Pregabalin versus placebo to prevent chronic pain after whiplash injury in at-risk individuals: results of a feasibility study for a large randomised controlled trial

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Author(s)
Nikles, Jane
Keijzers, Gerben
Mitchell, Geoffrey
Farrell, Scott F
Perez, Siegfried
Schug, Stephan
Ware, Robert S
McLean, Samuel A
Connelly, Luke B
Sterling, Michele
Griffith University Author(s)
Year published
2022
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There are few effective treatments for acute whiplash-associated disorders (WAD). Early features of central sensitisation predict poor recovery. The effect of pregabalin on central sensitisation might prevent chronic pain after acute whiplash injury. This double blind, placebo-controlled randomised controlled trial (RCT) examined feasibility and potential effectiveness of pregabalin compared to placebo for people with acute WAD. Twenty-four participants with acute WAD (<48 hours) and at risk of poor recovery (pain ≥ 5/10) were recruited from hospital Emergency Departments in Queensland, Australia and randomly assigned by ...
View more >There are few effective treatments for acute whiplash-associated disorders (WAD). Early features of central sensitisation predict poor recovery. The effect of pregabalin on central sensitisation might prevent chronic pain after acute whiplash injury. This double blind, placebo-controlled randomised controlled trial (RCT) examined feasibility and potential effectiveness of pregabalin compared to placebo for people with acute WAD. Twenty-four participants with acute WAD (<48 hours) and at risk of poor recovery (pain ≥ 5/10) were recruited from hospital Emergency Departments in Queensland, Australia and randomly assigned by concealed allocation to either pregabalin (n=10) or placebo (n=14). Pregabalin was commenced at 75 mg bd, titrated to 300 mg bd for 4 weeks, and then weaned over 1 week. Participants were assessed at 5 weeks, 3, 6 and 12 months. Feasibility issues included recruitment difficulties and greater attrition in the placebo group. For the primary clinical outcome of neck pain intensity, attrition at 5 weeks was: pregabalin: 10%, placebo: 36%, and at 12 months was: pregabalin: 10%, placebo: 43%. Pregabalin may be more effective than placebo for the primary clinical outcome of neck pain intensity at 3 months [Mean Difference: -4.0 (95% CI -6.2 to -1.7)] on an eleven point numerical rating scale. Effects were maintained at 6 but not 12 months. There were no serious adverse events. Minor adverse events were more common in the pregabalin group. A definitive large RCT of pregabalin for acute whiplash injury is warranted. Feasibility issues would need to be addressed with modifications to the protocol.
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View more >There are few effective treatments for acute whiplash-associated disorders (WAD). Early features of central sensitisation predict poor recovery. The effect of pregabalin on central sensitisation might prevent chronic pain after acute whiplash injury. This double blind, placebo-controlled randomised controlled trial (RCT) examined feasibility and potential effectiveness of pregabalin compared to placebo for people with acute WAD. Twenty-four participants with acute WAD (<48 hours) and at risk of poor recovery (pain ≥ 5/10) were recruited from hospital Emergency Departments in Queensland, Australia and randomly assigned by concealed allocation to either pregabalin (n=10) or placebo (n=14). Pregabalin was commenced at 75 mg bd, titrated to 300 mg bd for 4 weeks, and then weaned over 1 week. Participants were assessed at 5 weeks, 3, 6 and 12 months. Feasibility issues included recruitment difficulties and greater attrition in the placebo group. For the primary clinical outcome of neck pain intensity, attrition at 5 weeks was: pregabalin: 10%, placebo: 36%, and at 12 months was: pregabalin: 10%, placebo: 43%. Pregabalin may be more effective than placebo for the primary clinical outcome of neck pain intensity at 3 months [Mean Difference: -4.0 (95% CI -6.2 to -1.7)] on an eleven point numerical rating scale. Effects were maintained at 6 but not 12 months. There were no serious adverse events. Minor adverse events were more common in the pregabalin group. A definitive large RCT of pregabalin for acute whiplash injury is warranted. Feasibility issues would need to be addressed with modifications to the protocol.
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Journal Title
Pain
Volume
163
Issue
2
Copyright Statement
© 2022 LWW. This is a non-final version of an article published in final form in Pain 163 (2), pp. e274-e284, 2021. Reproduced in accordance with the copyright policy of the publisher. Please refer to the journal link for access to the definitive, published version.
Subject
Biomedical and clinical sciences
Psychology