search
Back to results

The Immediate Effects of Thoracic Transverse Mobilization in Patients With Primary Complaint of Mechanical Neck Pain: A Pilot Study

Primary Purpose

Mechanical Neck Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transverse vertebral pressures
Sponsored by
Robert Boyles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Neck Pain focused on measuring neck pain, transverse vertebral pressures, thoracic mobilization

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ages 18 to 6 years
  • mechanical neck pain defined as pain exacerbated by movement.

Exclusion Criteria:

  • unexplained night pain
  • unexplained weight loss
  • numbness and tingling in the arms and/or legs
  • balance or coordination problems
  • morning stiffness lasting greater than one hour
  • a history of whiplash injury within six weeks of treatment
  • diagnosis of osteoporosis
  • symptoms suggestive of nerve root compression
  • prior cervical or thoracic spine surgery
  • pending legal action

Sites / Locations

  • University of Puget Sound

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

symptomatic intervention group

aymptomatic non-intervention group

Arm Description

Paitients with mechanical neck pain were treated with transverse vertebral pressures

Sham treatment to aymptomatic subjects

Outcomes

Primary Outcome Measures

Change in Numerical Pain Rating Scale
Clinical meaningful change is a 2 point change

Secondary Outcome Measures

Cervical Range of Motion
Range of motion measurements were obtained using a bubble inclinometer

Full Information

First Posted
December 30, 2013
Last Updated
January 6, 2014
Sponsor
Robert Boyles
search

1. Study Identification

Unique Protocol Identification Number
NCT02028741
Brief Title
The Immediate Effects of Thoracic Transverse Mobilization in Patients With Primary Complaint of Mechanical Neck Pain: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert Boyles

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to explore the immediate effects of transversrse vertebral pressures (TVP) to the thoracic spine on cervical range of motion and pain in subjects with neck pain,
Detailed Description
Recruitment was by convenience sampling via referrals from local physical therapists and flyers posted on a university campus. Participants were assigned to either a transverse vertebral pressures mobilization group or a control group. Inclusion criteria for the mobilization group were 1) ages 18 to 60, and 2) mechanical neck pain defined as pain exacerbated by movement. Among the exclusion criteria were unexplained night pain, unexplained weight loss, numbness and tingling in the arms and/or legs, balance or coordination problems, morning stiffness lasting greater than one hour, a history of whiplash injury within six weeks of treatment, diagnosis of osteoporosis, symptoms suggestive of nerve root compression, prior cervical or thoracic spine surgery, or a pending legal action. Inclusion criteria for the control group were 1) ages 18 to 60, and 2) asymptomatic neck and thoracic regions over the previous six years by subject report. The latter group was labeled "control" in the sense that it allowed blinding of the rater rather than in the sense of a sham treatment group. The project was approved by the University of Puget Sound Institutional Review Board, and written informed consent was obtained from all the subjects. Outcome Measures Outcomes of interest were active neck motion, pressure pain threshold (PPT) and report of pain. For active range of motion, a single bubble inclinometer (MIE Inclinometer, Medical Research Ltd, London, UK) was used to measure flexion, extension, and side-flexion with the subjects seated. Since measurement of rotation by inclinometer would introduce a change from the sitting position, a universal goniometer was chosen to measure rotation. De Koning et al conducted a systematic review of seated inclinometry for quantifying active cervical ROM. Interrater intraclass correlation coefficients (ICCs) for flexion, extension and lateral flexion varied from 0.81 to 0.94 for healthy subjects and from 0.68 to 0.86 for those with neck pain. Among patients with mechanical neck pain, ICCs for cervical rotation using the universal goniometer in sitting have been reported as 0.77 to the right and 0.57 to the left.12 In order to consider a motion to have changed, we required statistical significance at ≤ 0.01 and a difference in degrees of ≥5. Before commencing the study, one researcher participated in a training session followed by intra-rater reliability testing for all ROM measurements. PPT, the minimum pressure that induces pain, was measured at the right lateral epicondyle using a hand-held digital algometer (Model FPX 25, Wagner Instruments, Greenwich CT.) Three measurements were taken separated by 10 second intervals, and the mean of these trials was used for analysis. Good to excellent reproducibility, intra-rater and inter-rater reliabilities for PPT have been reported.13-15 However, Prushansky et al reported a significant difference between raters which prompted the recommendation that PPT measurement should be performed by the same rater when utilized as an outcome measure. We followed this recommendation. An 11-point numerical pain rating scale (NPRS) was used to assess pain before and after the intervention. Cleland et al reported the psychometric properties of the NPRS specific to neck pain in a cohort of 137 patients. Test-retest reliability was moderate (ICC=.76; CI, .51-.87). The minimum clinically important difference for neck pain in his study was a change of 1.3 points. In our study, we selected a requirement of a 1.5-point change for clinical importance. Study Protocol After determining eligibility, baseline ROM and PPT scores were taken by one blinded rater, and subjects completed an NPRS. The mobilization group was treated with non-thrust transverse vertebral pressures as described by Maitland. The patient lay prone with arms to the side and in a "forehead rest position". Pressures were applied to spinal levels T1 through T4. The spinous process of T1 was identified by first locating C6 using the cervical extension method17 and then counting caudally. The researcher stood at the level of the vertebra to be mobilized on one side of the subject. The pad of the researcher's non-dominant thumb was placed in contact with the lateral aspect of the spinous process of T1, while the dominant thumb was placed on the dorsal side of the other thumb. Pressure was applied to the spinous process to produce small amplitude, low velocity oscillation into resistance to the end-range of the vertebra (Grades IV to IV+). This procedure was performed for 30 seconds, then sequentially applied to the next caudal level through T4. The same pattern of application was used on the subject's contralateral side. The entire procedure was repeated once again for a total of 8 minutes. This was followed by a repeat of the outcome measurements. The control group received no treatment. Each control subject assumed the same prone position for 8 minutes as was used with the mobilization group and outcome measurements were repeated. The researcher performing the outcome measurements was blinded to group assignment. All subjects were clothed such that no localized residual evidence of thoracic manual contact was visible. Statistical Analyses Data were analyzed with SPSS, Version 14.0 (SPSS, Inc, Chicago IL). We compared pre-intervention data between the transverse mobilization group and the control group utilizing independent t-tests for ROM and PPT, and the Mann-Whitney test for NPRS scores. We compared pre and post session measurements within each group utilizing paired t-tests for ROM and PPT, and the Wilcoxon signed-ranks test for NPRS scores.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Neck Pain
Keywords
neck pain, transverse vertebral pressures, thoracic mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
symptomatic intervention group
Arm Type
Experimental
Arm Description
Paitients with mechanical neck pain were treated with transverse vertebral pressures
Arm Title
aymptomatic non-intervention group
Arm Type
Sham Comparator
Arm Description
Sham treatment to aymptomatic subjects
Intervention Type
Other
Intervention Name(s)
Transverse vertebral pressures
Intervention Description
Graded transverse mobilization directed to the thoracic spine
Primary Outcome Measure Information:
Title
Change in Numerical Pain Rating Scale
Description
Clinical meaningful change is a 2 point change
Time Frame
baseline and 1 hour
Secondary Outcome Measure Information:
Title
Cervical Range of Motion
Description
Range of motion measurements were obtained using a bubble inclinometer
Time Frame
baseline and 1 hour
Other Pre-specified Outcome Measures:
Title
Pain Pressure Thresholds (PPT)
Description
PPT measured using a dgital algometer
Time Frame
baseline and 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ages 18 to 6 years mechanical neck pain defined as pain exacerbated by movement. Exclusion Criteria: unexplained night pain unexplained weight loss numbness and tingling in the arms and/or legs balance or coordination problems morning stiffness lasting greater than one hour a history of whiplash injury within six weeks of treatment diagnosis of osteoporosis symptoms suggestive of nerve root compression prior cervical or thoracic spine surgery pending legal action
Facility Information:
Facility Name
University of Puget Sound
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98416
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Immediate Effects of Thoracic Transverse Mobilization in Patients With Primary Complaint of Mechanical Neck Pain: A Pilot Study

We'll reach out to this number within 24 hrs