Chronic PainNCT02783365
Improving the Management of Chronic Pain in Primary Care
A study testing Photo-elicitation and online group support in people with Chronic Pain, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
There are an estimated 100 million Americans with chronic pain. The enormity of the problem at the societal level is staggering, not simply in terms of its sheer prevalence but also the societal costs, including health care expenditures, disability compensation, lost productivity, and lost employment potential. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Photo-elicitation and online group support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 2 Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will need to meet the following criteria in order to participate in the study:
- they must be between the ages of 18-75
- they must have an established care relationship with the practitioner (having had at least two previous visits for chronic pain of at least 6 months' duration)
- they must read and understand English
- they must be willing to sign a consent. Patients must have a device to take pictures (e.g., camera, phone, or tablet) and access to the internet in order to complete REDcap (the online data collection tool we will use to capture quantitative data in order to assess intervention impact), and participate in the online discussions via Facebook.
Who cannot join
- No terminal illness, and/or a life expectancy of < 1yr.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri, Dept. of Family and Community Medicine
Columbia, Missouri, 65212
About this study
There are an estimated 100 million Americans with chronic pain. The enormity of the problem at the societal level is staggering, not simply in terms of its sheer prevalence but also the societal costs, including health care expenditures, disability compensation, lost productivity, and lost employment potential. The pharmacological focus in treatment tends to give patients with chronic pain a negative stereotype as many are viewed as drug seeking, or worse, they are perceived to have an imaginary illness. It is argued that these stigmas not only negatively affect the patients' healthcare experience, but also perpetuate maladaptive coping. In addition, it is suggested that reliance on pharmacological approaches have contributed to the rate of overdoses from prescribed opioids. In order to address this burden facing society, patients need opportunities to foster a sense of self-efficacy to manage their pain, as well as improve their healthcare experience by allowing them to dialogue with their clinician openly and freely about their chronic pain, and coping strategies.
This study is designed to explore the impact of an intervention using photo-elicitation (based on Photovoice) and online group support (via Facebook) on participants' overall experience of chronic pain and patient-identified areas of function. Photovoice participants will utilize cameras that enable them to record issues related to their experiences, and subsequently display them. This method serves as an empowering tool to connect participants to key stakeholders in the community, facilitates change and opportunities that otherwise would not be available to marginalized groups.
Read the detailed description
This is a multi-site study occurring between the University of Missouri, and the American Academy of Family Physicians National Research Network (NRN). The University of Missouri will be responsible for the following:
- Coordinating the approval of initial protocol as well as subsequent amendments.
- Ensure that each site is using the correct version of the protocol.
- Serve as the study contact.
- Participate in the selection of qualified sites for participation (the NRN will be responsible for recruitment and randomization. This process will be overseen by MU).
- Monitor progress and oversee all conduct of the study at participating sites.
- Responsible for the data analysis, reporting, integrity, and accuracy of data.
There will be one protocol document, and each site will utilize this document. The lead site (MU) will develop the informed consent, which includes language that data will be shared with the NRN.
The NRN will be the Institutional Review Board (IRB) of record for the 18 practices recruited to participate within the NRN, and will provide a letter of authorization and final IRB approval to the lead PI (MU).
The study will test if a photo elicitation intervention combined with access to online community support and a chronic pain guideline can improve a 3-item measure of chronic pain [the PEG score: Pain intensity (P), Enjoyment of Life (E), and General Activity (G)] and a patient-identified area of function, compared to a group who receive the guideline alone.
- Conditions
- Chronic Pain
- Being tested
- Photo-elicitation and online group support
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photo-elicitation and online group supportBehavioural
See above information.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention uses photo-elicitation and online group support (via Facebook) to improve patients' overall experience of chronic pain and patient-identified areas of function. This intervention was informed by the Photovoice methodology developed by Wang and Burris (1994). Photovoice participants will utilize cameras that enable them to record issues related to their experiences, and subsequently display them in office visits with their physician or mid-level clinician. Receives: Behavioral: Photo-elicitation and online group support |
| Control | No intervention | Patients in the control practices will receive usual care and will be eligible to participate in the intervention after their participation in the study is completed at 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the score on the 3-item measure of chronic pain (PEG)
The PEG asks 3 questions about (1) severity of pain on average in the past week, (2) how much has pain interfered with your life during the past week, and (3) how much has pain interfered with your general activity.
Measured: Change from baseline to 12 months after enrollment
Secondary outcomes (3)
Change in the score on the Pain Self-Efficacy Questionnaire (PSEQ)
The PSEQ is a 10-item questionnaire asking "how confident you are" in performing activities in the specified areas.
Measured: Change from baseline to 12 months after enrollment
Change in the score on the Chronic Pain Acceptance Questionnaire (CPAQ)
We will use 8 of the 20 questions in the CPAQ, which ask about pain acceptance.
Measured: Change from baseline to 12 months after enrollment
Change in score on a scale measuring the patient-centeredness of an office visit (Stewart et al., 2004)
This scale of patient-centeredness asks 14 questions about how patient-centered the office visit was. We will use a subset of the 14 items.
Measured: Change from baseline to 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startJul 2016
- Primary completion2 Sep 2019
- Study completion2 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Family Physicians National Research Network
- Responsible party
- Principal investigator, Benjamin Crenshaw, University of Missouri-Columbia
- Investigators
- Benjamin H Crenshaw, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783365
- Sponsor's protocol ID
- 2004283
- Status last verified
- Sep 2019
- First submitted
- 17 May 2016
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: We will post de-identified data on an open-access website when the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Management of Chronic Pain in Primary Care
- ClinicalTrials.gov ID
- NCT02783365
- Acronym / sponsor ID
- 2004283
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- American Academy of Family Physicians National Research Network
- Study start
- Jul 2016 (actual)
- Primary completion
- 2 Sep 2019 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 26 May 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.
There are an estimated 100 million Americans with chronic pain. The enormity of the problem at the societal level is staggering, not simply in terms of its sheer prevalence but also the societal costs, including health care expenditures, disability compensation, lost productivity, and lost employment potential. The pharmacological focus in treatment tends to give patients with chronic pain a negative stereotype as many are viewed as drug seeking, or worse, they are perceived to have an imaginary illness. It is argued that these stigmas not only negatively affect the patients' healthcare experience, but also perpetuate maladaptive coping. In addition, it is suggested that reliance on pharmacological approaches have contributed to the rate of overdoses from prescribed opioids. In order to address this burden facing society, patients need opportunities to foster a sense of self-efficacy to manage their pain, as well as improve their healthcare experience by allowing them to dialogue with their clinician openly and freely about their chronic pain, and coping strategies.
This study is designed to explore the impact of an intervention using photo-elicitation (based on Photovoice) and online group support (via Facebook) on participants' overall experience of chronic pain and patient-identified areas of function. Photovoice participants will utilize cameras that enable them to record issues related to their experiences, and subsequently display them. This method serves as an empowering tool to connect participants to key stakeholders in the community, facilitates change and opportunities that otherwise would not be available to marginalized groups.
Detailed description
This is a multi-site study occurring between the University of Missouri, and the American Academy of Family Physicians National Research Network (NRN). The University of Missouri will be responsible for the following:
- Coordinating the approval of initial protocol as well as subsequent amendments.
- Ensure that each site is using the correct version of the protocol.
- Serve as the study contact.
- Participate in the selection of qualified sites for participation (the NRN will be responsible for recruitment and randomization. This process will be overseen by MU).
- Monitor progress and oversee all conduct of the study at participating sites.
- Responsible for the data analysis, reporting, integrity, and accuracy of data.
There will be one protocol document, and each site will utilize this document. The lead site (MU) will develop the informed consent, which includes language that data will be shared with the NRN.
The NRN will be the Institutional Review Board (IRB) of record for the 18 practices recruited to participate within the NRN, and will provide a letter of authorization and final IRB approval to the lead PI (MU).
The study will test if a photo elicitation intervention combined with access to online community support and a chronic pain guideline can improve a 3-item measure of chronic pain [the PEG score: Pain intensity (P), Enjoyment of Life (E), and General Activity (G)] and a patient-identified area of function, compared to a group who receive the guideline alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Photo-elicitation and online group supportThe intervention uses photo-elicitation and online group support (via Facebook) to improve patients' overall experience of chronic pain and patient-identified areas of function. This intervention was informed by the Photovoice methodology developed by Wang and Burris (1994). Photovoice participants will utilize cameras that enable them to record issues related to their experiences, and subsequently display them in office visits with their physician or mid-level clinician. |
| Control | No intervention | –Patients in the control practices will receive usual care and will be eligible to participate in the intervention after their participation in the study is completed at 12 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- they must be between the ages of 18-75
- they must have an established care relationship with the practitioner (having had at least two previous visits for chronic pain of at least 6 months' duration)
- they must read and understand English
- they must be willing to sign a consent. Patients must have a device to take pictures (e.g., camera, phone, or tablet) and access to the internet in order to complete REDcap (the online data collection tool we will use to capture quantitative data in order to assess intervention impact), and participate in the online discussions via Facebook.
Key exclusion criteria (1 listed)
- No terminal illness, and/or a life expectancy of < 1yr.
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 |
|---|---|---|
| Photo-elicitation and online group supportSee above information. | Behavioural | Intervention |
Primary outcome
Change in the score on the 3-item measure of chronic pain (PEG)
Time frame: Change from baseline to 12 months after enrollment
The PEG asks 3 questions about (1) severity of pain on average in the past week, (2) how much has pain interfered with your life during the past week, and (3) how much has pain interfered with your general activity.
3 secondary outcomes
Change in the score on the Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Change from baseline to 12 months after enrollment
Change in the score on the Chronic Pain Acceptance Questionnaire (CPAQ)
Time frame: Change from baseline to 12 months after enrollment
Change in score on a scale measuring the patient-centeredness of an office visit (Stewart et al., 2004)
Time frame: Change from baseline to 12 months after enrollment
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 13 Sep 2019.
- Individual participant dataSharing planned: Yes. We will post de-identified data on an open-access website when the study is completed.
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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.
Benjamin H Crenshaw, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photo-elicitation and online group support in people with Chronic Pain, run by University of Missouri-Columbia 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 1 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 13 Sep 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. 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?
Change in the score on the 3-item measure of chronic pain (PEG) (time frame: Change from baseline to 12 months after enrollment). 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 13 Sep 2019.