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Effects of pregabalin on central sensitization in patients with chronic pancreatitis in a randomized, controlled trial.

Bouwense SA, Olesen SS, Drewes AM, Poley JW, van Goor H, Wilder-Smith OH - PLoS ONE (2012)

Bottom Line: During the disease changes in central pain processing, e.g. central sensitization manifest as spreading hyperalgesia, can result from ongoing nociceptive input.The main effect parameter was the change in the sum of all body pain threshold values after three weeks of study treatment versus baseline values between both treatment groups. 64 patients were analyzed.For individual dermatomes, change vs. baseline pain thresholds was significantly greater in pregabalin vs. placebo patients for electric pain detection threshold in C5 (P = 0.005), electric pain tolerance threshold in C5 (P = 0.04) and L1 (P = 0.05), and pressure pain tolerance threshold in T4 (P = 0.004).

View Article: PubMed Central - PubMed

Affiliation: Pain and Nociception Neuroscience Research Group, Department of Surgery, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.

ABSTRACT

Background: Intense abdominal pain is the dominant feature of chronic pancreatitis. During the disease changes in central pain processing, e.g. central sensitization manifest as spreading hyperalgesia, can result from ongoing nociceptive input. The aim of the present study is to evaluate the effect of pregabalin on pain processing in chronic pancreatitis as assessed by quantitative sensory testing (QST).

Methods: This randomized, double-blind, placebo-controlled trial evaluated effects of pregabalin on pain processing. QST was used to quantify pain processing by measuring thresholds to painful electrical and pressure stimulation in six body dermatomes. Descending endogenous pain modulation was quantified using the conditioned pain modulation (CPM) paradigm to elicit a DNIC (diffuse noxious inhibitory controls) response. The main effect parameter was the change in the sum of all body pain threshold values after three weeks of study treatment versus baseline values between both treatment groups.

Results: 64 patients were analyzed. No differences in change in sum of pain thresholds were present for pregabalin vs. placebo after three weeks of treatment. For individual dermatomes, change vs. baseline pain thresholds was significantly greater in pregabalin vs. placebo patients for electric pain detection threshold in C5 (P = 0.005), electric pain tolerance threshold in C5 (P = 0.04) and L1 (P = 0.05), and pressure pain tolerance threshold in T4 (P = 0.004). No differences were observed between pregabalin and placebo regarding conditioned pain modulation.

Conclusion: Our study provides first evidence that pregabalin has moderate inhibitory effects on central sensitization manifest as spreading hyperalgesia in chronic pancreatitis patients. These findings suggest that QST can be of clinical use for monitoring pain treatments in the context of chronic pain.

Trial registration: ClinicalTrials.gov NCT00755573.

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Related in: MedlinePlus

Study enrollment and randomization.The majority of patients not meeting inclusion criteria had passed away, were free of pain or were no longer being treated in either of the hospitals.
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pone-0042096-g002: Study enrollment and randomization.The majority of patients not meeting inclusion criteria had passed away, were free of pain or were no longer being treated in either of the hospitals.

Mentions: From October 2008 to May 2010 a total of 236 patients diagnosed with chronic pancreatitis in the last five years in one of both hospitals were screened and 64 patients were randomized; the study was completed without any incident. The majority of patients not meeting inclusion criteria were free of pain, had passed away or were no longer being treated in either of the hospitals. 64 patients completed the study and were finally analyzed in the intention to treat analysis (Figure 2). The number of patients randomized to pregabalin or placebo treatment was equally distributed between both hospitals. All patients (24 women, 40 men; median age 53 years (IQR (interquartile range) 45–62)) had pain due to chronic pancreatitis and were on a stable analgesic therapy. Their median opioid consumption was 60 mg (IQR 11–150) of morphine equivalents/day. Their median VAS score before start of trial medication was 4 (IQR 2–5) at rest and 5 (IQR 4–7) during activity. Demographic data of the placebo and pregabalin group are provided in Table 1. The healthy control group consisted of 15 volunteers (7 women, 8 men; median age 38 years (IQR 35–49)). Only age was significantly different between the healthy controls and chronic pancreatitis patients (P = 0.0001).


Effects of pregabalin on central sensitization in patients with chronic pancreatitis in a randomized, controlled trial.

Bouwense SA, Olesen SS, Drewes AM, Poley JW, van Goor H, Wilder-Smith OH - PLoS ONE (2012)

Study enrollment and randomization.The majority of patients not meeting inclusion criteria had passed away, were free of pain or were no longer being treated in either of the hospitals.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3412837&req=5

pone-0042096-g002: Study enrollment and randomization.The majority of patients not meeting inclusion criteria had passed away, were free of pain or were no longer being treated in either of the hospitals.
Mentions: From October 2008 to May 2010 a total of 236 patients diagnosed with chronic pancreatitis in the last five years in one of both hospitals were screened and 64 patients were randomized; the study was completed without any incident. The majority of patients not meeting inclusion criteria were free of pain, had passed away or were no longer being treated in either of the hospitals. 64 patients completed the study and were finally analyzed in the intention to treat analysis (Figure 2). The number of patients randomized to pregabalin or placebo treatment was equally distributed between both hospitals. All patients (24 women, 40 men; median age 53 years (IQR (interquartile range) 45–62)) had pain due to chronic pancreatitis and were on a stable analgesic therapy. Their median opioid consumption was 60 mg (IQR 11–150) of morphine equivalents/day. Their median VAS score before start of trial medication was 4 (IQR 2–5) at rest and 5 (IQR 4–7) during activity. Demographic data of the placebo and pregabalin group are provided in Table 1. The healthy control group consisted of 15 volunteers (7 women, 8 men; median age 38 years (IQR 35–49)). Only age was significantly different between the healthy controls and chronic pancreatitis patients (P = 0.0001).

Bottom Line: During the disease changes in central pain processing, e.g. central sensitization manifest as spreading hyperalgesia, can result from ongoing nociceptive input.The main effect parameter was the change in the sum of all body pain threshold values after three weeks of study treatment versus baseline values between both treatment groups. 64 patients were analyzed.For individual dermatomes, change vs. baseline pain thresholds was significantly greater in pregabalin vs. placebo patients for electric pain detection threshold in C5 (P = 0.005), electric pain tolerance threshold in C5 (P = 0.04) and L1 (P = 0.05), and pressure pain tolerance threshold in T4 (P = 0.004).

View Article: PubMed Central - PubMed

Affiliation: Pain and Nociception Neuroscience Research Group, Department of Surgery, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.

ABSTRACT

Background: Intense abdominal pain is the dominant feature of chronic pancreatitis. During the disease changes in central pain processing, e.g. central sensitization manifest as spreading hyperalgesia, can result from ongoing nociceptive input. The aim of the present study is to evaluate the effect of pregabalin on pain processing in chronic pancreatitis as assessed by quantitative sensory testing (QST).

Methods: This randomized, double-blind, placebo-controlled trial evaluated effects of pregabalin on pain processing. QST was used to quantify pain processing by measuring thresholds to painful electrical and pressure stimulation in six body dermatomes. Descending endogenous pain modulation was quantified using the conditioned pain modulation (CPM) paradigm to elicit a DNIC (diffuse noxious inhibitory controls) response. The main effect parameter was the change in the sum of all body pain threshold values after three weeks of study treatment versus baseline values between both treatment groups.

Results: 64 patients were analyzed. No differences in change in sum of pain thresholds were present for pregabalin vs. placebo after three weeks of treatment. For individual dermatomes, change vs. baseline pain thresholds was significantly greater in pregabalin vs. placebo patients for electric pain detection threshold in C5 (P = 0.005), electric pain tolerance threshold in C5 (P = 0.04) and L1 (P = 0.05), and pressure pain tolerance threshold in T4 (P = 0.004). No differences were observed between pregabalin and placebo regarding conditioned pain modulation.

Conclusion: Our study provides first evidence that pregabalin has moderate inhibitory effects on central sensitization manifest as spreading hyperalgesia in chronic pancreatitis patients. These findings suggest that QST can be of clinical use for monitoring pain treatments in the context of chronic pain.

Trial registration: ClinicalTrials.gov NCT00755573.

Show MeSH
Related in: MedlinePlus