Chronic Musculoskeletal PainNCT03391661
University of Michigan / Wayne State Chronic Pain Study
A study testing Pain neuroscience education patient exercise in people with Chronic Musculoskeletal Pain, run by Wayne State University at 1 site in United States.
Trial summary
This study is designed to determine if a brief educational program can alter the attitudes and knowledge of individuals with chronic back pain, which is likely to be non-structural in nature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- Pain neuroscience education patient exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2017to 28 Feb 2019
- 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
- English-speaking adults ages 18 years or older with internet access who are referred to the University of Michigan Health Service Physical Medicine and Rehabilitation Spine Program identified the physician with chronic nonspecific back pain (longer than 3 months) or fibromyalgia. Degenerative changes seen on imaging are considered nonspecific. Alternatively, enrolled in the University of Michigan Health Research Volunteer Pool with a profile that includes chronic low back pain or fibromyalgia.
Who cannot join
- Any signs of a serious underlying condition (cancer, infection, cauda equine), spinal stenosis or radiculopathy, or other specific spinal cause (vertebral compression fracture or ankylosing spondylitis). Those patients who are being considered for an interventional spine procedures or surgical consults would not be included in this study.
- Individuals receiving or applying for compensation or disability, the inability to provide written informed consent, severe physical impairment (e.g. blindness, deafness), co-morbid medical condition limiting function (e.g. malignant cancer), the use of illicit drug use, or a psychiatric condition that would limit judgment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Physical Medicine and Rehabilitation Department
Ann Arbor, Michigan, 48109
About this study
Official title: Openness to Cognitive Approach of Nonspecific Chronic Pain
This study is designed to determine if a brief educational program can alter the attitudes and knowledge of individuals with chronic back pain, which is likely to be non-structural in nature.
Individuals will be randomly assigned to an experimental condition (performs written educational and emotional awareness exercises) or a control condition (completes a general health activities questionnaire). Comparisons will be made to assess the degree of centralized pain features and functional improvements at 1-month follow-up. A 10-month follow-up as a secondary endpoint is also planned.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- Pain neuroscience education patient exercise, Health behavior control intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience education patient exerciseBehavioural
Patients complete a 15 to 20-minute on-line exercise that inquires about 5 domains: the degree of central sensitization symptoms, catastrophizing and kinesiophobia, personality factors, stressors that triggered or exacerbated the pain, and adverse childhood experiences.
Health behavior control interventionBehavioural
Patients engage in a 15 to 20-minute on-line exercise examining their health behaviors in five domains: exercise, sleep, diet, hygiene, and social connections.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Pain and the Brain | Experimental | This condition is a 15 to 20-minute exercise that patients complete in which they examine variables in themselves that suggest that their pain is driven by central nervous system processes / their brains. Receives: Behavioral: Pain neuroscience education patient exercise |
| Health Behavior Control | Placebo comparator | This 15 to 20-minute exercise is designed as a control condition that has face validity as helpful and that relates to health. Thus, patients are asked to examine various domains of their own health behavior as engaged in over the past 24 hours (e.g., nutrition, sleep, exercise, hygiene, social connections). Receives: Behavioral: Health behavior control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory
Self-reported pain and dysfunction
Measured: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary outcomes (8)
Patient-Reported Outcomes Measurement Information System: Depression short form 8b
Self-reported depression
Measured: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a
Self-reported anxiety
Measured: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Patient-Reported Outcomes Measurement Information System: Anger short form 5a
Self-reported anger
Measured: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Pain attributions questionnaires
Two self-report questionnaires were developed to assess psychological and brain influences on pain. The 4-item psychological attribution scale assesses patients' beliefs that their thoughts and feelings and psychological therapy impacts pain, and the 3-item brain attribution scale assesses patient's beliefs that their pain is brain-based. Mean scores will be computed for both scales separately (0-4; higher scores indicating greater belief that pain is a brain-related [brain attribution] construct and that pain is affected by thoughts, feelings, and psychological interventions [psychological attribution])
Measured: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Pain Stages of Change Questionnaire
The Pain Stages of Change questionnaire (Kerns, Rosenberg, Jamison, Caudill, \& Haythornthwaite, 1997): an overall readiness score will be calculated using mean scores of the four subscales. Readiness is the sum of patient mean ratings for contemplation (C; 1-5), action (A; 1-5), and maintenance (M; 1-5), minus the mean score for precontemplation (PC; 1-5): C + A + M - PC = Readiness. Higher scores indicate greater readiness.
Measured: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Pain Catastrophizing Scale
Pain Catastrophizing Scale (Sullivan et al., 1995): A summed score of the 13 catastrophizing items will be computed (0-52, higher scores indicate greater catastrophizing)
Measured: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Tampa Scale for Kinesiophobia
The Tampa Kinesiophobia Scale (Miller, Kori, \&Todd, 1991): A mean score of the 11 items will be computed (1-4, higher scores indicating greater kinesiophobia)
Measured: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Satisfaction with Life Scale
The Satisfaction with Life Scale (Emmons, Larsen, \& Griffin, 1985): A mean score of the 5 items will be computed (1-7, higher scores indicating greater life satisfaction)
Measured: Change from baseline to 1-month follow-up (with secondary 10-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start10 Dec 2017
- Primary completion17 May 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Mark A. Lumley, Wayne State University
- Investigators
- David Kohns, MD, Principal investigator, University of MichiganMark A Lumley, PhD, Study director, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391661
- Sponsor's protocol ID
- HUM00121358
- Status last verified
- Jul 2019
- First submitted
- 22 Dec 2017
- Last updated
- 25 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Openness to Cognitive Approach of Nonspecific Chronic Pain
- ClinicalTrials.gov ID
- NCT03391661
- Acronym / sponsor ID
- HUM00121358
- Conditions
- Chronic Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 10 Dec 2017 (actual)
- Primary completion
- 17 May 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 5 Jan 2018 (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.
This study is designed to determine if a brief educational program can alter the attitudes and knowledge of individuals with chronic back pain, which is likely to be non-structural in nature.
Individuals will be randomly assigned to an experimental condition (performs written educational and emotional awareness exercises) or a control condition (completes a general health activities questionnaire). Comparisons will be made to assess the degree of centralized pain features and functional improvements at 1-month follow-up. A 10-month follow-up as a secondary endpoint is also planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Pain and the Brain | Experimental | Behavioral: Pain neuroscience education patient exerciseThis condition is a 15 to 20-minute exercise that patients complete in which they examine variables in themselves that suggest that their pain is driven by central nervous system processes / their brains. |
| Health Behavior Control | Placebo comparator | Behavioral: Health behavior control interventionThis 15 to 20-minute exercise is designed as a control condition that has face validity as helpful and that relates to health. Thus, patients are asked to examine various domains of their own health behavior as engaged in over the past 24 hours (e.g., nutrition, sleep, exercise, hygiene, social connections). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking adults ages 18 years or older with internet access who are referred to the University of Michigan Health Service Physical Medicine and Rehabilitation Spine Program identified the physician with chronic nonspecific back pain (longer than 3 months) or fibromyalgia. Degenerative changes seen on imaging are considered nonspecific. Alternatively, enrolled in the University of Michigan Health Research Volunteer Pool with a profile that includes chronic low back pain or fibromyalgia.
Key exclusion criteria (2 listed)
- Any signs of a serious underlying condition (cancer, infection, cauda equine), spinal stenosis or radiculopathy, or other specific spinal cause (vertebral compression fracture or ankylosing spondylitis). Those patients who are being considered for an interventional spine procedures or surgical consults would not be included in this study.
- Individuals receiving or applying for compensation or disability, the inability to provide written informed consent, severe physical impairment (e.g. blindness, deafness), co-morbid medical condition limiting function (e.g. malignant cancer), the use of illicit drug use, or a psychiatric condition that would limit judgment.
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 |
|---|---|---|
| Pain neuroscience education patient exercisePatients complete a 15 to 20-minute on-line exercise that inquires about 5 domains: the degree of central sensitization symptoms, catastrophizing and kinesiophobia, personality factors, stressors that triggered or exacerbated the pain, and adverse childhood experiences. | Behavioural | Chronic Pain and the Brain |
| Health behavior control interventionPatients engage in a 15 to 20-minute on-line exercise examining their health behaviors in five domains: exercise, sleep, diet, hygiene, and social connections. | Behavioural | Health Behavior Control |
Primary outcome
Brief Pain Inventory
Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Self-reported pain and dysfunction
8 secondary outcomes
Patient-Reported Outcomes Measurement Information System: Depression short form 8b
Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a
Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Patient-Reported Outcomes Measurement Information System: Anger short form 5a
Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Pain attributions questionnaires
Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Pain Stages of Change Questionnaire
Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Pain Catastrophizing Scale
Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Tampa Scale for Kinesiophobia
Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Satisfaction with Life Scale
Time frame: Change from baseline to 1-month follow-up (with secondary 10-month follow-up)
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 25 Jul 2019.
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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.
David Kohns, MD principal investigator
University of Michigan
Mark A Lumley, PhD study director
Wayne State 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 Pain neuroscience education patient exercise in people with Chronic Musculoskeletal Pain, run by Wayne State 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 1 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 25 Jul 2019. 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. Some participants in this study may receive a placebo. 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?
Brief Pain Inventory (time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)). 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 25 Jul 2019.