Low Back PainNCT03256617
The Development of a Cognitive Reassurance Training Program
A study testing Cognitive reassurance training in people with Low Back Pain, run by University of Utah at 1 site in United States.
Trial summary
The focus of this proposal is to evaluate the feasibility of a cognitive reassurance training program by examining changes in physical therapist low back pain beliefs and skills with training and evaluating the quality with which physical therapists apply cognitive reassurance to patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Cognitive reassurance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2017to 8 Nov 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Therapist inclusion criteria:
- University of Utah Health Care physical therapists and physical therapist assistants
- Employed at least 20 hours a week
- Licensed in the state of Utah
Therapist exclusion criteria:
- None
Patient inclusion criteria
- Primary reason for scheduling an evaluation with a physical therapist is low back pain (defined as symptoms of pain and/or numbness between the 12th rib and buttocks with or without referral in to one or both legs
- Current episode of low back pain ≤ 12 weeks duration
- Age 18-64
- Ability to read and speak English
Patient exclusion criteria
- Report being referred to physical therapy for specific low back pathology (e.g. fracture)
- Any lumbar surgery in the past 6 months
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health Care Out Patient Physical Therapy Clinics
Salt Lake City, Utah, 84132
About this study
Official title: The Development of a Cognitive Reassurance Training Program and Its Impact on Physical Therapist and Patient Outcomes
The focus of this proposal is to evaluate the feasibility of a cognitive reassurance training program by examining changes in physical therapist low back pain beliefs and skills with training and evaluating the quality with which physical therapists apply cognitive reassurance to patients. The secondary focus is to examine the association between physical therapist application of cognitive reassurance and short-term changes in patients' low back pain beliefs and expectations.
Read the detailed description
Identifying strategies to favorably alter unhelpful cognitions of patients with recent onset low back pain is a research priority and could help curb the transition from acute to chronic low back pain; lessening the need for prolonged and costly management. Current evidence suggests that psychological factors, including maladaptive pain beliefs and avoidant behaviors and expectations for recovery, are associated with poor outcomes in patients with low back pain. Recently, considerable attention has been given to training non-psychologists to provide psychologically based interventions for patients with low back pian. A recent review of interventions that included psychological approaches noted that all of the trials that failed to show benefit included delivery of the intervention by non-psychologists. Authors suggest that increasing the effort in selecting, training, supervising and assessing the competence of the practitioners delivering the treatment could improve results.
Low back pain comprises approximately 50% of the caseload of outpatient physical therapists physical therapists making physical therapists ideally positioned to manage the unhelpful cognitions of patients with low back pain. However, physical therapists often feel unprepared when managing the cognitive factors associated with low back pain. The purpose of this project is to develop and assess the effectiveness of a training program for physical therapists that focuses on cognitive reassurance; a novel cognitive intervention for patients with low back pain.
Cognitive reassurance is a communication approach in which maladaptive beliefs and expectations are identified. Tailored explanations for the patient's conditions are then provided, possible prognosis and treatment are discussed, and clarifications are offered. With adequate training, physical therapists could utilize cognitive reassurance to promote patients' understanding of his/her condition and modify maladaptive low back pain-related beliefs and expectations.
The proposed pilot study will use a pre-post design to examine the impact of cognitive reassurance training on the low back pain beliefs and skills in physical therapists and physical therapist assistants. Following the training the investigators will recruit patients who have scheduled an evaluation for low back pain with the physical therapists who attended the training. Patient data will be collected at baseline before the evaluation and follow up data at 2, 4 and 8 weeks.
The specific aims are: 1) Evaluate the feasibility of a cognitive reassurance training program for physical therapists that focuses on modifying physical therapists' beliefs and improving physical therapists' skill in the application of cognitive reassurance for patients with acute/subacute low back pain. 2) Evaluate the application of cognitive reassurance by physical therapists to patients with acute/sub-acute low back pain. 3) Examine the association between physical therapist application of cognitive reassurance and short-term changes in the patient's low back pain beliefs and expectations (low back pain beliefs, self-efficacy, pain catastrophizing, fear-avoidance).
- Conditions
- Low Back Pain
- Being tested
- Cognitive reassurance training
- Keywords
- low back pain, cognitive reassurance, physical therapist training
- 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.
Cognitive reassurance trainingOther
The 2-day training program includes 3 sessions that will consist of interactive didactic lectures, solving case studies and role-playing activities. The first session uses lecture and cases to present models of pain and disability, evidence based predictors of disability and delayed recovery and evidence based interventions for patients with low back pain. The second session uses role playing and case studies help the providers to 1) develop skills in identifying maladaptive beliefs about pain in patients with low back pain and 2) develop the skills to address diagnostic uncertainty and negative pain beliefs and 3) develop skills to educate patients with low back pain. The third session will use role playing and case studies to refine the provider' skills in providing cognitive reassurance to patients with low back pain.
| Study group | Role | What they receive |
|---|---|---|
| Provider training | Experimental | Not described Receives: Other: Cognitive reassurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in back beliefs questionnaire for health care providers
Measures providers' beliefs about back pain pre and post training
Measured: Baseline, 5 days
Low back pain vignettes
Measures provider decision making related to cognitive reassurance
Measured: End of 2nd day of therapist training
Skills assessment
Assess skills in the provision of cognitive reassurance during role-playing activity
Measured: End of 2nd day of therapist training
Secondary outcomes (7)
Change in the Pain Catastrophizing Scale
Measure of patient's pain catastrophizing
Measured: Baseline, 4 weeks and 8 weeks
Change in fear the Avoidance Beliefs Questionnaire
Measure of patient's fear-avoidance beliefs.
Measured: Baseline, 4 weeks and 8 weeks
Change in the Pain Self-efficacy Questionnaire
Measure of patient's pain self-efficacy
Measured: Baseline, 4 weeks and 8 weeks
Change in the Back Beliefs Questionnaire
Measure of patient's back beliefs
Measured: Baseline, 4 weeks and 8 weeks
Patient check list
Measure whether key messages of cognitive reassurance were perceived by the patient.
Measured: 2 weeks following initial evaluation for low back pain by a physical therapist
Open-ended question
Asks the patient to list the most important things they learned learned in physical therapy
Measured: 2 weeks following the initial evaluation for low back pain by a physical therapist
Provider check list
Measures whether key cognitive reassurance messages were provided to the patient by the provider
Measured: 2 weeks status post initial evaluation of patient with low back pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start19 May 2017
- Primary completion25 Aug 2017
- Study completion8 Nov 2018
Why it stopped: Recruiting beyond September 10, 2018 would mean that the training occurred more than a year in the past. For this reason, we terminated recruitment.
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.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post test design for the therapists followed by a prospective cohort of patients. We anticipate 50 physical therapy providers and 150 patients for a total of 200 participants.
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jake Magel, University of Utah
- Investigators
- Jake S Magel, PT, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256617
- Sponsor's protocol ID
- 00100188
- Status last verified
- Apr 2020
- First submitted
- 8 Aug 2017
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of a Cognitive Reassurance Training Program and Its Impact on Physical Therapist and Patient Outcomes
- ClinicalTrials.gov ID
- NCT03256617
- Acronym / sponsor ID
- 00100188
- Conditions
- Low Back Pain
- Keywords
- low back pain, cognitive reassurance, physical therapist training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting beyond September 10, 2018 would mean that the training occurred more than a year in the past. For this reason, we terminated recruitment.
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 19 May 2017 (actual)
- Primary completion
- 25 Aug 2017 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 22 Aug 2017 (actual)
- 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 focus of this proposal is to evaluate the feasibility of a cognitive reassurance training program by examining changes in physical therapist low back pain beliefs and skills with training and evaluating the quality with which physical therapists apply cognitive reassurance to patients. The secondary focus is to examine the association between physical therapist application of cognitive reassurance and short-term changes in patients' low back pain beliefs and expectations.
Detailed description
Identifying strategies to favorably alter unhelpful cognitions of patients with recent onset low back pain is a research priority and could help curb the transition from acute to chronic low back pain; lessening the need for prolonged and costly management. Current evidence suggests that psychological factors, including maladaptive pain beliefs and avoidant behaviors and expectations for recovery, are associated with poor outcomes in patients with low back pain. Recently, considerable attention has been given to training non-psychologists to provide psychologically based interventions for patients with low back pian. A recent review of interventions that included psychological approaches noted that all of the trials that failed to show benefit included delivery of the intervention by non-psychologists. Authors suggest that increasing the effort in selecting, training, supervising and assessing the competence of the practitioners delivering the treatment could improve results.
Low back pain comprises approximately 50% of the caseload of outpatient physical therapists physical therapists making physical therapists ideally positioned to manage the unhelpful cognitions of patients with low back pain. However, physical therapists often feel unprepared when managing the cognitive factors associated with low back pain. The purpose of this project is to develop and assess the effectiveness of a training program for physical therapists that focuses on cognitive reassurance; a novel cognitive intervention for patients with low back pain.
Cognitive reassurance is a communication approach in which maladaptive beliefs and expectations are identified. Tailored explanations for the patient's conditions are then provided, possible prognosis and treatment are discussed, and clarifications are offered. With adequate training, physical therapists could utilize cognitive reassurance to promote patients' understanding of his/her condition and modify maladaptive low back pain-related beliefs and expectations.
The proposed pilot study will use a pre-post design to examine the impact of cognitive reassurance training on the low back pain beliefs and skills in physical therapists and physical therapist assistants. Following the training the investigators will recruit patients who have scheduled an evaluation for low back pain with the physical therapists who attended the training. Patient data will be collected at baseline before the evaluation and follow up data at 2, 4 and 8 weeks.
The specific aims are: 1) Evaluate the feasibility of a cognitive reassurance training program for physical therapists that focuses on modifying physical therapists' beliefs and improving physical therapists' skill in the application of cognitive reassurance for patients with acute/subacute low back pain. 2) Evaluate the application of cognitive reassurance by physical therapists to patients with acute/sub-acute low back pain. 3) Examine the association between physical therapist application of cognitive reassurance and short-term changes in the patient's low back pain beliefs and expectations (low back pain beliefs, self-efficacy, pain catastrophizing, fear-avoidance).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post test design for the therapists followed by a prospective cohort of patients. We anticipate 50 physical therapy providers and 150 patients for a total of 200 participants.
| Arm | Type | Receives |
|---|---|---|
| Provider training | Experimental | Other: Cognitive reassurance training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| Cognitive reassurance trainingThe 2-day training program includes 3 sessions that will consist of interactive didactic lectures, solving case studies and role-playing activities. The first session uses lecture and cases to present models of pain and disability, evidence based predictors of disability and delayed recovery and evidence based interventions for patients with low back pain. The second session uses role playing and case studies help the providers to 1) develop skills in identifying maladaptive beliefs about pain in patients with low back pain and 2) develop the skills to address diagnostic uncertainty and negative pain beliefs and 3) develop skills to educate patients with low back pain. The third session will use role playing and case studies to refine the provider' skills in providing cognitive reassurance to patients with low back pain. | Other | Provider training |
Primary outcome
Change in back beliefs questionnaire for health care providers
Time frame: Baseline, 5 days
Measures providers' beliefs about back pain pre and post training
Low back pain vignettes
Time frame: End of 2nd day of therapist training
Measures provider decision making related to cognitive reassurance
Skills assessment
Time frame: End of 2nd day of therapist training
Assess skills in the provision of cognitive reassurance during role-playing activity
7 secondary outcomes
Change in the Pain Catastrophizing Scale
Time frame: Baseline, 4 weeks and 8 weeks
Change in fear the Avoidance Beliefs Questionnaire
Time frame: Baseline, 4 weeks and 8 weeks
Change in the Pain Self-efficacy Questionnaire
Time frame: Baseline, 4 weeks and 8 weeks
Change in the Back Beliefs Questionnaire
Time frame: Baseline, 4 weeks and 8 weeks
Patient check list
Time frame: 2 weeks following initial evaluation for low back pain by a physical therapist
Open-ended question
Time frame: 2 weeks following the initial evaluation for low back pain by a physical therapist
Provider check list
Time frame: 2 weeks status post initial evaluation of patient with low back pain
Results and safety
The study was stopped early (reason given: Recruiting beyond September 10, 2018 would mean that the training occurred more than a year in the past. For this reason, we terminated recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Jake S Magel, PT, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive reassurance training 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?
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: stopped early, as of the sponsor's last update on 16 Apr 2020. 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 was stopped early (reason given: Recruiting beyond September 10, 2018 would mean that the training occurred more than a year in the past. For this reason, we terminated recruitment.). Results are not available in the source record.
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?
Change in back beliefs questionnaire for health care providers (time frame: Baseline, 5 days). The study lists 3 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 16 Apr 2020; AzTrials last refreshed its copy on 28 Oct 2026.