NCT00279513

TRAUMEEL S in Reducing Pain After Correction of Hallux Valgus-Clinical Trial

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Hallux Valgus Repair Pain

Interventions

Type	Name	Description
DRUG	Traumeel S

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-01-19
• Last updated: 2011-04-05

Locations

1 site across 1 country: Israel