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Traumeel S for Reduction of Post Operative Pain Following Arthroscopy

Primary Purpose

Post-operative Pain

Status
Suspended
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Traumeel S: intra-operative irrigation + oral ingestion
Placebo
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring Homeopathy, Traumeel S, Arthroscopy, Pain management, Post-operative pain following arthroscopy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients of either sex undergoing unilateral arthroscopy for menisectomy or chondroplasty, w/o ligament reconstruction . Age 18 - 40 years. Meeting none of exclusion criteria. 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

Sites / Locations

  • Dept. of Orthopedic Surgery, Shaare Zedek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

TRAUMEEL S

comparable placebo remedy (injection and oral)

Outcomes

Primary Outcome Measures

Degree of pain at rest, as recorded daily by the patient and by the study assistant in the CRF, using a 11 point (0-10) numerical rating score (NRS-11), during the first two post operative days.

Secondary Outcome Measures

Degree of pain at rest, as recorded daily by the patient and by the study assistant in the CRF, using a 11 point (0-10) numerical rating score (NRS-11), during the six post operative days.
Total amount of primary oral analgesic tablets ingested, as reported by the patient and the study assistant in the CRF from Day 0 to Day 5 (six days), using a discrete scale.
Number of days on which oral rescue analgesic treatment was required, if any, as reported by the patient and the study assistant in the CRF, from Day 0 to Day 5 (six days) using a discrete scale.
Degree of pain upon performance of RoM on days 5 and 30 postoperatively as compared with baseline, using a 11 point (0-10) numerical rating score (NRS), along a discrete scale.
Knee function as measured by difference in RoM at 5 and 30 days postoperatively, as compared with baseline, on a continuous scale.
Degree of atrophy of quadriceps, as measured by difference in circumference of thigh 15 cm proximal to the upper pole of the patella with knee in full extension on 30 days post-operatively, as compared with baseline, on a continuous scale.
Difference in disease-related QoL, as measured by the difference in Lysholm knee score on 30 days post operatively as compared with baseline .
Occurrence of adverse events.

Full Information

First Posted
March 27, 2006
Last Updated
October 28, 2010
Sponsor
Shaare Zedek Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00307892
Brief Title
Traumeel S for Reduction of Post Operative Pain Following Arthroscopy
Official Title
A Randomised, Double- Blind, Placebo Controlled, Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Reducing Pain After Arthroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Suspended
Why Stopped
Inability to recruit patients
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shaare Zedek Medical Center

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
Homeopathy, Traumeel S, Arthroscopy, Pain management, Post-operative pain following arthroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
TRAUMEEL S
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
comparable placebo remedy (injection and oral)
Intervention Type
Drug
Intervention Name(s)
Traumeel S: intra-operative irrigation + oral ingestion
Intervention Description
homeopathic remedy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo remedy
Primary Outcome Measure Information:
Title
Degree of pain at rest, as recorded daily by the patient and by the study assistant in the CRF, using a 11 point (0-10) numerical rating score (NRS-11), during the first two post operative days.
Time Frame
30d
Secondary Outcome Measure Information:
Title
Degree of pain at rest, as recorded daily by the patient and by the study assistant in the CRF, using a 11 point (0-10) numerical rating score (NRS-11), during the six post operative days.
Time Frame
30d
Title
Total amount of primary oral analgesic tablets ingested, as reported by the patient and the study assistant in the CRF from Day 0 to Day 5 (six days), using a discrete scale.
Time Frame
30d
Title
Number of days on which oral rescue analgesic treatment was required, if any, as reported by the patient and the study assistant in the CRF, from Day 0 to Day 5 (six days) using a discrete scale.
Time Frame
6d
Title
Degree of pain upon performance of RoM on days 5 and 30 postoperatively as compared with baseline, using a 11 point (0-10) numerical rating score (NRS), along a discrete scale.
Time Frame
30d
Title
Knee function as measured by difference in RoM at 5 and 30 days postoperatively, as compared with baseline, on a continuous scale.
Time Frame
30d
Title
Degree of atrophy of quadriceps, as measured by difference in circumference of thigh 15 cm proximal to the upper pole of the patella with knee in full extension on 30 days post-operatively, as compared with baseline, on a continuous scale.
Time Frame
30d
Title
Difference in disease-related QoL, as measured by the difference in Lysholm knee score on 30 days post operatively as compared with baseline .
Time Frame
30d
Title
Occurrence of adverse events.
Time Frame
30d

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients of either sex undergoing unilateral arthroscopy for menisectomy or chondroplasty, w/o ligament reconstruction . Age 18 - 40 years. Meeting none of exclusion criteria. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Menachem Oberbaum, M.D.
Organizational Affiliation
Shaare Zedek Medical Center, Jerusalem, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel

12. IPD Sharing Statement

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Traumeel S for Reduction of Post Operative Pain Following Arthroscopy

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