Examination of Cervical Thoracic Differentiation Testing in Individuals With Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Thoracic spinal manipulation
Intervention type(s): Procedure
Intervention description(s): 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.
Other intervention name(s): HVLA thrust manipulation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: neck pain; physical examination; thoracic manipulation