Capsaicin 8% Patch and Chronic Postsurgical Neuropathic Pain

(1) Background: Surgery is a frequent cause of persistent pain, defined chronic post-surgical pain (CPSP). The capsaicin 8% patch (Qutenza®) is approved for the treatment of postherpetic neuralgia (PHN) and for diabetic peripheral neuropathy (DPN) of the feet. We propose a review of the literature on use of the capsaicin 8% patch to treat neuropathic pain associated with surgery; (2) Methods: We identified the articles by searching electronic databases using a combination of such terms as “capsaicin 8% patch”, “Qutenza®”, and “chronic postsurgical pain”; (3) Results: We identified 14 selected studies reporting on a total of 632 CPSP cases treated with capsaicin 8% patch. Treatment with the capsaicin 8% patch significantly reduced the average pain intensity. Only 5 studies reported adverse events (AEs) after the patch application. The most common AEs were erythema, burning sensation and pain; (4) Conclusions: Our review indicate that capsaicin 8% patch treatment for CPSP is effective, safe and well tolerated, but randomized controlled trials on efficacy, safety and tolerability should be conducted.

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A prospective cohort register-based study of chronic postsurgical pain and long-term use of pain medication after otorhinolaryngological surgery

Scientific Reports ◽

10.1038/s41598-021-84788-4 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Nina Graf ◽

Katharina Geißler ◽

Winfried Meißner ◽

Orlando Guntinas-Lichius

Keyword(s):

Rating Scale ◽

Numeric Rating Scale ◽

Postsurgical Pain ◽

Average Pain Intensity ◽

Chronic Postsurgical Pain ◽

Average Pain ◽

Patients At Risk ◽

Perioperative Assessment ◽

Numeric Rating

AbstractData on chronic postsurgical pain (CPSP) after otorhinolaryngological surgery are sparse. Adult in-patients treated in 2017 were included into the prospective PAIN OUT registry. Patients’ pain on the first postoperative day (D1), after six months (M6) and 12 months (M12) were evaluated. Determining factor for CPSP was an average pain intensity ≥ 3 (numeric rating scale 0–10) at M6. Risk factors associated with CPSP were evaluated by univariate and multivariate analyses. 10% of 191 included patients (60% male, median age: 52 years; maximal pain at D1: 3.5 ± 2.7), had CPSP. Average pain at M6 was 0.1 ± 0.5 for patients without CPSP and 4.2 ± 1.2 with CPSP. Average pain with CPSP still was 3.7 ± 1.1 at M12. Higher ASA status (Odds ratio [OR] = 4.052; 95% confidence interval [CI] = 1.453–11.189; p = 0.007), and higher minimal pain at D1 (OR = 1.721; CI = 1.189–2.492; p = 0.004) were independent predictors of CPSP at M6. Minimal pain at D1 (OR = 1.443; CI = 1.008–2.064; p = 0.045) and maximal pain at M6 (OR = 1.665; CI = 1.340–2.069; p < 0.001) were independent predictors for CPSP at M12. CPSP is an important issue after otorhinolaryngological surgery. Better instrument for perioperative assessment should be defined to identify patients at risk for CPSP.

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Thoracic Paravertebral Blockade Reduces Chronic Postsurgical Pain in Breast Cancer Patients: A Randomized Controlled Trial

Pain Medicine ◽

10.1093/pm/pnaa270 ◽

2020 ◽

Vol 21 (12) ◽

pp. 3539-3547

Author(s):

Zeng-Mao Lin ◽

Mu-Han Li ◽

Feng Zhang ◽

Xue Li ◽

Chun-Li Shao ◽

...

Keyword(s):

Breast Cancer ◽

Randomized Controlled Trial ◽

Neuropathic Pain ◽

Controlled Trial ◽

Cancer Surgery ◽

Breast Cancer Surgery ◽

Control Group ◽

Single Shot ◽

Randomized Controlled ◽

Chronic Postsurgical Pain

Abstract Objective To evaluate the effect of multilevel single-shot thoracic paravertebral blockade (PVB) on the occurrence of chronic postsurgical pain (CPSP) in patients undergoing breast cancer surgery. Design A randomized controlled trial with two parallel groups. Setting A tertiary hospital. Methods Patients scheduled for breast cancer surgery were randomized to receive either ultrasound-guided multilevel single-shot PVB from T2 to T5 (the PVB group) or nothing (the control group). Surgery was then performed under general anesthesia. Patients were followed up for 12 months after surgery. The primary end point was incidence of CPSP at six months after surgery. Results A total of 218 patients were enrolled and randomized; of these, 208 and 204 completed six- and 12-month follow-up, respectively. The incidence of CPSP at six months was significantly lower in the PVB group (12.5% [13/104]) than in the control group (24.0% [25/104], relative risk = 0.52, 95% CI = 0.28–0.96, P = 0.031). Pain scores within 48 hours both at rest and with movement were lower in the PVB group than the control group (P = 0.006 and P < 0.001, respectively). The percentages of patients with neuropathic pain were also lower in the PVB group than the control group at both six and 12 months after surgery (P = 0.016 and 0.028, respectively). Adverse events did not differ between groups. Conclusions For patients undergoing breast cancer surgery, multilevel single-shot PVB reduces the incidence of CPSP at six months; it also improves early postoperative analgesia and reduces neuropathic pain at six and 12 months after surgery.

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Mindfulness-based cognitive therapy and cognitive behavioral therapy for chronic pain in multiple sclerosis: a randomized controlled trial protocol

Trials ◽

10.1186/s13063-019-3761-1 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Dawn M. Ehde ◽

Kevin N. Alschuler ◽

Melissa A. Day ◽

Marcia A. Ciol ◽

Makena L. Kaylor ◽

...

Keyword(s):

Chronic Pain ◽

Usual Care ◽

Behavioral Therapy ◽

Controlled Trial ◽

Randomized Controlled ◽

Average Pain Intensity ◽

Average Pain ◽

Pre Treatment ◽

Management Approaches

Abstract Background Chronic pain is one of the most prevalent and disabling symptoms associated with multiple sclerosis (MS). Individuals with MS are interested in nonpharmacologic pain management approaches. Cognitive-behavioral therapy (CBT) is efficacious in improving MS-related pain outcomes. Mindfulness-based cognitive therapy (MBCT) is a promising, alternative approach. Little is known about moderators of these treatments’ outcomes, however. This article describes the study protocol for the first randomized controlled trial comparing MBCT, CBT, and usual care and examining treatment effect moderators in individuals with chronic pain and MS. Methods We will conduct a single-center, randomized, single blind, parallel-group trial comparing MBCT, CBT, and usual care in adults with MS and chronic pain. Both interventions will be delivered via eight group sessions using videoconferencing technology. Primary (average pain intensity) and secondary outcomes (including pain interference, depressive symptoms, fatigue, and sleep) will be assessed pre-treatment, mid-treatment, post-treatment, and at 6-month follow up. Potential treatment moderators will be assessed pre-treatment. We hypothesize that participants randomly assigned to MBCT or CBT will report significantly greater reductions in average pain intensity than participants assigned to usual care at post-treatment (primary study endpoint) and 6-month follow up. We also hypothesize that mindfulness, pain catastrophizing, and behavioral activation pre-treatment will moderate response to both active treatments, but not response to usual care. Discussion Findings will provide important new information about the efficacy and moderators of two nonpharmacologic pain management approaches delivered using technology to overcome common barriers to treatment access. The knowledge gained may lead to better patient-treatment matching and, ultimately, better pain treatment outcomes in MS. Trial registration ClinicalTrials.gov, NCT03782246. Registered on 20 December 2018.

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Validation of Painreportit Neuropathic Pain Scale in African American Adults with Sickle Cell Disease

Blood ◽

10.1182/blood.v128.22.3525.3525 ◽

2016 ◽

Vol 128 (22) ◽

pp. 3525-3525 ◽

Cited By ~ 2

Author(s):

Keesha Roach ◽

Robert E Molokie ◽

Zaijie Jim Wang ◽

Mariam O Ezenwa ◽

David Shuey ◽

...

Keyword(s):

Chronic Pain ◽

Neuropathic Pain ◽

Pain Intensity ◽

Sickle Cell ◽

Pain Scale ◽

Moderate Correlation ◽

Cell Disease ◽

Weak Correlation ◽

Average Pain Intensity ◽

Average Pain

Abstract Background: Pain in sickle cell disease (SCD) has been thought to be episodic, but more recent evidence has shown that individuals in this population also suffer from chronic pain likely resulting from central or peripheral neural damage (neuropathic pain). There is accumulating evidence from human and animal studies indicating potential neuropathic pain in SCD. A number of valid and reliable measures of neuropathic pain have been used to differentiate neuropathic from non-neuropathic types of pain. PAINReportIt, which takes about 10 to 18 minutes to complete, is a computer based self-report pain assessment tool based on the 1970 version of the McGill Pain Questionnaire. From PAINReportIt, a new subscale has been proposed as a measure of neuropathic pain that sums the number of neuropathic pain quality words selected. The PAINReportIt number of neuropathic pain (PR-NNP) scale, however, lacks validation in patients with SCD. Aim: The purpose of this study was to determine the construct validity for the PR-NNP by examining the associations between the PR-NNP and other valid and reliable measures of neuropathic pain (self-administered Leeds Assessment of Neuropathic Symptoms and Signs [S-LANSS] and the Neuropathic Pain Symptom Inventory [NPSI]) among adults with SCD. We hypothesized that the PR-NNP scores would be significantly correlated with S-LANSS and NPSI scores. Methods: This prospective instrument validation study was conducted in an ambulatory research setting with 79 adults diagnosed with SCD who had chronic pain within the prior 12 months (>3 on a 0-10 pain scale). The sample mean age was 36.0 ± 11.5 [ranged from 19-74 years], 63% were female, and 97% reported they were African American. The participants were asked to complete self-reported pain measures (PR-NNP, S-LANSS, NPSI, and PR-NNoc [number of nociceptive pain words]). Descriptive, correlational, and regression analyses were used. Results: Mean scores for average pain intensity, PR-NNP, NSPI, S-LANSS, and PR-NNoc appear in Table 1. Bivariate results indicated moderate correlation between the two validated measures of neuropathic pain (NPSI and S-LANSS; r= .57, p=.000). The NPSI was moderately correlated with PR-NNP (r= .43, p=.000), and weakly correlated with PR-NNoc (r=.35, p=.002). For S-LANSS, there was a moderate correlation with PR-NNP (r=0.41, p=.000) and a weak correlation with PR-NNoc (r=.30, p=.007). There was a weak correlation between average pain intensity and NPSI and S-LANSS, r=.37, p=.001 and r=.36, p=.001, respectively. Regression analysis including average pain intensity, PR-NNP, and PR-NNoc as predictors showed that controlling for PR-NNP and average pain, PR-NNoc was not significantly associated with either NPSI (p=.930) or S-LANSS (p=.731), while each point of increase in PR-NNP was associated with an increase of 1.9 (p=.004) in NPSI and of 0.8 (p=.003) in S-LANSS. The same analysis showed that a one point increase in the average pain intensity was associated with an increase of 2.7 (p=.001) in NPSI and of 1.0 (p=.001) in S-LANSS. Conclusions: Both average pain intensity and PR-NNP but not PR-NNoc have unique explanatory properties of both indicators of neuropathic pain (NPSI and S-LANSS). These findings support the construct validity of the PR-NNP as a potential screening tool for neuropathic pain in patients with SCD. Validation of PR-NNP is important for future neuropathic pain research in the sickle cell population, particularly in cases of multi-site trials, and in cases where the practitioner can detect the potential presence of neuropathic pain without use of expensive equipment. These findings are important because pain management in the sickle cell population often includes opioids, but easy and early detection of neuropathic pain could result in an opioid sparing pain management approach in this population. Disclosures No relevant conflicts of interest to declare.

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Progressive Response to Repeat Application of Capsaicin 179 mg (8% w/w) Cutaneous Patch in Peripheral Neuropathic Pain: Comprehensive New Analysis and Clinical Implications

Pain Medicine ◽

10.1093/pm/pnab113 ◽

2021 ◽

Author(s):

Rainer Freynhagen ◽

Charles Argoff ◽

Mariëlle Eerdekens ◽

Sylvia Engelen ◽

Serge Perrot

Keyword(s):

Neuropathic Pain ◽

Pain Intensity ◽

Brief Pain Inventory ◽

Initial Response ◽

Open Label ◽

Self Assessment ◽

Peripheral Neuropathic Pain ◽

Average Pain Intensity ◽

Average Pain ◽

Global Impression Of Change

Abstract Objective To investigate efficacy of repeated application of capsaicin 179 mg cutaneous patch in non-responders to the first application. Design Post hoc, as-treated analysis of two prospective trials (STRIDE and PACE) with 52-week follow-up. Blinding Open-label. Setting Multicenter clinical trial. Subjects STRIDE: non-diabetic neuropathic pain; PACE: painful diabetic peripheral neuropathy. Methods Patients were divided according to number of applications needed before ≥30% response on average pain intensity (question 5 of the Brief Pain Inventory [BPI-Q5]). We assessed change from baseline in average pain intensity (BPI-Q5), mean ‘interference with sleep’ score, Patient Global Impression of Change, quality of life (QOL) using EuroQol 5-dimension, and Self-Assessment of Treatment. Results In STRIDE and PACE, respectively, n = 306/313 received capsaicin patch; n = 60/96 had a response after the first application, n = 33/68 after the second, n = 11/43 after the third. Among patients without a ≥ 30% reduction in pain intensity at 3 months, 23.3%/28.1% achieved a ≥ 30% reduction at 6 months, increasing to 33.9%/45.7% at 12 months. Similar results were obtained using a decrease of ≥ 50% as responder definition. Progressive improvements in pain intensity in slower responders reached similar levels as those in early responders at month 12 and were accompanied by improvements in sleep, QOL, and patient satisfaction. Conclusions While some patients with peripheral neuropathic pain experience rapid improvements with a single treatment of capsaicin 179 mg patch, some may require two or three treatments before an initial response is observed. Similar benefits on pain, sleep, and QOL can be achieved in early and late responders.

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PSYCHO-EMOTIONAL ASPECTS IN THE FORMATION OF PAIN SYNDROME CHARACTERISTICS IN PATIENTS WITH MULTIPLE SCLEROSIS

Proceedings of the Shevchenko Scientific Society. Medical Sciences ◽

10.25040/ntsh2021.02.15 ◽

2021 ◽

Vol 65 (2) ◽

Author(s):

Myroslav Bozhenko ◽

◽

Tetyana Nehrych ◽

Nataliya Bozhenko ◽

◽

...

Keyword(s):

Multiple Sclerosis ◽

Neuropathic Pain ◽

Pain Intensity ◽

Pain Syndrome ◽

Anxiety And Depression ◽

Mcgill Pain Questionnaire ◽

Pain Syndromes ◽

Average Pain Intensity ◽

Average Pain ◽

The Relationship

Introduction: Pain syndromes, anxiety, and depression are common syndromes in multiple sclerosis (MS). Comorbidity of pain and depression or pain and anxiety exists in up to one-third of MS patients. Based on the biopsychosocial model of pain, given the high prevalence of these symptoms and their frequent combination in MS, which is significantly higher than in the general population, we can hypothesize the relationship between the characteristics of pain and anxiety and depression in patients with MS. Objectives: To assess the prevalence of anxiety and depression among MS patients with pain syndromes and analyze the relationship between anxiety and depression with pain syndromes' characteristics in patients with MS. Methods: Data were collected prospectively at Lviv Regional Multiple Sclerosis Center. 120 randomly selected patients with a confirmed diagnosis of multiple sclerosis were examined. 104 of them had pain syndromes during the last month. Complaints and medical history, analysis of medical records, neurological and general medical examination of the patients were collected. Depressive symptoms and anxiety were assessed in all patients using the Hospital Anxiety and Depression Scale (HADS) questionnaire. In patients with pain syndromes, the Visual analogue scale (VAS), Short-form McGill Pain Questionnaire 2 (SF-MPQ-2), Pain Detect were used to assess pain characteristics. Results: The levels of anxiety and depression were higher in the group of MS patients with pain. The level of anxiety was 9.0 [6,0; 12,75] in the group with pain and 7.0 [4,0; 9,25] in the group without pain (p=0.04). The level of depression was 7.0 [4,0; 10,0] in the group with pain and 4.0 [1,75; 6,0] in the group without pain (p<0,01). It was found that part of MS patients with pain syndromes with anxiety was 36.5%, and 29.8% had a subclinical level of anxiety; part of MS patients with pain syndromes with depression was 19.23%. The proportion of patients with anxiety was highest in patients with neuropathic pain: 56.3% ± 8.8% vs. 22.4% ± 6.0% with nociceptive, p<0.01. A similar situation is observed in patients with depression. The share of patients with depression was higher in the group with neuropathic pain 37.5% ± 8.6%, compared to 14.3% ± 5.0% with nociceptive, p=0.02. The proportion of patients with MS without signs of anxiety and depression is significantly higher among patients with nociceptive pain (p<0,05). Also, the correlational relationship between the level of anxiety and depression with the level of the neuropathic type of pain manifestation was found (r=0,40; p<0,01 and r=0,30; p<0,01). Levels of anxiety and depression correlated with the average pain intensity per month (r = 0,21; p=0,03) and did not have a statistically significant relationship with pain intensity at the time of examination and the strongest pain for the last month. The anxiety and depression had correlations with all components of the structure of pain syndromes (according to sfMPQ-2), but the most pronounced direct correlation was found between anxiety and the affective component of pain (r=0,57; p<0,01). It was also found that the level of anxiety was proved to be higher in patients who have 2-3 pain syndromes, than in patients with one pain syndrome: 12.0 [8,0; 14,0] points against 8.0 [5,0; 11,0] points, p<0.01. Besides, this localization of pain in the arms, shoulders and back was related to higher levels of anxiety (r=0.22; p=0.03). Conclusion: Pain syndromes, anxiety, and depression are widespread among patients with MS and there is a relationship between them. MS patients with pain have higher levels of anxiety and depression than MS patients without pain. It is also noteworthy that among MS patients with pain syndromes, high levels of anxiety are detected. Anxiety and depression also have a pronounced relationship with a neuropathic component of pain in patients with MS. Besides this, the presence of more than one pain syndrome, high average pain intensity per month is associated with higher levels of anxiety and depression. The localization of pain in the arms, shoulders and back is related to higher anxiety levels. These discoveries, combined with modern neuroimaging technologies used in the next step of our study, will provide a better understanding of both pain and its structure, as well as anxiety and depression

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Leriche Syndrome Misdiagnosed as Complex Regional Pain Syndrome in a Patient with Neuropathic Pain Caused by a Chip Fracture: A Case Report

Medicina ◽

10.3390/medicina57050486 ◽

2021 ◽

Vol 57 (5) ◽

pp. 486

Author(s):

Byeong-Cheol Lee ◽

Dae-Seok Oh ◽

Hyun-Seong Lee ◽

Se-Hun Kim ◽

Jae-Hong Park ◽

...

Keyword(s):

Neuropathic Pain ◽

Case Report ◽

Pain Intensity ◽

Pain Syndrome ◽

Leriche Syndrome ◽

Average Pain Intensity ◽

Chip Fracture ◽

Gait Dysfunction ◽

Average Pain ◽

The Right

Introduction: Leriche syndrome is an aortoiliac occlusive disease caused by atherosclerotic occlusion. We report a case of Leriche syndrome with a fracture that was suspected as complex regional pain syndrome (CRPS), as the post-traumatic pain gradually worsened in the form of excruciating neuropathic pain. Case Report: A 52-year-old woman with a history of hypertension was referred to the Department of Pain Medicine from a local orthopedic clinic because of suspected CRPS for excruciating neuropathic pain for one month. She complained of gait dysfunction and severe pain in the right foot following an incident of trauma with the right first toe. The average pain intensity assessed using the visual analog scale (VAS) was 90 (0: no pain, 100: the worst pain imaginable), and the neuropathic pain was evident as a score of 6/10 on Douleur neuropathique 4. Allodynia, hyperalgesia, blue discoloration of the skin, asymmetric temperature change (1.38 °C), and edematous soft tissue changes were observed. Ultrasonography showed a chip fracture in the first distal phalanx of the right first toe. The diagnosis was most probably CRPS type I according to the Budapest research criteria for CRPS. However, multiple pain management techniques were insufficient in controlling the symptoms. A month and a half later, an ankle-brachial index score of less than 0.4 suggested severe peripheral artery disease. Computed tomography angiography showed total occlusion between the infrarenal abdominal aorta and the bilateral common iliac arteries. Therefore, she underwent aortic-bifemoral bypass surgery with a diagnosis of Leriche syndrome. Three months after the surgery, the average pain intensity was graded as 10 on the VAS (0–100), the color of the skin of the right first toe improved and no gait dysfunction was observed. Conclusion: A chip fracture in a region with insufficient blood flow could manifest as excruciating neuropathic pain in Leriche syndrome.

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

10.2196/preprints.17293 ◽

2019 ◽

Author(s):

Beth D Darnall ◽

Parthasarathy Krishnamurthy ◽

Jeannette Tsuei ◽

Jorge D Minor

Keyword(s):

Chronic Pain ◽

Virtual Reality ◽

Pain Intensity ◽

Self Efficacy ◽

Data Set ◽

Convenience Sample ◽

Randomized Controlled ◽

Average Pain Intensity ◽

Pain Outcomes ◽

Average Pain

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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Does perioperative ketamine have a role in the prevention of chronic postsurgical pain: the ROCKet trial

British Journal of Pain ◽

10.1177/2049463717736076 ◽

2017 ◽

Vol 11 (4) ◽

pp. 166-168 ◽

Cited By ~ 5

Author(s):

Stephan A Schug ◽

Philip Peyton

Keyword(s):

Controlled Trial ◽

Cochrane Review ◽

Postsurgical Pain ◽

Pharmacological Prevention ◽

Surgical Pain ◽

Increased Risk ◽

Chronic Postsurgical Pain ◽

Zealand College ◽

Chronic Post Surgical Pain ◽

Randomised Controlled

Identifying operations and individuals with an increased risk of chronic postsurgical pain (CPSP) has led to significant interest in interventions with the potential to achieve primary prevention of this condition. Pharmacological prevention remains controversial with a Cochrane review identifying perioperative ketamine administration as the only intervention with possible benefit although, with only small, heterogeneous studies, the authors called for a large randomised controlled trial (RCT) to confirm the validity of this result. In response to these data, a group of researchers from Australia and Hong Kong designed the ROCKet trial – Reduction Of Chronic Post-surgical Pain with Ketamine, endorsed by the Australian and New Zealand College of Anaesthetists (ANZCA) Clinical Trials Network (CTN).

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

JMIR Formative Research ◽

10.2196/17293 ◽

2020 ◽

Vol 4 (7) ◽

pp. e17293 ◽

Cited By ~ 2

Author(s):

Beth D Darnall ◽

Parthasarathy Krishnamurthy ◽

Jeannette Tsuei ◽

Jorge D Minor

Keyword(s):

Chronic Pain ◽

Virtual Reality ◽

Pain Intensity ◽

Self Efficacy ◽

Data Set ◽

Convenience Sample ◽

Randomized Controlled ◽

Average Pain Intensity ◽

Pain Outcomes ◽

Average Pain

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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