A Randomised Controlled Trial of Multimodal Physiotherapy for Patients With Acute / Sub-acute Cervical Radiculopathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change from baseline in neck and arm pain (Numerical Pain Rating Scale)
研究概览
简要总结
Multimodal physiotherapy involving manual therapy and exercise has demonstrated a positive effect on pain and disability in sub-acute and chronic cervical radiculopathy (CR) but a research gap exists for optimal management in the first 12 weeks and short-term natural history of the condition is unclear, although thought to be favourable within the first 4 weeks. The primary aim of this single blind, 2 group randomised controlled trial (RCT) is to investigate the effects of a 4 week (6-8 sessions) programme of manual therapy, exercise and upper limb unloading tape compared to advice to stay active, on disability, pain and other biopsychosocial measures, in acute / sub-acute cervical radiculopathy patients. The hypothesis is that a 4 week multimodal physiotherapy programme will lead to changes in self-reported disability and pain, compared to advice to stay active, in patients with acute / sub-acute cervical radiculopathy. A secondary study objective is to identify whether variables from the baseline examination, group allocation and aetiology confirmed by MRI can predict outcome, as measured with the Global Rating of Change Scale (GROC). Subjects will be diagnosed with CR based on a diagnostic clinical prediction rule. Random group allocation, allocation concealment, blinded assessment and intention to treat analysis will be employed. Outcomes will be measured at baseline, 4 and 12 weeks. Patients' report of pain, disability and their rating of recovery will also be recorded by telephone interview at 6 months. An internal pilot feasibility study will be undertaken in advance of the main study to test recruitment and retention strategies. Statistical analysis of differences between groups will be done with ANOVAs and MANOVAs. Appropriate multivariable regression analysis will be used to explore predictors of outcome.
详细描述
Cervical radiculopathy (CR) has been defined by the North American Spine Society (NASS) as pain in a radicular pattern in one or both upper extremities related to compression and/or irritation of one or more cervical nerve roots, with signs and symptoms including varying degrees of sensory, motor, and reflex changes in addition to dysaesthesia and paraesthesia (Bono et al. 2011). CR is of particular clinical concern, given the higher levels of pain and disability associated with the presence of nerve-related arm pain resulting in higher healthcare costs for this cohort of people with neck pain (Rubinstein et al., 2007, Haldeman et al., 2008).
Multimodal physiotherapy involving manual therapy and exercise has demonstrated a positive effect on pain and disability for chronic (symptom duration > 3 months) CR (Boyles et al., 2011). No consensus on the optimum conservative management, or indeed optimal timing of such management, currently exists for acute / sub-acute cervical radiculopathy. The combined use of manual therapy with exercise for this cohort is now garnering interest; evident by the emergence of several randomised controlled trials (Nee et al., 2012, Langevin et al., 2015) involving treatment duration of 2-4 weeks. Langevin et al. (2015) demonstrated that using 2 varied programmes of manual therapy & exercise, led to similarly clinically significant improvements in pain and disability, particularly immediately after a 4 week intervention. However, without a 'no treatment' control group, natural recovery could not be excluded, confirming the need for adequate control groups in future trials (Langevin et al., 2015). The most recent Cochrane review of exercise for the treatment of mechanical neck disorders (MND) (including CR) concluded that there was low quality evidence to suggest a small pain reduction benefit with cervical stretch / strengthening / stabilization exercises in the short term in acute cervical radiculopathy (Gross et al., 2015). They also advocated for larger sample sizes and longer follow-up periods in future trials.
A randomised controlled trial of a 4 week course of a multimodal physiotherapy package (manual therapy (to spinal joints), exercise (mobility exercise, deep neck flexor and scapular muscle training), upper limb unloading tape (to offload the brachial plexus) and advice to stay active) for acute/sub-acute CR is proposed. As there is no strong evidence establishing best clinical practice for the conservative management of acute/sub-acute CR, a control group of advice to stay active and medication will be used.
Aims & Objectives:
The primary aim of this trial is to investigate the effects of a 4 week multimodal physiotherapy (MP) programme on neck and arm pain and resulting disability in CR, over 6 months, with the primary endpoint at 4 weeks.
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
- Single (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
- •Meets criteria for CR diagnosis on a clinical prediction rule (CPR) by demonstrating positive responses to at least 3 of the following 4 clinical tests: Spurling's Test, Upper Limb Neural Tissue Provocation Test 1 (ULNT 1), Cervical Distraction Test, and less than 60° of cervical rotation on the symptomatic side (Wainner et al., 2003).
- •Complaints of neck / periscapular pain, in addition to radicular pain, paraesthesia or numbness in the upper limb; aggravated by neck posture or movement (Thoomes et al., 2012).
- •Symptom duration must be greater than 2 weeks and less than 3 months.
- •Mean of Numerical Pain Rating Scale (NPRS) scores for both neck and arm pain must be ≥ 3/
- •Fluent in spoken and written English.
- •Willing to give informed consent.
排除标准
- •Previous physiotherapy / manual treatment to cervical spine within past 6 months.
- •Previous epidural injection since the onset of current symptoms.
- •Prior surgery to the cervicothoracic spine or currently symptomatic upper limb.
- •Current symptoms & signs of bilateral radiculopathy.
- •Myotomal paresis less than 4 / 5 on Medical Research Council Scale in affected upper limb.
- •Signs and symptoms suggestive of Cervical Spondylotic Myelopathy (CSM): bilateral paraesthesia, hyperreflexia, positive Babinski reflex and spasticity.
- •Diagnosis of any generalised neurological disorder e.g. multiple sclerosis.
- •Concurrent peripheral neuropathy affecting either upper limb e.g. carpal tunnel syndrome, thoracic outlet syndrome.
- •Medical red flags suggestive of serious pathology such as neoplastic conditions, upper cervical ligamentous instability, vertebral artery insufficiency and inflammatory or systemic disease (Childs et al., 2004).
- •Diagnosis of fibromyalgia.
- •Psychiatric diagnosis in past 6 months.
- •Ongoing litigation relating to cervical symptoms.
结局指标
主要结局
Change from baseline in neck and arm pain (Numerical Pain Rating Scale)
时间窗: 4 weeks
Neck and arm pain levels measured with the Numerical Pain Rating Scale for current, best and worst pain levels over last 24 hours (Jensen et al 1994)
Change from baseline in Neck Disability Index
时间窗: 4 weeks
Disability resulting from the cervical radiculopathy measured with the Neck Disability Index (Vernon and Mior 1991)
次要结局
- Upper Limb Neurodynamic test 1(Baseline, 4 weeks and 12 weeks)
- Change from baseline in Neck Disability Index(12 weeks and 6 months)
- Pressure Pain Thresholds measured with a SenseBox pressure algometer(Baseline, 4 weeks and 12 weeks)
- Hospital Anxiety Depression Scale(Baseline, 4 weeks and 12 weeks)
- Change from baseline in neck and arm pain levels (Numerical Pain Rating Scale)(12 weeks and 6 months)
- SF-12 version 2 Health Survey(Baseline, 4 weeks and 12 weeks)
- Cervical range of motion (ROM) measured with a CROM 3 device(Baseline, 4 weeks and 12 weeks)
- painDETECT Questionnaire(Baseline)
- Fear Avoidance Belief Questionnaire (Neck)(Baseline, 4 weeks and 12 weeks)