Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations

Gewandter, Jennifer S.; Dworkin, Robert H.; Turk, Dennis C.; McDermott, Michael P.; Baron, Ralf; Gastonguay, Marc R.; Gilron, Ian; Katz, Nathaniel; Mehta, Cyrus R.; Raja, Srinivasa N.; Senn, Stephen; Taylor, Clare; Cowan, Penney; Desjardins, Paul J.; Dimitrova, Rozalina; Dionne, Raymond A.; Farrar, John T.; Hewitt, David; Iyengar, Smriti; Jay, Gregory D.; Kalso, Eija; Kerns, Robert D.; Leff, Richard L.; Leong, Michael S.; Petersen, Karin L.; Ravina, Bernard; Rauschkolb, Christine; Rice, Andrew S.C.; Rowbotham, Michael C.; Sampaio, Cristina; Sindrup, Søren Hein; Stauffer, Joseph W.; Steigerwald, Ilona; Stewart, Jerry E.; Tobias, Jeffrey; Treede, Rolf‐Detlef; Wallace, Mark; White, Richard E.

doi:10.1016/j.pain.2014.05.025

Cited by 103 publications

(99 citation statements)

References 119 publications

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“…Treatment efficacy was quantified by calculating absolute differences and percentage change from baseline in both NPRS score and PTA. For each patient, a response was considered clinically relevant if the NPRS score was reduced by at least 30% relative to baseline [6,[8][9][10]. Mean and median statistics (with 95% CI) were computed for percentage change and absolute change.…”

Section: Discussionmentioning

confidence: 99%

Efficacy Analysis of Capsaicin 8% Patch in Neuropathic Peripheral Pain Treatment

et al. 2018

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Background/Aims: Several guidelines for neuropathic pain management and various effective drugs are available; however, neuropathic pain remains undertreated. This retrospective study aimed to evaluate the efficacy of topical capsaicin 8% in peripheral neuropathic pain in a routine clinical setting. Methods: Therapeutic efficacy was evaluated through pain intensity, using numerical pain rating scale at baseline and 7–14 days after each treatment, and using pain treatment area (PTA) assessed immediately before each treatment. Results: A total of 43 patients with either post-herpetic neuralgia or post-traumatic/post-surgical neuropathic pain were enrolled. The median percentage reduction in numerical pain rating scale score and in PTA was –40.0 (–50.0 to –33.3; 95% CI, bootstrap) and –35.1 (–50.9 to 3.4; 95% CI, bootstrap), respectively. Pain intensity and PTA were equally improved and reduced in both treated conditions. Conclusion: This study suggests that topical capsaicin 8% reduces peripheral neuropathic pain as well as treatment pain area.

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Section: Discussionmentioning

confidence: 99%

Efficacy Analysis of Capsaicin 8% Patch in Neuropathic Peripheral Pain Treatment

et al. 2018

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“…It is noted that placebo effects are typically large in trials of intra-articular therapies 38 , and the use of an active control may have further inflated the reported therapeutic effect 39,40 . However, this inflation of patient expectation was applicable to both arms and did not confound differentiation of the 40-mg FX006 dose from immediate-release triamcinolone acetonide.…”

Section: Discussionmentioning

confidence: 99%

An Intra-Articular, Extended-Release Formulation of Triamcinolone Acetonide Prolongs and Amplifies Analgesic Effect in Patients with Osteoarthritis of the Knee

Bodick

Lufkin

Willwerth

et al. 2015

The Journal of Bone and Joint Surgery

105

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“…The outcome of clinical trials in pain is strongly affected by the type of pain being treated, study design, patient population, and many related factors (Gewandter et al, 2014). Whereas preclinical studies are typically conducted in a genetically and environmentally (usually unenriched) uniform population of often young (and male) rodents, human populations enrolled in clinical pain trials tend to be older and of both sexes and are invariably more heterogeneous.…”

Section: Reconciling Preclinical and Clinical Studiesmentioning

confidence: 99%

CB₂Cannabinoid Receptors as a Therapeutic Target—What Does the Future Hold?

2014

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The past decades have seen an exponential rise in our understanding of the endocannabinoid system, comprising CB 1 and CB 2 cannabinoid receptors, endogenous cannabinoids (endocannabinoids), and the enzymes that synthesize and degrade endocannabinoids. The primary focus of this review is the CB 2 receptor. CB 2 receptors have been the subject of considerable attention, primarily due to their promising therapeutic potential for treating various pathologies while avoiding the adverse psychotropic effects that can accompany CB 1 receptor-based therapies. With the appreciation that CB 2 -selective ligands show marked functional selectivity, there is a renewed opportunity to explore this promising area of research from both a mechanistic as well as a therapeutic perspective. In this review, we summarize our present knowledge of CB 2 receptor signaling, localization, and regulation. We discuss the availability of genetic tools (and their limitations) to study CB 2 receptors and also provide an update on preclinical data on CB 2 agonists in pain models. Finally, we suggest possible reasons for the failure of CB 2 ligands in clinical pain trials and offer possible ways to move the field forward in a way that can help reconcile the inconsistencies between preclinical and clinical data.

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Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations

Cited by 103 publications

References 119 publications

Efficacy Analysis of Capsaicin 8% Patch in Neuropathic Peripheral Pain Treatment

Efficacy Analysis of Capsaicin 8% Patch in Neuropathic Peripheral Pain Treatment

An Intra-Articular, Extended-Release Formulation of Triamcinolone Acetonide Prolongs and Amplifies Analgesic Effect in Patients with Osteoarthritis of the Knee

CB₂Cannabinoid Receptors as a Therapeutic Target—What Does the Future Hold?

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Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations

Cited by 103 publications

References 119 publications

Efficacy Analysis of Capsaicin 8% Patch in Neuropathic Peripheral Pain Treatment

Efficacy Analysis of Capsaicin 8% Patch in Neuropathic Peripheral Pain Treatment

An Intra-Articular, Extended-Release Formulation of Triamcinolone Acetonide Prolongs and Amplifies Analgesic Effect in Patients with Osteoarthritis of the Knee

CB2Cannabinoid Receptors as a Therapeutic Target—What Does the Future Hold?

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CB₂Cannabinoid Receptors as a Therapeutic Target—What Does the Future Hold?