Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00279513
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : April 5, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Post Hallux Valgus Repair Pain Drug: Traumeel S Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Hallux Valgus
Study Start Date : September 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Pain

Secondary Outcome Measures :
  1. Analgesics consumed
  2. Days of "rescue" analgesic use
  3. Area of redness
  4. The safety treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00279513

Layout table for location information
Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Layout table for investigator information
Principal Investigator: Menachem Oberbaum, M.D. Shaare Zedek Medical Center, Jerusalem, Israel

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Menachem Oberbaum, MD, Shaare Zedek Medical Center Identifier: NCT00279513     History of Changes
Other Study ID Numbers: HV-2006
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: April 5, 2011
Last Verified: April 2011
Keywords provided by Shaare Zedek Medical Center:
hallux valgus
traumeel s
Additional relevant MeSH terms:
Layout table for MeSH terms
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired