NCT01258543

Brief Summary

The purpose of this study is to determine whether two osteopathic evaluators with less than 5 years experience will be able to determine the same location and nature of the primary lesion(s) or restriction(s)in patients with chronic non-specific back pain using a global osteopathic evaluation approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

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

November 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2010

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 13, 2011

Status Verified

June 1, 2011

Enrollment Period

2 months

First QC Date

December 10, 2010

Last Update Submit

June 9, 2011

Conditions

Inter-examiner ReliabilityLocation and Nature of Restriction or LesionNon-specific Back Pain

Keywords

Global osteopathic evaluationNon-specific back painInter-examiner reliability

Outcome Measures

Primary Outcomes (1)

  • Inter-examiner reliability

    Inter-examiner reliability between two evaluators for nature and location of primary restriction(s), lesion(s) found during a global osteopathic evaluation

    Day 1

Study Arms (1)

Non-specific back pain

Other: General Osteopathic Evaluation

Interventions

General Osteopathic EvaluationOTHER

2 general osteopathic evaluations of approximately 1 hour in duration done consecutively on the same day with a 15 minute break between evaluations

Non-specific back pain

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community Sample

You may qualify if:

  • Men and women ages 18-60
  • Must have a history of non-specific back pain (not due to any known pathology eg. disc herniation or disc degenerative disease) that is currently not irritated and has not been, in the past 8 weeks
  • Must be available for 3 consecutive hour

You may not qualify if:

  • Patients with a known cause for their back pain
  • Patients who have had a flare up of symptoms within the last 8 weeks
  • Patients who are currently undergoing any rehabilitation or who have received manual treatment in the last 8 weeks.
  • Patients who are taking daily medications for pain
  • Pregnant women
  • Major medical conditions: fractures, degenerative arthritis, inflammatory disorders, ankylosing spondylitis, multiple sclerosis, cancer, paralysis stroke or recent concussion history
  • Any other conditions that would prevent the participant from completing the evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Concordia Physio Sport

Brossard, Quebec, J4Z 1A7, Canada

Location

Related Publications (43)

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Study Officials

  • RenĂ© Pelletier, MSc., D.O

    STUDY DIRECTOR

  • Sabrina Silla, BSc., PT, DO

    STUDY DIRECTOR

  • Jaime Kirnan, BSc., CAT(c)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDIV

Study Record Dates

First Submitted

December 10, 2010

First Posted

December 13, 2010

Study Start

November 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

June 13, 2011

Record last verified: 2011-06

Locations

CA(1)