Embodiment in Virtual Reality for Treatment of Chronic Pain: A Feasibility Study (Preprint)

BACKGROUND Chronic pain has long been a major health burden that has been addressed through numerous forms of pharmacological and non-pharmacological treatment. One of the tenets of modern medicine is to minimize risk while providing efficacy. Because of its non-invasive nature, Virtual Reality provides an attractive platform for potentially developing novel therapeutic modalities. OBJECTIVE We describe a feasibility study that use embodiment in virtual reality as a treatment for chronic pain. The purpose of this study was to determine the feasibility of a novel virtual reality-based digital therapeutic for the treatment of chronic pain. METHODS An open label study assessed the feasibility of using virtual embodiment in virtual reality to treat chronic pain (Clinicaltrials.gov Identifier: NCT04060875). Twenty-four chronic pain patients were recruited from local pain clinics and completed eight session of a novel digital therapeutic that combines virtual embodiment with graded motor imagery to deliver functional rehabilitation exercises over the course of four weeks. Pain intensity as measured by a visual analog scale before and after each virtual embodiment training session was used as a primary outcome measure. Additionally, a battery of patient reported pain questionnaires (Fear and Avoidance Beliefs Questionnaire, OSWESTRY, Pain Catastrophizing Scale, and Patient Health Questionnaire) were administered before and after eight sessions of virtual embodiment training as exploratory outcome measures to get an indication if the measures are appropriate and warrant a larger randomized controlled trial. RESULTS A two-way ANOVA on session x pre vs. post Virtual embodiment training revealed that individual virtual embodiment training sessions significantly reduced the intensity of pain as measured by visual analog scale. Perceived disability due to lower back pain as measured by OSWESTRY significantly improved over the four-week course of virtual embodiment regimen. Improvement was also observed on the helplessness subscale of the Pain Catastrophizing Scale. CONCLUSIONS This study provide evidence that functional rehabilitation exercises delivered in virtual reality are safe and may have positive effects on alleviating the symptoms of chronic pain. These results support the justification for a larger randomized controlled trial to assess the extent to which virtual embodiment training can exert an effect on symptoms associated with chronic pain. CLINICALTRIAL Clinicaltrials.gov Identifier: NCT04060875

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Feasibility of a Hybrid Web-Based and In-Person Self-management Intervention Aimed at Preventing Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): A Pilot Randomized Controlled Trial

Pain Medicine ◽

10.1093/pm/pnz008 ◽

2019 ◽

Vol 20 (10) ◽

pp. 2018-2032 ◽

Cited By ~ 2

Author(s):

M Bérubé ◽

C Gélinas ◽

N Feeley ◽

G Martorella ◽

J Côté ◽

...

Keyword(s):

Chronic Pain ◽

Pain Catastrophizing ◽

Controlled Trial ◽

Self Management ◽

Anxiety And Depression ◽

Management Intervention ◽

Randomized Controlled ◽

Extremity Trauma ◽

Experimental Group ◽

Pilot Randomized Controlled Trial

Abstract Objective 1) To assess the feasibility of research methods to test a self-management intervention aimed at preventing acute to chronic pain transition in patients with major lower extremity trauma (iPACT-E-Trauma) and 2) to evaluate its potential effects at three and six months postinjury. Design A pilot randomized controlled trial (RCT) with two parallel groups. Setting A supraregional level 1 trauma center. Methods Fifty-six adult patients were randomized. Participants received the intervention or an educational pamphlet. Several parameters were evaluated to determine the feasibility of the research methods. The potential efficacy of iPACT-E-Trauma was evaluated with measures of pain intensity and pain interference with activities. Results More than 80% of eligible patients agreed to participate, and an attrition rate of ≤18% was found. Less than 40% of screened patients were eligible, and obtaining baseline data took 48 hours postadmission on average. Mean scores of mild pain intensity and pain interference with daily activities (<4/10) on average were obtained in both groups at three and six months postinjury. Between 20% and 30% of participants reported moderate to high mean scores (≥4/10) on these outcomes at the two follow-up time measures. The experimental group perceived greater considerable improvement in pain (60% in the experimental group vs 46% in the control group) at three months postinjury. Low mean scores of pain catastrophizing (Pain Catastrophizing Scale score < 30) and anxiety and depression (Hospital Anxiety and Depression Scale scores ≤ 10) were obtained through the end of the study. Conclusions Some challenges that need to be addressed in a future RCT include the small proportion of screened patients who were eligible and the selection of appropriate tools to measure the development of chronic pain. Studies will need to be conducted with patients presenting more serious injuries and psychological vulnerability or using a stepped screening approach.

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Randomized controlled trial of behavioral skills-based virtual reality (VR) for chronic low back pain: Study protocol for self-administered at-home VR therapy (Preprint)

10.2196/preprints.25291 ◽

2020 ◽

Author(s):

Laura Garcia ◽

Beth Darnall ◽

Parthasarathy Krishnamurthy ◽

Ian Mackey ◽

Josh Sackman ◽

...

Keyword(s):

Chronic Pain ◽

Randomized Controlled Trial ◽

Virtual Reality ◽

Low Back Pain ◽

Back Pain ◽

Pain Management ◽

Controlled Trial ◽

Low Back ◽

Behavioral Skills ◽

Randomized Controlled

BACKGROUND Chronic pain is one of the most common and debilitating health conditions. Treatments for chronic low back typically focus on biomedical treatment approaches. While psychosocial treatments exist, multiple barriers prevent broad access. There is a significant unmet need for integrative, easily accessible, non-opioid solutions for chronic pain. Virtual reality (VR) is an immersive technology allowing innovation in the delivery of behavioral pain treatments. Behavioral skills-based VR is effective at facilitating pain management and reducing pain-related concerns. Continued research on these emerging approaches is needed. OBJECTIVE In this randomized controlled trial, we seek to test the efficacy of a self-administered behavioral skills-based VR program as a non-pharmacological home-based pain management treatment for people with chronic low back pain (cLBP). METHODS We will randomize 180 individuals with cLBP to one of two VR programs: (1) EaseVRx (eight-week skills-based VR program); or (2) Sham VR (control condition). All participants will receive a virtual reality headset to minimize any biases related to the technology’s novelty. The Sham VR group had 2-D neutral content in a 3-D theater-like environment. Our primary outcome is average pain intensity and pain-related interference with activity, stress, mood, and sleep. Our secondary outcomes include patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction. We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition. Team statisticians blinded to treatment assignment will assess outcomes up to 6 months post-treatment using an approach suitable for the longitudinal nature of the data. RESULTS The study was approved by IRB on July 2, 2020. The protocol (NCT04415177) was registered on May 27, 2020. Recruitment for this study was completed in July 2020 and data collection will remain active until March 2021. In total, 186 participants were recruited. Multiple manuscripts will be generated from this study. The primary manuscript will be submitted for publication in the winter of 2020. CONCLUSIONS Effectively delivering behavioral treatments in VR could overcome barriers to care and provide scalable solutions to chronic pain’s societal burden. Our study could help shape future research and development of these innovative approaches. CLINICALTRIAL ClinicalTrials.gov, NCT04415177. https://clinicaltrials.gov/ct2/show/NCT04415177

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A Virtual Reality based intervention for surgical patients: study protocol of a randomized controlled trial

10.21203/rs.2.12519/v3 ◽

2020 ◽

Author(s):

Raluca Georgescu ◽

Anca Dobrean ◽

Cristina Alina Silaghi ◽

Horațiu Silaghi

Keyword(s):

Randomized Controlled Trial ◽

Virtual Reality ◽

Repeated Measures ◽

Standard Treatment ◽

Controlled Trial ◽

Self Report ◽

Control Group ◽

Randomized Controlled ◽

Pain Outcomes ◽

Before And After

Abstract Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for proper postoperative care. While several trials have investigated the analgesic effect of traditional non-pharmacological treatments, such as Cognitive Behaviors Therapies, the newer ways of delivering psychological interventions for pain after surgery are scarcely investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through Virtual Reality (VR) along with the standard pharmacological treatment return better pain relief outcomes than standard care in adult patients following surgery. Methods: This is a protocol of a parallel RCT conducted in one community hospital. In order to test the efficacy of VR environments for reducing pain intensity, in the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. It is intended that a minimum of 30 patients be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing an in-depth investigation of the effect of VR environments, the primary outcome will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment.

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A Virtual Reality based intervention for surgical patients: study protocol of a randomized controlled trial

10.21203/rs.2.12519/v4 ◽

2021 ◽

Author(s):

Raluca Georgescu ◽

Anca Dobrean ◽

Cristina Alina Silaghi ◽

Horațiu Silaghi

Keyword(s):

Randomized Controlled Trial ◽

Virtual Reality ◽

Repeated Measures ◽

Standard Treatment ◽

Controlled Trial ◽

Self Report ◽

Control Group ◽

Randomized Controlled ◽

Pain Outcomes ◽

Before And After

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Rumination-Focused Cognitive-Behavioral Therapy for Chronic Low Back Pain: A Randomized Controlled Trial

Galen Medical Journal ◽

10.31661/gmj.v9i0.1722 ◽

2020 ◽

Vol 9 ◽

Author(s):

Ali Soleymani ◽

Abbas Masjedi Arani ◽

Seyed Ahmad Raeissadat ◽

Mohammad Hassan Davazdahemami

Keyword(s):

Chronic Pain ◽

Randomized Controlled Trial ◽

Low Back Pain ◽

Back Pain ◽

Chronic Low Back Pain ◽

Pain Catastrophizing ◽

Behavioral Therapy ◽

Controlled Trial ◽

Low Back ◽

Randomized Controlled

Background: Chronic pain remains or reappears for more than 3 to 6 months, and it is influencing 20% of the global population. The pain catastrophizing affects pain intensity and psychological conditions of patients with chronic pain. Rumination-focused cognitive-behavioral therapy (RFCBT) targets rumination as the key component of pain catastrophizing. The aim of this study was to determine the effectiveness of RFCBT on depression, anxiety, and pain severity of individuals with chronic low back pain (LBP). Materials and Methods: In a randomized controlled trial, 30 patients aged between 20-55 years with diagnosed chronic LBP were chosen by convenience sampling and randomly allocated into intervention and control groups. All patients used their prescribed medications for pain management, but the intervention group received 12 weekly sessions of RFCBT, which was manualized psychotherapy to change unconstructive rumination to constructive rumination. Depression Anxiety and Stress scale-21 and chronic pain grade questionnaire were administered as pre-tests and re-administered after 3 and 6 months as post-test and follow-up assessments, respectively. Results: RFCBT significantly reduced depression (F1=23.01, P=0.001), anxiety (F1=25.7, P=0.001) and pain severity (F1=7.17, P=0.012) in patients with chronic LBP. Conclusion: RFCBT may offer benefits for treating patients with chronic low back pain when added to their usual pharmacological treatment. This benefit may be the result of targeting rumination as the key element of pain catastrophizing. [GMJ.2020;9:e1722]

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Efficacy of a Single-Session "Empowered Relief" Zoom-Delivered Group Intervention for Chronic Pain: Randomized Controlled Trial Conducted During COVID-19 (Preprint)

10.2196/preprints.29672 ◽

2021 ◽

Author(s):

Maisa Ziadni ◽

Lluvia Gonzalez-Castro ◽

Steven Anderson ◽

Parthasarathy Krishnamurthy ◽

Beth D Darnall

Keyword(s):

Chronic Pain ◽

Randomized Controlled Trial ◽

Pain Intensity ◽

Pain Catastrophizing ◽

Controlled Trial ◽

Post Treatment ◽

Single Session ◽

Randomized Controlled ◽

Secondary Outcomes ◽

High Engagement

BACKGROUND Pain-cognitive behavioral therapy is an evidence-based treatment for chronic pain, with significant patient burden including healthcare cost, travel, multiple sessions, and lack of access in remote areas. A previously developed and efficacious single-session intervention “Empowered Relief” (ER) based on CBT principles has particular salience and fills an urgent clinical need during COVID-19. However, key questions remain about the efficacy of online-delivered ER. OBJECTIVE The primary goal is to pilot test the comparative efficacy of a single-session videoconference-delivered ER group to a waitlist control (WLC) among individuals with chronic pain. We hypothesized that ER would be superior to WLC for reductions in pain catastrophizing, pain intensity, and other pain-related outcomes at 1-3 months post-treatment. METHODS We conducted a randomized controlled trial involving an online sample of adults (N=104) aged 18-80 years with self-reported chronic pain. Participants were randomized (1:1) to one of the two unblinded study groups: ER (n=50) or a WLC (n=54). Participants allocated to ER completed a Zoom-delivered class, and all participants completed follow-up surveys at 2 weeks, 1, 2, and 3 months post-treatment. All study procedures occurred remotely and electronically. The primary outcome was pain catastrophizing one-month post-treatment, with pain intensity, pain bothersomeness, and sleep disruption as secondary outcomes. We also report a more rigorous test of the durability of treatment effects at 3 months post-treatment. Data were collected from September 2020 - February 2021 and analyzed using intention-to-treat analysis. The analytic dataset included participants (18% clinic patients, 82% community) who completed at least one study surveys: ER (n=50) and WLC (n=51). RESULTS Participants (N=101) were 69.3% (70/101) female, with mean age of 49.76 years (SD 13.90; range 24.00-78.00); 32.7% (33/101) had an undergraduate degree, with self-reported chronic pain >= 3 months. Participants reported high engagement (94%), high satisfaction with ER (mean 8.26, SD 1.57; range 0-10), and Zoom-platform (92%). For the between-groups factor, ER was superior to WLC for all primary and secondary outcomes at 3 -months post-treatment (highest P=.0001), and between-groups Cohen d effect sizes ranged from 0.45 to 0.79, indicating superiority was of moderate to substantial clinical importance. At 3 months, clinically meaningful PCS reductions were found for ER but not for WLC (ER: PCS, -8.72, 42.25% reduction; WLC: PCS -2.25, 11.13% reduction). ER resulted in significant improvements in pain intensity, sleep disturbance, and clinical improvements in pain bothersomeness. CONCLUSIONS Zoom-delivered ER had high participant satisfaction and very high engagement. Among adults with chronic pain, this single-session, Zoom-delivered, skills-based pain class resulted in clinically significant improvement across a range of pain-related outcomes and sustained at 3 months. Online delivery of ER could allow greater accessibility of home-based pain treatment and could address the inconveniences and barriers faced by patients when attempting to receive in-person care. CLINICALTRIAL ClinicalTrials.gov Identifier NCT 04546685, Registered on 04 September 2020.

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A virtual reality-based intervention for surgical patients: study protocol of a randomized controlled trial

Trials ◽

10.1186/s13063-021-05196-7 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Raluca Diana Georgescu ◽

Anca Dobrean ◽

Cristina Alina Silaghi ◽

Horatiu Silaghi

Keyword(s):

Randomized Controlled Trial ◽

Virtual Reality ◽

Repeated Measures ◽

Standard Treatment ◽

Controlled Trial ◽

Self Report ◽

Control Group ◽

Randomized Controlled ◽

Pain Outcomes ◽

Before And After

Abstract Background Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for proper postoperative care. While several trials have investigated the analgesic effect of traditional non-pharmacological treatments, such as cognitive behavior therapies, the newer ways of delivering psychological interventions for pain after surgery are scarcely investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through virtual reality (VR) along with the standard pharmacological treatment return better pain relief outcomes than standard care in adult patients following surgery. Methods This is a protocol of a parallel RCT conducted in one community hospital. In order to test the efficacy of VR environments for reducing pain intensity, in the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. It is intended that a minimum of 30 patients be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing an in-depth investigation of the effect of VR environments, the primary outcome will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment.

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Correction: Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.27652 ◽

2021 ◽

Author(s):

Laura M Garcia ◽

Beth D Darnall ◽

Parthasarathy Krishnamurthy ◽

Ian G Mackey ◽

Josh Sackman ◽

...

Keyword(s):

Chronic Pain ◽

Randomized Controlled Trial ◽

Virtual Reality ◽

Low Back Pain ◽

Back Pain ◽

Chronic Low Back Pain ◽

Controlled Trial ◽

Low Back ◽

Behavioral Skills ◽

Randomized Controlled

UNSTRUCTURED Chronic pain is one of the most common and debilitating health conditions. Treatments for chronic low back pain typically focus on biomedical treatment approaches. While psychosocial treatments exist, multiple barriers prevent broad access. There is a significant unmet need for integrative, easily accessible, non-opioid solutions for chronic pain. Virtual reality (VR) is an immersive technology allowing innovation in the delivery of behavioral pain treatments. Behavioral skills-based VR is effective at facilitating pain management and reducing pain-related concerns. Continued research on these emerging approaches is needed. In this randomized controlled trial, we seek to test the efficacy of a self-administered behavioral skills-based VR program as a nonpharmacological home-based pain management treatment for people with chronic low back pain (cLBP). We will randomize 180 individuals with cLBP to 1 of 2 VR programs: (1) EaseVRx (8-week skills-based VR program); or (2) Sham VR (control condition). All participants will receive a VR headset to minimize any biases related to the technology's novelty. The Sham VR group had 2D neutral content in a 3D theater-like environment. Our primary outcome is average pain intensity and pain-related interference with activity, stress, mood, and sleep. Our secondary outcomes include patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction. We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition. Team statisticians blinded to treatment assignment will assess outcomes up to 6 months posttreatment using an approach suitable for the longitudinal nature of the data. The study was approved by the Western Institutional Review Board on July 2, 2020. The protocol (NCT04415177) was registered on May 27, 2020. Recruitment for this study was completed in July 2020, and data collection will remain active until March 2021. In total, 186 participants were recruited. Multiple manuscripts will be generated from this study. The primary manuscript will be submitted for publication in the winter of 2020. Effectively delivering behavioral treatments in VR could overcome barriers to care and provide scalable solutions to chronic pain's societal burden. Our study could help shape future research and development of these innovative approaches. ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177.

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