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| Tracking Information | |||||
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| First Received Date ICMJE | January 9, 2006 | ||||
| Last Updated Date | September 30, 2007 | ||||
| Start Date ICMJE | September 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Pain | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00279513 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | TRAUMEEL S in Reducing Pain After Correction of Hallux Valgus-Clinical Trial | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Post Hallux Valgus Repair Pain | ||||
| Intervention ICMJE | Drug: Traumeel S | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00279513 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | HV-2006 | ||||
| Study Sponsor ICMJE | Shaare Zedek Medical Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Shaare Zedek Medical Center | ||||
| Verification Date | September 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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