The Effect of Pregabalin on Pain Related to Walking in Patients With Diabetic Peripheral Neuropathy
Condition: Diabetic Peripheral Neuropathy; Nerve Pain
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Neuralgia
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis of this study is that pregabalin, 150 mg bid, will reduce general daytime pain
      in patients diagnosed with diabetic peripheral neuropathy and that it will also reduce the
      level of pain associated with walking. Consequently, it is hypothesized that the reduction in
      pain will result in an increase in the amount of walking they do during the day, improvements
      in their gait, balance, risk of falls and sleep patterns.
    

Detailed description: 
      Pregabalin (LYRICA®) is a potent and specific ligand at the alpha-2-delta subunit of
      voltage-gated calcium channels. It is currently approved for adjunctive therapy for
      neuropathic pain conditions. Patients with diabetic peripheral neuropathy suffer from pain in
      their feet which interferes with their ability to walk which includes less walking, an
      altered gait, and altered balance. At night the peripheral neuropathy also interferes with
      their sleep patterns.The hypothesis of this study is that pregabalin, 150 mg bid, will reduce
      general daytime pain in patients diagnosed with diabetic peripheral neuropathy and that it
      will also reduce the level of pain associated with walking. Consequently, it is hypothesized
      that the reduction in pain will result in an increase in the amount of walking they do during
      the day, improvements in their gait, balance, risk of falls and sleep patterns.Pain and sleep
      quality will be assessed with questionnaires but objective measurements will be used to
      assess gait, balance, daytime activities (including walking) and sleep patterns.

      Statistical Power Calculations were based on the fact that this is a randomized,
      double-blind, placebo-controlled, 2-period crossover study to be conducted at a single site.
      Comparisons will be drawn at baseline, at the completion of each 6 weeks of treatment/placebo
      arm. The study has been powered at 0.80 for a two-tail analysis with a sensitivity to detect
      a 30% delta in pain perception in 40 subjects. From previous studies, the cross-over design
      suggested has achieved significance with 20 patients per group. Forty-four patients will be
      recruited in total. Significance will be established at an alpha level of 0.05. Both
      parametric and non parametric correlations will be carried out between the different
      variables measured and progressive logistic regression to determine the relative
      contributions of pain relief on the primary and secondary variables being measured in the
      study.
    

Intervention name(s): Pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150mg bid; 150mg bid
Other intervention name(s): Lyrica
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Peripheral Neuropathy; Diabetic Pain