Traumeel S for Reduction of Post Operative Pain Following Arthroscopy
Status:
Suspended
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.