NCT01376687

Brief Summary

Back pain affects the majority of the population at some time. Currently there are no published and scientifically accepted objective measures to support manual medicine diagnostic and treatment techniques for back pain. The purpose of this project is to collect and evaluate objective (pressure and motion) data from standard clinical diagnostic tests.

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 all trials

Timeline
Completed

Started Sep 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

December 1, 2011

Status Verified

November 1, 2011

Enrollment Period

11 months

First QC Date

June 16, 2011

Last Update Submit

November 30, 2011

Conditions

Cervical Spine

Keywords

Osteopathic MedicineCervical SpineKinetics

Outcome Measures

Primary Outcomes (1)

  • Feasibility of obtaining force data during clinical assessment

    Assessment of force sensing equipment while conducting clinical diagnoses

    1 year

Study Arms (2)

Pain free

No pain in the cervical spine

Pain

Pain of 3 or greater on a VAS scale for the cervical spine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HEalthy and no pain in cervical spine Pain of 3 or greater in cervical spine

You may qualify if:

  • HEalthy and no pain in cervical spine
  • Pain of 3 or greater in cervical spine

You may not qualify if:

  • pain of less than 3 in the cervical spine region
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 20, 2011

Study Start

September 1, 2010

Primary Completion

August 1, 2011

Study Completion

November 1, 2011

Last Updated

December 1, 2011

Record last verified: 2011-11

Locations

US(1)