scholarly journals A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPalTM): study protocol for a multisite randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jennifer A. Rabbitts ◽  
Chuan Zhou ◽  
Rocio de la Vega ◽  
Homer Aalfs ◽  
Caitlin B. Murray ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Spinal Fusion ◽  
Acute Pain ◽  
Controlled Trial ◽  
Opioid Use ◽  
Cognitive Behavioral Intervention ◽  
Postsurgical Pain ◽  
Randomized Controlled ◽  
Chronic Postsurgical Pain

Abstract Background Spinal fusion surgery is associated with severe acute postsurgical pain and high rates of chronic postsurgical pain in adolescents. Psychological distress, sleep disturbance, and low pain self-efficacy predict higher acute pain and likelihood of developing chronic postsurgical pain. Interventions targeting baseline psychosocial risk factors have potential to interrupt a negative trajectory of continued pain and poor health-related quality of life (HRQL) over time but have not yet been developed and evaluated. This randomized controlled trial will test effectiveness of a digital peri-operative cognitive-behavioral intervention (SurgeryPalTM) vs. education-control delivered to adolescents and their parents to improve acute and chronic pain and health outcomes in adolescents undergoing spine surgery. Methods Adolescents 12–18 years of age undergoing spinal fusion for idiopathic conditions, and their parent, will be recruited from pediatric centers across the USA, for a target complete sample of 400 dyads. Adolescents will be randomized into 4 study arms using a factorial design to SurgeryPalTM or education control during 2 phases of treatment: (1) pre-operative phase (one-month before surgery) and (2) post-operative phase (1 month after surgery). Acute pain severity and interference (primary acute outcomes) and opioid use will be assessed daily for 14 days following hospital discharge. Chronic pain severity and interference (primary acute outcomes), as well as HRQL, parent and adolescent distress, sleep quality, and opioid use/misuse (secondary outcomes), will be assessed at 3 months and 6 months post-surgery. Discussion Demonstration of effectiveness and understanding optimal timing of perioperative intervention will enable implementation of this scalable psychosocial intervention into perioperative care. Ultimately, the goal is to improve pain outcomes and reduce reliance on opioids in adolescents after spine surgery. Trial registration NCT04637802 ClinicalTrials.gov. Registered on November 20, 2020

scholarly journals Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a Randomized Controlled Trial and Implementation Evaluation

2020 ◽  
Author(s):  
Abhimanyu Sud ◽  
Michelle L. A. Nelson ◽  
Darren K. Cheng ◽  
Alana Armas ◽  
Kirk Foat ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Health Care Providers ◽  
Controlled Trial ◽  
Pain Clinic ◽  
Care Providers ◽  
Opioid Use ◽  
Implementation Evaluation ◽  
Randomized Controlled

Abstract Background: Despite the high prevalence of comorbid chronic pain and depression, this comorbidity remains understudied. Meditation has demonstrated efficacy for both chronic pain and depression independently, yet there have been few studies examining its effectiveness when both conditions are present concurrently. Furthermore, while meditation is generally accepted as a safe and effective health intervention, little is known about how to implement meditation programs within or alongside the healthcare system. Methods: We will conduct a hybrid type 1 effectiveness-implementation evaluation. To measure effectiveness, we will conduct a randomized controlled trial (RCT) comparing Sahaj Samadhi Meditation (SSM) versus the Health Enhancement Program (HEP) in 160 people living with chronic pain, clinically significant depressive symptoms, and on long-term opioid therapy. Changes in depressive symptoms will be our primary outcome; pain severity, pain related function, opioid use, and quality of life will be the secondary outcomes. The primary endpoint will be at 12 weeks with a secondary endpoint at 24 weeks to measure sustainability of acute effects. Patients will be recruited from a community-based chronic pain clinic in a large urban centre in Mississauga, Canada. The meditation program will be delivered in the clinical environment where patients normally receive their chronic pain care by certified meditation teachers who are not regulated health care providers. We will use a mixed-methods design using the multi-level framework to understand the implementation of this particular co-location model. Discussion: Results of this hybrid evaluation will add important knowledge about the effectiveness of meditation for managing depressive symptoms in people with chronic pain. The implementation evaluation will inform both effectiveness outcomes and future program development, scalability, and sustainability. Trial Registration: ClinicalTrials.gov: NCT04039568, registered July 31, 2019. https://clinicaltrials.gov/ct2/show/NCT04039568

scholarly journals Stories to Communicate Individual Risk for Opioid Prescriptions for Back and Kidney Stone Pain: Protocol for the Life STORRIED Multicenter Randomized Clinical Trial (Preprint)

2020 ◽  
Author(s):  
Zachary F Meisel ◽  
Erica B Goldberg ◽  
Abby R Dolan ◽  
Esha Bansal ◽  
Karin V Rhodes ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Risk Communication ◽  
Acute Care ◽  
Acute Pain ◽  
Kidney Stone ◽  
Controlled Trial ◽  
Risk Information ◽  
Opioid Use ◽  
Information Sheet ◽  
Randomized Controlled

BACKGROUND Prescription opioid misuse in the United States is a devastating public health crisis; many chronic opioid users were originally prescribed this class of medication for acute pain. Video narrative–enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain. OBJECTIVE Our objective is to assess the effect of probabilistic and narrative-enhanced opioid risk communication on patient-reported outcomes, including knowledge, opioid use, and patient preferences, for patients who present to emergency departments with back pain and kidney stone pain. METHODS This is a multisite randomized controlled trial. Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain are eligible for this randomized controlled trial. A control group of patients receiving general risk information is compared to two intervention groups: one receiving the risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative–enhanced probabilistic ORT. We will study the effect of probabilistic and narrative-enhanced opioid risk communication on the following: risk awareness and recall at 14 days postenrollment, reduced use or preferences for opioids after the emergency department episode, and alignment with patient preference and provider prescription. To assess these outcomes, we administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the 3 months after discharge. RESULTS A total of 1302 patients were enrolled over 24 months. The mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96%) had back pain, and 334 out of 1302 (25.65%) were at medium or high risk. Demographics and ORT scores were equally distributed across arms. CONCLUSIONS This study seeks to assess the potential clinical role of narrative-enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, and stakeholder involvement as well as dissemination considerations. CLINICALTRIAL ClinicalTrials.gov NCT03134092; https://clinicaltrials.gov/ct2/show/NCT03134092 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19496

scholarly journals Paravertebral Block Versus Preemptive Ketamine Effect on Pain Intensity after Posterolateral Thoracotomies: A Randomized Controlled Trial

2020 ◽  
Vol 9 (3) ◽  
pp. 793
Author(s):  
Michał Borys ◽  
Agata Hanych ◽  
Mirosław Czuczwar
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Pain Intensity ◽  
Acute Pain ◽  
Controlled Trial ◽  
Pain Syndrome ◽  
Paravertebral Block ◽  
Posterolateral Thoracotomy ◽  
Randomized Controlled

Severe postoperative pain affects most patients after thoracotomy and is a risk factor for post-thoracotomy pain syndrome (PTPS). This randomized controlled trial compared preemptively administered ketamine versus continuous paravertebral block (PVB) versus control in patients undergoing posterolateral thoracotomy. The primary outcome was acute pain intensity on the visual analog scale (VAS) on the first postoperative day. Secondary outcomes included morphine consumption, patient satisfaction, and PTPS assessment with Neuropathic Pain Syndrome Inventory (NPSI). Acute pain intensity was significantly lower with PVB compared to other groups at four out of six time points. Patients in the PVB group used significantly less morphine via a patient-controlled analgesia pump than participants in other groups. Moreover, patients were more satisfied with postoperative pain management after PVB. PVB, but not ketamine, decreased PTPS intensity at 1, 3, and 6 months after posterolateral thoracotomy. Acute pain intensity at hour 8 and PTPS intensity at month 3 correlated positively with PTPS at month 6. Bodyweight was negatively associated with chronic pain at month 6. Thus, PVB but not preemptively administered ketamine decreases both acute and chronic pain intensity following posterolateral thoracotomies.

scholarly journals Stories to Communicate Individual Risk for Opioid Prescriptions for Back and Kidney Stone Pain: Protocol for the Life STORRIED Multicenter Randomized Clinical Trial

10.2196/19496 ◽  
2020 ◽  
Vol 9 (9) ◽  
pp. e19496
Author(s):  
Zachary F Meisel ◽  
Erica B Goldberg ◽  
Abby R Dolan ◽  
Esha Bansal ◽  
Karin V Rhodes ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Risk Communication ◽  
Acute Care ◽  
Acute Pain ◽  
Kidney Stone ◽  
Controlled Trial ◽  
Risk Information ◽  
Opioid Use ◽  
Information Sheet ◽  
Randomized Controlled

Background Prescription opioid misuse in the United States is a devastating public health crisis; many chronic opioid users were originally prescribed this class of medication for acute pain. Video narrative–enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain. Objective Our objective is to assess the effect of probabilistic and narrative-enhanced opioid risk communication on patient-reported outcomes, including knowledge, opioid use, and patient preferences, for patients who present to emergency departments with back pain and kidney stone pain. Methods This is a multisite randomized controlled trial. Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain are eligible for this randomized controlled trial. A control group of patients receiving general risk information is compared to two intervention groups: one receiving the risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative–enhanced probabilistic ORT. We will study the effect of probabilistic and narrative-enhanced opioid risk communication on the following: risk awareness and recall at 14 days postenrollment, reduced use or preferences for opioids after the emergency department episode, and alignment with patient preference and provider prescription. To assess these outcomes, we administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the 3 months after discharge. Results A total of 1302 patients were enrolled over 24 months. The mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96%) had back pain, and 334 out of 1302 (25.65%) were at medium or high risk. Demographics and ORT scores were equally distributed across arms. Conclusions This study seeks to assess the potential clinical role of narrative-enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, and stakeholder involvement as well as dissemination considerations. Trial Registration ClinicalTrials.gov NCT03134092; https://clinicaltrials.gov/ct2/show/NCT03134092 International Registered Report Identifier (IRRID) DERR1-10.2196/19496

scholarly journals Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a Randomized Controlled Trial and Implementation Evaluation

2020 ◽  
Author(s):  
Abhimanyu Sud ◽  
Michelle L. A. Nelson ◽  
Darren K. Cheng ◽  
Alana Armas ◽  
Kirk Foat ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Pain Clinic ◽  
Clinical Environment ◽  
Opioid Use ◽  
Urban Centre ◽  
Implementation Evaluation ◽  
Randomized Controlled

Abstract Background: Despite the high prevalence of comorbid chronic pain and depression, this comorbidity remains understudied. Meditation has demonstrated efficacy for both chronic pain and depression independently, yet there have been few studies examining its effectiveness when both conditions are present concurrently. Furthermore, while meditation is generally accepted as a safe and effective health intervention, little is known about how to implement meditation programs within or alongside the healthcare system. Methods: We will conduct a hybrid type 1 effectiveness-implementation evaluation. To measure effectiveness, we will conduct a randomized controlled trial (RCT) comparing Sahaj Samadhi Meditation (SSM) versus the Health Enhancement Program (HEP) in 160 people living with chronic pain, clinically significant depressive symptoms, and on long-term opioid therapy. Changes in depressive symptoms will be our primary outcome; pain severity, pain related function, opioid use, and quality of life will be the secondary outcomes. The primary endpoint will be at 12 weeks with a secondary endpoint at 24 weeks to measure sustainability of acute effects. Patients will be recruited from a community-based chronic pain clinic in a large urban centre in Mississauga, Canada. The meditation program will be delivered in the clinical environment where patients normally receive their chronic pain care by certified meditation teachers who are not regulated healthcare providers. We will use a mixed-methods design using the multi-level framework to understand the implementation of this particular co-location model. Discussion: Results of this hybrid evaluation will add important knowledge about the effectiveness of meditation for managing depressive symptoms in people with chronic pain. The implementation evaluation will inform both effectiveness outcomes and future program development, scalability, and sustainability. Trial Registration: ClinicalTrials.gov: NCT04039568, registered July 31, 2019. https://clinicaltrials.gov/ct2/show/NCT04039568

scholarly journals Online mindfulness-based intervention to prevent chronic pain after cardiac surgery: Protocol of a pilot randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Geraldine Martorella ◽  
Adam W. Hanley ◽  
Scott M. Pickett ◽  
Céline Gelinas
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Cardiac Surgery ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Management ◽  
Opioid Use ◽  
Pain Acceptance ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

BACKGROUND Cardiac surgeries are frequent procedures. However, pain after cardiac surgery may become chronic (lasting >3 months) in adults. Once discharged from the hospital, patients are at greater risk for chronic post-surgical pain (CPSP) and prolonged opioid use, as they need to self-manage their pain. Psychological risk and protective factors, such as pain-related catastrophic thoughts and pain acceptance, will determine their ability to cope and their opioid use, which makes a support for pain self-management crucial. Studies on mindfulness-based cognitive therapy (MBCT) have multiplied regarding their potential effect on pain acceptance and catastrophic thoughts. Brief, Online MBCT for the prevention of CPSP have not been examined. OBJECTIVE We will pilot test a brief online 4-week MBCT intervention for adults following discharge from hospital by 1) assessing the acceptability/feasibility of the intervention; and 2) examining preliminary effects on pain intensity, pain interference with activities and opioid use, as well as pain acceptance and catastrophic thoughts in the 6 months following surgery. METHODS A double blinded pilot randomized controlled trial will be used to assess the online MBCT intervention. Patients will be selected according to the following criteria: a) age ≥ 18 years, b) first-time elective cardiac surgery via a median sternotomy, c) worst pain in the past week ≥4/10, d) ability to understand and complete questionnaires in English, and e) ability to use an electronic device such as a smartphone, computer, or tablet. After baseline measures, 32 participants will be randomized into two groups: one receiving both the brief 4-week online MBCT intervention and usual care (Experimental Group), the other one receiving solely one standardized educational online session with weekly reminders and usual care (Attention Control Group). Peer-reviewed competitive funding was received from the Florida State University’s Council on Research and Creativity in January 2021 as well as research ethics approval. RESULTS Recruitment has started in June 2021. CONCLUSIONS This research is significant because it targets the trajectory of CPSP, a leading cause of disability and opioid misuse. It is the first study to assess MBCT for the prevention of CPSP after cardiac surgery in the recovery phase. This approach is innovative because it promotes pain self-management through the modulation of individual factors. If successful, the intervention could be expanded to numerous populations at risk for chronic pain. CLINICALTRIAL NCT04848428

scholarly journals Paravertebral Block Versus Preemptive Ketamine Effect on Pain Intensity after Posterolateral Thoracotomies: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Michał Borys ◽  
Agata Hanych ◽  
Mirosław Czuczwar
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Pain Intensity ◽  
Acute Pain ◽  
Controlled Trial ◽  
Pain Syndrome ◽  
Paravertebral Block ◽  
Posterolateral Thoracotomy ◽  
Randomized Controlled

Severe postoperative pain affects most patients after thoracotomy and is a risk factor for post-thoracotomy pain syndrome (PTPS). This randomized controlled trial compared preemptively administered ketamine versus paravertebral block (PVB) versus control in patients undergoing posterolateral thoracotomy. The primary outcome was acute pain intensity on the visual analog scale (VAS) on the first postoperative day. Secondary outcomes included morphine consumption, patient satisfaction, and PTPS assessment with Neuropathic Pain Syndrome Inventory (NPSI). Acute pain intensity was significantly lower with PVB compared to other groups at four out of six time points. Patients in the PVB group used significantly less morphine via a patient-controlled analgesia pump than participants in other groups. Moreover, patients were more satisfied with postoperative pain management after PVB. PVB, but not ketamine, decreased PTPS intensity at 1, 3, and 6 months after posterolateral thoracotomy. Acute pain intensity at hour 8 and PTPS intensity at month 3 correlated positively with PTPS at month 6. Bodyweight was negatively associated with chronic pain at month 6. Thus, PVB but not preemptively administered ketamine decreases both acute and chronic pain intensity following posterolateral thoracotomies. The trial was prospectively registered at the Australian New Zealand Clinical Trial Registry (https://www.anzctr.org.au/; ACTRN12616000900415; 07 July 2016).

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