Assessment of Pain and Activity Using an Electronic Pain Diary and Actigraphy Device in a Randomized, Placebo‐Controlled Crossover Trial of Celecoxib in Osteoarthritis of the Knee

Trudeau, Jeremiah; Inwegen, Richard Van; Eaton, Thomas A.; Bhat, Gajanan S.; Paillard, Florence; Ng, Dik; Tan, Keith; Katz, Nathaniel

doi:10.1111/papr.12167

Cited by 33 publications

(29 citation statements)

References 16 publications

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“…This measure could therefore represent a more reliable measure of the analgesic effect. A recent randomized, placebo‐controlled, crossover study of celecoxib in 63 patients (47 completers) showed that a responder (defined as a patient who had a 20% improvement in pain [numerical rating scale] or 10% improvement in activity [WOMAC function scale or actigraphy]) yielded larger differences between celecoxib and placebo 23. Although actigraphy was found to be more responsive than WOMAC, it would have been interesting to examine this composite approach in the current study.…”

Section: Discussionmentioning

confidence: 91%

Efficacy and safety of nonsteroidal anti‐inflammatory drugs in Asian patients with knee osteoarthritis: summary of a randomized, placebo‐controlled study

et al. 2015

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AimTo compare the efficacy, tolerability and safety of celecoxib, naproxen and placebo in Asian patients with osteoarthritis (OA) of the knee.MethodPatients of Asian descent with knee OA, aged ≥ 45 years, in a flare state with a functional capacity classification of I–III, received celecoxib 200 mg once daily, naproxen 500 mg twice daily or placebo, for 6 weeks. The change in Patient's Assessment of Arthritis Pain (week 6 vs. baseline) was the primary endpoint. Secondary endpoints, including Patient's and Physician's Global Assessments of Arthritis, Western Ontario and McMaster Universities OA Index (WOMAC), use of complementary and alternative medicines, incidence of treatment‐emergent adverse events (TEAEs) and measurements of upper gastrointestinal tolerability, were also assessed.ResultsThree hundred and sixty‐seven patients were randomized: 145 to celecoxib, 144 to naproxen and 78 to placebo. Celecoxib was as effective as naproxen in reducing OA pain (least squares mean change from baseline in visual analogue scale score [standard error] −37.1 [2.0] for celecoxib and −37.5 [2.0] for naproxen). Patient's and Physician's Global Assessment of Arthritis, WOMAC scores, Pain Satisfaction Scale and Patient Health Questionnaire‐9 showed statistically significant improvement in active treatment groups versus placebo, with the exception of naproxen WOMAC scores. Treatment‐related TEAEs occurred in 19 (13%), 34 (24%) and six (8%) patients in the celecoxib, naproxen and placebo groups, respectively.ConclusionCelecoxib and naproxen were comparable in their effects to reduce the signs and symptoms of knee OA in Asian patients. Celecoxib was shown to be safe and well tolerated in this patient population.

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Section: Discussionmentioning

confidence: 91%

Efficacy and safety of nonsteroidal anti‐inflammatory drugs in Asian patients with knee osteoarthritis: summary of a randomized, placebo‐controlled study

et al. 2015

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“…15 Another study used actigraphy to evaluate treatment-induced reduction of itchrelated sleep disruption in atopic dermatitis. Other studies have successfully employed actigraphy to assess similar endpoints.…”

Section: Discussionmentioning

confidence: 99%

“…14,15 In actigraphy, wearable digital sensors called accelerometers measure the accelerations of the device in motion along reference axes. 14,15 In actigraphy, wearable digital sensors called accelerometers measure the accelerations of the device in motion along reference axes.…”

Section: Activity Assessmentsmentioning

confidence: 99%

Activity Sensors to Evaluate the Effect of Sacubitril/Valsartan on Quality‐of‐Life in Heart Failure: rational and design of the AWAKE‐HF study

et al. 2019

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Aims Limited data are available regarding the ability of sacubitril/valsartan to provide clinically meaningful health-related quality of life (HRQoL) improvements among individuals with heart failure (HF). Objective measurement of physical activity and sleep using actigraphy can provide insight into daily functioning and HRQoL. Methods and resultsWe designed an 18 week, multicenter, randomized, double-blind, double-dummy, parallel-group study to objectively assess changes in function and HRQoL directly after initiating sacubitril/valsartan vs. enalapril in participants with HF in their home environments. A total of 136 outpatient, ambulatory participants with New York Heart Association Class II or III HF with reduced ejection fraction (HFrEF) will be included in the study. Patients will undergo a 2 week baseline observational phase (continuing current HF treatment); data from the second week of this phase will be the baseline value for comparison with those of subsequent periods. Patients will then enter an 8 week blinded-treatment phase (randomly assigned 1:1 to sacubitril/valsartan or enalapril), followed by an 8 week open-label extension phase (treatment with only sacubitril/valsartan). The primary efficacy endpoint is the change in mean activity counts during the most active 30 min of the participant's day between baseline and the final randomized treatment phase measurement. Secondary endpoints include the change in mean sleep activity during the randomized and open-label phases; questionnaires will also assess HRQoL measures. Rather than analysing pooled actigraphy data, the researchers are considering each participant to be acting as his or her own control. Conclusions This will be the first study to assess the effects of sacubitril/valsartan on objective measures of sleep and activity in individuals with HFrEF within the context of their daily lives. Wearable accelerometer devices will be used to gain insight into how the medication affects physical activity and sleep.

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“…Pain diaries can have both a diagnostic purpose, through helping clinicians and patients characterise the pain and its exacerbating factors, and a therapeutic purpose, helping guide decisions around the efficacy of trialled therapy. 3,4 Increasingly, patients are moving away from paper diaries to electronic diaries due Objective The aim of this study was to find out if Twitter could be used in a research context as a ubiquitous piece of software to record daily pain. Design This study was a feasibility study conducted electronically.…”

Section: Introductionmentioning

confidence: 99%

Twitter: a viable medium for daily pain diaries in chronic orofacial pain?

2015

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Assessment of Pain and Activity Using an Electronic Pain Diary and Actigraphy Device in a Randomized, Placebo‐Controlled Crossover Trial of Celecoxib in Osteoarthritis of the Knee

Abstract: We have identified composite pain-activity measures that are similarly or more responsive than pain-alone measures in patients with OA. Further research is warranted to determine the optimal method for computing these composites.

Cited by 33 publications

References 16 publications

Efficacy and safety of nonsteroidal anti‐inflammatory drugs in Asian patients with knee osteoarthritis: summary of a randomized, placebo‐controlled study

Efficacy and safety of nonsteroidal anti‐inflammatory drugs in Asian patients with knee osteoarthritis: summary of a randomized, placebo‐controlled study

Activity Sensors to Evaluate the Effect of Sacubitril/Valsartan on Quality‐of‐Life in Heart Failure: rational and design of the AWAKE‐HF study

Twitter: a viable medium for daily pain diaries in chronic orofacial pain?

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