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Musculoskeletal InjuryNCT03405610

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

A study testing The Toolkit for Optimal Recovery after Injury in people with Musculoskeletal Injury and Fracture, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Musculoskeletal Injury, Fracture
What is being tested?
The Toolkit for Optimal Recovery after Injury
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
1 Jul 2015to 1 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
The Toolkit for Optimal Recovery after Injury
Keywords
Psychiatry, Psychology, Psychosocial, Mind-Body
Medical subject headings
Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Toolkit for Optimal Recovery after InjuryBehavioural

    Also called ToR

    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.

Study groups in NCT03405610
Study groupRoleWhat they receive
Toolkit for Optimal Recovery after InjuryExperimentalThe 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.
Receives: Behavioral: The Toolkit for Optimal Recovery after Injury
Usual CareNo interventionThe Usual Care (UC) group will continue with their current medical care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of recruitment

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

    Measured: 0 Weeks

  2. Satisfaction with ToR

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

    Measured: 4 weeks; 3 months

  3. 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

    Measured: 4 weeks; 3 months

  4. Feasibility of outcome measures

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

    Measured: 0 weeks; 4 weeks; 3 months

  5. Adherence to ToR

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

    Measured: 4 weeks.

  6. Adherence to homework

    determined by number of homework logs returned

    Measured: 4 weeks

  7. Therapist adherence survey

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

    Measured: 4 weeks

Secondary outcomes (6)

  1. 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

    Measured: 0 Weeks, 4 Weeks, 3 Months

  2. 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

    Measured: 0 Weeks, 4 Weeks, 3 Months

  3. 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

    Measured: 0 Weeks, 4 Weeks, 3 Months

  4. 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

    Measured: 0 Weeks, 4 Weeks, 3 Months

  5. Pain intensity

    Numerical rating scale assessing pain form 0 to 10

    Measured: 0 Weeks, 4 Weeks, 3 Months

  6. 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;

    Measured: 0 Weeks, 4 Weeks, 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start1 Jul 2015
  3. Primary completion1 Aug 2018
  4. Study completion1 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03405610
Sponsor's protocol ID
2014P001194
Status last verified
Aug 2018
First submitted
3 Dec 2017
Last updated
17 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Vranceanu AM, Jacobs C, Lin A, Greenberg J, Funes CJ, Harris MB, Heng MM, Macklin EA, Ring D. Results of a feasibility randomized controlled trial (RCT) of the Toolkit for Optimal Recovery (TOR): a live video program to prevent chronic pain in at-risk adults with orthopedic injuries. Pilot Feasibility Stud. 2019 Feb 20;5:30. doi: 10.1186/s40814-019-0416-7. eCollection 2019.

    PubMed 30820341

Questions about this trial

What is this clinical trial studying?

A study testing The Toolkit for Optimal Recovery after Injury in people with Musculoskeletal Injury and Fracture, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of recruitment (time frame: 0 Weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03405610, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.

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