Traumeel S for Reduction of Post Operative Pain Following Arthroscopy

This study has suspended participant recruitment.
(Inability to recruit patients)
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00307892
First received: March 27, 2006
Last updated: October 28, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Post-operative Pain
Drug: Traumeel S: intra-operative irrigation + oral ingestion
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Shaare Zedek Medical Center:

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. [ Time Frame: 30d ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 30d ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Occurrence of adverse events. [ Time Frame: 30d ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 98
Study Start Date: January 2011
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
TRAUMEEL S
Drug: Traumeel S: intra-operative irrigation + oral ingestion
homeopathic remedy
Placebo Comparator: B
comparable placebo remedy (injection and oral)
Drug: Placebo
placebo remedy

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00307892

Locations
Israel
Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Menachem Oberbaum, M.D. Shaare Zedek Medical Center, Jerusalem, Israel
  More Information

No publications provided

Responsible Party: Menachem Oberbaum, MD, Shaare Zedek Medical Center, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT00307892     History of Changes
Other Study ID Numbers: Arth 06 CTIL
Study First Received: March 27, 2006
Last Updated: October 28, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Shaare Zedek Medical Center:
Homeopathy
Traumeel S
Arthroscopy
Pain management
Post-operative pain following arthroscopy

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014