Post Hallux Valgus Repair Pain Clinical Trial
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
| Verified date | April 2011 |
| Source | Shaare Zedek Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | December 2007 |
| Est. primary completion date | December 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Dept. of Orthopedic Surgery, Shaare Zedek Medical Center | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Shaare Zedek Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain | |||
| Secondary | Analgesics consumed | |||
| Secondary | Days of "rescue" analgesic use | |||
| Secondary | Area of redness | |||
| Secondary | The safety treatment |