--- a +++ b/matching/trials/NCT00000408.xml @@ -0,0 +1,185 @@ +<?xml version="1.0" encoding="UTF-8"?> +<clinical_study rank="204568"> + <!-- This xml conforms to an XML Schema at: + https://clinicaltrials.gov/ct2/html/images/info/public.xsd + and an XML DTD at: + https://clinicaltrials.gov/ct2/html/images/info/public.dtd --> + <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>