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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03405610
Other study ID # 2014P001194
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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