NCT00170118

Brief Summary

The majority of the study consists of standard of care treatment for people with low back pain that has lasted more than three months. Half of the participants in the study will receive physical therapy from physical therapists that have received additional training in an educational technique. In order to determine if there is a difference in patient outcome when the educational technique is used, you will be asked to complete five short surveys before receiving physical therapy (10 minutes total). A sample of the physical therapy sessions using the educational technique will be videotaped. The videotape will be of the physical therapist to prove they did use the educational technique, not of you the participant in the study. You will remain anonymous and will not be used and the tape will not be used for publication or presentation purposes. You will also be asked to complete one survey after participating in physical therapy (2 minutes), and all five short surveys (10 minutes total) six weeks after your last physical therapy session. You will be put in one of 2 groups by chance (as in the flip of a coin). A computerized selection process will be used to assign participants to the study. You will not know if you are in the study group or the non-study group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2005

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

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

January 28, 2010

Status Verified

January 1, 2010

Enrollment Period

1.3 years

First QC Date

September 13, 2005

Last Update Submit

January 27, 2010

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (5)

  • SF - 12

  • Self-efficacy for Managing Chronic disease 6-Item scale

  • Roland and Morris Disability Questionnaire

  • Pain Visual analog scale

  • Satisfaction with care question

Secondary Outcomes (1)

  • Disability status question

Interventions

motivational interviewingBEHAVIORAL

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Catherine K. Schmidt, MS DO

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

June 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

January 28, 2010

Record last verified: 2010-01

Locations

US(1)