Acute Musculoskeletal PainPIVOTNCT06035575
The Pain Intervention Via Video Optimization Trial
A study testing Educational video in people with Acute Musculoskeletal Pain and Chronic Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This project tests a brief evidence-based video to help educate patients regarding effective and safe pharmacologic and non-pharmacologic therapies for acute musculoskeletal pain (MSP). Subjects will be randomly placed into one of two study arms: intervention (educational video) and usual care. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Musculoskeletal Pain, Chronic Pain
- What is being tested?
- Educational video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2023to 11 Sep 2024
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- primary complaint of acute MSP
- if in the ED, discharge to home is anticipated
- average pain score ≥4 (0-10 scale) since pain onset
Who cannot join
- patient does not speak English
- primary pain located in the head, chest, or abdomen
- pain due to ischemia, infection, or some other cause not due to MSP (blood clot, kidney stone, etc.)
- primary pain due to self-injury
- patient is critically ill, including current diagnosis of cancer
- diagnosis of somatoform disorder, schizophrenia, dementia, or bipolar disorder
Show all 14Show fewer
- patient is a prisoner or in police custody
- patient is currently pregnant
- self-reported daily opioid use for more than seven consecutive days during the prior 30 days to the acute care visit
- resides in a nursing home or is homeless
- at-risk alcohol use
- speech, hearing, vision problems
- cognitively impaired (6-item Brief Screener)
- nonworking phone number (follow-up occurs via phone calls)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
About this study
Official title: Development of an Emergency Department Patient-Centered Intervention for the Primary Prevention of Long-Term Opioid Use
This project tests a brief evidence-based video to help educate patients regarding effective and safe pharmacologic and non-pharmacologic therapies for acute musculoskeletal pain (MSP). Subjects will be randomly placed into one of two study arms: intervention (educational video) and usual care. Patients will be contacted at baseline and at 1 and 3 months after the date of an emergency department (ED) or urgent care encounter for follow-up. The aim of this study is to evaluate the success of the intervention for improving pain recovery and preventing long-term opioid use among adults with musculoskeletal pain.
The overarching hypothesis of this work is that complementing prescribing policies with patient education based on a shared decision-making approach to pain management can improve pain recovery and reduce progression to long-term opioid use. The proposed study is innovative because it will be the first clinical trial of a patient-centered intervention designed for the primary prevention of long-term opioid use.
Read the detailed description
This study will use a two-arm, blinded, randomized controlled trial to estimate the effect of the adapted telehealth video intervention on pain recovery and opioid use at 3 months among opioid-naïve adult Emergency Department (ED) and urgent care patients with musculoskeletal pain.
This 2-year study will encompass the conduct and analysis of an assessor-blinded two-arm randomized controlled trial among 200 ED/urgent care patients with acute MSP. Randomization will be block stratified by the subject's age (18-40 years; 41+ years).
To test the efficacy of the intervention subjects will be randomized to one of two arms:
- Intervention (video)
- Usual Care (standard care provided by ED/urgent care provider and staff) Intervention: The telehealth intervention consists of an interactive video (~15 minutes) given to the patient after an ED/urgent care visit that provides essential pain treatment information and encourages patients to discuss treatment options with their ED/urgent care provider.
Following the video, the participant will contact the research team with his/her answers to the multiple choice questions posed during the video and/or confirm having watched the video within, at most, 5 days of the participant's discharge / acute care visit.
Evaluation: Data collection will occur for subjects in all arms of the study according to the schedule below:
- Baseline after the ED/urgent care visit via phone call interview
- 1 and 3 months after ED/urgent care discharge via phone call interview
Outcomes follow-up: A phone call questionnaire will be performed at 1 and 3 months following patient discharge from the ED/urgent care for patients in all arms of the study. This questionnaire will be designed to evaluate current pain as well as average, maximum, and minimum pain in the past week. Additional questions will include opioid use, pain interference with general activity, walking, sleep, and enjoyment of life; side effects; return ED/urgent care visits for pain; and other health care utilization for pain.
- Conditions
- Acute Musculoskeletal Pain, Chronic Pain
- Being tested
- Educational video
- Keywords
- Musculoskeletal Pain, Acute Pain, Emergency Department, Video, Opioid Addiction Prevention
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain, Acute Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoBehavioural
Development of the original video used a systematic approach that included a review of literature and current pain management guidelines and input from emergency physicians, geriatricians, and experts in pharmacology, physical therapy, and risk communication. The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The actress for the 13-minute video is a 56-year-old mixed-race woman who presents herself as a healthcare provider. The video script will typically be shown to the patient within 48-72 hours of the acute care visit, with a maximum window of 5 days post visit.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (video) | Experimental | Educational Video: Participants in this arm will watch an interactive pain management video, sent as a link to their email. Participants will send back answers to the multiple-choice questions posed during the video and/or confirm having watched the video within 5 days (at most) of their acute care visit or discharge from the ED. Receives: Behavioral: Educational video |
| Usual Care | No intervention | Participants will receive the typical care provided by medical personnel for their acute pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Pain Severity and Interference Scores
The Brief Pain Inventory-short form (BPI-SF) is an 11-item measure of pain severity and pain interference. Patients will rate pain severity and interference over the past week on a 0-10 numeric scale at 3 discrete time periods (baseline, 1 month, and 3 months). End points for the severity items include 0 which equals "no pain" and 10 which equals "pain as bad as you can imagine." End points for the interference items include 0 which equals "does not interfere" and 10 "completely interferes." Higher scores reflect more pain severity and more pain interference. A composite score will be calculated by averaging scores from both the pain severity and interference items (all 11-items). Results from the 3 time periods will be analyzed longitudinally.
Measured: Baseline (following ED or orthopedic urgent care visit) to month 3
Secondary outcomes (7)
Pain Severity on the BPI-SF
The BPI-SF is an 11-item measure of pain severity and pain interference with severity entailing 4 of the questions. Patient's will rate pain severity over the past week, on a 0-10 numeric rating scale, with a higher score reflecting more pain. End points include 0 which equals "no pain" and 10 which equals "pain as bad as you can imagine." Answers to each of the 4 questions will be reported for each time point (Month 1 and 3).
Measured: Up to 3 months
Pain Interference on the BPI-SF
The BPI-SF is an 11-item measure of pain severity and pain interference with interference with daily activities entailing 7 of the questions. Patient's will rate pain interference over the past week, on a 0-10 scale with a higher score reflecting more interference with activities. End points include 0 which equals "does not interfere" and 10 which equals "completely interferes." The patient's pain interference score from month 1 and 3 will be reported.
Measured: Up to 3 months
Opioid Use During the Past Week
Opioid use during the past week will be assessed by patient report and review of the patient's electronic health record at each of the follow-up time points. This will be a dichotomous outcome in which 'yes' will indicate opioid use in the past week and 'no' will indicate no opioid use in the past week. The patient's opioid use during the past week from month 1 and 3 will be reported.
Measured: Up to 3 months
PROMIS Measure: Physical Function-4
Patient report of physical function will be measured at each of the follow-up time points using the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function-4 for chores, ability to use stairs, walking, and running errands on a 5-point scale with end points of "without any difficulty" and "unable to do". Higher scores reflect less difficulty. These values will be compared to the value obtained from the baseline assessment with patients reporting their function prior to injury. The patient's physical function assessment from month 1 and 3 will be reported.
Measured: Up to 3 months
PROMIS Measure: Global Health-Physical 2a
Patient reported global health will be measured using the PROMIS Global Health-Physical 2a at each of the follow-up timepoints. General physical health is measured on a 5- point scale with end points of "excellent" and "poor," where higher scores reflect better physical health. Ability to carry out every day physical activities is measured on a 5 point scale with end points of "completely" and "not at all," where higher scores reflect better ability. These values will be compared to the value obtained from the baseline assessment with patients reporting global health prior to injury. The patient's global health assessment from month 1 and 3 will be reported.
Measured: Up to 3 months
Healthcare Utilization, Number of Visits to ED/urgent care
The number of visits to an ED or urgent care for pain will be collected through patient report and the patient's electronic health record. Analysis will compare these outcomes among study arms. The patient's healthcare utilization, specifically ED/urgent care, from month 1 and 3 will be reported.
Measured: Up to 3 months
Healthcare Utilization, Number of Visits to non-ED or Urgent Care Physicians
The number of visits to a physician's office for pain will be collected through patient report and the patient's electronic health record. Analysis will compare these outcomes among study arms. The patient's healthcare utilization, specifically non-ED or urgent care, from month 1 and 3 will be reported.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start26 Sep 2023
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Model description
- A total of 225 patients will be assigned to one of two treatment arms using 1:1 randomization, stratified by age (18-40 years; 41+ years) into randomly permuted blocks. Individuals will be recruited from orthopedic urgent care clinics and Emergency Departments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Elon University, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Michelle Meyer, PhD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035575
- Sponsor's protocol ID
- 22-1551
- Other IDs
- R49CE003092, 5114616
- Acronym
- PIVOT
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina.
Publications
Platts-Mills TF, Hollowell AG, Burke GF, Zimmerman S, Dayaa JA, Quigley BR, Bush M, Weinberger M, Weaver MA. Randomized controlled pilot study of an educational video plus telecare for the early outpatient management of musculoskeletal pain among older emergency department patients. Trials. 2018 Jan 5;19(1):10. doi: 10.1186/s13063-017-2403-8.
PubMed 29304831Gan TJ, Joshi GP, Zhao SZ, Hanna DB, Cheung RY, Chen C. Presurgical intravenous parecoxib sodium and follow-up oral valdecoxib for pain management after laparoscopic cholecystectomy surgery reduces opioid requirements and opioid-related adverse effects. Acta Anaesthesiol Scand. 2004 Oct;48(9):1194-207. doi: 10.1111/j.1399-6576.2004.00495.x.
PubMed 15352969Hurka-Richardson K, Platts-Mills TF, McLean SA, Weinberger M, Stearns SC, Bush M, Quackenbush E, Chari S, Aylward A, Kroenke K, Kerns RD, Weaver MA, Keefe FJ, Berkoff D, Meyer ML. Brief Educational Video plus Telecare to Enhance Recovery for Older Emergency Department Patients with Acute Musculoskeletal Pain: an update to the study protocol for a randomized controlled trial. Trials. 2022 May 12;23(1):400. doi: 10.1186/s13063-022-06310-z.
PubMed 35550175
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Emergency Department Patient-Centered Intervention for the Primary Prevention of Long-Term Opioid Use
- ClinicalTrials.gov ID
- NCT06035575
- Acronym / sponsor ID
- PIVOT / 22-1551
- Conditions
- Acute Musculoskeletal Pain, Chronic Pain
- Keywords
- Musculoskeletal Pain, Acute Pain, Emergency Department, Video, Opioid Addiction Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Elon University, Centers for Disease Control and Prevention
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 13 Sep 2023 (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 project tests a brief evidence-based video to help educate patients regarding effective and safe pharmacologic and non-pharmacologic therapies for acute musculoskeletal pain (MSP). Subjects will be randomly placed into one of two study arms: intervention (educational video) and usual care. Patients will be contacted at baseline and at 1 and 3 months after the date of an emergency department (ED) or urgent care encounter for follow-up. The aim of this study is to evaluate the success of the intervention for improving pain recovery and preventing long-term opioid use among adults with musculoskeletal pain.
The overarching hypothesis of this work is that complementing prescribing policies with patient education based on a shared decision-making approach to pain management can improve pain recovery and reduce progression to long-term opioid use. The proposed study is innovative because it will be the first clinical trial of a patient-centered intervention designed for the primary prevention of long-term opioid use.
Detailed description
This study will use a two-arm, blinded, randomized controlled trial to estimate the effect of the adapted telehealth video intervention on pain recovery and opioid use at 3 months among opioid-naïve adult Emergency Department (ED) and urgent care patients with musculoskeletal pain.
This 2-year study will encompass the conduct and analysis of an assessor-blinded two-arm randomized controlled trial among 200 ED/urgent care patients with acute MSP. Randomization will be block stratified by the subject's age (18-40 years; 41+ years).
To test the efficacy of the intervention subjects will be randomized to one of two arms:
- Intervention (video)
- Usual Care (standard care provided by ED/urgent care provider and staff) Intervention: The telehealth intervention consists of an interactive video (~15 minutes) given to the patient after an ED/urgent care visit that provides essential pain treatment information and encourages patients to discuss treatment options with their ED/urgent care provider.
Following the video, the participant will contact the research team with his/her answers to the multiple choice questions posed during the video and/or confirm having watched the video within, at most, 5 days of the participant's discharge / acute care visit.
Evaluation: Data collection will occur for subjects in all arms of the study according to the schedule below:
- Baseline after the ED/urgent care visit via phone call interview
- 1 and 3 months after ED/urgent care discharge via phone call interview
Outcomes follow-up: A phone call questionnaire will be performed at 1 and 3 months following patient discharge from the ED/urgent care for patients in all arms of the study. This questionnaire will be designed to evaluate current pain as well as average, maximum, and minimum pain in the past week. Additional questions will include opioid use, pain interference with general activity, walking, sleep, and enjoyment of life; side effects; return ED/urgent care visits for pain; and other health care utilization for pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 225 patients will be assigned to one of two treatment arms using 1:1 randomization, stratified by age (18-40 years; 41+ years) into randomly permuted blocks. Individuals will be recruited from orthopedic urgent care clinics and Emergency Departments.
| Arm | Type | Receives |
|---|---|---|
| Intervention (video) | Experimental | Behavioral: Educational videoEducational Video: Participants in this arm will watch an interactive pain management video, sent as a link to their email. Participants will send back answers to the multiple-choice questions posed during the video and/or confirm having watched the video within 5 days (at most) of their acute care visit or discharge from the ED. |
| Usual Care | No intervention | –Participants will receive the typical care provided by medical personnel for their acute pain. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years of age
- primary complaint of acute MSP
- if in the ED, discharge to home is anticipated
- average pain score ≥4 (0-10 scale) since pain onset
Key exclusion criteria (14 listed)
- patient does not speak English
- primary pain located in the head, chest, or abdomen
- pain due to ischemia, infection, or some other cause not due to MSP (blood clot, kidney stone, etc.)
- primary pain due to self-injury
- patient is critically ill, including current diagnosis of cancer
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 |
|---|---|---|
| Educational videoDevelopment of the original video used a systematic approach that included a review of literature and current pain management guidelines and input from emergency physicians, geriatricians, and experts in pharmacology, physical therapy, and risk communication. The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The actress for the 13-minute video is a 56-year-old mixed-race woman who presents herself as a healthcare provider. The video script will typically be shown to the patient within 48-72 hours of the acute care visit, with a maximum window of 5 days post visit. | Behavioural | Intervention (video) |
Primary outcome
Combined Pain Severity and Interference Scores
Time frame: Baseline (following ED or orthopedic urgent care visit) to month 3
The Brief Pain Inventory-short form (BPI-SF) is an 11-item measure of pain severity and pain interference. Patients will rate pain severity and interference over the past week on a 0-10 numeric scale at 3 discrete time periods (baseline, 1 month, and 3 months). End points for the severity items include 0 which equals "no pain" and 10 which equals "pain as bad as you can imagine." End points for the interference items include 0 which equals "does not interfere" and 10 "completely interferes." Higher scores reflect more pain severity and more pain interference. A composite score will be calculated by averaging scores from both the pain severity and interference items (all 11-items). Results from the 3 time periods will be analyzed longitudinally.
7 secondary outcomes
Pain Severity on the BPI-SF
Time frame: Up to 3 months
Pain Interference on the BPI-SF
Time frame: Up to 3 months
Opioid Use During the Past Week
Time frame: Up to 3 months
PROMIS Measure: Physical Function-4
Time frame: Up to 3 months
PROMIS Measure: Global Health-Physical 2a
Time frame: Up to 3 months
Healthcare Utilization, Number of Visits to ED/urgent care
Time frame: Up to 3 months
Healthcare Utilization, Number of Visits to non-ED or Urgent Care Physicians
Time frame: Up to 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 20 Sep 2024.
- Background: PubMed 29304831Platts-Mills TF, Hollowell AG, Burke GF, Zimmerman S, Dayaa JA, Quigley BR, Bush M, Weinberger M, Weaver MA. Randomized controlled pilot study of an educational video plus telecare for the early outpatient management of musculoskeletal pain among older emergency department patients. Trials. 2018 Jan 5;19(1):10. doi: 10.1186/s13063-017-2403-8.
- Background: PubMed 15352969Gan TJ, Joshi GP, Zhao SZ, Hanna DB, Cheung RY, Chen C. Presurgical intravenous parecoxib sodium and follow-up oral valdecoxib for pain management after laparoscopic cholecystectomy surgery reduces opioid requirements and opioid-related adverse effects. Acta Anaesthesiol Scand. 2004 Oct;48(9):1194-207. doi: 10.1111/j.1399-6576.2004.00495.x.
- Background: PubMed 35550175Hurka-Richardson K, Platts-Mills TF, McLean SA, Weinberger M, Stearns SC, Bush M, Quackenbush E, Chari S, Aylward A, Kroenke K, Kerns RD, Weaver MA, Keefe FJ, Berkoff D, Meyer ML. Brief Educational Video plus Telecare to Enhance Recovery for Older Emergency Department Patients with Acute Musculoskeletal Pain: an update to the study protocol for a randomized controlled trial. Trials. 2022 May 12;23(1):400. doi: 10.1186/s13063-022-06310-z.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina.
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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.
Michelle Meyer, PhD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Acute Musculoskeletal Pain and Chronic Pain, run by University of North Carolina, Chapel Hill 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 4 inclusion and 14 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 20 Sep 2024. 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?
Combined Pain Severity and Interference Scores (time frame: Baseline (following ED or orthopedic urgent care visit) to month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06035575, which also lists 3 linked publications.
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 20 Sep 2024; AzTrials last refreshed its copy on 28 Oct 2026.