Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty
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|ClinicalTrials.gov Identifier: NCT00222365|
Recruitment Status : Terminated
First Posted : September 22, 2005
Last Update Posted : November 14, 2006
This is an add-on, double blind, and randomised clinical trial with three groups: a homeopathic group, a placebo group, and a temporal control group.
The aim of this trial is to assess the effect of homeopathy on the consumption of morphine delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Arnica montana, 5 CH Drug: Bryonia alba, 5 CH Drug: Hypericum perforatum, 5 CH Drug: Ruta graveolens, 3 DH||Phase 3|
We test the effectiveness of an homeopathic drug versus placebo and a temporal control group (patient with no add-on treatment) following orthopedic knee surgery.
All patients have a PCA of morphine for 24 hours after surgery. After this period they can take an oral tablet of morphine on request.
Group A: Patients with study treatment (homeopathy) allocation. Double blind group with 70 patients
Group B: Patients with placebo allocation. Double blind group with 70 patients
Group C: Temporal control group with patients who take only the morphine. Open group with 25 patients
The total power: 70 +70 + 25 = 165 patients
- To assess the effect of homeopathy in terms of morphine consumption delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.
- To assess the effect of homeopathy in terms of total morphine consumption between H24 and H72 after a knee ligamentoplasty.
- To assess the effect of homeopathy on the pain perception using a analogical visual scale for 72 hours.
- To asses the placebo effect of the homeopathic treatment.
Main Assessment Criterion:
- Morphine consumption delivered by PCA between 0 and 24 hours after knee ligamentoplasty
Secondary Assessment Criteria:
- Morphine consumption between 0 and 72 hours after ligamentoplasty
- Pain assessment at H0, H4, H24 and H72 using 10 cm Analogical Visual Scale
- age ranging from 18 to 60.
- patients candidates for a ligamentoplasty of the anterior cruciate ligament.
- patient with corticoid and immunodepressor treatment
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty|
|Study Start Date :||December 2003|
|Study Completion Date :||May 2006|
- Morphine consumption delivered by PCA between 0 and 24 hours after a knee ligamentoplasty
- Morphine consumption between 0 and 72 hours after the ligamentoplasty
- Pain assessment at hour 0 (H0), H4, H24 and H72 with 10 cm Analogical Visual Scale
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 ClinicalTrials.gov identifier (NCT number): NCT00222365
|University Hospital of Grenoble|
|Grenoble, France, 38043|
|Principal Investigator:||CRACOWSKI Jean-Luc, Dr||Clinical Trial Center|