Gabapentin for sub-acute radicular leg pain (GABARAD)

Conditions

radicular leg pain

Brief summary

Change in average leg pain intensity (measured on a numeric rating scale (NRS) from 0 to 10 over the last 24 hours) from baseline to week 6, based on least squares means and standard errors derived from the primary repeated measures mixed linear model, adjusted for baseline values.

Detailed description

Change from baseline to the 6 weeks assessment in aA (NRS - at 1, 2, 4 weeks)maximal leg pain, average back NRS pain and changes in NRS pain last 24 hours, pain related disability (ODIswestry), general health, (all 1, 2, 4, 6 weeks) with least squares means and standard errors derived estimates derived from the main repeated measures mixed linear model, adjusted for baseline values., Change in work status during the 6 week treatment period compared between Gabapentin and placebo., Occurence of AEs and SAEs in Gabapentin compared to placebo, Intake of other analgesics compared between the Gabapentin and placebo group during a 6 weeks treatment period.

Related papers

No related papers found yet.

Interventions

DRUGGabapentin ”Orifarm”

DRUGhårde kapsler

DRUGGELATIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in average leg pain intensity (measured on a numeric rating scale (NRS) from 0 to 10 over the last 24 hours) from baseline to week 6, based on least squares means and standard errors derived from the primary repeated measures mixed linear model, adjusted for baseline values.	—

Secondary

Measure	Time frame
Change from baseline to the 6 weeks assessment in aA (NRS - at 1, 2, 4 weeks)maximal leg pain, average back NRS pain and changes in NRS pain last 24 hours, pain related disability (ODIswestry), general health, (all 1, 2, 4, 6 weeks) with least squares means and standard errors derived estimates derived from the main repeated measures mixed linear model, adjusted for baseline values., Change in work status during the 6 week treatment period compared between Gabapentin and placebo., Occurence of AEs and SAEs in Gabapentin compared to placebo, Intake of other analgesics compared between the Gabapentin and placebo group during a 6 weeks treatment period.	—

Measure

Time frame

Change from baseline to the 6 weeks assessment in aA (NRS - at 1, 2, 4 weeks)maximal leg pain, average back NRS pain and changes in NRS pain last 24 hours, pain related disability (ODIswestry), general health, (all 1, 2, 4, 6 weeks) with least squares means and standard errors derived estimates derived from the main repeated measures mixed linear model, adjusted for baseline values., Change in work status during the 6 week treatment period compared between Gabapentin and placebo., Occurence of AEs and SAEs in Gabapentin compared to placebo, Intake of other analgesics compared between the Gabapentin and placebo group during a 6 weeks treatment period.

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Countries

Denmark

Outcome results

None listed