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Toolkit for Optimal Recovery after Orthopedic Injury for Orthopedic Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MAOrthopedic InjuryToolkit for Optimal Recovery after Orthopedic Injury - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
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1
pre-operative counseling with their caregiver

Study Objectives

5 Primary · 27 Secondary · Reporting Duration: throughout the study completion, on average of 3 years

Baseline
Appropriateness rated by participants randomized to TOR, assessed by the Credibility and Expectancy Scale
Month 3
Coping and emotional function
Numerical Rating Scale
Physical function performance-based
Physical function self-report
Within group change in narcotic analgesics
Within group change in rescue analgesics (non-narcotic)
Duration of project, (two years)
Adverse events
Feasibility of data collection for performance based measures of physical function (walk/grip test) at each of the 3 time points
Feasibility of data collection of adverse events
Feasibility of data collection of rescue analgesics (narcotic)
Analgesics
Therapist adherence/fidelity to session
End of study
Feasibility of collecting data on feasibility of study implementation
Post-Test
Acceptability of treatment (satisfaction) assessed with the Client Satisfaction Questionnaire (patients randomized to TOR only)
Year 2
Feasibility of recruitment among all patients
Year 3
Acceptability as rated by therapist
Acceptability of TOR (attendance for patients randomized to TOR)
Adherence to TOR homework
Appropriateness as perceived by study staff
Feasibility of collecting Orthopedic staff satisfaction measures
Feasibility of collecting appropriateness measures
Feasibility of data collection
Feasibility of obtaining data on Orthopedic staff perceived cost-benefit
Feasibility of obtaining data on Orthopedic staff perceived ease of referrals
Feasibility of randomization/adherence to assigned arm for all enrolled patients all enrolled patients
Feasibility of study implementation as perceived by study staff
Fidelity to study procedures
Orthopedic staff feasibility of referral
Perceived acceptability for those who completed the satisfaction measures
Perceived acceptability of staff regarding cost-benefit
Perceived acceptability of staff regarding ease of referral

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
2
TU-100
1
pre-operative counseling with their caregiver

Trial Design

2 Treatment Groups

Minimally Enhanced Usual Care (MEUC) - Control
1 of 2
Toolkit for Optimal Recovery after Orthopedic Injury - Active
1 of 2

Active Control

Experimental Treatment

180 Total Participants · 2 Treatment Groups

Primary Treatment: Toolkit for Optimal Recovery after Orthopedic Injury · No Placebo Group · N/A

Toolkit for Optimal Recovery after Orthopedic Injury - Active
Behavioral
Experimental Group · 1 Intervention: Toolkit for Optimal Recovery after Orthopedic Injury · Intervention Types: Behavioral
Minimally Enhanced Usual Care (MEUC) - Control
Other
ActiveComparator Group · 1 Intervention: Minimally Enhanced Usual Care (MEUC) · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: throughout the study completion, on average of 3 years

Who is running the clinical trial?

Vanderbilt University Medical CenterOTHER
784 Previous Clinical Trials
599,148 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,733 Previous Clinical Trials
31,216,170 Total Patients Enrolled
University of Texas at AustinOTHER
297 Previous Clinical Trials
67,758 Total Patients Enrolled
University of KentuckyOTHER
173 Previous Clinical Trials
226,176 Total Patients Enrolled
Ana-Maria Vranceanu, PhDPrincipal InvestigatorMassachusetts General Hospital
17 Previous Clinical Trials
1,638 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have scored high on either the Pain Catastrophizing Scale (PCS) or the Short Form Pain Anxiety Scale (PASS-20).
You had a serious bone injury, like a fracture or dislocation, within the last 1-2 months.

Who else is applying?

What state do they live in?
Massachusetts100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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)." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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