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临床试验/NCT02618278
NCT02618278已完成3 期

Physiotherapy Management of Lumbar Radicular Syndrome; Does Early Intervention Improve Outcomes?

Michael Reddington0 个研究点目标入组 80 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
80
主要终点
Patients willing to be randomised

研究概览

简要总结

This study aims to evaluate the whether receiving physiotherapy early after onset of the problem is better than waiting a few weeks to see if it gets better before starting physiotherapy. 80 people with sciatica will take part in the study, half of which will receive physiotherapy 2 weeks after seeing their G.P. The other half will receive physiotherapy at the usual time, around 6 weeks after seeing their G.P.

详细描述

Sciatica is a relatively common problem which is often caused by nerve compression or irritation due to a lower back (Lumbar) disc prolapse. The problem is likely to improve in time as the body heals itself. However, this can take many months or sometime years. Sciatica can be a very painful condition, it may cause pins and needles, numbness or weakness in the legs affected. This, can cause great difficulty for people carrying out normal day to day activities.

Physiotherapy is often used to help people with sciatica but in many places in the United Kingdom it can take many weeks or months to begin therapy.

This study aims to see if having physiotherapy at 2 weeks after the patient has seen their G.P helps them get back to normal day to day function. This will be compared with another group of patients who will have physiotherapy at the 'usual' time of around 6 weeks after they have seen their G.P.The investigators will also be interviewing participants for their views of sciatica and physiotherapy. Each patient will receive a goal orientated physiotherapy management programme with achievement of those goals acting as secondary outcomes. Primary outcomes are feasibility objectives including patient recruitment rates, acceptability of outcome measures and intervention and rates of adverse events.

This is a pilot study which means that the investigators won't be directly comparing the 2 groups, but seeing if doing a full-scale study in the future is going to be feasible.The investigators will do this by measuring several different things, such as whether patients want to take part in the study or not, whether the tests the investigators will perform are the right tests and to see if the patients and physiotherapists find the treatment useful.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18-70 years of age with unilateral LRS defined as pain and or sensory disturbance and or weakness in a dermatomal and or myotomal distribution.

排除标准

  • Patients with bilateral LRS.
  • Patients with 'red flag' signs and symptoms of potential serious pathology.
  • Cancer at the time of the study.
  • Proven vascular claudication.
  • Cauda Equina Syndrome (CES).
  • Spinal fracture within the last 3 months.
  • Chronic regional pain syndromes.
  • Recent lower limb fracture.
  • CVA with physical or psychiatric disability.
  • Poor English skills (necessitating the use of an interpreter and invalidating outcomes measures-ODI).
  • Other significant co-morbidities preventing regular attendance at physiotherapy clinics.
  • Patients with significant mental health problems for which treatment adherence may be difficult or psychologically disabling.

结局指标

主要结局

Patients willing to be randomised

时间窗: 26 weeks

The willingness of patients to be randomised will be collected together with reasons for not wanting to be randomised.

Ability to recruit patients

时间窗: 26 weeks

Ability to recruit patients within the 26 week limit

Ability to initiate treatment

时间窗: 2 weeks for intervention arm, 6 weeks for control

Demonstrate the ability to organise physiotherapy appointments expeditiously

Ensure patient safety

时间窗: 52 weeks

Record all adverse and serious adverse events

次要结局

  • EQ5D-5L(Baseline, 6 weeks, 12 weeks, 26 weeks)
  • Back & leg pain(Baseline, 6 weeks, 12 weeks, 26 weeks)
  • Oswestry Disability Index (ODI)(Baseline, 6 weeks, 12 weeks, 26 weeks)
  • Goal achievement(26 weeks)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael Reddington

NIHR Clinical Doctoral Research Fellow

Sheffield Teaching Hospitals NHS Foundation Trust

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