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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00222365
• Other study ID #: DCIC 03 10
• Status: Terminated
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: November 9, 2006
• Start date: December 2003
• Est. completion date: May 2006

Study information

• Verified date: July 2006
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 165
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Arnica montana, 5 CH

• Bryonia alba, 5 CH

• Hypericum perforatum, 5 CH

• Ruta graveolens, 3 DH

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (5)

Barnes J, Resch KL, Ernst E. Homeopathy for postoperative ileus? A meta-analysis. J Clin Gastroenterol. 1997 Dec;25(4):628-33. Erratum in: J Clin Gastroenterol 1998 Apr;26(3):231. — View 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. — View Citation

Ernst E. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol. 2002 Dec;54(6):577-82. Review. — View 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. Erratum in: Lancet 1998 Jan 17;351(9097):220. — View Citation

Lökken 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption delivered by PCA between 0 and 24 hours after a knee ligamentoplasty
Secondary	Morphine consumption between 0 and 72 hours after the ligamentoplasty
Secondary	Pain assessment at hour 0 (H0), H4, H24 and H72 with 10 cm Analogical Visual Scale