Physiotherapy After Anterior Cervical Spine Surgery for Cervical Disc Disease. A Prospective Randomised Study to Compare Internet-based Neck-specific Exercise With Prescribed Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Neck Disability Index (NDI)
研究概览
简要总结
Background: Patients suffering residual disability after anterior decompression and fusion (ACDF) surgery for cervical disc disease may be prescribed physical activity (PPA) or neck-specific exercises (NSE). Currently, we lack data for the success of either approach. There is also a knowledge-gap concerning the use of internet-based care for chronic neck pain, inclusive of cervical disc disease. The scarcity of these data, and the high proportion of patients with various degrees of incapacity following ACDF, warrants increased efforts to investigate and improve cost-effective rehabilitation.
Objective: To investigate the effectiveness of a structured, internet-based NSE program, versus PPA following ACDF surgery.
Methods: This is a prospective, randomised, experimental, longitudinal multicentre study, that includes 140 patients with residual disability (≥30% on the Neck Disability Index; NDI) following ACDF for radiculopathy due to cervical disc disease. Patient recruitment occurs following attendance at routine clinical appointments, scheduled for 3-months post-surgery. Patients are then randomised to one of two groups (70 patients/group), scheduled for a 3-month treatment of either internet-based NSE or PPA. Questionnaires on background data, pain and discomfort, physical and mental capacity, satisfaction with care, and health and workplace factors are completed, with physical measurements of neck-related function performed by independent test leaders blinded to randomisation. Measurements are performed at inclusion, after the 3-month treatments (end of treatment), and at a 2-year follow-up. Radiography will be completed at the 2-year follow-up. Preoperative data will be collected from the Swedish Spine Registry (Swespine). Data on healthcare consumption, drug use, and sick leave will be requested from the relevant national registers.
详细描述
The purpose of the study is to investigate whether internet-based, structured NSE, differs from PPA after surgery for cervical disc disease, in relation to function, pain, work capacity, health-related quality of life, satisfaction with care, and cost effectiveness.
The hypothesis is that internet-based NSE will be superior in terms of outcome measures to PPA. This assumption, based on an earlier study of patients with chronic WAD, remains untested for individuals with residual disability following ACDF. The project is expected to lead to improved care, well-being, and patient satisfaction, and, as a result, a reduced societal burden.
Design This is a prospective, randomised, experimental longitudinal multicentre study, with a two-year follow-up. Questionnaires are distributed and physical measurements taken at baseline, at the end of treatment (3 months after enrolment), and after 2 years. Preoperative data is collected from Swespine. Patients are recruited from the surgical unit following regular follow-up visits to the physiotherapist/surgeon at approximately 3 months postoperatively.
Should the study criteria be met, and after the receipt of written and oral informed consent, the patient completes a questionnaire and undergoes physical measurements of neck-related function. The patient is then randomised (computerised block randomisation list compiled by statisticians) to one of two groups for 3 months of treatment with a) internet-based NSE with 3 visits to the physiotherapist or b) PPA with 3 visits to the physiotherapist. In addition, and prior to treatment, patients in both groups are examined by a physiotherapist, in accordance with Swedish law.
The test leader is a physiotherapist at the surgical unit who is not involved in study treatment and is blinded to the randomisation groups. Qualified clinicians will perform X-rays and (potentially) ultrasound registration. Following randomization the results will be put into an opaque envelope that contains the name of the patient and their randomisation group, which is sent to the physiotherapy outpatient care clinic. Questionnaires and tests of physical neck-related function are conducted at baseline (before randomisation), after 3 months (when the treatment ends), and after 2 years. Participant physiotherapists will be provided oral, written, and practical training, and are able to consult project managers at any time. Exercise diaries and the number of care contacts will be recorded for both groups.
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)
盲法说明
Single Blind (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for each surgical department:
- •Record data in Swespine
- •Inclusion criteria for surgery:
- •Cervical disc disease, confirmed by MRI data compatible with clinical findings (neurological examination performed by neck surgeon i.e. neurosurgeon/orthopaedic surgeon) that show nerve root compression in the cervical spine.
- •Radiculopathy with pain in one or both arms, with or without sensory and/or motor deficit
- •At least 3 months of persistent arm pain
- •Inclusion criteria for the study:
- •ACDF due to cervical disc disease (disc herniation with or without osteophytes, or stenosis caused by osteophytes) in one or two segmental levels
- •Aged 18-75 years
- •Residual disability (approximately) 3 months after surgery (at the re-visit to the surgeon/ physiotherapist at the neurosurgery/ neuroorthopedic clinic) in terms of the Neck Disability Index (NDI ≥30%).
- •Access to a computer/tablet/smartphone and the Internet
- •Motivated to exercise
排除标准
- •Exclusion criteria:
- •Myelopathy
- •Previous fracture or dislocation of the cervical spine
- •Malignancy or benign spinal tumour (e.g. neuromas)
- •Spinal infection, ongoing post-operative infection, or previous spondylodiscitis
- •Previous cervical spine surgery
- •Factors that are contraindicated for study participation or which hinder treatment or follow-up because of systemic disease, physical or mental illness, injury, inconvenience, or postoperative complications.
- •Known alcohol/drug abuse
- •Lack of ability to write/comprehend/or express oneself in the Swedish language
研究组 & 干预措施
Prescribed Physical Activity
General physical exercises combined with 3 visits at a physiotherapy clinic (plus an additional first visit), exercises mainly performed outside the health care system during 12 weeks.
干预措施: Prescribed Physical Activity (Other)
Exercises with Internet support
Neck-specific exercises with Internet support combined with 3 visits at a physiotherapy clinic (plus an additional first visit), exercises mainly performed outside the health care system during 12 weeks.
干预措施: Exercises with Internet support (Other)
结局指标
主要结局
Neck Disability Index (NDI)
时间窗: Change from baseline to 3 months (the end of treatment) and 24 months follow-up. Preoperative data from the Swespine register
Self-reported neck-specific function
次要结局
- Distribution of pain by a Pain Drawing assessed with images(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Use of pain medications(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Pain intensities of the neck, arm, and head, measured using the Visual Analogue Scale (VAS 0-100 mm).(Change from baseline to 3 months (the end of treatment) and 24 months follow-up. Pre-operative data from the Swespine register)
- Pain intensities for the neck and arm will be assessed and registered using the Numeric Rating Scale (NRS) 0-10 scale in accordance with the Swespine registry(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Dizziness/balance by the Dizziness Handicap Inventory (DHI)(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Confidence in ability measured by the Self-Efficacy Scale (SES).(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Hospital Anxiety and Depression Scale (HAD).(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Work Ability Index (WAI), short form(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Modified Odom(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Fear Avoidance Beliefs Questionnaire (FABQ).(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Health related quality of life measured by the EuroQuol five dimensions (EQ-5D)(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Requirements - effort support in the workplace: Effort Reward Imbalance (ERI)(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Ergonomics questions and how work is perceived(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Swedish Standard Classification of Occupations (SSY) code(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Patient Enablement Instrument (PEI) questionnaire(Follow-up at 3 months (the end of treatment) and 24 months follow-up)
- Health-care consumption, number of visits(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Consumption of analgesic drugs prescribed through the drug registry(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Endurance in the dorsal and ventral neck muscles, measured in seconds(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- MRI may be measured in a sub-group(Change from baseline to 3 months follow-up)
- Global rating of change scale(Change from baseline to 3 and 24 months follow-ups, measured at follow-ups)
- Headache questions by VAS and the Headache Handicap Inventory (HIT-6)(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Disaster thoughts measured by the Pain Catastrophising Scale (PCS).(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Patient Specific Functional Scale (PSFS).(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Sickness presence measured by the Stanford preseenteism scale(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Satisfaction with symptoms measured by the Cherkin symptom satisfaction scale(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Level of physical activity score, a combination of 2 questions (everyday physical activity and exercise/sport/open-air activity) to a combined 4-point score(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Sick-leave registration, number of days and episodes(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Neck movement measured using the cervical range of motion device (CROM) in degrees(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Ultrasound registrations may be measured in a sub-group, deformation and deformation rate(Change from baseline to 3 months follow-up)
- Frequency of pain(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Sensorimotor control of ventral neck muscles, in the supine position, with stabilizer (mm HG)(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Neurology, clinical judgement yes/no(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Standing on one leg with eyes closed (Solec test)(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Hand strength measured with a hand dynamometer (Jamar)(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
- Conventional radiography, with side views taken during neutral positioning and dynamic flexion/extension(Occurs routinely in the clinic for visits 3 months after surgery. Additional X-rays will be taken at the 2-year follow up to)
- Register data for care use. To measure/monitor care use(Change from baseline to 3 months (the end of treatment) and 24 months follow-up)
研究者
Anneli Peolsson
Professor, PhD, PT
Linkoeping University