Acute Orthopedic InjuryTORNCT04973696
Toolkit for Optimal Recovery After Orthopedic Injury
A study testing Toolkit for Optimal Recovery after Orthopedic Injury in people with Acute Orthopedic Injury, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a multi-site randomized feasibility trial of the Toolkit for Optimal Recovery after Orthopedic Injury (TOR), a mind-body program to prevent persistent pain and disability in at-risk patients with acute orthopedic injury, versus a minimally-enhanced usual care (MEUC) control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Orthopedic Injury
- What is being tested?
- Toolkit for Optimal Recovery after Orthopedic Injury
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2021to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male and female outpatients in the Level 1 Trauma Center of one of the 4 sites, age 18 years or older
- Sustained one more more acute orthopedic injuries (e.g., fracture, dislocation, rupture) approximately 1-2 months earlier (acute phase)
- Score ≥20 on the Pain Catastrophizing Scale (PCS) or ≥40 on the Short Form Pain Anxiety Scale (PASS-20)
- Willing to participate and comply with the requirements of the study protocol, including randomization, questionnaire completion, and potential home practice and weekly sessions.
- No psychotropics for at least 2 weeks prior to initiation of treatment or stable for >6 weeks and willing to maintain a stable dose
- Cleared by orthopedic surgeon for activities using the injured limb within the next 4 weeks
- Able to meaningfully participate (e.g., English speaking and comprehension, stable living situation as determined by the medical staff at each site)
- A score of 8/10 or more on the Short Portable Mental Status Questionnaire ONLY IF a participant is 65 or older, or if a participant's cognitive abilities are unclear to research staff
Who cannot join
- Serious comorbidity expected to worsen in the next 3 months (e.g., malignancy)
- Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use
- Current suicidal ideation
- Other unmanaged serious non-orthopedic injuries that occurred alongside the orthopedic injury (i.e., TBI, ruptured internal organs, etc.)
- Practice of meditation, or other mind body techniques that elicit the RR, for at least 45 total minutes a week each week over the last 3 months
- Currently in litigation or under Workman's Comp
- Surgery complications (e.g., uncontrolled infection, need for repeat surgery)
- Self-reported pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02140
About this study
Official title: Toolkit for Optimal Recovery After Orthopedic Injury; A Multisite Feasibility Study to Prevent Persistent Pain and Disability
This is a multi-site randomized feasibility trial of the Toolkit for Optimal Recovery after Orthopedic Injury (TOR), a mind-body program to prevent persistent pain and disability in at-risk patients with acute orthopedic injury, versus a minimally-enhanced usual care (MEUC) control. TOR is a 4-session program delivered via secure live video to patients at risk for chronic pain, 1-2 months after an orthopedic traumatic injury. The primary aim of this study is to determine whether the study methodology (i.e., implementation, randomization, procedures and assessment of outcome measures) and delivery of TOR meet a priori set benchmarks for feasibility, acceptability, and appropriateness, necessary for the success of the subsequent efficacy trial.
Read the detailed description
Study Rationale:
The care of patients with acute orthopedic injuries follows an outdated biomedical model, and consists primarily of surgical interventions and pain medications, despite strong evidence for the pivotal role of psychosocial factor in transition to persistent pain and disability.
We developed the first mind-body program - The Toolkit for Optimal Recovery after orthopedic injury (TOR) - to prevent chronic pain and disability in at-risk patients with orthopedic injuries. TOR is based on the fear avoidance model and teaches skills (e.g., mindfulness and relaxation, adaptive thinking, acceptance) to help optimize recovery. Each TOR session is 45 minutes long, and there are 4 sessions delivered within a period of 4-5 weeks (TOR and control arm will be yoked for the timing of interventions).
Primary Objective The primary objective is to conduct a multi-site feasibility RCT of TOR versus MEUC control in order to determine whether the study methodology and TOR meet a priori set benchmarks necessary for the success of the subsequent efficacy trial. There are 5 primary outcomes: 1. Feasibility of recruitment (assessed by number of participants who agree to participate); 2. Appropriateness (assessed with the Credibility and Expectancy Scale); 3. Feasibility of data collection (self-report; assessed by number of participants who complete these measures at the 3 time points); 4. Treatment satisfaction (assessed with the Client Satisfaction Scale); and 5. Acceptability of TOR (adherence to sessions).
It should be noted that some of the feasibility outcomes/markers will be reported for both groups together (i.e. TOR and MEUC combined, for example the feasibility of data collection), but others were only collected and reported for the TOR group, because they were assessing the intervention specifically; the intervention was only administered in the TOR arm, and thus this outcome can only be reported for the TOR arm. Outcomes will clearly state which groups they are reported for, if results are combined, and rationale will be provided for this decision.
Hypothesis: We expect that TOR will meet all a priori set benchmarks.
Secondary Objectives:
There will be 27 secondary outcomes. Outcomes (both primary and secondary) will be reported for all sites combined, unless otherwise noted in an outcome description. Several secondary outcomes (which will be noted) will assess whether the intervention (TOR) tested in this study is feasible, acceptable, and satisfactory, from the point of view of the staff and surgeons in the orthopedic clinics (sites of recruitment for intervention participants). These feasibility secondary outcomes do not reflect the perspectives or numbers of the actual participants (180 planned) who were enrolled in the trial, but rather those of the staff and surgeons in the clinics where these participants are being treated for their orthopedic injury, and from which referrals for participation in the study came.
Study Design:
In the present study, 180 patients with acute orthopedic injuries from the Level I Trauma Centers at Massachusetts General Hospital (Boston, MA), Dell Medical School (Austin, TX), the University of Kentucky (Lexington, KY), and Vanderbilt University Medical Center (Nashville, TN) who are at risk for chronic pain and disability are planned to be enrolled. After consent and baseline assessments, participants will be randomly assigned to TOR or to a minimally enhanced usual care control (MEUC). Subjects in the TOR group undergo a 4-week session (~45 minutes each), individual, live video, synchronous mind-body intervention. The MEUC group will receive a pamphlet containing brief summarized information that reflects the intervention topics (e.g., the trajectory of pain and recovery after orthopedic illness). In addition, participants in both groups will receive usual medical care as determined by the medical team. Participants in both groups will complete assessments at baseline, after the completion of TOR, and 3 months (from baseline) later.
- Conditions
- Acute Orthopedic Injury
- Being tested
- Toolkit for Optimal Recovery after Orthopedic Injury, Minimally Enhanced Usual Care (MEUC)
- Keywords
- Mind-Body, Pain, Physical Function, Disability, Psychosocial
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toolkit for Optimal Recovery after Orthopedic InjuryBehavioural
The Toolkit (TOR) is a 4-session, individual, live video, synchronous program developed specifically for patients with orthopedic acute injuries who are at risk for chronic pain and disability. The program teaches evidence-based mind-body skills (e.g., relaxation and mindfulness; myths about pain; activity pacing; acceptance and values based goal setting). Participants gain access to a website downloaded on their phones as an app. The website included explainer videos of skills and recordings of mindfulness and relaxation exercises. In addition, participants will receive usual care as determined by medical team.
Minimally Enhanced Usual Care (MEUC)Other
The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.
| Study group | Role | What they receive |
|---|---|---|
| Toolkit for Optimal Recovery after Orthopedic Injury - Active | Experimental | The Toolkit (TOR) is a 4-session, individual, live video, synchronous program developed specifically for patients with orthopedic acute injuries who are at risk for chronic pain and disability. The program teaches evidence-based mind-body skills (e.g., relaxation and mindfulness; myths about pain; activity pacing; acceptance and values based goal setting). Participants gain access to a website downloaded on their phones as an app. The website included explainer videos of skills and recordings of mindfulness and relaxation exercises. In addition, participants will receive usual care as determined by medical team. Receives: Behavioral: Toolkit for Optimal Recovery after Orthopedic Injury |
| Minimally Enhanced Usual Care (MEUC) - Control | Active comparator | The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. Receives: Other: Minimally Enhanced Usual Care (MEUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment Among All Patients
We will report number of participants who consented to participate out of those eligible, evaluated at the end of study. This number is not the same as the number who were actually enrolled and randomized in the trial (195).
Measured: At the end of the entire enrollment period of the study, which was about 1 year and 10 months.
Appropriateness of Treatment Program, Rated by Participants Randomized to TOR and Assessed by the Credibility and Expectancy Scale
A measure of participant's expectations and believed credibility for program (i.e. appropriateness), as assessed by the Credibility and Expectancy Scale. This scale has a range of 3 to 27 points, with higher ratings indicating more belief that the program is logical and will help with the intended outcome. This measure was the count of patients who scored above or below the scale's theoretical midpoint (i.e. the midpoint is not based on the collected data) on the Credibility and Expectancy Scale
Measured: Baseline
Feasibility of Data Collection
This outcome will assess the feasibility of collecting the data used to assess and compare the TOR intervention to MEUC (usual care); it is not looking at the data itself or comparing two arms, but just the feasibility of collecting it. To assess this feasibility marker of our intervention, we will report the number of patients who complete their study assessments, for both TOR and MEUC together, at all of their required timepoints in the study.
Measured: On the participant level, data was collected over the course of 4 months (baseline through followup). Counts reported here and described above were summed at the final end of all study activities (a total duration of 1 year 10 months).
Acceptability of Treatment (Satisfaction) Assessed With the Client Satisfaction Questionnaire (Patients Randomized to TOR Only)
Participant's satisfaction with treatment received after completion of TOR was assessed using the Client Satisfaction Questionnaire. In this questionnaire, items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction. This measure is the count of participants in TOR who scored above the scale's theoretical midpoint (i.e. the midpoint is not based on the collected data) on the Client Satisfaction Questionnaire.
Measured: Assessed at Post-Test, which was approximately 4 weeks after a participant's enrollment in the study and baseline assessment.
Acceptability of TOR (Attendance for Patients Randomized to TOR)
We will the report total number of patients in the TOR intervention who attend all four sessions that are part of their intervention.
Measured: On the participant level, the data for this outcome was collected over the course of the intervention and its sessions (4 weeks). Counts of attendance were summed at the end of the study (~1 year and 10 months).
Secondary outcomes (36)
Feasibility of Randomization/Adherence to Assigned Arm, for All Enrolled Patients
We will report number of participants who are randomized within one arm and complete post-test.
Measured: Assessed the counts for the study as a whole at the end of study completion, which was about 1 year and 10 months. On the participant level, the time from randomization to posttest took place over an average of 4 weeks.
Orthopedic Staff Feasibility of Referral
We will report the number of surgeons and staff who make at least 5 referrals across all four sites, to assess whether referrals for this trial (and thus our intervention) are feasible for surgeons and clinic staff to complete. Referrals could come from providers at any point over the course of the intervention/study.
Measured: On the staff member level, the data for this outcome was collected over the course of the entire intervention/study (about 1 year and 7 months total from the start of referrals and participant enrollment in the study).
Fidelity to Study Procedures (Minor Deviations)
We will report number of minor deviations per each separate, site among all enrolled patients (both TOR and MEUC combined at each site). This is appropriate for the fidelity benchmark of collecting minor deviations; we are only assessing our ability to adhere to the study procedures consistently and not drift in administration (i.e. fidelity), and we are not comparing fidelity in any way between the arms.
Measured: On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of deviations were summed at the end of the study (~1 year and 10 months).
Fidelity to Study Procedures (Major Deviations)
We will report number of major deviations per each separate site among all enrolled patients (both TOR and MEUC combined at each site). This is appropriate for the fidelity benchmark of collecting major deviations; we are only assessing our ability to adhere to the study procedures consistently and not drift in administration (i.e. fidelity), and we are not comparing fidelity in any way between the arms.
Measured: On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of deviations were summed at the end of the study (~1 year and 10 months).
Adherence to TOR Homework
The number of participants who returned at least 1 out of 3 homework logs (1 log was given per week), that have 4 out of 7 days of practice reported on those logs.
Measured: On the participant level, the data for this outcome was collected over the course of the intervention and its sessions (4 weeks). Counts were then summed at the end of the study (~1 year and 10 months).
Acceptability as Rated by Therapist
Assessed using a therapist scale rating patient participation quality in each session. We will report the number of TOR sessions that scored over 7 (out of 10 possible points). There were 304 total TOR sessions delivered over the course of the study, and 294 sessions received a score over 7.
Measured: On the participant level, the data for this outcome was collected over the course of the intervention and its sessions (4 weeks). Counts that met our criteria noted in the description were then summed at the end of the study (~1 year and 10 months).
Perceived Satisfaction of Staff
We will report the number of surgeons and staff who score over 7 on the satisfaction question that was part of a study feedback survey.
Measured: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Perceived Acceptability of Staff Regarding Ease of Referral
We will report number of surgeons and staff who score over 7 on the ease of referral question that was part of a study feedback survey.
Measured: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Perceived Acceptability of Staff Regarding Cost-benefit for the Patient
We will report the number of surgeons and staff who score over 7 on the cost-benefit (patient) question that was part of a study feedback survey.
Measured: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Perceived Acceptability of Staff Regarding Cost-benefit for the Clinic
We will report the number of surgeons and staff who score over 7 on the cost-benefit (clinic) question that was part of a study feedback survey.
Measured: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Study Implementation as Perceived by Study Staff
We will report the number of surgeons and staff who score over 7 on the feasibility of study implementation question that was part of a study feedback survey.
Measured: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Appropriateness as Perceived by Study Staff
We will report the number of surgeons and staff who score over 7 on the appropriateness question that was part of a study feedback survey. This question assessed the the perceived appropriateness (relevance, compatibility) of the study for their patient population.
Measured: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Satisfaction
We will report the number of surgeons and study staff who complete the study feedback survey.
Measured: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Perceived Ease of Referrals
We will report the number of surgeons and staff who complete the ease of referral question that was part of a study feedback survey.
Measured: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Perceived Cost-benefit (Patient) Measure
We will report the number of surgeons and staff who complete the perceived cost-benefit (patient) measure question that was part of a study feedback survey.
Measured: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Perceived Cost-benefit (Clinic) Measure
We will report the number of surgeons and staff who complete the perceived cost-benefit (clinic) measure question that was part of a study feedback survey.
Measured: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Feasibility of Study Implementation
We will report the number of surgeons and staff who complete the feasibility question that was part of a study feedback survey.
Measured: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Perceived Appropriateness
We will report the number of surgeons and staff who complete the perceived appropriateness measure question that was part of a study feedback survey.
Measured: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Numerical Rating Scale (Pain at Rest), Change Between Time Points
Rating of participant's pain at rest using the Numerical Rating Scale, a Likert scale with 0 being no pain and 10 being the worst possible pain. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Numerical Rating Scale (Pain During Activity), Change Between Time Points
Rate of participant's pain with activity using the Numerical Rating Scale, a Likert scale with 0 being no pain and 10 being the worst possible pain. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Short Musculoskeletal Function Assessment (SMFA), Change Between Time Points
The Short Musculoskeletal Function Assessment (SMFA) assesses one's self-report physical function and the extent to which a participant is bothered by their functioning. Scores range from 46 to 230. Higher scores represent greater dysfunction or bother. Means reported reflect the Mean Difference between the time points noted in the row title. A decrease in score between baseline and posttest or baseline and followup (i.e. a more negative difference, or larger negative difference, as reported here) reflects improvements in physical function.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Center for Epidemiologic Study of Depression (CES-D), Change Between Time Points
The Center for Epidemiologic Study of Depression (CES-D), a 20-item measure assesses depressive symptomatology; scores range from 0-60 and higher scores indicate greater depressive symptomatology. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
PTSD Checklist- Civilian Measure (PCL-C), Change Between Time Points
The 17-item PTSD Checklist civilian measure assesses post-traumatic stress; scores range from 17-85 with higher scores indicating greater post-traumatic stress. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Pain Catastrophizing Scale (PCS), Change Between Time Points.
The Pain Catastrophizing Scale (PCS), a 13-item measure assesses hopelessness, helplessness and rumination about pain, with items ranging from 0-4 and total scores ranging from 0-52, with higher scores indicating higher levels of pain catastrophizing. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Pain Anxiety Scale, Short Form (PASS-20), Change Between Time Points
The Pain Anxiety Scale, short form (PASS-20) assesses cognitive and somatic symptoms of anxiety, items range from 0-100 and higher scores indicating greater pain anxiety. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Measure of Current Status (MOCS-A), Change Between Time Points.
The Measure of Current Status (MOCS-A) assesses ability to engage in healthy coping skills, with items ranging from 0-4, total score ranging from 0-52, and higher scores reflect greater self-perceived current state. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Cognitive and Affective Mindfulness Scale- Revised (CAMS-R), Change Between Time Points.
The Measure of Current Status (MOCS-A) assesses mindfulness, with total score ranging from 12-48. Higher scores indicate greater mindfulness. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Feasibility of Data Collection of Rescue Analgesics (Non-narcotic)
We will report number of participants with complete data on non-narcotic rescue analgesics (non-narcotic) among all enrolled patients with orthopedic injuries, via self-report log. This is appropriate for the feasibility benchmark of collecting non-narcotic rescue analgesics; we are only assessing our ability to feasibly collect this information, and we are not comparing feasibility in any way between the arms.
Measured: On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of complete data were summed at the end of the study (~1 year and 10 months).
Feasibility of Data Collection of Rescue Analgesics (Narcotic)
We will report number of participants with complete data on narcotic rescue analgesics among all enrolled patients with orthopedic injuries, via self-report log. This is appropriate for the feasibility benchmark of collecting narcotic rescue analgesics; we are only assessing our ability to feasibly collect this information, and we are not comparing feasibility in any way between the arms.
Measured: On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of complete data were summed at the end of the study (~1 year and 10 months).
Adverse Events (Serious and Non-serious)
We will report number of adverse events (serious and non-serious) per each separate site among all enrolled patients with orthopedic injuries (both TOR and MEUC combined at each site). This is appropriate to report the arms together because we are not comparing adverse events in any way between the arms.
Definition of an adverse event in this study: throughout the study, subjects were monitored for the occurrence of events defined as any undesirable experience or unanticipated risk. Lack of effect of treatment was not considered an event.
Measured: On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of complete data were summed at the end of the study (~1 year and 10 months).
Feasibility of Data Collection of Adverse Events
We will report number of participants with completed data on their adverse events, among enrolled patients with orthopedic injuries in the TOR arm. Data will be reported by study clinicians, for all sites and both arms combined. This is appropriate for the feasibility benchmark of collecting the adverse event data, since we are interested in whether it is feasible for our treatment/study intervention, which is part of the TOR arm only.
Measured: On the participant level, data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of complete data were summed at the end of the study (~1 year and 10 months).
Therapist Adherence/Fidelity to Session
We will report the number of adherence/fidelity "points" that therapists achieved from reviewers during their fidelity checks, over the course of the study. These fidelity checks were done by assessing a checklist review of audio recordings of the sessions, and were completed by 2 raters, for 16 different TOR therapists.
Measured: On the fidelity reviewer level, the data for this outcome was collected over the course of the intervention as the sessions were delivered by therapists (4 weeks of delivery). Reviews/points were then summed at end of the study (~1 year and 10 months).
Within-group Use of Rescue Analgesics (Non-narcotic)
Self-report of past-week rescue analgesics use was collected from participants at each assessment timepoint and is reported here for each timepoint; timepoint is indicated in the row title.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Within Group Use of Rescue Analgesics (Narcotic)
Self-report of past-week rescue analgesics use was collected from participants at each assessment timepoint and is reported here for each timepoint; timepoint is indicated in the row title.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
2-tailed Pearson Correlation (TOR and MEUC)
We assessed the correlation between change scores in the Short Musculoskeletal Function Assessment (SMFA) and change scores on the following mechanistic targets of the TOR intervention: Center for Epidemiologic Study of Depression (CES-D), Posttraumatic Stress Disorder Checklist (PCL), Pain Catastrophizing Scale (PCS), Pain Anxiety Scale Short Form (PASS), Measures of Current Status (MOCS), and Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Change scores reflected the difference in score between baseline (week 0) and post-test (week 4). Possible correlations range from 0-1; the closer a correlation score is to 1, the more correlated (associated, related) the two measures being compared are. This means that the closer a correlation in change scores is to 1, the more related a change in SMFA is to a change in the named mechanistic target of the intervention.
Measured: Baseline (Week 0), Post-Test (Week 4)
Physical Function Self-report, Change Between Time Points
The PROMIS Physical Function (v1.0 8b) assesses one's ability to carry out activities that require physical actions, ranging from self-care to social activities to work. Raw scores are converted to T scores, which are standardized scores based on the average in the population (a score of 50 would indicate matching the average score in the reference, general population. T scores range from 8-40, with a higher score reflecting greater physical function and ability to carry out the activity. Means reported reflect the Mean Difference between the time points in the row titles listed. For the differences reported, a bigger difference thus reflects a greater improvement in physical function.
Measured: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start21 Sep 2021
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Orthopedic InjuryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin, University of Kentucky, Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
- Investigators
- Ana-Maria Vranceanu, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973696
- Sponsor's protocol ID
- 2020P000095
- Acronym
- TOR
- Status last verified
- Jun 2025
- First submitted
- 13 Jul 2021
- Last updated
- 27 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jochimsen KN, Hooker JE, Szapary CL, Bakhshaie J, Vranceanu AM. Psychosocial Intervention and Rehabilitation Utilization Together Improve Pain and Function After Traumatic Orthopaedic Injuries: A Secondary Analysis of a Randomized Controlled Trial. Clin Orthop Relat Res. 2025 Mar 4;483(8):1514-1524. doi: 10.1097/CORR.0000000000003433.
PubMed 40737137McDermott K, Rush C, Pham T, Hooker J, Louis C, Rochon EA, Vranceanu AM. PTSD symptoms, pain catastrophizing, and pain outcomes after acute orthopedic injury. Pain Med. 2024 Dec 1;25(12):758-767. doi: 10.1093/pm/pnae068.
PubMed 39078722
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toolkit for Optimal Recovery After Orthopedic Injury; A Multisite Feasibility Study to Prevent Persistent Pain and Disability
- ClinicalTrials.gov ID
- NCT04973696
- Acronym / sponsor ID
- TOR / 2020P000095
- Conditions
- Acute Orthopedic Injury
- Keywords
- Mind-Body, Pain, Physical Function, Disability, Psychosocial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Texas at Austin, University of Kentucky, Vanderbilt University Medical Center
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Posted 27 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-site randomized feasibility trial of the Toolkit for Optimal Recovery after Orthopedic Injury (TOR), a mind-body program to prevent persistent pain and disability in at-risk patients with acute orthopedic injury, versus a minimally-enhanced usual care (MEUC) control. TOR is a 4-session program delivered via secure live video to patients at risk for chronic pain, 1-2 months after an orthopedic traumatic injury. The primary aim of this study is to determine whether the study methodology (i.e., implementation, randomization, procedures and assessment of outcome measures) and delivery of TOR meet a priori set benchmarks for feasibility, acceptability, and appropriateness, necessary for the success of the subsequent efficacy trial.
Detailed description
Study Rationale:
The care of patients with acute orthopedic injuries follows an outdated biomedical model, and consists primarily of surgical interventions and pain medications, despite strong evidence for the pivotal role of psychosocial factor in transition to persistent pain and disability.
We developed the first mind-body program - The Toolkit for Optimal Recovery after orthopedic injury (TOR) - to prevent chronic pain and disability in at-risk patients with orthopedic injuries. TOR is based on the fear avoidance model and teaches skills (e.g., mindfulness and relaxation, adaptive thinking, acceptance) to help optimize recovery. Each TOR session is 45 minutes long, and there are 4 sessions delivered within a period of 4-5 weeks (TOR and control arm will be yoked for the timing of interventions).
Primary Objective The primary objective is to conduct a multi-site feasibility RCT of TOR versus MEUC control in order to determine whether the study methodology and TOR meet a priori set benchmarks necessary for the success of the subsequent efficacy trial. There are 5 primary outcomes: 1. Feasibility of recruitment (assessed by number of participants who agree to participate); 2. Appropriateness (assessed with the Credibility and Expectancy Scale); 3. Feasibility of data collection (self-report; assessed by number of participants who complete these measures at the 3 time points); 4. Treatment satisfaction (assessed with the Client Satisfaction Scale); and 5. Acceptability of TOR (adherence to sessions).
It should be noted that some of the feasibility outcomes/markers will be reported for both groups together (i.e. TOR and MEUC combined, for example the feasibility of data collection), but others were only collected and reported for the TOR group, because they were assessing the intervention specifically; the intervention was only administered in the TOR arm, and thus this outcome can only be reported for the TOR arm. Outcomes will clearly state which groups they are reported for, if results are combined, and rationale will be provided for this decision.
Hypothesis: We expect that TOR will meet all a priori set benchmarks.
Secondary Objectives:
There will be 27 secondary outcomes. Outcomes (both primary and secondary) will be reported for all sites combined, unless otherwise noted in an outcome description. Several secondary outcomes (which will be noted) will assess whether the intervention (TOR) tested in this study is feasible, acceptable, and satisfactory, from the point of view of the staff and surgeons in the orthopedic clinics (sites of recruitment for intervention participants). These feasibility secondary outcomes do not reflect the perspectives or numbers of the actual participants (180 planned) who were enrolled in the trial, but rather those of the staff and surgeons in the clinics where these participants are being treated for their orthopedic injury, and from which referrals for participation in the study came.
Study Design:
In the present study, 180 patients with acute orthopedic injuries from the Level I Trauma Centers at Massachusetts General Hospital (Boston, MA), Dell Medical School (Austin, TX), the University of Kentucky (Lexington, KY), and Vanderbilt University Medical Center (Nashville, TN) who are at risk for chronic pain and disability are planned to be enrolled. After consent and baseline assessments, participants will be randomly assigned to TOR or to a minimally enhanced usual care control (MEUC). Subjects in the TOR group undergo a 4-week session (~45 minutes each), individual, live video, synchronous mind-body intervention. The MEUC group will receive a pamphlet containing brief summarized information that reflects the intervention topics (e.g., the trajectory of pain and recovery after orthopedic illness). In addition, participants in both groups will receive usual medical care as determined by the medical team. Participants in both groups will complete assessments at baseline, after the completion of TOR, and 3 months (from baseline) later.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toolkit for Optimal Recovery after Orthopedic Injury - Active | Experimental | Behavioral: Toolkit for Optimal Recovery after Orthopedic InjuryThe Toolkit (TOR) is a 4-session, individual, live video, synchronous program developed specifically for patients with orthopedic acute injuries who are at risk for chronic pain and disability. The program teaches evidence-based mind-body skills (e.g., relaxation and mindfulness; myths about pain; activity pacing; acceptance and values based goal setting). Participants gain access to a website downloaded on their phones as an app. The website included explainer videos of skills and recordings of mindfulness and relaxation exercises. In addition, participants will receive usual care as determined by medical team. |
| Minimally Enhanced Usual Care (MEUC) - Control | Active comparator | Other: Minimally Enhanced Usual Care (MEUC)The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female outpatients in the Level 1 Trauma Center of one of the 4 sites, age 18 years or older
- Sustained one more more acute orthopedic injuries (e.g., fracture, dislocation, rupture) approximately 1-2 months earlier (acute phase)
- Score ≥20 on the Pain Catastrophizing Scale (PCS) or ≥40 on the Short Form Pain Anxiety Scale (PASS-20)
- Willing to participate and comply with the requirements of the study protocol, including randomization, questionnaire completion, and potential home practice and weekly sessions.
- No psychotropics for at least 2 weeks prior to initiation of treatment or stable for >6 weeks and willing to maintain a stable dose
Key exclusion criteria (8 listed)
- Serious comorbidity expected to worsen in the next 3 months (e.g., malignancy)
- Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use
- Current suicidal ideation
- Other unmanaged serious non-orthopedic injuries that occurred alongside the orthopedic injury (i.e., TBI, ruptured internal organs, etc.)
- Practice of meditation, or other mind body techniques that elicit the RR, for at least 45 total minutes a week each week over the last 3 months
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 |
|---|---|---|
| Toolkit for Optimal Recovery after Orthopedic InjuryThe Toolkit (TOR) is a 4-session, individual, live video, synchronous program developed specifically for patients with orthopedic acute injuries who are at risk for chronic pain and disability. The program teaches evidence-based mind-body skills (e.g., relaxation and mindfulness; myths about pain; activity pacing; acceptance and values based goal setting). Participants gain access to a website downloaded on their phones as an app. The website included explainer videos of skills and recordings of mindfulness and relaxation exercises. In addition, participants will receive usual care as determined by medical team. | Behavioural | Toolkit for Optimal Recovery after Orthopedic Injury - Active |
| Minimally Enhanced Usual Care (MEUC)The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team. | Other | Minimally Enhanced Usual Care (MEUC) - Control |
Primary outcome
Feasibility of Recruitment Among All Patients
Time frame: At the end of the entire enrollment period of the study, which was about 1 year and 10 months.
We will report number of participants who consented to participate out of those eligible, evaluated at the end of study. This number is not the same as the number who were actually enrolled and randomized in the trial (195).
Appropriateness of Treatment Program, Rated by Participants Randomized to TOR and Assessed by the Credibility and Expectancy Scale
Time frame: Baseline
A measure of participant's expectations and believed credibility for program (i.e. appropriateness), as assessed by the Credibility and Expectancy Scale. This scale has a range of 3 to 27 points, with higher ratings indicating more belief that the program is logical and will help with the intended outcome. This measure was the count of patients who scored above or below the scale's theoretical midpoint (i.e. the midpoint is not based on the collected data) on the Credibility and Expectancy Scale
Feasibility of Data Collection
Time frame: On the participant level, data was collected over the course of 4 months (baseline through followup). Counts reported here and described above were summed at the final end of all study activities (a total duration of 1 year 10 months).
This outcome will assess the feasibility of collecting the data used to assess and compare the TOR intervention to MEUC (usual care); it is not looking at the data itself or comparing two arms, but just the feasibility of collecting it. To assess this feasibility marker of our intervention, we will report the number of patients who complete their study assessments, for both TOR and MEUC together, at all of their required timepoints in the study.
Acceptability of Treatment (Satisfaction) Assessed With the Client Satisfaction Questionnaire (Patients Randomized to TOR Only)
Time frame: Assessed at Post-Test, which was approximately 4 weeks after a participant's enrollment in the study and baseline assessment.
Participant's satisfaction with treatment received after completion of TOR was assessed using the Client Satisfaction Questionnaire. In this questionnaire, items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction. This measure is the count of participants in TOR who scored above the scale's theoretical midpoint (i.e. the midpoint is not based on the collected data) on the Client Satisfaction Questionnaire.
Acceptability of TOR (Attendance for Patients Randomized to TOR)
Time frame: On the participant level, the data for this outcome was collected over the course of the intervention and its sessions (4 weeks). Counts of attendance were summed at the end of the study (~1 year and 10 months).
We will the report total number of patients in the TOR intervention who attend all four sessions that are part of their intervention.
36 secondary outcomes
Feasibility of Randomization/Adherence to Assigned Arm, for All Enrolled Patients
Time frame: Assessed the counts for the study as a whole at the end of study completion, which was about 1 year and 10 months. On the participant level, the time from randomization to posttest took place over an average of 4 weeks.
Orthopedic Staff Feasibility of Referral
Time frame: On the staff member level, the data for this outcome was collected over the course of the entire intervention/study (about 1 year and 7 months total from the start of referrals and participant enrollment in the study).
Fidelity to Study Procedures (Minor Deviations)
Time frame: On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of deviations were summed at the end of the study (~1 year and 10 months).
Fidelity to Study Procedures (Major Deviations)
Time frame: On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of deviations were summed at the end of the study (~1 year and 10 months).
Adherence to TOR Homework
Time frame: On the participant level, the data for this outcome was collected over the course of the intervention and its sessions (4 weeks). Counts were then summed at the end of the study (~1 year and 10 months).
Acceptability as Rated by Therapist
Time frame: On the participant level, the data for this outcome was collected over the course of the intervention and its sessions (4 weeks). Counts that met our criteria noted in the description were then summed at the end of the study (~1 year and 10 months).
Perceived Satisfaction of Staff
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Perceived Acceptability of Staff Regarding Ease of Referral
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Perceived Acceptability of Staff Regarding Cost-benefit for the Patient
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Perceived Acceptability of Staff Regarding Cost-benefit for the Clinic
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Study Implementation as Perceived by Study Staff
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Appropriateness as Perceived by Study Staff
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Satisfaction
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Perceived Ease of Referrals
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Perceived Cost-benefit (Patient) Measure
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Perceived Cost-benefit (Clinic) Measure
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Feasibility of Study Implementation
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Perceived Appropriateness
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Numerical Rating Scale (Pain at Rest), Change Between Time Points
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Numerical Rating Scale (Pain During Activity), Change Between Time Points
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Short Musculoskeletal Function Assessment (SMFA), Change Between Time Points
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Center for Epidemiologic Study of Depression (CES-D), Change Between Time Points
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
PTSD Checklist- Civilian Measure (PCL-C), Change Between Time Points
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Pain Catastrophizing Scale (PCS), Change Between Time Points.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Pain Anxiety Scale, Short Form (PASS-20), Change Between Time Points
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Measure of Current Status (MOCS-A), Change Between Time Points.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Cognitive and Affective Mindfulness Scale- Revised (CAMS-R), Change Between Time Points.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Feasibility of Data Collection of Rescue Analgesics (Non-narcotic)
Time frame: On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of complete data were summed at the end of the study (~1 year and 10 months).
Feasibility of Data Collection of Rescue Analgesics (Narcotic)
Time frame: On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of complete data were summed at the end of the study (~1 year and 10 months).
Adverse Events (Serious and Non-serious)
Time frame: On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of complete data were summed at the end of the study (~1 year and 10 months).
Feasibility of Data Collection of Adverse Events
Time frame: On the participant level, data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of complete data were summed at the end of the study (~1 year and 10 months).
Therapist Adherence/Fidelity to Session
Time frame: On the fidelity reviewer level, the data for this outcome was collected over the course of the intervention as the sessions were delivered by therapists (4 weeks of delivery). Reviews/points were then summed at end of the study (~1 year and 10 months).
Within-group Use of Rescue Analgesics (Non-narcotic)
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Within Group Use of Rescue Analgesics (Narcotic)
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
2-tailed Pearson Correlation (TOR and MEUC)
Time frame: Baseline (Week 0), Post-Test (Week 4)
Physical Function Self-report, Change Between Time Points
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40737137Jochimsen KN, Hooker JE, Szapary CL, Bakhshaie J, Vranceanu AM. Psychosocial Intervention and Rehabilitation Utilization Together Improve Pain and Function After Traumatic Orthopaedic Injuries: A Secondary Analysis of a Randomized Controlled Trial. Clin Orthop Relat Res. 2025 Mar 4;483(8):1514-1524. doi: 10.1097/CORR.0000000000003433.
- Derived from this study: PubMed 39078722McDermott K, Rush C, Pham T, Hooker J, Louis C, Rochon EA, Vranceanu AM. PTSD symptoms, pain catastrophizing, and pain outcomes after acute orthopedic injury. Pain Med. 2024 Dec 1;25(12):758-767. doi: 10.1093/pm/pnae068.
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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.
Ana-Maria Vranceanu, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toolkit for Optimal Recovery after Orthopedic Injury in people with Acute Orthopedic Injury, run by Massachusetts General Hospital 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 8 inclusion and 8 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 27 Jun 2025. 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?
Yes. Results are posted in the registry (first posted 27 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of Recruitment Among All Patients (time frame: At the end of the entire enrollment period of the study, which was about 1 year and 10 months.). The study lists 5 primary outcomes in all. 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 NCT04973696, which also lists 2 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 27 Jun 2025.