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

Phase 3

Completed

• Conditions: Post Hallux Valgus Repair Pain

• Registration Number: NCT00279513
• Lead Sponsor: Shaare Zedek Medical Center

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 Description

Not available

Study Timeline

• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-17
• Study First Posted: 2006-01-19
• Study Start: 2006-09
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-03
• Last Update Posted: 2011-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients of either sex undergoing unilateral surgical correction of Hallux Valgus.

Age over 18 years. Signature upon informed consent form. Meeting none of exclusion criteria.

Exclusion criteria Participation in another clinical trial within 4 weeks prior to enrollment. Inability to comply with the study protocol. Previous surgical Hallux Valgus correction on ipsilateral foot. Current use of analgesia for any other reason.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain

Secondary Outcome Measures

Name	Time	Method
Analgesics consumed
Days of "rescue" analgesic use
Area of redness
The safety treatment

Trial Locations

Locations (1)

Dept. of Orthopedic Surgery, Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel