Nuclear Magnetic Resonance Therapy in Knee Osteoarthrosis: A Double Blind Ranomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NHS Grampian
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Oxford Knee Score
研究概览
简要总结
Nuclear Magnetic Resonance Therapy (NMRT) is gaining as a novel mode of therapy in osteoarthrosis. A prospective double blind randomised study of 100 patients was conducted to investigate efficacy of NMRT in the treatment of mild to moderate osteoarthrosis (OA) of the knee joint.
The null hypothesis was that there is no benefit of NMRT over placebo in mild to moderate oteoarthosis of the knee.
详细描述
This study was approved by the Regional Ethics Committee. Patients were recruited from referrals made by General Practitioners to a single Orthopaedic Outpatient Department between October 2007 and February 2008. The study was a prospective placebo controlled, double blind randomised mono centric study with a follow up period of 6 months.
All potential trial participants demonstrated symptomatic mild to moderate OA of the knee joint diagnosed by an experienced consultant orthopaedic surgeon. Radiographic evidence was gathered by means of standard clinical standing antero-posterior and lateral radiographs of the knee.
Baseline assessment included :
- clinical examination
- active Range of movement
- plain radiographs
- WOMAC osteoarthritis index
- Oxford Knee Score (OKS)
- Severity of pain VAS.
- Strength and frequency of any painkillers taken.
- Phyasiotherapy Study design was directed at use of NMRT in a clinical setting. It was therefore considered valid to not restrict the use of the pain killers and physiotherapy. Positional Magnetic Resonance Imaging (pMRI) scan of the knee joint was undertaken.
Randomisation was carried out by means of visually identical computer chip cards numbered from 1 to 100 which had been independently programmed by the manufacturer. Thus, half of the computer chip cards (n=50) were programmed to activate the magnetic fields (= treatment group) and remaining half (n=50) were programmed not to activate magnetic fields (=placebo group) of the device. The research team and patients were blinded to the programmed activity of the cards. The magnetic resonance indicator LED lamp on the device was disabled by the manufacturer to ensure that the operator and patients were blinded to the therapy status. Every patient entering the study was asked to choose a numbered card from those available, and this card was then used to operate the device for that specific patient for all five sessions of NMRT.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthrosis of the knee(s)
- •Moderately severe (grade 1-2)
排除标准
- •Prior knee surgery
- •Implanted metallic devices
结局指标
主要结局
Oxford Knee Score
时间窗: 12 weeks
Patient administered validated questions
次要结局
未报告次要终点
研究者
S Barker
Consultant Orthopaedic Surgeon
NHS Grampian