Post Hallux Valgus Repair Pain Clinical Trial
Official title:
A Randomised, Double- Blind, Placebo Controlled, Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Reducing Pain After Surgical Correction of Hallux Valgus
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment