A Randomized Controlled Trial Testing a Skills-Based Program Called "A Toolkit for Optimal Recovery" Delivered Via Secure Live Video Compared to Standard Medical Care in Patients With Acute Musculoskeletal Injuries
Sponsor study identifier
interventional
55
1 country
1
Study Start
July 1, 2015
Actual (reported)Primary Completion
August 1, 2018
Actual (reported)Study Completion
August 1, 2018
Actual (reported)The aims of this study are to test a manualized mind body skills-building program aimed at preventing the development of chronic pain and disability following acute musculoskeletal injury in at-risk patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2018
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 1, 2015
Actual (reported)December 3, 2017
Actual (reported)January 23, 2018
Actual (reported)August 1, 2018
Actual (reported)August 1, 2018
Actual (reported)Feasibility of recruitment
We will report number of patients approached, number who agreed to participate/were screened, number of patients randomized
0 Weeks
Satisfaction with ToR
3 questions assessing satisfaction with the physical recovery, with the care delivered, and with the clinician.
4 weeks; 3 months
Acceptability
We will report number of patients who finished ToR and UC and completed post-test from those who started the study (were randomized); We will also report number of participants who provided 3 months follow up
4 weeks; 3 months
Feasibility of outcome measures
We will report number of missing items and calculate reliability of outcome measures
0 weeks; 4 weeks; 3 months
Pain Catastrophizing
0 Weeks, 4 Weeks, 3 Months
Pain Anxiety
0 Weeks, 4 Weeks, 3 Months
Depression
0 Weeks, 4 Weeks, 3 Months
Post Traumatic Stress Disorder
0 Weeks, 4 Weeks, 3 Months
Pain intensity
0 Weeks, 4 Weeks, 3 Months
The Toolkit for Optimal Recovery after Injury (ToR) is a mind body skills based program delivered individually via secure live video. The format is a 4-week program with weekly meetings and a focus on teaching skills to optimize recovery and prevent chronic pain and disability.
The Usual Care (UC) group will continue with their current medical care.
The Toolkit for Optimal Recovery after Injury (ToR) is a skills based mind body program that was designed to prevent the development of chronic pain and disability following an acute musculoskeletal injury (e.g., fracture). The program has 4 sessions and it is delivered via live video. Patients learn myth about recovery after injury, false and real pain alarms, the fear avoidance model and how to prevent the disability spiral, mindfulness based exercises and activity pacing.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Vranceanu AM, Jacobs C, Lin A, Greenberg J, Funes CJ, Harris MB, Heng MM, Macklin EA, Ring D. Results of a feasibility randomized controlled trial (RCT) of the Toolkit for Optimal Recovery (TOR): a live video program to prevent chronic pain in at-risk adults with orthopedic injuries. Pilot Feasibility Stud. 2019 Feb 20;5:30. doi: 10.1186/s40814-019-0416-7. eCollection 2019.
Ana-Maria Vranceanu, PhD
Massachusetts General Hospital
55 participants (actual enrollment reported by the registry).
First Submitted
December 3, 2017
First Posted
January 23, 2018
Study Start
July 1, 2015
Actual (reported)Early Range of Motion in 5th Metacarpal Fracture
Adherence to ToR
We will report number of participants who completed at least 3 out of 4 ToR sessions
4 weeks.
Adherence to homework
determined by number of homework logs returned
4 weeks
Therapist adherence survey
Items assessing whether the therapist taught each of the skills included in each of the 4 sessions
4 weeks
Contact the study team to confirm eligibility.
Primary Completion
August 1, 2018
Actual (reported)Study Completion
August 1, 2018
Actual (reported)Last Updated
August 17, 2018
Record last verified: 2018-08
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Source: ClinicalTrials.gov.
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