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

Massachusetts General Hospital55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Musculoskeletal Injury Fracture

Interventions

The Toolkit for Optimal Recovery after InjuryBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Feasibility of recruitment

We will report number of patients approached, number who agreed to participate/were screened, number of patients randomized

Time frame: 0 Weeks

Satisfaction with ToR

3 questions assessing satisfaction with the physical recovery, with the care delivered, and with the clinician.

Time frame: 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

Time frame: 4 weeks; 3 months

Feasibility of outcome measures

We will report number of missing items and calculate reliability of outcome measures

Time frame: 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

Time frame: 4 weeks.

Adherence to homework

determined by number of homework logs returned

Time frame: 4 weeks

Therapist adherence survey

Items assessing whether the therapist taught each of the skills included in each of the 4 sessions

Time frame: 4 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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