A Skills-Based Program Delivered Via Secure Live Video to Patients With Acute Musculoskeletal Trauma

Not Applicable

Completed

• Conditions: Musculoskeletal Injury; Fracture
• Interventions: Behavioral: The Toolkit for Optimal Recovery after Injury

• Registration Number: NCT03405610
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-07-01
• Study First Submitted: 2017-12-03
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-23
• Status Verified: 2018-08
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-01
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Diagnosis of musculoskeletal injury in the past 1-2 months
• 18 years of age or older
• English fluency and literacy
• PCS OR, PASS score above median split

Exclusion Criteria

• Major medical comorbidity expected to worsen in the next 6 months
• Comorbid chronic pain condition
• Antidepressant medication change in the past 6 months
• Secondary gains such as litigations or workers compensation procedures
• Diagnosis of psychosis, bipolar disorder or active substance dependence (by self report)
• Unwilling or unable to use videoconferencing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toolkit for Optimal Recovery after Injury	The Toolkit for Optimal Recovery after Injury	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.

Primary Outcome Measures

Name	Time	Method
Adherence to ToR	4 weeks.	We will report number of participants who completed at least 3 out of 4 ToR sessions
Satisfaction with ToR	4 weeks; 3 months	3 questions assessing satisfaction with the physical recovery, with the care delivered, and with the clinician.
Acceptability	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
Adherence to homework	4 weeks	determined by number of homework logs returned
Therapist adherence survey	4 weeks	Items assessing whether the therapist taught each of the skills included in each of the 4 sessions
Feasibility of recruitment	0 Weeks	We will report number of patients approached, number who agreed to participate/were screened, number of patients randomized
Feasibility of outcome measures	0 weeks; 4 weeks; 3 months	We will report number of missing items and calculate reliability of outcome measures

Secondary Outcome Measures

Name	Time	Method
Pain Catastrophizing	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
Post Traumatic Stress Disorder	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
Physical Function	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;
Pain Anxiety	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
Pain intensity	0 Weeks, 4 Weeks, 3 Months	Numerical rating scale assessing pain form 0 to 10
Depression	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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States