Department of Medical and Health Sciences, Physiotherapy, Faculty of Health Sciences, Linköping University, SE-58183 Linköping, Sweden.
BMC Musculoskelet Disord. 2014 Feb 6;15:34. doi: 10.1186/1471-2474-15-34.
Many patients with cervical disc disease require leave from work, due to long-lasting, complex symptoms, including chronic pain and reduced levels of physical and psychological function. Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits, but not the non-specific neck pain and the frequent illness. No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery. The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease, with respect to function, disability, work capability, and cost effectiveness.
METHODS/DESIGN: This study was designed as a prospective, randomised, controlled, multi-centre study. An independent, blinded investigator will compare two alternatives of rehabilitation. We will include 200 patients of working age, with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression. After providing informed consent, study participants will be randomised to one of two alternative physiotherapy regimes; (A) customary treatment (information and advice on a specialist clinic); or (B) customary treatment plus active physiotherapy. Physiotherapy will follow a standardised, structured programme of neck-specific exercises combined with a behavioural approach. All patients will be evaluated both clinically and subjectively (with questionnaires) before surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The main outcome variable will be neck-specific disability. Cost-effectiveness will also be calculated.
We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease.
ClinicalTrials.gov identifier: NCT01547611.
许多患有颈椎间盘疾病的患者由于持续时间长、症状复杂,包括慢性疼痛和身体及心理功能下降,需要请假。对少数节段进行手术有望解决与椎间盘相关的疼痛,并减少神经功能缺损,但不能解决非特异性颈部疼痛和频繁发作的疾病。目前还没有研究调查手术后的物理治疗是否可以改善手术的效果。本研究的主要目的是评估结构良好的康复计划是否可以在颈椎间盘疾病的常规手术后治疗中带来益处,具体表现在功能、残疾、工作能力和成本效益方面。
方法/设计:本研究设计为前瞻性、随机、对照、多中心研究。一名独立的、盲法的研究者将比较两种康复方案。我们将纳入 200 名符合临床发现和颈椎神经根压迫症状的颈椎间盘疾病的成年患者。在获得知情同意后,研究参与者将被随机分配到两种替代物理治疗方案之一:(A)常规治疗(在专科诊所获得信息和建议);或(B)常规治疗加主动物理治疗。物理治疗将遵循标准化、结构化的颈部特定运动方案,结合行为方法。所有患者将在手术前和手术后 6 周、3 个月、6 个月、12 个月和 24 个月进行临床和主观(通过问卷)评估。主要结局变量将是颈部特定的残疾。成本效益也将被计算。
我们预计,这项研究的结果将提供证据,支持颈椎间盘疾病引起的颈椎神经根病变手术后应用物理治疗康复。
ClinicalTrials.gov 标识符:NCT01547611。