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Toolkit for Optimal Recovery after Orthopedic Injury for Orthopedic Injury (TOR Trial)

N/A
Waitlist Available
Led By Ana-Maria Vranceanu, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Score ≥20 on the Pain Catastrophizing Scale (PCS) or ≥40 on the Short Form Pain Anxiety Scale (PASS-20)
Sustained one more more acute orthopedic injuries (e.g., fracture, dislocation, rupture) approximately 1-2 months earlier (acute phase)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study completion, on average of 3 years
Awards & highlights

TOR Trial Summary

This trial is testing a mind-body program to prevent persistent pain and disability in at-risk patients with an acute orthopedic injury, compared to usual care. The trial is testing the feasibility of the program delivery and assessment methods, to see if they meet the benchmarks necessary for the success of the subsequent efficacy trial.

Eligible Conditions
  • Acute Orthopedic Injury

TOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have scored high on either the Pain Catastrophizing Scale (PCS) or the Short Form Pain Anxiety Scale (PASS-20).
Select...
You had a serious bone injury, like a fracture or dislocation, within the last 1-2 months.

TOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of project, (two years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of project, (two years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of TOR (attendance for patients randomized to TOR)
Acceptability of treatment (satisfaction) assessed with the Client Satisfaction Questionnaire (patients randomized to TOR only)
Appropriateness rated by participants randomized to TOR, assessed by the Credibility and Expectancy Scale
+2 more
Secondary outcome measures
Acceptability as rated by therapist
Adherence to TOR homework
Adverse events
+24 more

TOR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Toolkit for Optimal Recovery after Orthopedic Injury - ActiveExperimental Treatment1 Intervention
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.
Group II: Minimally Enhanced Usual Care (MEUC) - ControlActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Toolkit for Optimal Recovery after Orthopedic Injury
2021
N/A
~190

Find a Location

Who is running the clinical trial?

University of KentuckyOTHER
185 Previous Clinical Trials
226,461 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
856 Previous Clinical Trials
672,011 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,174 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to be involved in this experiment currently available?

"According to the clinicaltrials.gov information, this experiment is presently in need of volunteers. Initially posted on September 15th 2021, it was most recently updated on March 23rd 2022."

Answered by AI

What is the principal aim of this medical experiment?

"This trial strives to determine the acceptability of TOR for patients in a three-year timeframe. Secondary objectives include gauging randomization and adherence, assessing appropriateness as perceived by research staff, and measuring pain levels with the Numerical Rating Scale (NRS)."

Answered by AI

What is the aggregate amount of participants enrolled in this trial?

"Indeed, according to clinicaltrials.gov the study published on September 15th 2021 is actively recruiting for 180 patients at a single site. The trial was last updated on March 23rd 2022."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Toolkit for Optimal Recovery After Orthopedic Injury
Ana-Maria Vranceanu, PhD 2021. "Toolkit for Optimal Recovery After Orthopedic Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04973696.
~52 spots leftby Apr 2025
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