TRAUMEEL S in Reducing Pain After Correction of Hallux Valgus-Clinical Trial
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
Hallux valgus is a common deformity of the big toe, defined as medial deflection of the first
metatarsal bone along with lateral deflection of the first toe. Surgery has been shown to be
beneficial when compared to orthoses or no treatment. While generally effective, surgery
entails significant post-operative pain, inflammation and edema, and several weeks of limited
mobility. This will be a double-blind, randomized, placebo-controlled study comparing the
homeopathic drug Traumeel S with placebo in pain reduction after surgical Hallux valgus
correction.
80 patients, over the age of 18 years, undergoing surgical correction of unilateral hallux
valgus will be enrolled in the trial. The patients will be randomized to two groups, one
receiving oral Traumeel S and the other oral placebo tablets. Patients will take active or
placebo medication for 13 days or until they have a NRS score of 3 or less for 2 consecutive
days. Pain will be reported daily by the patient on the patient diary, using an 11-point
numerical rating score (NRS-11) during 13 days post-operatively. They will also be asked to
report daily consumption of primary and "rescue" analgesics for 13 days post-operatively.
Patients will be contacted daily by the research assistant to encourage compliance and to
record their daily NRS and analgesic consumption in the CRF. Patients will be evaluated by
physicians at six and 13 days postoperatively for redness and compliance.