Low Back PainNCT02648373
Patient Education for Patients With Back Pain Referred to Physical Therapy
A study testing Patient Education in people with Low Back Pain, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to evaluate patients with low back pain who are scheduled to begin physical therapy but have not yet had their first appointment to better understand their beliefs and attitudes and to evaluate the effects of an educational session about low back pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2015
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chief complaint of non-specific low back pain scheduled to receive outpatient physical therapy
- age 18-60
- duration of current symptoms < 8weeks
- referred to physical therapy from a non-surgeon provider
- no treatment received for low back pain in past year other than physician office visits.
Who cannot join
- Diagnosis provided by the referral source indicating a specific pathoanatomical source for LBP including fracture, spondylolesthesis, ankylosing spondylitis, radiculopathy
- any red flags in the patient's general medical screening questionnaire (i.e. tumor, metabolic diseases etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Utah Healthcare System
Salt Lake City, Utah, 84108
About this study
Official title: Effect of a Patient Education Intervention for Patients With Low Back Pain Referred to Physical Therapy
The purpose of this study is to evaluate patients with low back pain who are scheduled to begin physical therapy but have not yet had their first appointment to better understand their beliefs and attitudes and to evaluate the effects of an educational session about low back pain.
Read the detailed description
The investigators will conduct a randomized trial to examine the effectiveness of a patient education session provided prior to beginning physical therapy on outcomes of usual physical therapy for acute/sub-acute low back pain patients. The study compares two groups, one group will be treated with usual physical therapy with no pre-treatment education and the other group will also receive the pre-treatment. Patients will be followed after 6 weeks and 3 months. Physical therapy care is left to the discretion of the physical therapist in conjunction with the patient. Outcomes will include pain and disability, and patients attitude and believes (pain catastrophizing, fear avoidance behavior). The overall hypothesis is that the additional educational treatment may address and improve pain, disability and fear.
- Conditions
- Low Back Pain
- Being tested
- Patient Education, Control
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient EducationBehavioural
An educational video was watched based on Consumer Reports Choosing Wisely patient education supporting the recommendation that imaging is not helpful early for low back pain and the best strategy is to remain as active as possible. Key themes were discussed with a physical therapist and the patient's questions were answered.
ControlOther
Patients receive no additional intervention. They will begin physical therapy and receive care at the therapist's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | Patients receive an educational video about low back pain based on the Consumer Reports Choosing Wisely recommendation for patients with back pain to avoid early imaging and remain as active as possible. After the video the evaluator and patient discussed key themes from the video and the patient was able to ask any questions. Previously scheduled physical therapy then began with treatment at the therapist's discretion. Receives: Behavioral: Patient Education |
| Control | Active comparator | Previously scheduled physical therapy was provided with treatment at the therapist's discretion. No educational intervention was provided before beginning physical therapy Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
Self-report measure of low back pain-related disability
Measured: 6 weeks
Pain as measured by the Numeric Pain Rating Scale
Self-report measure of pain intensity on 0-10 rating scale
Measured: 6 weeks
Secondary outcomes (9)
Fear Avoidance beliefs Questionnaire
Self-report measure of fear avoidance beliefs about physical activity and work
Measured: baseline, 6 weeks, 3 months
Pain Catastrophizing Scale
Self-report measure of pain catastrophizing beliefs
Measured: baseline, 6 weeks, 3 months
Pain Beliefs Questionnaire
Self-report questionnaire used to measure patients' beliefs about the causes and consequences of pain with 2 subscales: organic (i.e, biomedical) and psychological.
Measured: baseline, 6 weeks, 3 months
Global Rating of Change
Self-report global rating of improvement in condition since baseline assessed on 0-15 scale
Measured: 6 weeks, 3 months
Physical Therapy Visits: Number of physical therapy episodes attended after baseline
Number of physical therapy episodes attended after baseline
Measured: 6 weeks, 3 months
Treatment Self-Regulation Questionnaire
Self-report questionnaire examining motivations to attend physical therapy
Measured: baseline, 6 weeks, 3 months
Hospital Anxiety and Depression Scale
Self-report questionnaire assessing anxiety and depression in separate sub-scales
Measured: baseline, 6 weeks, 3 months
Oswestry Disability Scale
Self-report measure of low back pain-related disability
Measured: baseline, 3 months
Numeric Pain Rating
Self-report measure of pain intensity on 0-10 scale
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Fritz, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648373
- Sponsor's protocol ID
- IRB00072901
- Status last verified
- Jan 2016
- First submitted
- 27 May 2015
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Patient Education Intervention for Patients With Low Back Pain Referred to Physical Therapy
- ClinicalTrials.gov ID
- NCT02648373
- Acronym / sponsor ID
- IRB00072901
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Jan 2016 (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 purpose of this study is to evaluate patients with low back pain who are scheduled to begin physical therapy but have not yet had their first appointment to better understand their beliefs and attitudes and to evaluate the effects of an educational session about low back pain.
Detailed description
The investigators will conduct a randomized trial to examine the effectiveness of a patient education session provided prior to beginning physical therapy on outcomes of usual physical therapy for acute/sub-acute low back pain patients. The study compares two groups, one group will be treated with usual physical therapy with no pre-treatment education and the other group will also receive the pre-treatment. Patients will be followed after 6 weeks and 3 months. Physical therapy care is left to the discretion of the physical therapist in conjunction with the patient. Outcomes will include pain and disability, and patients attitude and believes (pain catastrophizing, fear avoidance behavior). The overall hypothesis is that the additional educational treatment may address and improve pain, disability and fear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: Patient EducationPatients receive an educational video about low back pain based on the Consumer Reports Choosing Wisely recommendation for patients with back pain to avoid early imaging and remain as active as possible. After the video the evaluator and patient discussed key themes from the video and the patient was able to ask any questions. Previously scheduled physical therapy then began with treatment at the therapist's discretion. |
| Control | Active comparator | Other: ControlPreviously scheduled physical therapy was provided with treatment at the therapist's discretion. No educational intervention was provided before beginning physical therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chief complaint of non-specific low back pain scheduled to receive outpatient physical therapy
- age 18-60
- duration of current symptoms < 8weeks
- referred to physical therapy from a non-surgeon provider
- no treatment received for low back pain in past year other than physician office visits.
Key exclusion criteria (2 listed)
- Diagnosis provided by the referral source indicating a specific pathoanatomical source for LBP including fracture, spondylolesthesis, ankylosing spondylitis, radiculopathy
- any red flags in the patient's general medical screening questionnaire (i.e. tumor, metabolic diseases etc.).
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 EducationAn educational video was watched based on Consumer Reports Choosing Wisely patient education supporting the recommendation that imaging is not helpful early for low back pain and the best strategy is to remain as active as possible. Key themes were discussed with a physical therapist and the patient's questions were answered. | Behavioural | Education |
| ControlPatients receive no additional intervention. They will begin physical therapy and receive care at the therapist's discretion. | Other | Control |
Primary outcome
Oswestry Disability Index
Time frame: 6 weeks
Self-report measure of low back pain-related disability
Pain as measured by the Numeric Pain Rating Scale
Time frame: 6 weeks
Self-report measure of pain intensity on 0-10 rating scale
9 secondary outcomes
Fear Avoidance beliefs Questionnaire
Time frame: baseline, 6 weeks, 3 months
Pain Catastrophizing Scale
Time frame: baseline, 6 weeks, 3 months
Pain Beliefs Questionnaire
Time frame: baseline, 6 weeks, 3 months
Global Rating of Change
Time frame: 6 weeks, 3 months
Physical Therapy Visits: Number of physical therapy episodes attended after baseline
Time frame: 6 weeks, 3 months
Treatment Self-Regulation Questionnaire
Time frame: baseline, 6 weeks, 3 months
Hospital Anxiety and Depression Scale
Time frame: baseline, 6 weeks, 3 months
Oswestry Disability Scale
Time frame: baseline, 3 months
Numeric Pain Rating
Time frame: baseline, 3 months
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 7 Jan 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Low Back Pain, run by University of Utah 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 2 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 7 Jan 2016. 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?
Oswestry Disability Index (time frame: 6 weeks). The study lists 2 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 7 Jan 2016.