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TRAUMEEL S in Reducing Pain After Correction of Hallux Valgus-Clinical Trial
This study is currently recruiting participants.
Study NCT00279513   Information provided by Shaare Zedek Medical Center
First Received: January 9, 2006   Last Updated: September 30, 2007   History of Changes

January 9, 2006
September 30, 2007
September 2006
 
Pain
Same as current
Complete list of historical versions of study NCT00279513 on ClinicalTrials.gov Archive Site
  • Analgesics consumed
  • Days of "rescue" analgesic use
  • Area of redness
  • The safety treatment
Same as current
 
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

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.

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Post Hallux Valgus Repair Pain
Drug: Traumeel S
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
 
 
 

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.

Both
18 Years and older
No
Contact: Menachem Oberbaum, M.D. 972-2-6666395 oberbaum@szmc.org.il
Israel
 
NCT00279513
 
HV-2006
Shaare Zedek Medical Center
 
Principal Investigator: Menachem Oberbaum, M.D. Shaare Zedek Medical Center, Jerusalem, Israel
Shaare Zedek Medical Center
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP