“My Surgical Success”: Effect of a Digital Behavioral Pain Medicine Intervention on Time to Opioid Cessation After Breast Cancer Surgery—A Pilot Randomized Controlled Clinical Trial

Darnall, Beth D.; Ziadni, Maisa S.; Krishnamurthy, Parthasarathy; Flood, Pamela; Heathcote, Lauren C.; Mackey, Ian; Taub, Chloe J.; Wheeler, Amanda

doi:10.1093/pm/pnz094

Cited by 64 publications

(78 citation statements)

References 39 publications

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“…Digital therapeutics offer independent, home-based, on-demand access to behavioral treatment for acute and chronic pain. For instance, a brief, web-based, 90-min, skilled-based pain treatment was shown to reduce postsurgical opioid use in women who underwent surgery for breast cancer [ 14 ]. For chronic pain, digital multisession interventions have been shown to be effective [ 15 - 17 ].…”

Section: Introductionmentioning

confidence: 99%

Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: Randomized Controlled Pilot Study

Darnall¹,

Krishnamurthy²,

Tsuei³

et al. 2020

JMIR Form Res

Self Cite

103

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Background Patients with chronic pain often have limited access to comprehensive care that includes behavioral pain management strategies. Virtual reality (VR) is an immersive technology and emerging digital behavioral pain therapy with analgesic efficacy for acute pain. We found no scientific literature on skills-based VR behavioral programs for chronic pain populations. Objective The primary aim of this study is to evaluate the feasibility of a self-administered VR program that included content and skills informed by evidence-based behavioral treatment for chronic pain. The secondary aim is to determine the preliminary efficacy of the VR program in terms of average pain intensity and pain-related interference with activity, stress, mood, and sleep, and its impact on pain-related cognition and self-efficacy. The tertiary aim was to conduct a randomized controlled trial (RCT) and compare the VR treatment with an audio-only treatment. This comparison isolated the immersive effects of the VR program, thereby informing potential mechanisms of effect. Methods We conducted an RCT involving a web-based convenience sample of adults (N=97) aged 18-75 years with self-reported chronic nonmalignant low back pain or fibromyalgia, with an average pain intensity >4 over the past month and chronic pain duration >6 months. Enrolled participants were randomly assigned to 1 of 2 unblinded treatments: (1) VR: a 21-day, skills-based VR program for chronic pain; and (2) audio: an audio-only version of the 21-day VR program. The analytic data set included participants who completed at least 1 of 8 surveys administered during the intervention period: VR (n=39) and audio (n=35). Results The VR and audio groups launched a total of 1067 and 1048 sessions, respectively. The majority of VR participants (n=19/25, 76%) reported no nausea or motion sickness. High satisfaction ratings were reported for VR (n=24/29, 83%) and audio (n=26/33, 72%). For VR efficacy, symptom improvement over time was found for each pain variable (all P<.001), with results strengthening after 2 weeks. Importantly, significant time×group effects were found in favor of the VR group for average pain intensity (P=.04), pain-related inference with activity (P=.005), sleep (P<.001), mood (P<.001), and stress (P=.003). For pain catastrophizing and pain self-efficacy, we found a significant declining trend for both treatment groups. Conclusions High engagement and satisfaction combined with low levels of adverse effects support the feasibility and acceptability of at-home skills-based VR for chronic pain. A significant reduction in pain outcomes over the course of the 21-day treatment both within the VR group and compared with an audio-only version suggests that VR has the potential to provide enhanced treatment and greater improvement across a range of pain outcomes. These findings provide a foundation for future research on VR behavioral interventions for chronic pain.

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Section: Introductionmentioning

confidence: 99%

Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: Randomized Controlled Pilot Study

Darnall¹,

Krishnamurthy²,

Tsuei³

et al. 2020

JMIR Form Res

Self Cite

103

View full text Add to dashboard Cite

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“…Other digital interventions exist that support PROM feedback for individuals with symptomatic cancer [10,12,[31][32][33]. Some provide Web-based pain management advice [34], deliver psychological therapies or support for individuals with cancer pain [35,36] or focus on specific situations such as post-surgical pain management [37]. Most psychoeducational and PROM feedback interventions can achieve small reductions in pain intensity, and it is difficult to know which components are effective [21].…”

Section: Context With Other Literaturementioning

confidence: 99%

Can-Pain-a digital intervention to optimise cancer pain control in the community: development and feasibility testing

Adam

Bond

Burton

et al. 2020

Support Care Cancer

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Purpose To develop a novel digital intervention to optimise cancer pain control in the community. This paper describes intervention development, content/rationale and initial feasibility testing. Methods Determinants of suboptimal cancer pain management were characterised through two systematic reviews; patient, caregiver and healthcare professional (HCP) interviews (n = 39); and two HCP focus groups (n = 12). Intervention mapping was used to translate results into theory-based content, creating the app "Can-Pain". Patients with/without a linked caregiver, their general practitioners and community palliative care nurses were recruited to feasibility test Can-Pain over 4 weeks. Results Patients on strong opioids described challenges balancing pain levels with opioid intake, side effects and activities and communicating about pain management problems with HCPs. Can-Pain addresses these challenges through educational resources, contemporaneous short-acting opioid tracking and weekly patient-reported outcome monitoring. Novel aspects of Can-Pain include the use of contemporaneous breakthrough analgesic reports as a surrogate measure of pain control and measuring the level at which pain becomes bothersome to the individual. Patients were unwell due to advanced cancer, making recruitment to feasibility testing difficult. Two patients and one caregiver used Can-Pain for 4 weeks, sharing weekly reports with four HCPs. Can-Pain highlighted unrecognised problems, promoted shared understanding about symptoms between patients and HCPs and supported shared decision-making. Conclusions Preliminary testing suggests that Can-Pain is feasible and could promote patient-centred pain management. We will conduct further small-scale evaluations to inform a future randomised, stepped-wedge trial.

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“…To date, the US lacks scalable behavioral medicine for pain thereby underscoring the need for solutions that are accessible, low-cost, and lowburden. Evidence-based, skills-based behavioral medicine for pain has been shown to reduce pain-specific distress [4,5], pain intensity [6], pain bothersomeness [7], improve response to pain treatments [8], and reduce opioid use among perioperative patients [9].…”

Section: Introductionmentioning

confidence: 99%

“…A single-session, 2-h skills-based pain management class ("Empowered Relief" (ER)) was shown to reduce pain-specific distress and improve self-regulation at 4week follow-up in a cohort of 57 mixed-etiology chronic pain patients receiving treatment at a tertiary referral, multidisciplinary chronic pain clinic [4]. A recent randomized controlled trial showed that a digital version of the class, adapted to the perioperative setting, effectively enhanced time to opioid cessation after breast cancer surgery compared to a digital health education control ("My Surgical Success") [9]. Importantly, neither "Empowered Relief" nor "My Surgical Success" direct patients to use less opioid medication.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial

Ziadni

Chen

Winslow

et al. 2020

Trials

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Background: Independent of pain intensity, pain-specific distress is highly predictive of pain treatment needs, including the need for prescription opioids. Given the inherently distressing nature of chronic pain, there is a need to equip individuals with pain education and self-regulatory skills that are shown to improve adaptation and improve their response to medical treatments. Brief, targeted behavioral medicine interventions may efficiently address the key individual factors, improve self-regulation in the context of pain, and reduce the need for opioid therapy. This highlights the critical need for targeted, cost-effective interventions that efficiently address the key psychological factors that can amplify the need for opioids and increased risk for misuse. In this trial, the primary goal is to test the comparative efficacy of a single-session skills-based pain management class to a health education active control group among patients with chronic pain who are taking opioids. Methods/design: Our study is a randomized, double-blind clinical trial testing the superiority of our 2-h, singlesession skills-based pain management class against a 2-h health education class. We will enroll 136 adult patients with mixed-etiology chronic pain who are taking opioid prescription medication and randomize 1:1 to one of the two treatment arms. We hypothesize superiority for the skills-based pain class for pain control, self-regulation of pain-specific distress, and reduced opioid use measured by daily morphine equivalent. Team researchers masked to treatment assignment will assess outcomes up to 12 months post treatment.

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“My Surgical Success”: Effect of a Digital Behavioral Pain Medicine Intervention on Time to Opioid Cessation After Breast Cancer Surgery—A Pilot Randomized Controlled Clinical Trial

Cited by 64 publications

References 39 publications

Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: Randomized Controlled Pilot Study

Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: Randomized Controlled Pilot Study

Can-Pain-a digital intervention to optimise cancer pain control in the community: development and feasibility testing

Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial

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