regional (cervical or thoracic)
unloading tests Ho1: The CTDT and regional unloading tests will not demonstrate reliability
greater than κ=.75 Ha1: The CTDT and regional unloading tests will demonstrate reliability
greater than κ=.75
Aim 2: Determine if there are differences in pain response following thoracic manipulation
between subjects with positive and negative CTDT results.
Ho2: There will be no difference in response (change in pain, VAS) following thoracic
manipulation between participants with positive CTDT and negative CTDT results Ha2: There
will be statistically significant differences in response (change in pain, VAS) between
individuals with positive CTDT results compared to those with negative CTDT results
Aim 3: Determine if a relationship exists between CTDT results and the results of cervical
and thoracic unloading tests.
Ho3: There will be no statistically significant correlation between CTDT results and results
of unloading tests Ha3: There will be significant correlations between positive CTDT results
and positive thoracic unloading results
Aim 4: Determine if a relationship exists between overall result (responder/non-responder)
and CTDT results Ho4: There will not be a significant relationship between responder status
and CTDT results Ha4: There will be a significant relationship, Φ>.06, between responder
status and CTDT result.
Aim 5: Determine if a relationship exists between overall result (responder/non-responder)
and various demographic factors (Neck Disability Index (NDI) score, age, pain level, duration
of symptoms) A total of 50 subjects will be recruited into this trial. All subjects will
first complete a brief screening questionnaire to determine study eligibility. All eligible
subjects will then undergo an informed consent process including the opportunity to have all
questions answered. Once consent is obtained, subjects will then be screened by a licensed
physical therapist to rule out any contraindications to study participation. Subjects will
also complete the neck disability index (NDI). This questionnaire will be used as a baseline
variable to ensure group equality for levels of self perceived disability due to their neck
pain.
This study will consist of two distinct, but concurrent, phases. The first will consist of a
reliability phase. A total of 20 subjects will be tested by each of two trained examiners on
the same day for both the CTDT and two unloading tests. These 20 subjects will be part of the
larger subject pool, and will be a sample of convenience based on the availability of two
examiners on the day of enrollment. Each investigator will perform the CTDT; additionally the
investigator will perform a cervical distraction test and a separate thoracic distraction
test. These findings will be recorded, and then a second investigator (blinded to the results
of the first investigator) will repeat these tests to allow for determination of inter-rater
reliability. Upon completion of the reliability testing, these subjects will proceed directly
to the intervention phase of the study. Subjects enrolled on days with only one examiner
available, or after 20 subjects have been assessed for reliability, will enroll directly into
the second phase.
The intervention phase will include the thoracic manipulation intervention. Subjects will
first be asked to complete a visual analog pain scale, both at rest and while moving their
head to their most painful position. In the event that a subject has equal pain with rotation
to both sides, they will be asked to choose the most bothersome side as our reference
criterion. The CTDT and unloading tests will be performed as described below. For all
subjects, the investigator will then perform up to two supine thoracic thrust manipulations.
Post-intervention, subjects will repeat the VAS in both the resting and provocative
positions. Change in pain on the VAS will be compared to the subject's FINAL trial of the
CTDT and unloading tests for data analysis.
Specific tests and interventions:
VAS Pain will be assessed for all subjects using a 100mm VAS, both at rest and in their most
provocative position. This will be administered both pre and post manipulation as the measure
of change. Subject ratings of pain on the VAS will be measured by a blinded examiner who will
not be aware of CTDT group assignment.
Cervico-thoracic differentiation test (CTDT) Subjects will be tested via CTDT as described by
Evjenth & Gloeck. The test reportedly differentiates between pain originating in the cervical
and upper thoracic regions. The test will be performed with subjects sitting in erect posture
as described by Dunleavy and Goldberg, with an investigator facing them. Subjects will be
asked to move through full cervical range of motion (ROM) in each direction (flexion,
extension, right rotation, left rotation) to find their most painful direction. They will
then be asked to move into their most painful cervical motion until their pain comes on. The
investigator will note this position and it will be considered to be the motion of interest
for the outcome analysis, and the subject will complete a VAS for their pain experienced
while in this position. The subject will then return the head/neck to the resting posture;
the thoracic spine will be positioned opposite the provocative cervical direction, with the
participant asked to repeat the painful cervical motion while the examiner holds the subject
in the new thoracic position. This position of the cervical spine will again be noted by the
investigator, and the investigator will ask the subject: "Are your symptoms 'better',
'worse', or 'the same'"? A positive test includes a response of 'better', as well as 'the
same' when a significant improvement in cervical motion (operationally defined as more than
10 degrees) is obtained. A negative test includes a response of 'worse', as well as 'the
same' when a significant improvement in cervical motion is not observed.
Cervical unloading The cervical unloading test will be performed as described by Kaltenborn.
This test involves unloading of the cervical and upper thoracic vertebrae. The test will be
performed with subjects sitting in erect posture with an investigator standing behind them.
If the subjects have pain in the neutral cervical position, cervical unloading will be
performed by the investigator in the neutral posture. However, if the subjects do not have
pain in this neutral cervical position, cervical unloading will be performed with the
cervical spine in the position identified as most provocative. In both scenarios, cervical
unloading consists of the investigator gently lifting upward on the subject's head to unload
his/her cervical spine. The subject will then be asked to report if his/her pain is 'better',
'worse', or 'the same'. A positive test is indicated if the subject reports 'better', while a
negative test is indicated if the subject reports 'worse' or 'the same'.
Thoracic unloading The thoracic unloading test will be performed as described by Kaltenborn.
This test involves unloading of the thoracic vertebrae. The test will be performed with
subjects sitting in erect posture with an investigator standing behind them. If the subjects
have pain in the neutral position, thoracic unloading will be performed by the investigator
in the neutral posture. However, if the subjects do not have pain in this neutral position,
thoracic unloading will be performed with the cervical spine in the position identified as
the concordant sign. In all scenarios, the subjects will be asked to cross their arms by
putting their hands on their opposite upper arms. Thoracic unloading consists of the
investigator gently lifting upward on the subject's elbows to unload his/her thoracic spine.
The subject will then be asked to report if his/her pain is 'better', 'worse', or 'the same'.
A positive test is indicated if the subject reports 'better', while a negative test is
indicated if the subject reports 'worse' or 'the same'.
Grade V thrust manipulation Supine grade V thrust manipulation will be performed as described
by Cleland and Karas. The supine technique was selected as it has been shown to elicit a
greater change in pain when compared to seated techniques, and is more readily applied to the
upper thoracic region than prone techniques. First, the examiner will assess joint play of
the segments of the upper thoracic spine. The most hypomobile (stiff) and/or painful segment
between T1-T4 will be determined at the examiner's discretion, 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 selected thoracic segment bilaterally in order to block the inferior vertebrae
of the hypomobile segment. The subject will cross his/her arms over his/her chest to the
point where his/her 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 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. After completion of this manipulation, subjects will be
returned to an erect sitting position and asked to complete a second VAS, both at rest and in
the predetermined provocative position.
A-prioi levels of significance will be established at the p=.05 level.
Data will be analyzed quantitatively in aggregate form. Inter rater reliability will be
assessed with the Kappa statistic.
Groups (CTDT +,-) will be analyzed for baseline differences for age, gender, NDI score,
direction of concordant sign, and chronicity.
Tests of difference will be utilized to assess for statistically significant differences
between the positive and negative CTDT response groups. This will include t-tests or
non-parametric equivalent tests for within and between group change; selection will be based
on normality of data/meeting parametric assumptions.
Criterion referenced validity of the CTDT and regional unloading tests will be determined
using responder analysis. The reference criterion will be pain relief meeting/not meeting the
minimal clinically important difference (MCID) on the VAS following thoracic manipulation
(the intervention purportedly indicated as the result of a positive CTDT). Subjects will be
identified as responders/non-responders based on a change in VAS score in the concordant
position, pre-post manipulation. The classification of responder will be determined by
exceeding the established MCID of the 100mm VAS, reported to be change of at least 15mm or
20%.
The statistical relationship between responder status and CTDT test response will be analyzed
as dichotomous nominal variables, assessed via Fisher's Exact Test.
