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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Hall

Brief 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.


Detailed Summary:
Sponsor: Shaare Zedek Medical Center

Current Primary Outcome: Pain

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Analgesics consumed
  • Days of "rescue" analgesic use
  • Area of redness
  • The safety treatment


Original Secondary Outcome: Same as current

Information By: Shaare Zedek Medical Center

Dates:
Date Received: January 9, 2006
Date Started: September 2006
Date Completion:
Last Updated: April 3, 2011
Last Verified: April 2011