Chronic Low Back PainNCT00170118
Effects of Motivational Interviewing on Self-Efficacy and Standardized Low Back Pain Outcomes in Patients With Chronic Back Pain"
A study testing motivational interviewing in people with Chronic Low Back Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
The majority of the study consists of standard of care treatment for people with low back pain that has lasted more than three months. Half of the participants in the study will receive physical therapy from physical therapists that have received additional training in an educational technique. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Sep 2006
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Exclusion Criteria Medical /legal involvement Active workers compensation Infection or tumor in spine Active systemic disease in the lumbar spine Multiple other musculoskeletal problems that require Treatment Patients receiving more than 2 PT sessions
Inclusion Criteria Three or more months of low back pain Ability to read, write and speak English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Motivational Interviewing on Self-Efficacy and Standardized Low Back Pain Outcomes in Patients With Chronic Back Pain
The majority of the study consists of standard of care treatment for people with low back pain that has lasted more than three months. Half of the participants in the study will receive physical therapy from physical therapists that have received additional training in an educational technique. In order to determine if there is a difference in patient outcome when the educational technique is used, you will be asked to complete five short surveys before receiving physical therapy (10 minutes total). A sample of the physical therapy sessions using the educational technique will be videotaped. The videotape will be of the physical therapist to prove they did use the educational technique, not of you the participant in the study. You will remain anonymous and will not be used and the tape will not be used for publication or presentation purposes. You will also be asked to complete one survey after participating in physical therapy (2 minutes), and all five short surveys (10 minutes total) six weeks after your last physical therapy session.
You will be put in one of 2 groups by chance (as in the flip of a coin). A computerized selection process will be used to assign participants to the study. You will not know if you are in the study group or the non-study group.
Read the detailed description
This is a pilot study to evaluate the impact of MI on self-efficacy and outcomes for chronic low back pain.
Design Prospective randomized, single blind pilot, controlled study. Patients will be referred from E10 and the Spine Center by contacting the study coordinator. The Coordinator will meet with potential participants, determine if they meet the inclusion and exclusion criteria, obtain informed consent, assess self-efficacy using the Stanford Self efficacy instrument, use en bloc randomization for self-efficacy to the experimental and control group. They will then complete the SF-12, a VAS pain scale, and the Roland and Morris Disability questionnaire, a few questions about employment status and 1 question about satisfaction with care.
The experimental group(goal n=20) will be treated by physical therapists that have been trained in motivational interviewing techniques by a PhD and a sample of these sessions will be videotaped for validation purposes. The control group(goal n=20) will receive PT from any PT as per the normal standard of care.
Both the experimental and control group will complete an additional self-efficacy instrument prior to leaving. Six weeks after the patients participate in a motivational interview session they will be mailed a repeat of all of the previously mentioned instruments including the self-efficacy tool. Patients who return the completed instruments will receive forty dollars. If effect size is small, this pilot study will be underpowered, if a clinically significant trend is observed additional funding will be sought and the experimental and control n will be expanded to 64.
Setting Tertiary academic medical center Participants Referrals from a Spine Center, or a large outpatient Physical Medicine and Rehabilitation practice with at least three months of chronic low back pain.
Primary Outcome Measure Self-efficacy for Managing Chronic disease 6-Item scale
Main Outcome Measures Roland and Morris Disability Questionnaire Pain VAS Satisfaction with care question Disability status question SF-12 Exclusion Criteria Medical /legal involvement Active workers compensation Infection or tumor in spine Active systemic disease in the lumbar spine Multiple other musculoskeletal problems that require Treatment Patients receiving more than 2 PT sessions
Inclusion Criteria Three or more months of low back pain Ability to read, write and speak English
- Conditions
- Chronic Low Back Pain
- Being tested
- motivational interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
SF - 12
Self-efficacy for Managing Chronic disease 6-Item scale
Roland and Morris Disability Questionnaire
Pain Visual analog scale
Satisfaction with care question
Secondary outcomes (1)
Disability status question
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Catherine K. Schmidt, MS DO, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170118
- Sponsor's protocol ID
- 49-05
- Status last verified
- Jan 2010
- First submitted
- 13 Sep 2005
- Last updated
- 28 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motivational Interviewing on Self-Efficacy and Standardized Low Back Pain Outcomes in Patients With Chronic Back Pain
- ClinicalTrials.gov ID
- NCT00170118
- Acronym / sponsor ID
- 49-05
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 15 Sep 2005 (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.
The majority of the study consists of standard of care treatment for people with low back pain that has lasted more than three months. Half of the participants in the study will receive physical therapy from physical therapists that have received additional training in an educational technique. In order to determine if there is a difference in patient outcome when the educational technique is used, you will be asked to complete five short surveys before receiving physical therapy (10 minutes total). A sample of the physical therapy sessions using the educational technique will be videotaped. The videotape will be of the physical therapist to prove they did use the educational technique, not of you the participant in the study. You will remain anonymous and will not be used and the tape will not be used for publication or presentation purposes. You will also be asked to complete one survey after participating in physical therapy (2 minutes), and all five short surveys (10 minutes total) six weeks after your last physical therapy session.
You will be put in one of 2 groups by chance (as in the flip of a coin). A computerized selection process will be used to assign participants to the study. You will not know if you are in the study group or the non-study group.
Detailed description
This is a pilot study to evaluate the impact of MI on self-efficacy and outcomes for chronic low back pain.
Design Prospective randomized, single blind pilot, controlled study. Patients will be referred from E10 and the Spine Center by contacting the study coordinator. The Coordinator will meet with potential participants, determine if they meet the inclusion and exclusion criteria, obtain informed consent, assess self-efficacy using the Stanford Self efficacy instrument, use en bloc randomization for self-efficacy to the experimental and control group. They will then complete the SF-12, a VAS pain scale, and the Roland and Morris Disability questionnaire, a few questions about employment status and 1 question about satisfaction with care.
The experimental group(goal n=20) will be treated by physical therapists that have been trained in motivational interviewing techniques by a PhD and a sample of these sessions will be videotaped for validation purposes. The control group(goal n=20) will receive PT from any PT as per the normal standard of care.
Both the experimental and control group will complete an additional self-efficacy instrument prior to leaving. Six weeks after the patients participate in a motivational interview session they will be mailed a repeat of all of the previously mentioned instruments including the self-efficacy tool. Patients who return the completed instruments will receive forty dollars. If effect size is small, this pilot study will be underpowered, if a clinically significant trend is observed additional funding will be sought and the experimental and control n will be expanded to 64.
Setting Tertiary academic medical center Participants Referrals from a Spine Center, or a large outpatient Physical Medicine and Rehabilitation practice with at least three months of chronic low back pain.
Primary Outcome Measure Self-efficacy for Managing Chronic disease 6-Item scale
Main Outcome Measures Roland and Morris Disability Questionnaire Pain VAS Satisfaction with care question Disability status question SF-12 Exclusion Criteria Medical /legal involvement Active workers compensation Infection or tumor in spine Active systemic disease in the lumbar spine Multiple other musculoskeletal problems that require Treatment Patients receiving more than 2 PT sessions
Inclusion Criteria Three or more months of low back pain Ability to read, write and speak English
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| motivational interviewing | Behavioural | – |
Primary outcome
SF - 12
Self-efficacy for Managing Chronic disease 6-Item scale
Roland and Morris Disability Questionnaire
Pain Visual analog scale
Satisfaction with care question
1 secondary outcome
Disability status question
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 28 Jan 2010.
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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.
Catherine K. Schmidt, MS DO principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motivational interviewing in people with Chronic Low Back Pain, run by Mayo Clinic 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?
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 28 Jan 2010. 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.
What does the primary outcome measure?
SF - 12. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2010.