Completed

Evaluation of a Low Back Pain Patient Education Program

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What is being tested

Patient education evaluation

Procedure
Who is being recruted

Back Pain
+1

+ Neurologic Manifestations
+ Pain
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 1998
See protocol details

Summary

Principal SponsorStanford University
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 1998Actual date on which the first participant was enrolled.

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.

Official TitleEvaluation of a Low Back Pain Patient Education Program 
NCT00000408
Principal SponsorStanford University
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
580 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Back Pain
Neurologic Manifestations
Pain
Low Back Pain
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Stanford UniversityPalo Alto, United StatesSee the location
CompletedOne Study Center