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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.
This is a pilot randomized feasibility trial of the mind body program Toolkit for Optimal Recovery versus usual medical care. The Toolkit is delivered via secure live video to patients at risk for chronic pain, at 1-2 months after injury. The primary aim of this study is to determine the feasibility and acceptability of the program, randomization, procedures and outcome measures. Secondarily, we report means and standard deviation and explore change in quantitative outcomes in the Toolkit compared to usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toolkit for Optimal Recovery after Injury | Experimental | 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. |
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| Usual Care | No Intervention | The Usual Care (UC) group will continue with their current medical care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Toolkit for Optimal Recovery after Injury | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Catastrophizing | Pain Catastrophizing Scale (PCS); items are summed to generate a total score; scores range from 0 to 52; higher scores indicate greater pain catastrophizing | 0 Weeks, 4 Weeks, 3 Months |
| Pain Anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana-Maria Vranceanu, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30820341 | Derived | 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. |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Pain Anxiety Symptom Scale (PASS); items are summed to generate a total score; scores range from 0-100; higher sores indicate greater pain anxiety
| 0 Weeks, 4 Weeks, 3 Months |
| Depression | Center for Epidemiologic Studies Depression Scale (CESD); items are summed to generate a total score; scores range from 0 to 60; higher scores indicate greater depressive symptomatology | 0 Weeks, 4 Weeks, 3 Months |
| Post Traumatic Stress Disorder | Post Traumatic Stress Disorder Checklist (PCL); items are summed to generate a total score; scores range from 17 to 85; higher scores indicate greater post traumatic stress | 0 Weeks, 4 Weeks, 3 Months |
| Pain intensity | Numerical rating scale assessing pain form 0 to 10 | 0 Weeks, 4 Weeks, 3 Months |
| Physical Function | Short Musculoskeletal Function Assessment (SMFA); two scores are generated by summing items 1-34 for Function Index and 35-46 for Bothersome Index; | 0 Weeks, 4 Weeks, 3 Months |