Individuals with diabetic peripheral neuropathy were unable to use a "new" strategy gait pattern to reduce peak plantar pressures long term (1 week). The use of visual feedback following the trial did not assist in the learning of a new walking pattern.

BackgroundIncreasing experimental and clinical evidence suggests that illumination of the skin with relatively low intensity light may lead to therapeutic results such as reduced pain or improved wound healing. The goal of this study was to evaluate prospectively whether socks made from polyethylene terephthalate (PET) incorporating optically active particles (Celliant™) ameliorates chronic foot pain resulting from diabetic neuropathy or other disorders. Such optically modified fiber is thought to modify the illumination of the skin in the visible and infrared portions of the spectrum, and consequently reduce pain.MethodsA double-blind, randomized trial with 55 subjects (38 men, 17 women) enrolled (average age 59.7 ± 11.9 years), 26 with diabetic neuropathy and 29 with other pain etiologies. Subjects twice completed the Visual Analogue Scale (VAS), Brief Pain Inventory (BPI), McGill Pain Questionnaire (MPQ), and SF-36 a week apart (W1+2) before receiving either control or Celliant™ socks. The same questionnaires were answered again one and two weeks (W3+4) later. The questionnaires provided nine scores for analyzing pain reduction: one VAS score, two BPI scores, five MPQ scores, and the bodily pain score on the SF-36. Mean W1+2 and W3+4 scores were compared to measure pain reduction.ResultsMore pain reduction was reported by Celliant™ subjects for 8 of the 9 pain questions employed, with a significant (p = 0.043) difference between controls and Celliant™ for McGill question III. In neuropathic subjects, Celliant™ caused more pain reduction in 6 of the 9 questions, but not significantly. In non-neuropathic subjects 8 of 9 questions showed more pain reduction with the Celliant™ socks.ConclusionSocks with optically modified PET (Celliant™) appear to have a beneficial impact on chronic foot pain. The mechanism could be related to the effects seen with illumination of tissues with visible and infrared light.Trial RegistrationClinicalTrials.gov NCT00458497

OBJECTIVE Assess the efficacy of Farabloc for treating chronic phantom limb pain (PLP). DESIGN Randomized, double-blind, placebo controlled trial. SETTING VA Long Beach Healthcare System Outpatient Amputee Clinic. PARTICIPANTS We randomized 57 subjects into two groups: true Farabloc (n=30) and sham Farabloc (n=27). Inclusion criteria included age ≥ 18 years, upper or lower extremity amputation with healed stump, and ≥ 3 episodes of PLP during previous 6 weeks. INTERVENTIONS Subjects received two true or sham Farabloc limb covers to be worn over the prosthesis and stumps 24 hours/day for 12 weeks. MAIN OUTCOME MEASURES Primary outcome measure was the numerical pain rating scale of PLP level (0-10). Secondary outcomes included overall pain level (0-10), PLP frequency/week, and the Veterans RAND 12-Item Health Survey (VR-12). We collected data at baseline, 6-week, and 12-week follow-up visits. RESULTS Demographic and clinical characteristics were not significantly different between groups. The true Farabloc group reported non-significant reductions in PLP from 5.9 (SD = 1.9) at baseline to 3.9 (SD = 1.7) at the 12-week follow-up. The sham Farabloc group also had non-significant reducations in PLP from 6.5 (SD = 1.8) to 4.2 (SD = 2.3). PLP did not differ significantly between the two groups at 6 weeks (mean difference, +0.8 [95% confidence intervals (CI), −1.4 to 3]) or at 12 weeks (mean difference, +0.2 [ 95% CI −1.9 to 2.3]). Similarly, overall pain level, PLP episodes/week, and VR-12 physical and mental health component scores did not differ between two groups at 6 weeks and 12 weeks. CONCLUSIONS True Farabloc did not significantly decrease PLP levels or frequency of PLP episodes/week, overall bodily pain levels, or VR-12 physical and mental health component scores compared with sham Farabloc in our Veteran amputee sample.

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