Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty
1 other identifier
interventional
165
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 pain
Started Dec 2003
Typical duration for phase_3 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedNovember 14, 2006
July 1, 2006
September 14, 2005
November 9, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morphine consumption delivered by PCA between 0 and 24 hours after a knee ligamentoplasty
Secondary Outcomes (2)
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
Interventions
Eligibility Criteria
You may qualify if:
- Age ranging from 18 to 60 years.
- Patients who are candidates for a ligamentoplasty of the anterior cruciate ligament.
You may not qualify if:
- Patients with corticoid and immunodepressor treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Grenoble
Grenoble, 38043, France
Related Publications (5)
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.
PMID: 9451677BACKGROUNDErnst 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.
PMID: 12492603BACKGROUNDLinde 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.
PMID: 9310601BACKGROUNDLokken 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.
PMID: 7613277BACKGROUNDCucherat 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.
PMID: 10853874RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CRACOWSKI Jean-Luc, Dr
Clinical Trial Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 22, 2005
Study Start
December 1, 2003
Study Completion
May 1, 2006
Last Updated
November 14, 2006
Record last verified: 2006-07