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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00222365

Enrollment

165

Registered

2005-09-22

Start date

2003-12-31

Completion date

2006-05-31

Last updated

2006-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

homeopathy, assessment, pain, ligamentoplasty

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

Interventions

DRUGArnica montana, 5 CH

DRUGBryonia alba, 5 CH

DRUGHypericum perforatum, 5 CH

DRUGRuta graveolens, 3 DH

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Morphine consumption delivered by PCA between 0 and 24 hours after a knee ligamentoplasty	—

Secondary

Measure	Time frame
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	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026