Effectiveness of Physical Therapy Plus TIOBEC® (α-Lipoic Acid + Vitamin B, C, and E) on Complex Regional Pain Syndrome (CRPS): A Small Case Series/Pilot Study

Background: Complex regional pain syndrome (CRPS) is a frequent and devastating complication that occurs after trauma and immobilization and is very frequent after wrist fractures (1% - 37%) and after volar locking plate fixation (3% - 10%). The development of CRPS considerably lengthens the time of recovery after a traumatic injury, causing a great impact on work, social activities and psychological well-being. Objectives: To demonstrate the efficacy of physical therapy and TIOBEC® (a combination of α-lipoic acid and vitamin B, C, and E) in terms of pain amelioration and edema reduction in the management of CRPS in a small series of patients. Methods: Prospective before-and-after study. The protocol of treatment included physical therapy (electromagnetic fields applied to the symptomatic limb [20 Hz-50 Gauss-20 min] followed by manual therapy [assisted, active and resisted mobilization plus manual drainage]) plus oral medication (TIOBEC® 400 mg) prescribed twice a day. Components of TIOBEC® included α-lipoic acid (800 mg), vitamin C (60 mg), niacin (36 mg), vitamin E (10 mg), vitamin B1 (25 mg), vitamin B2 (25 mg), vitamin B6 (9.5 mg), vitamin B12 (25 µg) and folic acid (400 µg). Outcome measures included VAS (visual analog scale) pain scale, reduction of edema at the metacarpal phalangeal joint (hand/foot) and functional evaluation (by Kapandji score) before-and-after treatment. Outcome measures were evaluated at baseline and at mid-term (4 months follow-up period). Results: Five patients (mean [SD] age: 61 [7.9]) who had been diagnosed clinically by neurophysiological sympathetic skin-response, gammagraphy, and radiography were recruited in the study. Mean electrotherapy and manual therapy sessions were 40 ± 27.83. Mean oral medication (TIOBEC®) was 84 ± 13.41 days. Physical therapy and TIOBEC® decreased pain from 6.6 ± 0.54 to 2.8 ± 1.3 (P = 0.001), decreased edema from 12 ± 5.7 mm to 4 ± 4.18 mm (P = 0.035) and improved functional Kapandji score from 6.2 ± 2.77 to 9.4 ± 1.34 (P = 0.029). Neither of the patients stopped oral medication nor reported adverse events. Conclusions: The protocol that includes the electromagnetic field, manual therapy, and TIOBEC® may be safely used in patients with CRPS in an attempt to ameliorate pain, to reduce edema and to improve function. In light of the results of this study, the protocol used might accelerate recovery time. More studies are needed to corroborate the present results observed in this pilot study.