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

Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405610
• Other study ID #: 2014P001194
• Status: Completed
• Phase: N/A
• Start date: July 1, 2015
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fracture
• Musculoskeletal Injury

Intervention

Behavioral:
• The Toolkit for Optimal Recovery after Injury
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment	We will report number of patients approached, number who agreed to participate/were screened, number of patients randomized	0 Weeks
Primary	Satisfaction with ToR	3 questions assessing satisfaction with the physical recovery, with the care delivered, and with the clinician.	4 weeks; 3 months
Primary	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
Primary	Feasibility of outcome measures	We will report number of missing items and calculate reliability of outcome measures	0 weeks; 4 weeks; 3 months
Primary	Adherence to ToR	We will report number of participants who completed at least 3 out of 4 ToR sessions	4 weeks.
Primary	Adherence to homework	determined by number of homework logs returned	4 weeks
Primary	Therapist adherence survey	Items assessing whether the therapist taught each of the skills included in each of the 4 sessions	4 weeks
Secondary	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
Secondary	Pain Anxiety	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
Secondary	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
Secondary	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
Secondary	Pain intensity	Numerical rating scale assessing pain form 0 to 10	0 Weeks, 4 Weeks, 3 Months
Secondary	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