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

NCT00279513 | Completed Phase 3

• 1 other identifier: HV-2006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Hallux Valgus Repair Pain

Keywords

homeopathy; hallux valgus; pain; traumeel s

Outcome Measures

Primary Outcomes (1)

• Pain

Secondary Outcomes (4)

• Analgesics consumed

• Days of "rescue" analgesic use

• Area of redness

• The safety treatment

Interventions

Traumeel S DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Dept. of Orthopedic Surgery, Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Related Publications (1)

• Singer SR, Amit-Kohn M, Weiss S, Rosenblum J, Maoz G, Samuels N, Lukasiewicz E, Freedman L, Paltiel O, Itzchaki M, Niska M, Oberbaum M. Traumeel S for pain relief following hallux valgus surgery: a randomized controlled trial. BMC Clin Pharmacol. 2010 Apr 12;10:9. doi: 10.1186/1472-6904-10-9.

  PMID: 20380750 DERIVED

MeSH Terms

Conditions

Hallux Valgus; Pain

Interventions

Traumeel S

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Menachem Oberbaum, M.D.

  Shaare Zedek Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 9, 2006
• First Posted: January 19, 2006
• Study Start: September 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 5, 2011

Record last verified: 2011-04

Locations

IL (1)