Abstract
Background
Approximately 20% to 50% of patients develop persistent pain after traumatic orthopaedic injuries. Psychosocial factors are an important predictor of persistent pain; however, there are no evidence-based, mind-body interventions to prevent persistent pain for this patient population.
Questions/purposes
(1) Does the Toolkit for Optimal Recovery after Injury (TOR) achieve a priori feasibility benchmarks in a multisite randomized control trial (RCT)? (2) Does TOR demonstrate a preliminary effect in improving pain, as well as physical and emotional function?
Methods
This pilot RCT of TOR versus a minimally enhanced usual care comparison group (MEUC) was conducted among 195 adults with an acute orthopaedic traumatic injury at risk for persistent pain at four geographically diverse Level 1 trauma centers between October 2021 to August 2023. Fifty percent (97 of 195) of participants were randomized to TOR (mean age 43 ± 17 years; 67% [65 of 97] women) and 50% (98) to MEUC (mean age 45 ± 16 years; 67% [66 of 98] women). In TOR, 24% (23 of 97) of patients were lost to follow-up, whereas in the MEUC, 17% (17 of 98) were lost. At 4 weeks, 78% (76 of 97) of patients in TOR and 95% (93 of 98) in the MEUC completed the assessments; by 12 weeks, 76% (74 of 97) of patients in TOR and 83% (81 of 98) in the MEUC completed the assessments (all participants were still included in the analysis consistent with an intention-to-treat approach). The TOR has four weekly video-administered sessions that teach pain coping skills. The MEUC is an educational pamphlet. Both were delivered in addition to usual care. Primary outcomes were feasibility of recruitment (the percentage of patients who met study criteria and enrolled) and data collection, appropriateness of treatment (the percent of participants in TOR who score above the midpoint on the Credibility and Expectancy Scale), acceptability (the percentage of patients in TOR who attend at least three of four sessions), and treatment satisfaction (the percent of participants in TOR who score above the midpoint on the Client Satisfaction Scale). Secondary outcomes included additional feasibility (including collecting data on narcotics and rescue medications and adverse events), fidelity (whether the intervention was delivered as planned) and acceptability metrics (patients and staff), pain (numeric rating scale), physical function (Short Musculoskeletal Function Assessment questionnaire [SMFA], PROMIS), emotional function (PTSD [PTSD Checklist], depression [Center for Epidemiologic Study of Depression]), and intervention targets (pain catastrophizing, pain anxiety, coping, and mindfulness). Assessments occurred at baseline, 4 and 12 weeks.
Results
Several outcomes exceeded a priori benchmarks: feasibility of recruitment (89% [210 of 235] of eligible participants consented), appropriateness (TOR: 73% [66 of 90] scored > midpoint on the Credibility and Expectancy Scale), data collection (79% [154 of 195] completed all surveys), satisfaction (TOR: 99% [75 of 76] > midpoint on the Client Satisfaction Scale), and acceptability (TOR: 73% [71 of 97] attended all four sessions). Participation in TOR, compared with the MEUC, was associated with improvement from baseline to postintervention and from baseline to follow-up in physical function (SMFA, baseline to post: -7 [95% CI -11 to -4]; p < 0.001; baseline to follow-up: -6 [95% CI -11 to -1]; p = 0.02), PROMIS (PROMIS-PF, baseline to follow-up: 2 [95% CI 0 to 4]; p = 0.045), pain at rest (baseline to post: -1.2 [95% CI -1.7 to -0.6]; p < 0.001; baseline to follow-up: -1 [95% CI -1.7 to -0.3]; p = 0.003), activity (baseline to post: -0.7 [95% CI -1.3 to -0.1]; p = 0.03; baseline to follow-up: -0.8 [95% CI -1.6 to -0.1]; p = 0.04), depressive symptoms (baseline to post: -6 [95% CI -9 to -3]; p < 0.001; baseline to follow-up: -5 [95% CI -9 to -2]; p < 0.002), and posttraumatic symptoms (baseline to post: -4 [95% CI -7 to 0]; p = 0.03; baseline to follow-up: -5 [95% CI -9 to -1]; p = 0.01). Improvements were generally clinically important and sustained or continued through the 3 months of follow-up (that is, above the minimum clinically important different [MCID] of 7 for the SMFA, the MCID of 3.6 for PROMIS, the MCID of 2 for pain at rest and pain during activity, the MCID of more than 10% change in depressive symptoms, and the MCID of 10 for posttraumatic symptoms). There were treatment-dependent improvements in pain catastrophizing, pain anxiety, coping, and mindfulness.
Conclusion
TOR was feasible and potentially efficacious in preventing persistent pain among patients with an acute orthopaedic traumatic injury. Using TOR in clinical practice may prevent persistent pain after orthopaedic traumatic injury.
Level of Evidence
Level I, therapeutic study.
Introduction
Acute orthopaedic traumatic injuries (such as fractures, ruptures, dislocations) are common and costly [5, 21, 22]. Approximately 20% to 50% of patients develop persistent pain and disability despite making good physical recoveries [7, 9, 21], leading to high healthcare costs and a substantial public health burden [5, 15, 22]. Psychosocial factors play an important role in recovery after injury [5, 30-32], yet to date there are no psychosocial interventions with established efficacy in the prevention of persistent pain in this population [1].
Over the past 10 years, our interdisciplinary team used a sequential approach to develop the Toolkit for Optimal Recovery after Injury (TOR), a mind-body program aimed at preventing persistent pain and disability after an acute orthopaedic traumatic injury. TOR showed evidence of feasibility in a small pilot feasibility randomized control trial (RCT) [34, 35]. However, this small trial had methodological weaknesses. First, 50% of surgeons noted skepticism about the role of psychosocial factors in recovery after acute orthopaedic injury and did not make referrals, which is consistent with prior research [33]. Second, we recruited primarily White patients from one hospital, which limited the generalizability of findings, making it unclear whether our study procedures and intervention would show similar feasibility, acceptability, and satisfaction across geographically diverse Level 1 trauma clinics.
To address these limitations, we conducted focus groups and interviews with staff at three geographically diverse Level 1 trauma centers (79 participants) [4] and developed brief educational materials for surgeons to increase their knowledge of the role of psychosocial factors in recovery after injury and increase their confidence in making referrals. We also tried to integrate recruitment into clinic flow; to tailor the study protocol to each clinic; to identify a surgeon champion at each clinic; and to use simple, destigmatizing language. Here we present results from a multisite feasibility RCT of TOR versus control.
In this study, we asked: (1) Does TOR achieve a priori feasibility benchmarks in a multisite RCT? (2) Does TOR demonstrate a preliminary effect in improving pain, as well as physical and emotional function?
Patients and Methods
Study Design and Setting
We conducted a multisite, pilot RCT at four Level 1 orthopaedic trauma centers at the Massachusetts General Hospital, Dell Medical School, Vanderbilt University Medical Center, and the University of Kentucky Medical Center. We conducted a “run-in” period (September 2021 to October 2021) to refine procedures. We refer to this as a pilot study because it was not fully powered for efficacy (that is, it was powered to detect only large effect sizes).
Participants
Official RCT recruitment occurred from October 2021 to August 2023 (Supplement Digital Content 1; http://links.lww.com/CORR/B299). We aimed to enroll 180 participants. We followed the CONSORT reporting guidelines [8, 27]. With a cross-site reliance agreement, the Massachusetts General Hospital Institutional Review Board (IRB) and an external data and safety monitoring board oversaw the implementation of all study procedures. All participants provided written informed consent before participation.
Potentially eligible participants were identified by a research assistant via the electronic medical record or through the medical and surgical staff. Verbal consent was obtained for screening procedures, and orthopaedic surgeons were notified (verbally or via a note with the study logo attached to the door) of patients who screened in (scored ≥ 20 on the Pain Catastrophizing Scale or ≥ 40 on the Pain Anxiety Scale-Short Form). Surgeons described the study to eligible participants during a clinic visit using a brief script developed by our study team.
For patients who expressed interest, the surgeon introduced the research assistant who finalized the screening process. Inclusion criteria were: (1) adult, (2) acute orthopaedic traumatic injury (such as, fracture, dislocation, or rupture) approximately 1 to 2 months earlier, (3) willing to comply with study protocol, (4) free of concurrent psychotropic medications for more than 2 weeks or stable for longer than 6 weeks, (5) cleared by surgeon, (6) able to meaningfully participate (for example, speak English, or have a stable living situation), and (7) scored ≥ 8 out of 10 on the Short Portable Mental Status Questionnaire for those older than 65 or if staff identified any cognitive concerns. We excluded patients who: (1) had a serious medical illness that was expected to worsen in the next 3 months (such as, malignancy), (2) had serious mental illness/instability, (3) current suicidal ideation with plan, (4) other concurrent severe injuries that could impact participation (such as, traumatic brain injury), (5) currently in litigation or under workers compensation, (6) surgery complications (infection, need for repeat surgery), (7) practice meditation or mind-body techniques for more than 45 minutes a week over the last 3 months, and (8) self-reported pregnancy per our IRB.
Randomization, Allocation Concealment, and Follow-up
We used a computer-generated randomization sequence to randomize participants 1:1 to TOR or a minimally enhanced usual care comparison group (MEUC) stratified by site. Treatment assignments were implemented using REDCap [14]. All study staff aside from the statistician were blind to the allocation algorithm. Participants were not blinded. Self-report measures were collected at baseline, postintervention, and 12 weeks from baseline. A participant was considered enrolled in TOR if they completed at least one treatment session and enrolled in the MEUC if they completed baseline (no sessions in the MEUC).
In all, 195 patients were eligible and randomized (97 to TOR, 98 to MEUC). Fourteen percent (14 of 97) of patients randomized to TOR did not start treatment, but they are included in all analyses following the intention-to-treat principle. In TOR, 24% (23 of 97) were lost to follow-up, whereas in MEUC, 17% (17 of 98) were lost. The posttreatment survey completion rates were 78% (76 of 97) for TOR and 95% (93 of 98) for the MEUC. The 12-week follow-up survey completion rates were 76% (74 of 97) for TOR and 83% (81 of 98) for the MEUC. All participants were still included in the analysis given the intention-to-treat approach. Overall, less than 2% (80 of 5270) of questionnaires were incomplete (Fig. 1). Of 97 randomized TOR participants, 73% (71) completed all four sessions. We used intent to treat (all patients who completed baseline and were randomized, regardless of whether they started treatment were included in the analyses).
Fig. 1.
Flow chart for this study demonstrating how we assessed eligibility, our exclusion criteria, and our randomization process; M = Massachusetts General Hospital; UK = University of Kentucky Medical Center; D = Dell Medical School; V = Vanderbilt University Medical Center.
Descriptive Data
Race and ethnicity were self-reported by participants on a demographic survey instrument in REDCapTM. There were no differences in baseline demographics and outcomes between the enrolled participants across the treatment groups except for the baseline level of pain during activity, which was higher in the MEUC group (mean TOR 5.5 ± 2.4; mean MEUC 6.3 ± 2.5; t = -2.4; p = 0.02) (Table 1).
Table 1.
Descriptive statistics for all randomized participants
| Characteristic | TOR (n = 97) | MEUC (n = 98) |
| Age in years | 43 ± 17 | 45 ± 16 |
| Sex | ||
| Male | 33 (32) | 33 (32) |
| Female | 67 (65) | 67 (66) |
| Gender | ||
| Man | 32 (31) | 33 (32) |
| Woman | 65 (63) | 63 (62) |
| Genderqueer/gender fluid/nonbinary | 3 (3) | 3 (3) |
| Prefer not to say | 0 (0) | 1 (1) |
| Raceb | ||
| American Indian Alaska Native | 0 (0) | 1 (1) |
| Asian | 4 (4) | 5 (5) |
| Black/African American | 7 (7) | 8 (8) |
| More than one race | 5 (5) | 7 (7) |
| White | 78 (76) | 74 (73) |
| Choose not to answer | 5 (5) | 4 (4) |
| Ethnicitya,b | ||
| Hispanic | 14 (14) | 13 (13) |
| Non-Hispanic | 83 (80) | 85 (83) |
| Choose not to answer | 3 (3) | 2 (2) |
| Education | ||
| Less than high school | 1 (1) | 6 (6) |
| Completed high school or GED | 21 (20) | 27 (26) |
| Some college/associate degree | 30 (29) | 24 (23) |
| Completed 4 years of college | 31 (30) | 19 (19) |
| Graduate/professional degree | 16 (15) | 23 (23) |
| Choose not to answer | 2 (2) | 1 (1) |
| Employment | ||
| Employed full-time | 50 (48) | 50 (49) |
| Employed part-time | 16 (15) | 9 (9) |
| Going to school full- or part-time | 4 (4) | 2 (2) |
| Keeping house/housemaker | 1 (1) | 2 (2) |
| Other | 3 (3) | 7 (7) |
| Retired | 10 (10) | 8 (8) |
| Unemployed | 16 (15) | 16 (16) |
| Choose not to answer | 1 (1) | 5 (5) |
| Income | ||
| Less than USD 10,000 | 9 (9) | 17 (17) |
| USD 10,000 to less than USD 15,000 | 5 (5) | 6 (6) |
| USD 15,000 to less than USD 20,000 | 4 (4) | 0 (0) |
| USD 20,000 to less than USD 25,000 | 9 (9) | 3 (3) |
| USD 25,000 to less than USD 35,000 | 10 (10) | 7 (7) |
| USD 35,000 to less than USD 50,000 | 14 (14) | 11 (11) |
| USD 50,000 to less than USD 75,000 | 6 (6) | 12 (12) |
| USD 75,000 or more | 26 (25) | 29 (28) |
| Choose not to answer | 16 (15) | 14 (14) |
| Marital status | ||
| Single, never married | 41 (40) | 37 (36) |
| Married | 36 (35) | 40 (39) |
| Living with significant other | 4 (4) | 4 (4) |
| Separated/divorced | 12 (12) | 14 (14) |
| Widowed | 6 (6) | 4 (4) |
| Choose not to answer | 0 (0) | 1 (1) |
| Clinical outcome variables | ||
| SMFA | 47 ± 16 | 50 ± 15 |
| PROMIS-PF | 31 ± 7 | 30 ± 7 |
| Pain at rest | 3.7 ± 2.4 | 3.7 ± 2.4 |
| Pain during activity | 5.5 ± 2.4 | 6.3 ± 2.5 |
| PCS | 23 ± 11 | 23 ± 10 |
| PASS | 56 ± 16 | 55 ± 15 |
| CES-D (depressive symptoms) | 25 ± 12 | 24 ± 12 |
| PCL | 39 ± 15 | 40 ± 17 |
| MOCS | 2 ± 1 | 2 ± 1 |
| CAMS | 31 ± 6 | 31 ± 6 |
Data presented as mean ± SD or % (n).
Sites differed based on ethnicity (more patients identified as Hispanic or Latino/Latina at Dell compared with the other three sites; p < 0.001), race (more patients selected “Choose not to answer” at Dell and there were more patients who identified as Asian at MGH; p = 0.035), education (lower levels of education at VUMC compared with the other three sites; p < 0.001), SMFA scores (VUMC had higher SMFA scores compared with the other three sites [VUMC: 58.4 ± 13.1; MGH: 44.8 ± 16.3; Dell: 46.6 ± 15.9; Kentucky: 48.0 ± 14.3; p < 0.001]), pain at rest (patients at MGH had lower pain at rest than those at VUMC [MGH: 3.061 ± 2.1; VUMC: 4.8 ± 2.7; p = 0.004]), pain during activity (patients at MGH had lower pain during activity than those at Dell [MGH: 5.0 ± 2.5; Dell: 6.4 ± 2.3; p = 0.01] and VUMC [VUMC: 7.0 ± 2.7; p = 0.002]), PCS scores (patients at VUMC had higher PCS scores than those at MGH [VUMC: 28.3 ± 10.5; MGH: 21.0 ± 10.4; p = 0.013]), and PCL scores (patients at VUMC had higher PCL scores than those at MGH [VUMC: 48.6 ± 17.0; MGH: 37.1 ± 15.4; p = 0.01] and those at Kentucky [Kentucky: 37.4 ± 14.1; p = 0.01]).
Race and ethnicity were self-reported by participants on a demographic survey instrument in REDCapTM; MGH = Massachusetts General Hospital; VUMC = Vanderbilt University Medical Center; GED = general education diploma; SMFA = Short Musculoskeletal Function Assessment Questionnaire, scores range from 0 to 100 and higher scores indicate worse physical function; PROMIS = Patient-Reported Outcomes Measurement Information System-Physical Function and lower scores indicate greater disability; pain at rest and during activity: 10-point numeric rating scale (NRS), 0 indicates no pain and 10 indicates the worst pain imaginable; PCS = Pain Catastrophizing Scale, scores range from 0 to 52 and higher scores indicate greater catastrophic thinking about pain; PASS = Pain Anxiety Scale Short Form, scores range 0 to 100 and higher scores indicate more severe pain anxiety; CES-D = Center for Epidemiologic Study of Depression, scores range from 0 to 60 and higher scores indicate more severe depression symptoms; PCL = Posttraumatic Stress Disorder Checklist, scores range from 17 to 85 and higher scores indicate more severe symptoms; MOCS = Measures of Current Status, scores range 0 to 4 and higher scores indicate more effective coping; CAMS = Cognitive and Affective Mindfulness Scale-Revised, scores range from 12 to 48 and higher scores indicate greater mindfulness.
Treatment Conditions
Toolkit for Optimal Recovery after Injury (TOR) Active Intervention
TOR entails 4 weekly sessions (45 minutes each) delivered via live video (synchronous Zoom meetings). It teaches mind-body skills to improve recovery and decrease the likelihood of persistent pain. TOR teaches skills through didactics, in-session activities, and home-skill practice assignments (Table 2). Practicing was facilitated through a web platform with all program skills and instructions as individual recordings. We downloaded this platform on TOR participants’ phones as an app after randomization. TOR was delivered by five different, trained clinical psychologists with mind-body and pain expertise.
Table 2.
Description of the TOR, an individual four-session virtual intervention delivered by clinical psychologists for individuals after traumatic orthopaedic injuries
| Session number | Session title | Skills |
| Session #1 | Taking charge of your recovery | •Bust myths about pain •Set recovery goals •Brain-body connection exercise •Deep breathing •Body scan |
| Session #2 | Building awareness to manage pain and improve recovery | •Recovery spiral versus disability spiral (understand thoughts, behaviors, and feelings that promote recovery vs disability) •Mindful breathing •Mindful stop (pause, breath, observe mindfully, and proceed with awareness) |
| Session #3 | Thoughts and behaviors that speed up recovery | •Mindfulness of pain •Challenge unhelpful thoughts about pain •Moving parts of the body that were injured |
| Session #4 | Putting it all together | •Acceptance •Recovery spiral •Skills review and consolidation |
MEUC Control
The MEUC is a booklet containing brief, summarized information that reflects the active intervention topics, including the anticipated trajectory of pain and recovery after acute orthopaedic traumatic injury, the role of relaxation strategies to manage pain, and the importance of returning to engagement in activities of daily living.
Outcome Measures
The five primary outcomes were feasibility of recruitment (percentage of eligible patients that agree to participate), appropriateness of treatment, feasibility of data collection, acceptability of TOR (adherence to sessions), and treatment satisfaction for TOR (Table 3). Secondary outcomes were feasibility of randomization, fidelity to study protocol, acceptability as rated by study clinicians, feasibility of study procedures, feasibility of data collection for rescue analgesics (narcotics), fidelity to TOR sessions, change in rescue analgesics (narcotic and nonnarcotic), surgeon- and staff-specific feasibility, and change in patient-reported outcomes that are depicted under “Study Instruments” and were assessed at baseline, as well as at 4 and 12 weeks.
Table 3.
Primary and secondary feasibility outcomesa
| Primary outcomes | ||
| Marker | Proposed benchmark | Observed benchmark |
|
Feasibility of recruitment Percentage of eligible participants that agree to participate |
≥ 70% eligible will agree to participate | 89% (210 of 235) of eligible participants consented to participateb |
|
Appropriateness of treatment Assessed with the Credibility and Expectancy Scale, evaluated at baseline (TOR only) |
≥ 70% participants with score over the scale’s midpoint | 73% (66 of 90) of participants randomized to TOR who completed the measure scored above the midpointc |
|
Feasibility of data collection
Percentage of participants who complete surveys at all three timepoints |
≥ 70% participants will complete surveys | 79% (154 of 195) of randomized participants completed all surveysc |
|
Treatment satisfaction Assessed with the Client Satisfaction Scale, evaluated at posttreatment (TOR only) |
≥ 70% participants with score over the scale’s midpoint | 99% (75 of 76) of TOR participants who completed the measure scored above the midpointb |
|
Acceptability of TOR Percentage of TOR participants who attend ≥ 3 of 4 sessions |
≥ 70% TOR participants will attend ≥ 3 of 4 sessions | 73% (71 of 97) of participants randomized to TOR attended all four sessionsc |
| Secondary outcomes | ||
| Marker | Proposed benchmark | Observed benchmark |
| Fidelity to study protocol | < 5 protocol deviations per site | MGH: 7 minor, 1 major Dell: 1 minor, 0 major UK: 3 minor, 0 major VUMC: 4 minor, 0 major Some minor deviations apply to all sites but were reported by MGH |
| Feasibility of randomization | ≥ 70% of participants who start within one arm, complete posttests | TOR: 78% (76 of 97) of participants randomized to TOR completed posttestsc |
| MEUC: 95% (93 of 98) of participants randomized to MEUC completed posttestsb,c | ||
| Feasibility of data collection (patient) | ||
| Feasibility of data collection of walk test and grip test | No longer collected | NA |
| Feasibility of data collection for rescue analgesics (nonnarcotic) | ≥ 70% of participants with data | 79% (155 of 195) of randomized participants completed data at all timepointsc |
| Feasibility of data collection for rescue analgesics (narcotic) | ≥ 70% of participants with data | 79% (155 of 195) of randomized participants completed data at all timepointsc |
| Adverse events | ||
| Feasibility of data collection of adverse events | ≥ 70% of participants with data | 100% of enrolled participants had complete data adverse events (reported by clinician)b |
| Number of adverse events | Minimal | MGH: 0 adverse events, 1 serious adverse event UK: 1 adverse event, 1 serious adverse event Dell: 2 adverse events, 0 serious adverse events VUMC: 0 adverse events, 1 serious adverse event |
| Session adherence and acceptability | ||
| Fidelity to TOR sessions | ≥ 75% adherence (checklist and audio recordings) for ≥ 70% participants | 93%; of 7360 possible total points, clinicians earned a score of 6829 across fidelity checks (two raters, 20% of audios) |
| Adherence to TOR homework | ≥ 1 of 3 homework logs returned with 4 of 7 days of practice by ≥ 70% participants | 76% (74 of 97) of participants randomized to TOR completed 4 of 7 logs at least 1 of 3 weeksc |
| Acceptability as rated by study clinicians | ≥ 75% sessions with score over 7 | 97%; of the 304 TOR sessions conducted, 294 sessions received a participation quality score over 7 |
| Staff feasibility and acceptability | ||
| Satisfaction | ||
| Feasibility of data collection | ≥ 70% will complete satisfaction measures | 91% (20 of 22) of staff completed the satisfaction measureb |
| Perceived satisfaction of staff | ≥ 70% staff with score ≥ 7 | 75% (15 of 20) of staff completers scored satisfaction ≥ 7 |
| Ease of referrals | ||
| Feasibility of data collection | ≥ 70% will complete measure of perceived ease of referrals | 100% (22 of 22) of staff completed the ease of referral measureb |
| Perceived staff acceptability | ≥ 70% staff with score ≥ 7 | 100% (22 of 22) of staff rated ease of referral ≥ 7b |
| Feasibility of referral | ≥ 80% surgeons make at least five referrals per site | 89% (25 of 28) of staff referred ≥ 5 patients |
| Cost-benefit (patient) | ||
| Feasibility of data collection | ≥ 70% of staff will complete cost-benefit (patient) measure | 86% (19 of 22) of staff reported data on the perceived cost-benefit to the patientb |
| Perceived staff acceptability | ≥ 70% staff with score ≥ 7 | 79% (15 of 19) of staff rated the cost-benefit to patient ≥ 7 |
| Cost-benefit (clinic) | ||
| Feasibility of data collection | ≥ 70% of staff will complete cost-benefit (clinic) measure | 95% (21 of 22) of staff reported data on the perceived cost-benefit to the clinicb |
| Perceived staff acceptability | ≥ 70% staff with score ≥ 7 | 71% (15 of 21) of staff rated the cost-benefit to clinic ≥ 7 |
| Feasibility of implementation | ||
| Feasibility of data collection | ≥ 70% will complete measure of study implementation | 86% (19 of 22) of staff completed the implementation measureb |
| Perceived staff acceptability | ≥ 70% staff with score ≥ 7 | 79% (15 of 19) of staff rated feasibility of implementation ≥ 7 |
| Appropriateness | ||
| Feasibility of data collection | ≥ 70% will complete measure of appropriateness | 73% (16 of 22) of staff completed the appropriateness measure |
| Perceived staff acceptability | ≥ 70% staff with score ≥ 7 | 88% (14 of 16) of staff rated appropriateness ≥ 7b |
The estimates of person-to-person variation in outcomes are reported in efficacy analyses.
There were instances where the observed ratings surpassed the established benchmark for excellence, as detailed in Supplemental Table 1, which outlines the cutoffs for these excellent benchmarks.
Calculations are conservative and include participants who were randomized but not enrolled in TOR (n = 14); TOR = Toolkit for Optimal Recovery after Injury; MEUC = minimally enhanced usual care; MGH = Massachusetts General Hospital; UK = University of Kentucky Medical Center; Dell = Dell Medical School; VUMC = Vanderbilt University Medical Center.
Study Instruments
Pain
We assessed pain intensity both at rest and during activity using the numeric rating scale (NRS). The NRS is a 0 to 10 scale, where higher scores indicate more severe pain. The minimum clinically important difference (MCID) for the NRS is 2 [11, 12, 25].
Physical Function
The Short Musculoskeletal Function Assessment Questionnaire (SMFA; 46 items) assesses physical function and musculoskeletal disability [37]. It has two subscales calculated by summing up individual items: function and bothersome symptoms. The total items are summed and transformed into a final score ranging from 0 to 100. Higher scores indicate lower physical function. The MCID for SMFA is 7 [19]. The Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF Version 2.0; 8 items) assesses the capacity to carry out tasks involving physical activity. The resulting T-score is a standardized score with a mean of 50 and an SD of 10. Lower scores indicate greater disability. The MCID for PROMIS-PF is 3.6 [26, 28].
Depression
The Center for Epidemiologic Study of Depression (CES-D; 20 items, range 0 to 60) assesses symptoms of depression [23], with higher scores indicating more-severe depression symptoms. The MCID is a greater than 10% improvement between time points [24].
Posttraumatic Stress
The Posttraumatic Stress Disorder Checklist (PCL;17 items, range 17 to 85) assesses posttraumatic stress symptom severity linked to the acute orthopaedic traumatic injury [36]. Clinically important symptoms are calculated based on the DSM Diagnostic and Statistical Manual of Mental Disorders algorithm, and the MCID is 10 [6].
Putative Mechanisms: Pain Catastrophizing, Pain Anxiety, Coping, and Mindfulness
The Pain Catastrophizing Scale (PCS) assesses catastrophic thinking about pain (13 items, range 0 to 52), and higher scores indicate higher catastrophic thinking [29]. The Pain Anxiety Scale Short Form (PASS-20) assesses anxiety about pain (20 items, range 0 to 100), and higher scores indicate more severe pain anxiety [18]. The MCID is 4.5 for PCS [10] and a change of greater than 30% between timepoints [2, 20] for PASS. The Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) assesses mindfulness (12 items, range 12 to 48) [13]. The Measures of Current Status Part A (MOCS-A) assesses coping (13 items, range 0 to 4) [3]. MCIDs are not available for the CAMS-R or MOCS.
Feasibility Outcomes
The primary feasibility markers include: (1) feasibility of recruitment, measured by the percentage of participants who agreed to participate from those eligible; (2) appropriateness of TOR treatment, assessed with the Credibility and Expectancy Questionnaire; (3) feasibility of data collection, assessed by percentage of participants who completed the measures at the three timepoints (baseline, posttreatment, and 3 months’ follow-up); (4) acceptability, measured as percentage of participants who are randomized within one arm and complete the posttest; and (5) treatment satisfaction, assessed with the Client Satisfaction Scale (Table 3).
Ethical Approval
Ethical approval for this study was obtained from the Massachusetts General Hospital Institutional Review Board (Protocol # 2020P000095).
Statistical Analysis
We calculated standard univariate statistics (numbers, proportions, means, and SDs). For feasibility and efficacy analysis, in line with the intention-to-treat principle, we included all participants allocated to the TOR or MEUC group, regardless of whether or not they initiated treatment. For efficacy analysis, we implemented a shared baseline linear mixed-model repeated-measures ANOVA, utilizing SAS version 9.4 (SAS Institute). The analysis was conducted using restricted maximum likelihood estimation. To accommodate correlations between successive measurements, we applied an autoregressive model of the first order (AR1). The shared-baseline model linearly adjusts for any potential differences in baseline levels of the outcome measure. The covariance estimation in mixed models implicitly accounts for missing data, which helps reduce bias in our estimates. We ran post hoc tests of treatment-dependent variations in the hypothesized outcome variables from baseline to posttreatment and to the 3-month follow-up. These variations were estimated using linear contrasts of least-square means, presented as point estimates along with their unadjusted 95% confidence intervals (CIs). This approach allowed us to evaluate both within-group and between-group differences in the outcome variables at different timepoints. For inferential purposes, we used two-tailed p values with a significance level of p < 0.05. We did not apply corrections for multiple comparisons, considering the post hoc exploratory nature of the efficacy tests and the focus of study on feasibility.
Study Size
Our primary aim focuses on trial feasibility, acceptability, and credibility. Power was calculated a priori. A sample of 180 patients is required to establish feasibility, acceptability, credibility and other feasibility benchmarks. The study had at least an 80% probability of concluding that a given feasible criterion evaluated among all enrollees was met if the expected proportion of enrolled participants who met that criterion was at least 76%. For criteria specific to participants randomized to TOR, the study would have at least an 80% probability of concluding that a given feasible criterion was met if the expected proportion of participants randomized to TOR who met that criterion was at least 78%. For evaluations of surgeon- and staff-reported assessments, the study would have at least an 80% probability of concluding that a given feasible criterion were met if the expected proportion of staff who meet that criterion was at least 80%. Although the primary aim of the trial was feasibility, this sample provided 80% power (1-β error probability) to detect a large effect size (between-group difference), with a two-tailed α-error probability of 0.05.
Results
Feasibility Benchmarks
We achieved or exceeded our predefined benchmarks for primary outcomes (89% [210 of 235] feasibility of recruitment, 73% [66 of 90] appropriateness, 79% [154 of 195] survey completion rate, 99% [75 of 76] TOR satisfaction, and 73% [71 of 97] acceptability of TOR) (Table 3). This pattern of achieving or surpassing benchmarks was consistent for secondary feasibility outcomes as well (estimates of person-to-person variation in outcomes are also reported in preliminary efficacy analyses) (Table 3).
Data collection from staff was successful, and staff scored above the expected cutoff on question items related to satisfaction (75% [15 of 20]), ease of referral (100% [22 of 22]), patient cost-benefit (79% [15 of 19]), clinic cost-benefit (71% [15 of 21]), feasibility of implementation (79% [15 of 19]), and appropriateness (88% [14 of 16]). The referral rate was 89% [25 of 28]. These benchmarks were largely consistent across the four sites, with few instances where benchmarks were narrowly not met for certain secondary outcomes at site level (Supplemental Table 1; http://links.lww.com/CORR/B301).
Pain, Physical Function, and Emotional Function
From baseline to posttreatment, participants randomized to TOR and MEUC experienced improvement in physical function SMFA (MCID 7) (TOR -16 [95% CI -19 to -13]; p < 0.001; MEUC -8 [95% CI -11 to -6]; p < 0.001), physical function PROMIS (MCID 3.6) (TOR 6 [95% CI 5 to 8]; p < 0.001; MEUC 4 [95% CI 3 to 6]; p < 0.001), pain at rest (MCID 2) (TOR -1.7 [95% CI -2.1 to -1.2]; p < 0.001; MEUC -0.5 [95% CI -0.9 to -0.1]; p = 0.02), pain during activity (MCID 2) (TOR -1.7 [95% CI -2.1 to -1.2]; p < 0.001; MEUC -1 [95% CI -1.4 to -0.6]; p < 0.001), pain catastrophizing (MCID 4.5) (TOR -14 [95% CI -16 to -12]; p < 0.001; MEUC -6 [95% CI -8 to -4]; p < 0.001), pain-related anxiety (MCID of > 30% change) (TOR -38 [95% CI -41 to -34]; p < 0.001; MEUC -13 [95% CI -17 to -10; p < 0.001), depressive symptoms (MCID of >10% change) (TOR -9 [95% CI -11 to -7]; p < 0.001; MEUC -3 [95% CI -5 to -1]; p = 0.004), and posttraumatic symptoms score (MCID 10) (TOR -7 [95% CI -10 to -5]; p < 0.001; MEUC -4 [95% CI -6 to -1]; p = 0.004). Participants in TOR, but not MEUC, also showed improvements in adaptive coping skills (TOR 0.4 [95% CI 0.2 to 0.5]; p < 0.001), and mindfulness (TOR 3 [95% CI 2 to 4]; p < 0.001) (Table 4 and Supplemental Figs. 1-10; http://links.lww.com/CORR/B300). Improvements were clinically meaningful (above the MCID) for physical function SMFA score (TOR and MEUC), physical function PROMIS score (TOR and MEUC), pain catastrophizing (TOR and MEUC), pain-related anxiety (TOR), and depressive symptoms (TOR and MEUC). The magnitude of improvement from baseline to posttreatment was in favor of TOR for physical function SMFA score (-7 [95% CI -11 to -4]; p < 0.001), physical function PROMIS score (2 [95% CI 0 to 4]; p = 0.045), pain at rest (-1.2 [95% CI -1.7 to -0.6]; p < 0.001), pain during activity (-0.7 [95% CI -1.3 to -0.1]; p = 0.03), pain catastrophizing (-8 [95% CI -11 to -5]; p < 0.001), pain-related anxiety (-25 [95% CI -29 to -20]; p < 0.001), depressive symptoms (-6 [95% CI -9 to -3]; p < 0.001), posttraumatic symptoms score (-4 [95% CI -7 to 0]; p = 0.03), coping skills (0.4 [95% CI 0.2 to 0.6]; p < 0.001), and mindfulness (3 [95% CI 1 to 5]; p = 0.001) (Supplemental Table 2; http://links.lww.com/CORR/B302).
Table 4.
Means and SDs at baseline, posttreatment, and 3 months posttreatment for all participants who completed baseline ± intent to treat (n = 195)
| Outcome measure | Group | Baseline | Posttreatment | 3 months posttreatment |
| SMFA | TOR | 47 ± 16 (n = 97) | 31 ± 19 (n = 76) | 24 ± 19 (n = 74) |
| MEUC | 50 ± 15 (n = 98) | 41 ± 20 (n = 94) | 32 ± 22 (n = 81) | |
| PROMIS-PF | TOR | 31 ± 7 (n = 97) | 37 ± 9 (n = 76) | 43 ± 9 (n = 74) |
| MEUC | 30 ± 7 (n = 96) | 35 ± 9 (n = 93) | 41 ± 10 (n = 81) | |
| Pain during activity | TOR | 3.7 ± 2.4 (n = 97) | 3.9 ± 2.6 (n = 76) | 3.3 ± 2.8 (n = 74) |
| MEUC | 3.7 ± 2.4 (n = 98) | 5.2 ± 2.8 (n = 93) | 4.6 ± 3.0 (n = 81) | |
| Pain at rest | TOR | 5.5 ± 2.4 (n = 96) | 2.0 ± 1.9 (n = 76) | 1.7 ± 2.1 (n = 74) |
| MEUC | 6.3 ± 2.5 (n = 97) | 3.2 ± 2.7 (n = 93) | 2.8 ± 2.7 (n = 81) | |
| PCS | TOR | 23 ± 11 (n = 97) | 9 ± 8 (n = 76) | 8 ± 9 (n = 75) |
| MEUC | 23 ± 10 (n = 98) | 18 ± 13 (n = 94) | 16 ± 14 (n = 87) | |
| PASS | TOR | 56 ± 16 (n = 97) | 18 ± 16 (n = 76) | 18 ± 17 (n = 74) |
| MEUC | 55 ± 15 (n = 98) | 42 ± 25 (n = 94) | 36 ± 27 (n = 82) | |
| CES-D | TOR | 25 ± 12 (n = 97) | 15 ± 10 (n = 76) | 15 ± 12 (n = 74) |
| MEUC | 25 ± 12 (n = 98) | 21 ± 13 (n = 92) | 20 ± 15 (n = 81) | |
| PCL | TOR | 39 ± 15 (n = 97) | 31 ± 11 (n = 76) | 29 ± 12 (n = 74) |
| MEUC | 40 ± 17 (n = 98) | 37 ± 15 (n = 92) | 36 ± 18 (n = 81) | |
| MOCS | TOR | 2 ± 1 (n = 97) | 2 ± 1 (n = 76) | 2 ± 1 (n = 74) |
| MEUC | 2 ± 1 (n = 98) | 2 ± 1 (n = 92) | 2 ± 1 (n = 79) | |
| CAMS-R | TOR | 31 ± 6 (n = 97) | 35 ± 8 (n = 76) | 34 ± 8 (n = 74) |
| MEUC | 31 ± 6 (n = 98) | 31 ± 7 (n = 92) | 32 ± 8 (n = 80) |
SMFA = Short Musculoskeletal Function Assessment Questionnaire, scores range from 0 to 100 where higher scores indicate worse physical function; PROMIS-PF = Patient-Reported Outcomes Measurement Information System-Physical Function, lower scores indicate greater disability; pain at rest and during activity = 10-point numeric rating scale (NRS) where 0 indicates no pain and 10 indicates the worst pain imaginable; PCS = Pain Catastrophizing Scale, scores range from 0 to 52 and higher scores indicate greater catastrophic thinking about pain; PASS = Pain Anxiety Scale Short Form, scores range 0 to 100 and higher scores indicate more severe pain anxiety; CES-D = Center for Epidemiologic Study of Depression, scores range from 0 to 60 and higher scores indicate more severe depression symptoms; PCL = Posttraumatic Stress Disorder Checklist, scores range from 17 to 85 and higher scores indicate more severe symptoms; MOCS = Measures of Current Status, scores range 0 to 4 and higher scores indicate more effective coping; CAMS-R = Cognitive and Affective Mindfulness Scale-Revised, scores range from 12 to 48 and higher scores indicate greater mindfulness.
The within-group treatment improvements sustained through the 3-month follow-up visit (Supplemental Table 2; http://links.lww.com/CORR/B302). By 3 months postbaseline, the pattern of clinically important improvements mirrored those observed in the baseline-to-posttreatment comparison. Additionally, we observed a clinically important improvement in pain and PTSD outcomes only for participants receiving TOR (improvement in pain during activity: -2.4, PTSD: -10, and a near-clinically important improvement in pain at rest: -2.0). The between-group comparison of baseline to 3-month improvement in outcomes continued to favor the TOR group, except for the physical function PROMIS score (2 [95% CI -1 to 4]; p = 0.13) (Supplemental Table 2; http://links.lww.com/CORR/B302).
Discussion
Traumatic orthopaedic injuries are common [5, 21, 22] and associated with a heavy public health burden [5, 15, 22] as up to 50% of patients develop persistent pain [7, 9, 21]. Psychosocial factors, including pain anxiety and catastrophizing, increase the risk of developing persistent pain [15, 30-32]. Tailored mind-body interventions to mitigate this risk feasibly and effectively are currently unavailable. Thus, our team developed TOR, which aims to fill this gap and provide at-risk patients with the psychological skills to successfully navigate recovery from traumatic orthopaedic injury. In this paper, we answered the questions: (1) Does TOR achieve a priori feasibility benchmarks in a multisite RCT? (2) Does TOR demonstrate a preliminary effect in improving pain as well as physical and emotional function among patients at risk for persistent pain?
Limitations
First, the main goal was multisite feasibility, and we conducted post hoc rather than prespecified tests of efficacy, without applying corrections for multiple comparisons. The within-group improvement in all TOR outcomes and mechanisms, as well as the superiority of TOR over the MEUC on most questionnaires despite not being fully powered, strongly suggests that TOR has potential for benefit in improving physical, emotional, and pain outcomes among orthopaedic trauma patients. However, we do need a fully powered efficacy trial to ensure confidence of true efficacy on outcomes. At the present moment, the National Center for Complementary and Integrative Health is reviewing our proposal for a multisite, fully powered, efficacy trial of TOR versus MEUC. Second, the sample has a low representation of Black patients. Although we believe that the mechanisms of TOR are the same across racial and ethnic groups, based on these data, we cannot claim generalizability to the Black population. Future studies should select sites that are better able to enroll Black patients. Third, 14 patients were randomized to TOR but did not initiate treatment. Although our feasibility markers for TOR were high, future studies should ensure that patients are fully committed to initiating treatment before randomization. Because we used intent-to-treat principles, our results likely underestimate the impact of TOR on outcomes. Fourth, we did not test for mediation and moderation effects, including potential differential improvement by therapist. Although important, these tests are not appropriate for a pilot study, but will be tested in the future fully powered RCT. We specifically included a 3-month follow-up because we were interested in understanding whether our intervention can prevent persistent pain (lasting 3 months or longer) and disability after acute pain from an orthopaedic traumatic injury.
Feasibility Benchmarks
We met or exceeded all patient and staff feasibility benchmarks across the four sites. For patients, we observed excellent feasibility (ability to recruit participants quickly as well as to randomize and retain them with low attrition rates). Most participants completed all study measures across the three timepoints, and those in TOR believed that the program would help improve their recovery trajectory, and they experienced high satisfaction with the program. For staff, we observed excellent feasibility of referrals, implementation, data collection, satisfaction, and ease of the study procedures and referral process. Taken together, these findings suggest that TOR content and methodology is appropriate for both patients and orthopaedic trauma staff.
Pain, Physical Function, and Emotional Function
Participation in both TOR and the MEUC was associated with some level of within-group improvement from baseline to posttreatment across the main outcomes of physical function (SMFA and PROMIS), pain (at rest and with activity), and symptoms of depression and PTSD. Improvements were clinically meaningful for both TOR and the MEUC on physical function and symptoms of depression. The improvement was not clinically meaningful for pain and symptoms of PTSD. The magnitude of improvements after TOR was higher than MEUC on all outcomes. The within-group improvements sustained through the 3-month follow-up. From baseline to 3 months, participants in TOR experienced a clinically meaningful improvement in pain with activity and PTSD. This pattern of results shows that TOR can improve physical function, pain, depression, and PTSD, and can prevent transition from acute to persistent pain. This finding is important as prior studies and systematic reviews addressing acute orthopaedic traumatic injuries found either no or small improvements in similar outcomes [16], which completely faded over time [17]. We observed a similar pattern of results across our putative mechanistic targets, but participation in TOR and not MEUC was associated with improvement in mindfulness and adaptive coping skills. This pattern of results supports the content of TOR, which teaches mindfulness and coping to improve pain anxiety and pain catastrophizing.
Conclusion
This trial met all a priori feasibility benchmarks (for patients and staff). Participation in TOR was associated with improvement in all outcomes and putative mechanisms. These improvements were higher than those in the MEUC. Findings support a fully powered efficacy RCT of TOR versus MEUC, and subsequent implementation in routine care. TOR has the potential to be the first feasible, acceptable, and efficacious program to prevent transition from acute to persistent pain among patients at risk for persistent pain and disability following orthopaedic trauma (those with high levels of catastrophic thinking about pain or pain anxiety).
Group Authors
Members of the TOR Study Team include: Clinicians: James Doorley, Julia Hooker, Brooke Duarte, Ryan Mace, and Terence Penn; Research Coordinators: Nate Choukas, Amanda Priest, Cara Vantrease, Niels Brinkman, Sina Ramtin, Ali Azarpey, Tom Crijns, Melle Broekman, Gary Ulrich, Matthew Eubank, Lucy Bowers, and Kameron Kraus; Staff: Drs. Marilyn Heng, John Esposito, Mark Fleming, Derek Stenquist, Christine Cahalan, Eric Moghadamian, David Zuelzer, Arun Aneja, Daniel Primm, Raymond Wright, Robert H. Boyce, Alex A. Jahangir, Phillip M. Mitchell, Manish K. Sethi, Daniel J. Stinner, and Austin Hill.
Footnotes
aMembers of the TOR Study Team are listed in an Appendix at the end of this article.
The institution of one or more of the authors (A-MV) has received, during the study period, funding from the National Center for Complementary and Integrative Health (U01AT010462 [R01AT010462]).
One of the authors (KRA) certifies receipt of personal payments or benefits, during the study period, in an amount of less than USD 10,000 from NeuroSpinal Innovation.
All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request.
Ethical approval for this study was obtained from the Massachusetts General Hospital Institutional Review Board (Protocol # 2020P000095).
This work was performed at The Massachusetts General Hospital, Boston, MA, USA.
Contributor Information
Kate N. Jochimsen, Email: kjochimsen@mgh.harvard.edu.
Julie R. Brewer, Email: jrbrewer@mgh.harvard.edu.
Ellie A. Briskin, Email: eab4006@med.cornell.edu.
Robert A. Parker, Email: rparker4@mgh.harvard.edu.
Eric A. Macklin, Email: emacklin@mgh.harvard.edu.
David Ring, Email: david.ring@austin.utexas.edu.
Cale Jacobs, Email: cjacobs@bwh.harvard.edu.
Thuan Ly, Email: thly@mgh.harvard.edu.
Kristin R. Archer, Email: kristin.archer@vumc.org.
Caitlin E. W. Conley, Email: caitlin.conley2@uky.edu.
Mitchel Harris, Email: mbharris@mgh.harvard.edu.
Paul E. Matuszewski, Email: pmatuszewski@uky.edu.
William T. Obremskey, Email: william.obremskey@vumc.org.
David Laverty, Email: david.laverty@austin.utexas.edu.
Jafar Bakhshaie, Email: jbakhshaie@mgh.harvard.edu.
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