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Completed

NCT Number: NCT03405610

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Toolkit for Optimal Recovery after Injury

Behavioral

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

Primary outcomes

  1. Feasibility of recruitment

    Time frame: 0 Weeks

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

  2. Satisfaction with ToR

    Time frame: 4 weeks; 3 months

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

  3. Acceptability

    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

  4. Feasibility of outcome measures

    Time frame: 0 weeks; 4 weeks; 3 months

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

  5. Adherence to ToR

    Time frame: 4 weeks.

    We will report number of participants who completed at least 3 out of 4 ToR sessions

  6. Adherence to homework

    Time frame: 4 weeks

    determined by number of homework logs returned

  7. Therapist adherence survey

    Time frame: 4 weeks

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

Secondary outcomes

  1. Pain Catastrophizing

    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

  2. Pain Anxiety

    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

  3. Depression

    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

  4. Post Traumatic Stress Disorder

    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

  5. Pain intensity

    Time frame: 0 Weeks, 4 Weeks, 3 Months

    Numerical rating scale assessing pain form 0 to 10

  6. Physical Function

    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;

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2018
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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