Danish Pain Research Center starts study of palmitoylethanolamide in Spinal Cord Injury Neuropathic Pain

spinal cord vascularisation

spinal cord vascularisation

The Danish Pain Research Center starts in 2013 a special study of the efficacy of palmitoylethanolamide in spinal injury. The study however is small, only 80 patients will be entered. Furthermore, the study design is flawed, as only 1 dose of PEA has been selected, while there has never been conducted a dose-finding study in the indication (post SCI pain).

Outcome parameters:

Primary Outcome Measures:

  • Change in mean pain intensity on a 0-10 numerical rating scale from baseline week to last week of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:

  • Spasticity/spasms and sleep disturbance, change in mean score from baseline to last week of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Modified Tardieu and clonus over ankle joints [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Spasticity and spasms on a 0-10 NRS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Health related quality of life S-TOPS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Global Impression of Change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pain relief of overall pain and at-and below level pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • allodynia(touch and cold) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pain symptoms evaluated by NPSI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • pain impact on activities, sleep and mood [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • effect on unpleasantness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • escape medication [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Insomnia Severity Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • anxiety(GAD-10) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • depression(MDI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • NNT for 33% and 50% pain reduction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Combined spasticity and pain score (CPSS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Numbers of responders (33% pain reduction) in those with and without allodynia/hyperalgesia and those with different pain symptoms (NPSI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Time period of study:

Start Date: May 2013

Estimated Study Completion Date: April 2015

Estimated Primary Completion Date: February 2015

Study design: Randomized, double-blinded, placebo-controlled, parallel, multi-center study of

PEA with a week of baseline period followed by 1 x 12 weeks treatment period.

Treatment: Given palmitoylethanolamide 600mg x 2 daily or corresponding placebo and kept on that dose for 12 weeks.

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