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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014