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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

March 27, 2006
October 28, 2010
January 2011
January 2012   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00307892 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Traumeel S for Reduction of Post Operative Pain Following Arthroscopy
A Randomised, Double- Blind, Placebo Controlled, Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Reducing Pain After Arthroscopy

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Post-operative Pain
  • Drug: Traumeel S: intra-operative irrigation + oral ingestion
    homeopathic remedy
  • Drug: Placebo
    placebo remedy
  • Active Comparator: A
    TRAUMEEL S
    Intervention: Drug: Traumeel S: intra-operative irrigation + oral ingestion
  • Placebo Comparator: B
    comparable placebo remedy (injection and oral)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
98
Not Provided
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00307892
Arth 06 CTIL
Not Provided
Menachem Oberbaum, MD, Shaare Zedek Medical Center, Jerusalem, Israel
Shaare Zedek Medical Center
Not Provided
Principal Investigator: Menachem Oberbaum, M.D. Shaare Zedek Medical Center, Jerusalem, Israel
Shaare Zedek Medical Center
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP