Back to resultsLow Back Pain Patient Education Evaluation
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient education evaluation
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Health education, Back injury, Chronic pain, Education/evaluation planning, Outcomes research
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
email discussion group
rancomized control group
Arm Description
usual care
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000408
First Posted
November 3, 1999
Last Updated
April 30, 2013
Sponsor
Stanford University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT00000408
Brief Title
Low Back Pain Patient Education Evaluation
Official Title
Evaluation of a Low Back Pain Patient Education Program
Study Type
Interventional
2. Study Status
Record Verification Date
February 2003
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
February 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Health education, Back injury, Chronic pain, Education/evaluation planning, Outcomes research
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
580 (Actual)
8. Arms, Groups, and Interventions
Arm Title
email discussion group
Arm Type
Experimental
Arm Title
rancomized control group
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Procedure
Intervention Name(s)
Patient education evaluation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate R. Lorig, Dr.P.H.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11926853
Citation
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.
Results Reference
result
PubMed Identifier
16122642
Citation
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.
Results Reference
result
Learn more about this trial
Low Back Pain Patient Education Evaluation
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