Low Back PainNCT00000408
Low Back Pain Patient Education Evaluation
A study testing Patient education evaluation in people with Low Back Pain, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Patient education evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1998to Feb 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Low Back Pain Patient Education Program
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Patient education evaluation
- Keywords
- Health education, Back injury, Chronic pain, Education/evaluation planning, Outcomes research
- Medical subject headings
- Low Back Pain, Health Education, Back Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education evaluationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| email discussion group | Experimental | Not described Receives: Procedure: Patient education evaluation |
| rancomized control group | No intervention | usual care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startFeb 1998
- Primary completionFeb 2002
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Kate Lorig, Stanford University
- Investigators
- Kate R. Lorig, Dr.P.H., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000408
- Sponsor's protocol ID
- R01AR044939
- Other IDs
- R01AR044939
- Status last verified
- Feb 2003
- First submitted
- 3 Nov 1999
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11926853Bruce 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.
PubMed 16122642
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Low Back Pain Patient Education Program
- ClinicalTrials.gov ID
- NCT00000408
- Acronym / sponsor ID
- R01AR044939
- Conditions
- Low Back Pain
- Keywords
- Health education, Back injury, Chronic pain, Education/evaluation planning, Outcomes research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Feb 1998
- Primary completion
- Feb 2002 (actual)
- Study completion
- Feb 2002 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| email discussion group | Experimental | Procedure: Patient education evaluation |
| rancomized control group | No intervention | –usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient education evaluation | Procedure or surgery | email discussion group |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
- Results publication: PubMed 11926853Lorig 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 publication: PubMed 16122642Bruce 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate R. Lorig, Dr.P.H. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education evaluation in people with Low Back Pain, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000408, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.