Physiotherapy after anterior cervical spine surgery for cervical disc disease: study protocol of a prospective randomised study to compare internet-based neck-specific exercise with prescribed physical activity

• Published in: BMJ open 2019, Vol.9 (2), p.e027387
• Main Authors: Peolsson, Anneli, Peterson, Gunnel, Hermansen, Anna, Ludvigsson, Maria Landén, Dedering, Åsa, Löfgren, Håkan
• Format: Article
• Language: English
• Subjects: Biomechanical Phenomena; Cervical Vertebrae - physiopathology; Cervical Vertebrae - surgery; Cost-Benefit Analysis; Decompression, Surgical - adverse effects; Decompression, Surgical - economics; Decompression, Surgical - rehabilitation; Exercise; Humans; Hypotheses; Internet; Intervertebral Disc Degeneration - economics; Intervertebral Disc Degeneration - surgery; Intervertebral Disc Displacement - economics; Intervertebral Disc Displacement - surgery; Multicenter Studies as Topic; Neck pain; Orthopedic Procedures - adverse effects; Orthopedic Procedures - economics; Orthopedic Procedures - rehabilitation; Patient satisfaction; Physical fitness; Physical therapy; Physical Therapy Modalities - economics; Primary care; Prospective Studies; Quality of life; Radiculopathy - diagnosis; Radiculopathy - surgery; Randomized Controlled Trials as Topic; Recovery of Function; Rehabilitation; Smartphones; Sports and Exercise Medicine; Surgery; Sweden; Time Factors; Treatment Outcome; Work Capacity Evaluation
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2018-027387

IntroductionPatients suffering from remaining disability after anterior cervical decompression and fusion (ACDF) surgery for cervical disc disease may be prescribed physical activity (PPA) or neck-specific exercises (NSEs). Currently, we lack data for the success of either approach. There is also a knowledge gap concerning the use of internet-based care for cervical disc disease. The scarcity of these data, and the high proportion of patients with various degrees of incapacity following ACDF, warrant increased efforts to investigate and improve cost-effective rehabilitation. The objective is to compare the effectiveness of a structured, internet-based NSE programme, versus PPA following ACDF surgery.Methods and analysisThis is a prospective, randomised, multicentre study that includes 140 patients with remaining 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 at 3 months postsurgery. Patients are then randomised to one of two groups (70 patients/group) for a 3-month treatment programme/period 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, along with physical measures of neck-related function conducted by independent test leaders blinded to randomisation. Measures are collected 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. Data on healthcare consumption, drug use and sick leave will be requested from the relevant national registers.Ethical considerationsThis study was approved by the Regional Ethical Review Board in Linköping Ref. 2016/283–31 and 2017/91– 32. The scientists are independent with no commercial ties. Patients are recruited after providing written informed consent. Patient data are presented at group level such that no connection to any individual can be made. All data are anonymised when reported, and subject to the Swedish Official Secrets Health Acts. The test leaders are independent and blinded for randomisation. Exercises, both general and neck-specific, have been used extensively in clinical practice and we anticipate no harm from their implementation other than a risk of m