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Traumeel S for Reduction of Post Operative Pain Following Arthroscopy

NCT ID: NCT00307892

Last Updated: 2010-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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The perception of pain is a complex process that is not yet fully understood. With outpatient knee arthroscopy becoming standard of care, postoperative pain management has become increasingly important in caring for patients. Traumeel S is a homeopathic complex widely used in German-speaking Europe for orthopedic pain and inflammation. It contains a mixture of medicinal plants and minerals, all highly diluted. In some recent studies, Traumeel has shown anti-inflammatory and analgesic activity.

In this study, the efficacy of Traumeel S will be compared with placebo in reducing pain during the first 48 hours after arthroscopy. Also compared will be 6 day pain levels, analgesic consumption, quality of life, post operative knee function, quadriceps atrophy and safety.

The study design is double blind RCT. 98 patients, aged 18-40 and undergoing arthroscopic meniscectomy or chondroplasty will be enrolled in the trial. Patients will be randomized to receive either intraoperative join irrigation with Traumeel S and oral treatment with Traumeel S, or placebo irrigation and oral ingestion. Patients will continue to take active or placebo medication for 6 days. Pain will be recorded daily by the patient in the patient diary using an 11-point numerical rating score (NRS-11. Patients will also record daily consumption of primary and "rescue" analgesics. Range of motion (RoM) will be measured on days 6 and 30 post-operatively, and the Lysholm knee scale and circumference of thigh above patella will be measured at 30 days. All these measures will be compared with baseline. Patients will be contacted daily by the research assistant to encourage compliance and to record their daily NRS and analgesic consumption in the CRF.

Detailed Description

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Conditions

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Post-operative Pain

Keywords

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Homeopathy Traumeel S Arthroscopy Pain management Post-operative pain following arthroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

TRAUMEEL S

Group Type ACTIVE_COMPARATOR

Traumeel S: intra-operative irrigation + oral ingestion

Intervention Type DRUG

homeopathic remedy

B

comparable placebo remedy (injection and oral)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo remedy

Interventions

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Traumeel S: intra-operative irrigation + oral ingestion

homeopathic remedy

Intervention Type DRUG

Placebo

placebo remedy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients of either sex undergoing unilateral arthroscopy for menisectomy or chondroplasty, w/o ligament reconstruction .
* Age 18 - 40 years.

Exclusion Criteria

* Participation in another clinical trial within 4 weeks prior to enrollment.
* Inability to comply with the study protocol.
* Impossibility to be reached during the whole follow-up period (7 days post operative)
* Refused to give oral consent to the telephone interviews
* Previous arthroscopy on ipsilateral knee.
* Current use of analgesia for any other reason except for the knee complaint.
* Any disease considered to inhibit wound healing (e.g. Diabetes mellitus, Berger, any PVD, DVT).
* Known sensitivity to dipyrone or diclofenac
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Shaare Zedek Medical Center, Jerusalem, Israel

Principal Investigators

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Menachem Oberbaum, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center, Jerusalem, Israel

Locations

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Dept. of Orthopedic Surgery, Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Arth 06 CTIL

Identifier Type: -

Identifier Source: org_study_id