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Trial record 54 of 424 for:    shaare zedek

Traumeel S for Reduction of Post Operative Pain Following Arthroscopy

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ClinicalTrials.gov Identifier: NCT00307892
Recruitment Status : Suspended (Inability to recruit patients)
First Posted : March 28, 2006
Last Update Posted : October 29, 2010
Sponsor:
Information provided by:
Shaare Zedek Medical Center

Tracking Information
First Submitted Date  ICMJE March 27, 2006
First Posted Date  ICMJE March 28, 2006
Last Update Posted Date October 29, 2010
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2006)
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.
Change History Complete list of historical versions of study NCT00307892 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Occurrence of adverse events. [ Time Frame: 30d ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2006)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Traumeel S for Reduction of Post Operative Pain Following Arthroscopy
Official Title  ICMJE A Randomised, Double- Blind, Placebo Controlled, Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Reducing Pain After Arthroscopy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post-operative Pain
Intervention  ICMJE
  • Drug: Traumeel S: intra-operative irrigation + oral ingestion
    homeopathic remedy
  • Drug: Placebo
    placebo remedy
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 27, 2006)
98
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00307892
Other Study ID Numbers  ICMJE Arth 06 CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Menachem Oberbaum, MD, Shaare Zedek Medical Center, Jerusalem, Israel
Study Sponsor  ICMJE Shaare Zedek Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Menachem Oberbaum, M.D. Shaare Zedek Medical Center, Jerusalem, Israel
PRS Account Shaare Zedek Medical Center
Verification Date October 2010

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