Post Hallux Valgus Repair PainPhase 3NCT00279513
TRAUMEEL S in Reducing Pain After Correction of Hallux Valgus-Clinical Trial
A Phase 3 study testing Traumeel S in people with Post Hallux Valgus Repair Pain, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Hallux Valgus Repair Pain
- What is being tested?
- Traumeel S
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Sep 2006to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
Jerusalem, 91031
About this study
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
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
- Being tested
- Traumeel S
- Keywords
- homeopathy, hallux valgus, pain, traumeel s
- Medical subject headings
- Hallux Valgus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traumeel SDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Secondary outcomes (4)
Analgesics consumed
Days of "rescue" analgesic use
Area of redness
The safety treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Hallux Valgus Repair PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Menachem Oberbaum, M.D., Principal investigator, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279513
- Sponsor's protocol ID
- HV-2006
- Status last verified
- Apr 2011
- First submitted
- 9 Jan 2006
- Last updated
- 5 Apr 2011
- Results posted
- No
Publications
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.
PubMed 20380750
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00279513
- Acronym / sponsor ID
- HV-2006
- Conditions
- Post Hallux Valgus Repair Pain
- Keywords
- homeopathy, hallux valgus, pain, traumeel s
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 19 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traumeel S | Drug | – |
Primary outcome
Pain
4 secondary outcomes
Analgesics consumed
Days of "rescue" analgesic use
Area of redness
The safety treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2011.
- Derived from this study: PubMed 20380750Singer 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menachem Oberbaum, M.D. principal investigator
Shaare Zedek Medical Center, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Traumeel S in people with Post Hallux Valgus Repair Pain, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00279513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2011.