N/A
N=195
Toolkit for Optimal Recovery After Orthopedic Injury
Acute Orthopedic Injury
Bottom Line
View on ClinicalTrials.gov: NCT04973696 ↗Enrolled (actual)
195
Serious AEs
1.5%
Results posted
Jun 2025
Primary outcome: Primary: Feasibility of Recruitment Among All Patients — 210 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Toolkit for Optimal Recovery after Orthopedic Injury (Behavioral); Minimally Enhanced Usual Care (MEUC) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Recruitment Among All Patients |
210 | — |
| PRIMARY Appropriateness of Treatment Program, Rated by Participants Randomized to TOR and Assessed by the Credibility and Expectancy Scale |
66 | — |
| PRIMARY Feasibility of Data Collection |
154 | — |
| PRIMARY Acceptability of Treatment (Satisfaction) Assessed With the Client Satisfaction Questionnaire (Patients Randomized to TOR Only) |
75 | — |
| PRIMARY Acceptability of TOR (Attendance for Patients Randomized to TOR) |
71 | — |
| SECONDARY Feasibility of Randomization/Adherence to Assigned Arm, for All Enrolled Patients |
76; 93 | — |
| SECONDARY Orthopedic Staff Feasibility of Referral |
25 | — |
| SECONDARY Fidelity to Study Procedures (Minor Deviations) |
7; 1; 4; 3 | — |
| SECONDARY Fidelity to Study Procedures (Major Deviations) |
1; 0; 0; 0 | — |
| SECONDARY Adherence to TOR Homework |
74 | — |
| SECONDARY Acceptability as Rated by Therapist |
294 | — |
| SECONDARY Perceived Satisfaction of Staff |
15 | — |
| SECONDARY Perceived Acceptability of Staff Regarding Ease of Referral |
22 | — |
| SECONDARY Perceived Acceptability of Staff Regarding Cost-benefit for the Patient |
15 | — |
| SECONDARY Perceived Acceptability of Staff Regarding Cost-benefit for the Clinic |
15 | — |
| SECONDARY Feasibility of Study Implementation as Perceived by Study Staff |
15 | — |
| SECONDARY Appropriateness as Perceived by Study Staff |
14 | — |
| SECONDARY Feasibility of Obtaining Data on Orthopedic Staff Satisfaction |
20 | — |
| SECONDARY Feasibility of Obtaining Data on Orthopedic Staff Perceived Ease of Referrals |
22 | — |
| SECONDARY Feasibility of Obtaining Data on Orthopedic Staff Perceived Cost-benefit (Patient) Measure |
19 | — |
| SECONDARY Feasibility of Obtaining Data on Orthopedic Staff Perceived Cost-benefit (Clinic) Measure |
21 | — |
| SECONDARY Feasibility of Obtaining Data on Orthopedic Staff Feasibility of Study Implementation |
19 | — |
| SECONDARY Feasibility of Obtaining Data on Orthopedic Staff Perceived Appropriateness |
16 | — |
| SECONDARY Numerical Rating Scale (Pain at Rest), Change Between Time Points |
-1.7; -0.5; -2.0; -1.0 | — |
| SECONDARY Numerical Rating Scale (Pain During Activity), Change Between Time Points |
-1.7; -1.0; -2.4; -1.6 | — |
| SECONDARY Short Musculoskeletal Function Assessment (SMFA), Change Between Time Points |
-16; -8; -24; -18 | — |
| SECONDARY Center for Epidemiologic Study of Depression (CES-D), Change Between Time Points |
-9; -3; -10; -4 | — |
| SECONDARY PTSD Checklist- Civilian Measure (PCL-C), Change Between Time Points |
-7; -4; -10; -5 | — |
| SECONDARY Pain Catastrophizing Scale (PCS), Change Between Time Points. |
-14; -6; -15; -8 | — |
| SECONDARY Pain Anxiety Scale, Short Form (PASS-20), Change Between Time Points |
-38; -13; -38; -19 | — |
| SECONDARY Measure of Current Status (MOCS-A), Change Between Time Points. |
0.4; 0.01; 0.4; 0.1 | — |
| SECONDARY Cognitive and Affective Mindfulness Scale- Revised (CAMS-R), Change Between Time Points. |
3; 0; 3; 1 | — |
| SECONDARY Feasibility of Data Collection of Rescue Analgesics (Non-narcotic) |
155 | — |
| SECONDARY Feasibility of Data Collection of Rescue Analgesics (Narcotic) |
155 | — |
| SECONDARY Adverse Events (Serious and Non-serious) |
0; 2; 0; 1; 1; 0 | — |
| SECONDARY Feasibility of Data Collection of Adverse Events |
97 | — |
| SECONDARY Therapist Adherence/Fidelity to Session |
6829 | — |
| SECONDARY Within-group Use of Rescue Analgesics (Non-narcotic) |
22.9; 64.3; 9.2; 60.6; 9.5; 61.3 | — |
| SECONDARY Within Group Use of Rescue Analgesics (Narcotic) |
22.9; 33.7; 9.2; 19.1; 9.5; 13.8 | — |
| SECONDARY 2-tailed Pearson Correlation (TOR and MEUC) |
0.6; 0.7; 0.4; 0.5; 0.3; 0.4 | — |
| SECONDARY Physical Function Self-report, Change Between Time Points |
6; 4; 12; 11 | — |
Summary
This is a multi-site randomized feasibility trial of the Toolkit for Optimal Recovery after Orthopedic Injury (TOR), a mind-body program to prevent persistent pain and disability in at-risk patients with acute orthopedic injury, versus a minimally-enhanced usual care (MEUC) control. TOR is a 4-session program delivered via secure live video to patients at risk for chronic pain, 1-2 months after an orthopedic traumatic injury. The primary aim of this study is to determine whether the study methodology (i.e., implementation, randomization, procedures and assessment of outcome measures) and delivery of TOR meet a priori set benchmarks for feasibility, acceptability, and appropriateness, necessary for the success of the subsequent efficacy trial.
Eligibility Criteria
Inclusion Criteria
- Male and female outpatients in the Level 1 Trauma Center of one of the 4 sites, age 18 years or older
- Sustained one more more acute orthopedic injuries (e.g., fracture, dislocation, rupture) approximately 1-2 months earlier (acute phase)
- Score ≥20 on the Pain Catastrophizing Scale (PCS) or ≥40 on the Short Form Pain Anxiety Scale (PASS-20)
- Willing to participate and comply with the requirements of the study protocol, including randomization, questionnaire completion, and potential home practice and weekly sessions.
- No psychotropics for at least 2 weeks prior to initiation of treatment or stable for >6 weeks and willing to maintain a stable dose
- Cleared by orthopedic surgeon for activities using the injured limb within the next 4 weeks
- Able to meaningfully participate (e.g., English speaking and comprehension, stable living situation as determined by the medical staff at each site)
- A score of 8/10 or more on the Short Portable Mental Status Questionnaire ONLY IF a participant is 65 or older, or if a participant's cognitive abilities are unclear to research staff
Exclusion Criteria
- Serious comorbidity expected to worsen in the next 3 months (e.g., malignancy)
- Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use
- Current suicidal ideation
- Other unmanaged serious non-orthopedic injuries that occurred alongside the orthopedic injury (i.e., TBI, ruptured internal organs, etc.)
- Practice of meditation, or other mind body techniques that elicit the RR, for at least 45 total minutes a week each week over the last 3 months
- Currently in litigation or under Workman's Comp
- Surgery complications (e.g., uncontrolled infection, need for repeat surgery)
- Self-reported pregnancy
Data sourced from ClinicalTrials.gov (NCT04973696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.