Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty

This study has been terminated.
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00222365
First received: September 14, 2005
Last updated: November 9, 2006
Last verified: July 2006

September 14, 2005
November 9, 2006
December 2003
Not Provided
Morphine consumption delivered by PCA between 0 and 24 hours after a knee ligamentoplasty
Same as current
Complete list of historical versions of study NCT00222365 on ClinicalTrials.gov Archive Site
  • 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
  • Morphine consumption between 0 and 72 hours after the ligamentoplasty
  • Pain assessment at H0, H4, H24 and H72 with 10 cm Analogical Visual Scale
Not Provided
Not Provided
 
Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty
Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty

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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pain
  • Drug: Arnica montana, 5 CH
  • Drug: Bryonia alba, 5 CH
  • Drug: Hypericum perforatum, 5 CH
  • Drug: Ruta graveolens, 3 DH
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
165
May 2006
Not Provided

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00222365
DCIC 03 10
Not Provided
Not Provided
University Hospital, Grenoble
Not Provided
Principal Investigator: CRACOWSKI Jean-Luc, Dr Clinical Trial Center
University Hospital, Grenoble
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP