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:Traditional Chinese medication (TCM) has analgesic and anti-inflammatory effects in patients with knee osteoarthritis (OA). We conducted the first systematic review of the best quantitative and qualitative evidence currently available in order to evaluate the effectiveness of TCM in relieving pain in knee OA. A comprehensive literature search was conducted using three English and four Chinese biomedical databases from their inception through March 1, 2015. We included randomized controlled trials of TCM for knee OA with intervention durations of at least two weeks. The effects of TCM on pain and other clinical symptoms were measured with the visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total effectiveness rate, which was used to assess overall pain, physical performance and wellness, was also measured. Two researchers independently extracted data on study design, population characteristics, duration, intervention, outcomes, risk of bias, and primary results. We performed a random-effects meta-analysis when appropriate. We also explored factors that could explain the heterogeneity by conducting subgroup and meta-regression analyses. Twenty-three studies, totaling 2362 subjects, met the eligibility criteria. Treatments were formulated with an average of 8 Chinese herbs and were prescribed based on the traditional Chinese diagnostic method of syndrome differentiation. The mean treatment duration was seven weeks, with oral administration occurring one to three times a day. Compared with non-steroidal anti-inflammatory drugs and intra-articular hyaluronate injections, 18 of the studies showed significantly improved VAS pain scores (Mean Difference [MD] [Formula: see text] 0.56; 95% confidence interval [CI], 0.18 to 0.94; [Formula: see text]), six of the studies showed significantly improved WOMAC pain subscale scores (MD [Formula: see text] 2.23; 95% CI, 0.56 to 3.91; [Formula: see text]), and 16 of the trials showed significantly improved total effectiveness rates (risk ratio [Formula: see text] 1.12; 95% CI, 1.05 to 1.19; [Formula: see text] 0.0003). In addition, TCM showed a lower risk of adverse events than standard western treatments. This evidence suggests that TCM is safe and effective for improving pain, function, and wellness in treatments of knee OA. However, there is inherent clinical heterogeneity (diverse TCM formulations, controls, and treatment regimens) among the included trials. Despite these limitations, the potential analgesic effects of TCM warrant further methodologically rigorous research to determine the clinical implications of TCM on pain management in knee OA.

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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