Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT03405610
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: ToR
Time frame: 0 Weeks
We will report number of patients approached, number who agreed to participate/were screened, number of patients randomized
Time frame: 4 weeks; 3 months
3 questions assessing satisfaction with the physical recovery, with the care delivered, and with the clinician.
Time frame: 4 weeks; 3 months
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
Time frame: 0 weeks; 4 weeks; 3 months
We will report number of missing items and calculate reliability of outcome measures
Time frame: 4 weeks.
We will report number of participants who completed at least 3 out of 4 ToR sessions
Time frame: 4 weeks
determined by number of homework logs returned
Time frame: 4 weeks
Items assessing whether the therapist taught each of the skills included in each of the 4 sessions
Time frame: 0 Weeks, 4 Weeks, 3 Months
Pain Catastrophizing Scale (PCS); items are summed to generate a total score; scores range from 0 to 52; higher scores indicate greater pain catastrophizing
Time frame: 0 Weeks, 4 Weeks, 3 Months
Pain Anxiety Symptom Scale (PASS); items are summed to generate a total score; scores range from 0-100; higher sores indicate greater pain anxiety
Time frame: 0 Weeks, 4 Weeks, 3 Months
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
Time frame: 0 Weeks, 4 Weeks, 3 Months
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
Time frame: 0 Weeks, 4 Weeks, 3 Months
Numerical rating scale assessing pain form 0 to 10
Time frame: 0 Weeks, 4 Weeks, 3 Months
Short Musculoskeletal Function Assessment (SMFA); two scores are generated by summing items 1-34 for Function Index and 35-46 for Bothersome Index;
Massachusetts General Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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