NCT02028741

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,

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

December 30, 2013

Last Update Submit

January 6, 2014

Conditions

Mechanical Neck Pain

Keywords

neck paintransverse vertebral pressuresthoracic mobilization

Outcome Measures

Primary Outcomes (1)

  • Change in Numerical Pain Rating Scale

    Clinical meaningful change is a 2 point change

    baseline and 1 hour

Secondary Outcomes (1)

  • Cervical Range of Motion

    baseline and 1 hour

Other Outcomes (1)

  • Pain Pressure Thresholds (PPT)

    baseline and 1 hour

Study Arms (2)

symptomatic intervention group

EXPERIMENTAL

Paitients with mechanical neck pain were treated with transverse vertebral pressures

Other: Transverse vertebral pressures

aymptomatic non-intervention group

SHAM COMPARATOR

Sham treatment to aymptomatic subjects

Other: Transverse vertebral pressures

Interventions

Transverse vertebral pressuresOTHER

Graded transverse mobilization directed to the thoracic spine

aymptomatic non-intervention groupsymptomatic intervention group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Puget Sound

Tacoma, Washington, 98416, United States

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Associate Proferssor

Study Record Dates

First Submitted

December 30, 2013

First Posted

January 7, 2014

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

US(1)