<?xml version="1.0" encoding="UTF-8"?>
<clinical_study rank="204568">
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<required_header>
<download_date>ClinicalTrials.gov processed this data on December 16, 2015</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/show/NCT00000408</url>
</required_header>
<id_info>
<org_study_id>R01AR044939</org_study_id>
<secondary_id>R01AR044939</secondary_id>
<nct_id>NCT00000408</nct_id>
</id_info>
<brief_title>Low Back Pain Patient Education Evaluation</brief_title>
<official_title>Evaluation of a Low Back Pain Patient Education Program</official_title>
<sponsors>
<lead_sponsor>
<agency>Stanford University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Stanford University</source>
<oversight_info>
<authority>United States: Federal Government</authority>
<has_dmc>No</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
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.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
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.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>February 1998</start_date>
<completion_date type="Actual">February 2002</completion_date>
<primary_completion_date type="Actual">February 2002</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<study_design>Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment</study_design>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">580</enrollment>
<condition>Low Back Pain</condition>
<arm_group>
<arm_group_label>email discussion group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>rancomized control group</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>usual care</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Patient education evaluation</intervention_name>
<arm_group_label>email discussion group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
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
</textblock>
</criteria>
<gender>Both</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Kate R. Lorig, Dr.P.H.</last_name>
<role>Principal Investigator</role>
<affiliation>Stanford University</affiliation>
</overall_official>
<location>
<facility>
<name>Stanford University</name>
<address>
<city>Palo Alto</city>
<state>California</state>
<zip>94305</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<results_reference>
<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.</citation>
<PMID>11926853</PMID>
</results_reference>
<results_reference>
<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.</citation>
<PMID>16122642</PMID>
</results_reference>
<verification_date>February 2003</verification_date>
<lastchanged_date>April 30, 2013</lastchanged_date>
<firstreceived_date>November 3, 1999</firstreceived_date>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Stanford University</investigator_affiliation>
<investigator_full_name>Kate Lorig</investigator_full_name>
<investigator_title>professor</investigator_title>
</responsible_party>
<keyword>Health education</keyword>
<keyword>Back injury</keyword>
<keyword>Chronic pain</keyword>
<keyword>Education/evaluation planning</keyword>
<keyword>Outcomes research</keyword>
<is_fda_regulated>No</is_fda_regulated>
<has_expanded_access>No</has_expanded_access>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Back Pain</mesh_term>
<mesh_term>Low Back Pain</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
