NCT04973696|CompletedResults
Toolkit for Optimal Recovery After Orthopedic Injury
TOR
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TOR
Sponsor study identifier
interventional
195
1 country
1
Study Start
September 21, 2021
Actual (reported)Primary Completion
August 15, 2023
Actual (reported)Study Completion
August 15, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 15, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 13, 2021
Actual (reported)July 22, 2021
Actual (reported)September 21, 2021
Actual (reported)August 15, 2023
Actual (reported)August 15, 2023
Actual (reported)June 27, 2025
Actual (reported)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).
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
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.
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).
Feasibility of Randomization/Adherence to Assigned Arm, for All Enrolled Patients
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
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)
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)
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 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.
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.
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.
Massachusetts General Hospital
Boston, Massachusetts, 02140, United States
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.
McDermott 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.
Ana-Maria Vranceanu, PhD
Massachusetts General Hospital
195 participants (actual enrollment reported by the registry).
First Submitted
July 13, 2021
First Posted
July 22, 2021
Study Start
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.
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.
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).
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).
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
September 21, 2021
Actual (reported)Primary Completion
August 15, 2023
Actual (reported)Study Completion
August 15, 2023
Actual (reported)Last Updated
June 27, 2025
Results First Posted
June 27, 2025
Record last verified: 2025-06
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Source: ClinicalTrials.gov.
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