A Randomized, Single-Blind, Controlled, Parallel Assignment Study of Exercise Versus Education as Adjuvant in the Treatment of Peripheral Neuropathic Pain

OBJECTIVE:Some forms of chronic pain are receptive to exercise therapy for maintenance of pain relief. We evaluated the impact of a balanced exercise program in the management of human peripheral neuropathic pain compared with an educational intervention. METHODS:This was a single-center, randomized, single-blind, controlled study using an intention-to-treat protocol. Patients with confirmed neuropathic pain and a pain score ≥4 (0 to 10 scale) on visual analog scale (VAS) continued their regular pain therapies and were randomized to 6 months of either a balanced exercise program or an educational program. VAS for pain severity was the primary outcome variable. Characteristics of pain, function, mood, anxiety, sleep, and quality of life along with Single Stage Treadmill Walking Test calculating maximal oxygen consumption (VO2) formed the secondary outcome measures. RESULTS:Seventy-eight patients were screened and 54 participated, with 28 randomized to exercise and 26 randomized to education. A total of 19 (68%) and 20 patients (77%) completed exercise and education, respectively. VAS scores improved 17% for the exercise group as compared with 9% for the education group (P=0.08). The only secondary outcome measure demonstrating improvement was VO2, which improved in exercise participants (25.6±4.5 mL/kg/min at baseline vs. 28.9±3.8 mL/kg/min at 6 mo). DISCUSSION:A balanced exercise program was beneficial for exercise capacity, but produced only a medium-sized effect without statistical significance. A small sample size and unexpectedly high dropout rates may have limited our ability to demonstrate statistically significant improvement in pain relief.