Clinical trial NCT00222365: Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty
Official title: Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain
Keywords: homeopathy
assessment
pain
ligamentoplasty
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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

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

Eligibility criteria: Inclusion Criteria:

* Age ranging from 18 to 60 years.
* Patients who are candidates for a ligamentoplasty of the anterior cruciate ligament.

Exclusion Criteria:

* Patients with corticoid and immunodepressor treatment

Primary outcomes:
measure: Morphine consumption delivered by PCA between 0 and 24 hours after a knee ligamentoplasty
Secondary outcomes:
measure: Morphine consumption between 0 and 72 hours after the ligamentoplasty
measure: Pain assessment at hour 0 (H0), H4, H24 and H72 with 10 cm Analogical Visual Scale
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
Study officials:
affiliation: Clinical Trial Center
name: CRACOWSKI Jean-Luc, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.