Traumeel S for Reduction of Post Operative Pain Following Arthroscopy

NCT00307892 | Suspended Phase 3

• 1 other identifier: Arth 06 CTIL
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain

Keywords

Homeopathy; Traumeel S; Arthroscopy; Pain management; Post-operative pain following arthroscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  30d

Secondary Outcomes (8)

• 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.

  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.

  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.

  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.

  30d

• Knee function as measured by difference in RoM at 5 and 30 days postoperatively, as compared with baseline, on a continuous scale.

  30d

Study Arms (2)

A

ACTIVE COMPARATOR

TRAUMEEL S

Drug: Traumeel S: intra-operative irrigation + oral ingestion

B

PLACEBO COMPARATOR

comparable placebo remedy (injection and oral)

Drug: Placebo

Interventions

Traumeel S: intra-operative irrigation + oral ingestion DRUG

homeopathic remedy

A

Placebo DRUG

placebo remedy

B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of either sex undergoing unilateral arthroscopy for menisectomy or chondroplasty, w/o ligament reconstruction .
• Age 18 - 40 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Dept. of Orthopedic Surgery, Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Eating

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Menachem Oberbaum, M.D.

  Shaare Zedek Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2006
• First Posted: March 28, 2006
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Last Updated: October 29, 2010

Record last verified: 2010-10

Locations

IL (1)