Dataset Information

Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial.

ABSTRACT: Importance: Limited evidence is available regarding long-term outcomes of opioids compared with nonopioid medications for chronic pain.

Objective: To compare opioid vs nonopioid medications over 12 months on pain-related function, pain intensity, and adverse effects.

Design, setting, and participants: Pragmatic, 12-month, randomized trial with masked outcome assessment. Patients were recruited from Veterans Affairs primary care clinics from June 2013 through December 2015; follow-up was completed December 2016. Eligible patients had moderate to severe chronic back pain or hip or knee osteoarthritis pain despite analgesic use. Of 265 patients enrolled, 25 withdrew prior to randomization and 240 were randomized.

Interventions: Both interventions (opioid and nonopioid medication therapy) followed a treat-to-target strategy aiming for improved pain and function. Each intervention had its own prescribing strategy that included multiple medication options in 3 steps. In the opioid group, the first step was immediate-release morphine, oxycodone, or hydrocodone/acetaminophen. For the nonopioid group, the first step was acetaminophen (paracetamol) or a nonsteroidal anti-inflammatory drug. Medications were changed, added, or adjusted within the assigned treatment group according to individual patient response.

Main outcomes and measures: The primary outcome was pain-related function (Brief Pain Inventory [BPI] interference scale) over 12 months and the main secondary outcome was pain intensity (BPI severity scale). For both BPI scales (range, 0-10; higher scores?=?worse function or pain intensity), a 1-point improvement was clinically important. The primary adverse outcome was medication-related symptoms (patient-reported checklist; range, 0-19).

Results: Among 240 randomized patients (mean age, 58.3 years; women, 32 [13.0%]), 234 (97.5%) completed the trial. Groups did not significantly differ on pain-related function over 12 months (overall P?=?.58); mean 12-month BPI interference was 3.4 for the opioid group and 3.3 for the nonopioid group (difference, 0.1 [95% CI, -0.5 to 0.7]). Pain intensity was significantly better in the nonopioid group over 12 months (overall P?=?.03); mean 12-month BPI severity was 4.0 for the opioid group and 3.5 for the nonopioid group (difference, 0.5 [95% CI, 0.0 to 1.0]). Adverse medication-related symptoms were significantly more common in the opioid group over 12 months (overall P?=?.03); mean medication-related symptoms at 12 months were 1.8 in the opioid group and 0.9 in the nonopioid group (difference, 0.9 [95% CI, 0.3 to 1.5]).

Conclusions and relevance: Treatment with opioids was not superior to treatment with nonopioid medications for improving pain-related function over 12 months. Results do not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain.

Trial registration: clinicaltrials.gov Identifier: NCT01583985.

SUBMITTER: Krebs EE

PROVIDER: S-EPMC5885909 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial.

Krebs Erin E EE Gravely Amy A Nugent Sean S Jensen Agnes C AC DeRonne Beth B Goldsmith Elizabeth S ES Kroenke Kurt K Bair Matthew J MJ Noorbaloochi Siamak S

JAMA 20180301 9

<h4>Importance</h4>Limited evidence is available regarding long-term outcomes of opioids compared with nonopioid medications for chronic pain.<h4>Objective</h4>To compare opioid vs nonopioid medications over 12 months on pain-related function, pain intensity, and adverse effects.<h4>Design, setting, and participants</h4>Pragmatic, 12-month, randomized trial with masked outcome assessment. Patients were recruited from Veterans Affairs primary care clinics from June 2013 through December 2015; fol ...[more]

PMID: 29509867

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Project description:Opioids represent an efficacious therapeutic modality for some, but not all pain states. Singular reliance on opioid therapy for pain management has limitations, and abuse potential has deleterious consequences for patient and society. Our understanding of pain biology has yielded insights and opportunities for alternatives to conventional opioid agonists. The aim is to have efficacious therapies, with acceptable side effect profiles and minimal abuse potential, which is to say an absence of reinforcing activity in the absence of a pain state. The present work provides a nonexclusive overview of current drug targets and potential future directions of research and development. We discuss channel activators and blockers, including sodium channel blockers, potassium channel activators, and calcium channel blockers; glutamate receptor-targeted agents, including N-methyl-D-aspartate, α-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid, and metabotropic receptors. Furthermore, we discuss therapeutics targeted at γ-aminobutyric acid, α2-adrenergic, and opioid receptors. We also considered antagonists of angiotensin 2 and Toll receptors and agonists/antagonists of adenosine, purine receptors, and cannabinoids. Novel targets considered are those focusing on lipid mediators and anti-inflammatory cytokines. Of interest is development of novel targeting strategies, which produce long-term alterations in pain signaling, including viral transfection and toxins. We consider issues in the development of druggable molecules, including preclinical screening. While there are examples of successful translation, mechanistically promising preclinical candidates may unexpectedly fail during clinical trials because the preclinical models may not recapitulate the particular human pain condition being addressed. Molecular target characterization can diminish the disconnect between preclinical and humans' targets, which should assist in developing nonaddictive analgesics.

Project description:IntroductionGlobally, the rate of opioid prescription is high for chronic musculoskeletal conditions despite guidelines recommending against their use as their adverse effects outweigh their modest benefit. Deprescribing opioids is a complex process that can be hindered by multiple prescriber- and patient-related barriers. These include fear of the process of, or outcomes from, weaning medications, or a lack of ongoing support. Thus, involving patients, their carers, and healthcare professionals (HCPs) in the development of consumer materials that can educate and provide support for patients and HCPs over the deprescribing process is critical to ensure that the resources have high readability, usability, and acceptability to the population of interest.ObjectiveThis study aimed to (1) develop two educational consumer leaflets to support opioid tapering in older people with low back pain (LBP) and hip or knee osteoarthritis (HoKOA), and (2) evaluate the perceived usability, acceptability, and credibility of the consumer leaflets from the perspective of consumers and HCPs.DesignThis was an observational survey involving a consumer review panel and an HCP review panel.Participants30 consumers (and/or their carers) and 20 HCPs were included in the study. Consumers were people older than 65 years of age who were currently experiencing LBP or HoKOA, and with no HCP background. Carers were people who provided unpaid care, support, or assistance to an individual meeting the inclusion criteria for consumers. HCPs included physiotherapists (n = 9), pharmacists (n = 7), an orthopaedic surgeon (n = 1), a rheumatologist (n = 1), nurse practitioner (n = 1) and a general practitioner (n = 1), all with at least three years of clinical experience and who reported working closely with this target patient population within the last 12 months.MethodsPrototypes of two educational consumer leaflets (a brochure and a personal plan) were developed by a team of LBP, OA, and geriatric pharmacotherapy researchers and clinicians. The leaflet prototypes were evaluated by two separate chronological review panels involving (1) consumers and/or their carers, and (2) HCPs. Data collection for both panels occurred via an online survey. Outcomes were the perceived usability, acceptability, and credibility of the consumer leaflets. Feedback received from the consumer panel was used to refine the leaflets, before circulating the leaflets for further review by the HCP panel. Additional feedback from the HCP review panel was then used to refine the final versions of the consumer leaflets.ResultsBoth consumers and HCPs perceived the leaflets and personal plan to be usable, acceptable, and credible. Consumers rated the brochure against several categories, which scored between 53 and 97% positive responses. Similarly, the overall feedback provided by HCPs was 85-100% positive. The modified System Usability Scale scores obtained from HCPs was 55-95% positive, indicating excellent usability. Feedback for the personal plan from both HCPs and consumers was largely positive, with consumers providing the highest positive ratings (80-93%). While feedback for HCPs was also high, we did identify that prescribers were hesitant to provide the plan to patients frequently (no positive responses).ConclusionsThis study led to the development of a leaflet and personal plan to support the reduction of opioid use in older people with LBP or HoKOA. The development of the consumer leaflets incorporated feedback provided by HCPs and consumers to maximise clinical effectiveness and future intervention implementation.

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Dataset Information

Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial.

Publications

Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial.

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