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Mechanical Neck PainNCT02028741

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

A study testing Transverse vertebral pressures in people with Mechanical Neck Pain, run by Robert Boyles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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, Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Mechanical Neck Pain
What is being tested?
Transverse vertebral pressures
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
1 siteUnited States
Study dates
Jan 2011to Dec 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • diagnosis of osteoporosis
  • symptoms suggestive of nerve root compression
  • prior cervical or thoracic spine surgery
  • pending legal action

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Puget Sound

    Tacoma, Washington, 98416

Other trials in United States

About this study

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,

Read the 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.

Being tested
Transverse vertebral pressures
Keywords
neck pain, transverse vertebral pressures, thoracic mobilization
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transverse vertebral pressuresOther

    Graded transverse mobilization directed to the thoracic spine

Study groups in NCT02028741
Study groupRoleWhat they receive
symptomatic intervention groupExperimentalPaitients with mechanical neck pain were treated with transverse vertebral pressures
Receives: Other: Transverse vertebral pressures
aymptomatic non-intervention groupSham comparatorSham treatment to aymptomatic subjects
Receives: Other: Transverse vertebral pressures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Numerical Pain Rating Scale

    Clinical meaningful change is a 2 point change

    Measured: baseline and 1 hour

Secondary outcomes (1)
  1. Cervical Range of Motion

    Range of motion measurements were obtained using a bubble inclinometer

    Measured: baseline and 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2014 (estimated)
  2. Study startJan 2011
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02028741
Sponsor's protocol ID
UPS2011
Status last verified
Jan 2014
First submitted
30 Dec 2013
Last updated
7 Jan 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Transverse vertebral pressures in people with Mechanical Neck Pain, run by Robert Boyles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Numerical Pain Rating Scale (time frame: baseline and 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2014.

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