Low Back Pain Patient Education Evaluation | NCT00000408

Studies
Low Back Pain Patient Education Evaluation

NCT00000408

Sponsor

Stanford University

Status

Completed

Last Update Posted

May 3, 2013Estimated

Enrollment

580Actual

Phase

Not Applicable

Conditions

Low Back Pain

Interventions

Patient education evaluation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01AR044939	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2003

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1998

Primary Completion Date

Feb 2002Actual

Completion Date

Feb 2002Actual

First Submitted Date

Nov 3, 1999

First Submission Date that Met QC Criteria

Nov 3, 1999

First Posted Date

Nov 4, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2013

Last Update Posted Date

May 3, 2013Estimated

Name	Class
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Back pain is one of the most common of all symptoms. It is also a great cause of days lost from work and visits to health care providers. This study will develop and evaluate an approach to low back pain that allows subjects to talk with each other and with health professionals via an Internet discussion group. Results we will look at include health behaviors, such as exercise; health status, such as pain and disability; and health care use, such as number of visits to doctors and other health care providers. Anyone 18 years old or older who lives in the United States and has ongoing Internet access can take part in the study. All subjects must have back pain and meet the eligibility criteria listed below.

Detailed Description

This study will develop and evaluate in a randomized trial a low back pain intervention that allows subjects to talk with each other and with health professionals via an Internet discussion group. The intervention consists of a book and a videotape and is based on interaction with other participants in the program and health professionals through a closed password protected moderated Internet discussion group. Outcome measures include health behaviors, such as exercise; health status, such as pain and disability; and health care use, such as number of visits to doctors and other health care providers. Patients will be randomized either to the treatment group and followed for 6, 12, 18, and 24 months with the intervention.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

580Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
email discussion group	Experimental		Procedure: Patient education evaluation
rancomized control group	No Intervention	usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patient education evaluation	Procedure		email discussion group

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must live in the United States
Must understand and write English
Must have access to a computer with e-mail and expect to have this access for at least 3 years
Must be 18 years old
Must have seen a doctor for back pain at least once in the past year

Exclusion Criteria:

Pregnancy
Back surgery in the past 6 months
Expectation of having back surgery in the next 6 months
Back pain due to a car accident or other major injury within the last 6 months
Back pain or sciatica due to systemic disease (inflammatory rheumatic diseases, tumor, or other)
Major physical or mental health condition for which one is currently being treated that severely limits daily activities
Terminal illness
Receiving disability or workers compensation insurance payments for back pain or sciatica
Presently involved in legal proceedings because of back pain or sciatica
Difficulty with bladder or bowel control that began with back pain or sciatica
No visits to a doctor in the past year for back pain or sciatica
Numbness in crotch area that began with back pain or sciatica
Age under 18

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kate R. Lorig, Dr.P.H.	Stanford University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Palo Alto	California	94305	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11926853	Result	Lorig KR, Laurent DD, Deyo RA, Marnell ME, Minor MA, Ritter PL. Can a Back Pain E-mail Discussion Group improve health status and lower health care costs?: A randomized study. Arch Intern Med. 2002 Apr 8;162(7):792-6. doi: 10.1001/archinte.162.7.792.
16122642	Result	Bruce B, Lorig K, Laurent D, Ritter P. The impact of a moderated e-mail discussion group on use of complementary and alternative therapies in subjects with recurrent back pain. Patient Educ Couns. 2005 Sep;58(3):305-11. doi: 10.1016/j.pec.2004.08.012.

ID	Term
D017116	Low Back Pain
D006266	Health Education
D019567	Back Injuries
D059350	Chronic Pain

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms