A Randomised, Double- Blind, Placebo Controlled, Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Reducing Pain After Arthroscopy
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex undergoing unilateral arthroscopy for menisectomy or chondroplasty, w/o ligament reconstruction .
- •Age 18 - 40 years.
- •Meeting none of exclusion criteria.
排除标准
- •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
研究组 & 干预措施
B
comparable placebo remedy (injection and oral)
干预措施: Placebo (Drug)
结局指标
主要结局
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.
时间窗: 30d
次要结局
- 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)
- 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.(30d)
- Difference in disease-related QoL, as measured by the difference in Lysholm knee score on 30 days post operatively as compared with baseline .(30d)
- Occurrence of adverse events.(30d)