Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty
NCT ID: NCT00222365
Last Updated: 2006-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
165 participants
INTERVENTIONAL
2003-12-31
2006-05-31
Brief Summary
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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.
Detailed Description
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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
Main Objective:
* To assess the effect of homeopathy in terms of morphine consumption delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.
Secondary Objectives:
* 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
Inclusion Criteria:
* age ranging from 18 to 60.
* patients candidates for a ligamentoplasty of the anterior cruciate ligament.
Exclusion Criteria:
* patient with corticoid and immunodepressor treatment
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Arnica montana, 5 CH
Bryonia alba, 5 CH
Hypericum perforatum, 5 CH
Ruta graveolens, 3 DH
Eligibility Criteria
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Inclusion Criteria
* Patients who are candidates for a ligamentoplasty of the anterior cruciate ligament.
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Principal Investigators
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CRACOWSKI Jean-Luc, Dr
Role: PRINCIPAL_INVESTIGATOR
Clinical Trial Center
Locations
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University Hospital of Grenoble
Grenoble, , France
Countries
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References
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Barnes J, Resch KL, Ernst E. Homeopathy for postoperative ileus? A meta-analysis. J Clin Gastroenterol. 1997 Dec;25(4):628-33. doi: 10.1097/00004836-199712000-00016.
Ernst E. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol. 2002 Dec;54(6):577-82. doi: 10.1046/j.1365-2125.2002.01699.x.
Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet. 1997 Sep 20;350(9081):834-43. doi: 10.1016/s0140-6736(97)02293-9.
Lokken P, Straumsheim PA, Tveiten D, Skjelbred P, Borchgrevink CF. Effect of homoeopathy on pain and other events after acute trauma: placebo controlled trial with bilateral oral surgery. BMJ. 1995 Jun 3;310(6992):1439-42. doi: 10.1136/bmj.310.6992.1439.
Cucherat M, Haugh MC, Gooch M, Boissel JP. Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group. Eur J Clin Pharmacol. 2000 Apr;56(1):27-33. doi: 10.1007/s002280050716.
Other Identifiers
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DCIC 03 10
Identifier Type: -
Identifier Source: org_study_id