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
  Purpose

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 Intervention Phase
Pain
Drug: Arnica montana, 5 CH
Drug: Bryonia alba, 5 CH
Drug: Hypericum perforatum, 5 CH
Drug: Ruta graveolens, 3 DH
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Morphine consumption delivered by PCA between 0 and 24 hours after a knee ligamentoplasty

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 165
Study Start Date: December 2003
Estimated Study Completion Date: May 2006
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00222365

Locations
France
University Hospital of Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: CRACOWSKI Jean-Luc, Dr Clinical Trial Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00222365     History of Changes
Other Study ID Numbers: DCIC 03 10
Study First Received: September 14, 2005
Last Updated: November 9, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
homeopathy
assessment
pain
ligamentoplasty

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014