Comparison of the patient-derived modified Japanese Orthopaedic Association scale and the European myelopathy score.

PURPOSE: To compare the patient-derived modified Japanese Orthopaedic Association (P-mJOA) scale with the European myelopathy score (EMS) for the assessment of patients with degenerative cervical myelopathy (DCM). METHODS: In this register-based cohort study with prospectively collected data, included patients were surgically treated for DCM and had reported both P-mJOA and EMS scores at baseline, 1-year follow-up, and/or 2-year follow-up to the Swedish Spine Register. P-mJOA and EMS scores were defined as severe (P-mJOA 0-11 and EMS 5-8), moderate (P-mJOA 12-14 and EMS 9-12), or mild (P-mJOA 15-18 and EMS 13-18). P-mJOA and EMS mean scores were compared, and agreement was evaluated with Spearman's rank correlation coefficient (ρ), the intraclass correlation coefficient (ICC), and kappa (κ) statistics. RESULTS: Included patients (n = 714, mean age 63.2 years, 42.2% female) completed 937 pairs of the P-mJOA and the EMS. The mean P-mJOA and EMS scores were 13.9 ± 3.0 and 14.5 ± 2.7, respectively (mean difference -0.61 [95% CI -0.72 to -0.51; p < 0.001]). Spearman's ρ was 0.84 (p < 0.001), and intra-rater agreement measured with ICC was 0.83 (p < 0.001). Agreement of severity level measured with unweighted and weighted κ was fair (κ = 0.22 [p < 0.001]; κ = 0.34 [p < 0.001], respectively). Severity levels were significantly higher using the P-mJOA (p < 0.001). CONCLUSION: The P-mJOA and the EMS had similar mean scores, and intra-rater agreement was high, whereas severity levels only demonstrated fair agreement. The EMS has a lower sensitivity for detecting severe myelopathy but shows an increasing agreement with the P-mJOA for milder disease severity. A larger interval to define severe myelopathy with the EMS is recommended.

Determining the level of cervical radiculopathy: Agreement between visual inspection of pain drawings and magnetic resonance imaging.

BACKGROUND AND AIMS: Pain drawings are commonly used in the clinical assessment of people with cervical radiculopathy. This study aimed to assess (1) the agreement of clinical interpretation of pain drawings and MRI findings in identifying the affected level of cervical radiculopathy, (2) the agreement of these predictions based on the pain drawing among four clinicians from two different professions (i.e., physiotherapy and surgery) and (3) the topographical pain distribution of people presenting with cervical radiculopathy (C4-C7). METHODS: Ninety-eight pain drawings were obtained from a baseline assessment of participants in a randomized clinical trial, in which single-level cervical radiculopathy was determined using MRI. Four experienced clinicians independently rated each pain drawing, attributing the pain distribution to a single nerve root (C4-C7). A post hoc analysis was performed to assess agreement. OUTCOME MEASURES: Percentage agreement and kappa values were used to assess the level of agreement. Topographic pain frequency maps were created for each cervical radiculopathy level as determined by MRI. RESULTS: The radiculopathy level determined from the pain drawings showed poor overall agreement with MRI (mean = 35.7%, K = -0.007 to 0.139). The inter-clinician agreement ranged from fair to moderate (K = 0.212-0.446). Topographic frequency maps revealed that pain distributions were widespread and overlapped markedly between patients presenting with different levels cervical radiculopathy. CONCLUSION: This study revealed a lack of agreement between the segmental level affected determined from the patient's pain drawing and the affected level as identified on MRI. The large overlap of pain and non-dermatomal distribution of pain reported by patients likely contributed to this result.

Work Ability After Anterior Cervical Decompression and Fusion Followed by a Structured Postoperative Rehabilitation: Secondary Outcomes of a Prospective Randomized Controlled Multi-Centre Trial with a 2-year Follow-up.

Purpose Information on work ability after ACDF and postoperative rehabilitation is lacking. The aim of the present study is therefore to investigate the work ability benefits of a structured postoperative treatment (SPT) over a standard care approach (SA) in patients who underwent anterior cervical decompression and fusion (ACDF) for cervical radiculopathy and factors important to the 2-year outcome. Methods Secondary outcome and prediction model of a prospective randomized controlled multi-centre study with a 2-year follow-up (clinicaltrials.gov NCT01547611). The Work Ability Index (WAI) and Work Ability Score (WAS) were measured at baseline and up to 2 years after ACDF in 154 patients of working age who underwent SPT or SA after surgery. Predictive factors for the WAI at 2 years were analysed. Results Both WAI and WAS significantly improved with SPT and SA (p < 0.001), without any between-group differences. Thoughts of being able to work within the next 6 months, Neck Disability Index (NDI), and work-related neck load explained 59% of the variance in WAI at the 2-year follow-up after ACDF. Conclusions Patients improved over time without group differences, suggesting the improvement to be surgery related. Expectation to work within the next 6 months, self-reported neck functioning and work-related neck load were important to work ability and are central factors to ask early after ACDF, to identifying further interventions promoting return to work.

Neck-Related Physical Function, Self-Efficacy, and Coping Strategies in Patients With Cervical Radiculopathy: A Randomized Clinical Trial of Postoperative Physiotherapy.

OBJECTIVE: The purpose of this study was to compare postoperative rehabilitation with structured physiotherapy to the standard approach in patients with cervical radiculopathy (CR) in a prospective randomized study at 6 months follow-up based on measures of neck-related physical function, self-efficacy, and coping strategies. METHODS: Patients with persistent CR and scheduled for surgery (N = 202) were randomly assigned to structured postoperative physiotherapy or a standard postoperative approach. Structured postoperative physiotherapy combined neck-specific exercises with a behavioral approach. Baseline, 3-month, and 6-month evaluations included questionnaires and clinical examinations. Neck muscle endurance, active cervical range of motion, self-efficacy, pain catastrophizing (CSQ-CAT), perceived control over pain, and ability to decrease pain were analyzed for between-group differences using complete case and per-protocol approaches. RESULTS: No between-group difference was reported at the 6-month follow-up (P = .05-.99), but all outcomes had improved from baseline (P < .001). Patients undergoing structured postoperative physiotherapy with ≥50% attendance at treatment sessions had larger improvements in CSQ-CAT (P = .04) during the rehabilitation period from 3 to 6 months after surgery compared with the patients who received standard postoperative approach. CONCLUSIONS: No between-group difference was found at 6 months after surgery based on measures of neck-related physical function, self-efficacy, and coping strategies. However, the results confirm that neck-specific exercises are tolerated by patients with CR after surgery and may suggest a benefit from combining surgery with structured postoperative physiotherapy for patients with CR.

Individual factors associated with neck disability in patients with cervical radiculopathy scheduled for surgery: a study on physical impairments, psychosocial factors, and life style habits.

PURPOSE: The influence of individual factors on patient-reported outcomes is important in the interpretation of disability and treatment effectiveness. The purpose of this study was to assess how physical impairments, psychosocial factors, and life style habits were associated with neck disability based on the Neck Disability Index (NDI), in patients with cervical radiculopathy scheduled for surgery. METHODS: This cross-sectional study included 201 patients (105 men, 96 women; mean age 50 years). Data included self-reported measures and a clinical examination. Multiple linear regressions were performed to identify significant influencing factors. RESULTS: Pain, physical impairments in the cervical active range of motion, low self-efficacy, depression, and sickness-related absences explained 73% of the variance in NDI scores (p < 0.001). CONCLUSION: Assessments of physical impairments and psychosocial factors in patients with cervical radiculopathy could improve the description of neck disability and the interpretation of treatment outcomes in longitudinal studies.

Outcome of physiotherapy after surgery for cervical disc disease: a prospective randomised multi-centre trial.

BACKGROUND: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01547611.

Comparison of posterior muscle-preserving selective laminectomy and laminectomy with fusion for treating cervical spondylotic myelopathy: study protocol for a randomized controlled trial.

BACKGROUND: Cervical spondylotic myelopathy (CSM) is the predominant cause of spinal cord dysfunction in the elderly. The patients are often frail and susceptible to complications. Posterior surgical techniques involving non-fusion are complicated by postlaminectomy kyphosis and instrumented fusion techniques by distal junction kyphosis, pseudarthrosis, or implant failure. The optimal surgical approach is still a matter of controversy. Since anterior and posterior fusion techniques have been compared without presenting any superiority, the objective of this study is to compare stand-alone laminectomy with laminectomy and fusion to determine which treatment has the lowest frequency of reoperations. METHODS: This is a multicenter randomized, controlled, parallel-group non-inferiority trial. A total of 300 adult patients are allocated in a ratio of 1:1. The primary endpoint is reoperation for any reason at 5 years of follow-up. Sample size and power calculation were performed by estimating the reoperation rate after laminectomy to 3.5% and after laminectomy with fusion to 7.4% based on the data from the Swedish spine registry (Swespine) on patients with CSM. Secondary outcomes are the patient-derived Japanese Orthopaedic Association (P-mJOA) score, Neck Disability Index (NDI), European Quality of Life Five Dimensions (EQ-5D), Numeric Rating Scale (NRS) for neck and arm pain, Hospital Anxiety and Depression Scale (HADS), development of kyphosis measured as the cervical sagittal vertical axis (cSVA), and death. Clinical and radiological follow-up is performed at 3, 12, 24, and 60 months after surgery. The main inclusion criterium is 1-4 levels of CSM in the subaxial spine, C3-C7. The REDcap software will be used for safe data management. Data will be analyzed according to the modified intention to treat (mITT) population, defined as randomized patients who are still alive without having emigrated or left the study after 2 and 5 years. DISCUSSION: This will be the first randomized controlled trial comparing two of the most common surgical treatments for CSM: the posterior muscle-preserving selective laminectomy and posterior laminectomy with instrumented fusion. The results of the myelopathy randomized controlled (MyRanC) study will provide surgical treatment recommendations for CSM. This may result in improvements in surgical treatment and clinical practice regarding CSM. TRIAL REGISTRATION: ClinicalTrials.gov NCT04936074 . Registered on 23 June 2021.

Neurological outcomes after surgery and postoperative rehabilitation for cervical radiculopathy due to disc disease: a 2-year-follow-up of a randomized clinical trial.

Reports on neurological outcomes in patients with cervical radiculopathy (CR) undergoing surgery and postoperative rehabilitation are important to inform prognosis. This 2-year-follow-up of a randomized clinical trial aimed to compare secondary neurological outcomes between structured postoperative rehabilitation and a standard approach after surgery for CR. A secondary aim was to increase knowledge about recovery of neurological impairments in relation to patient-reported neck disability. Neurological outcomes included assessment of sensibility, motor function, arm reflexes and the Spurling test. A total of 153 and 135 participants (> 70% response rate) completed the clinical examination. Between-group differences, changes over time, and associations between persistent neurological impairments and the Neck Disability Index were investigated. No between-group differences were reported (p > 0.07), and neurological impairments in sensibility, motor function, and a positive Spurling test decreased over time in both groups (p < 0.04). Persistent impairments in sensibility and reflex arm were most frequent at follow-up, whereas, a persistent positive Spurling test, and impairments in motor function were associated with higher NDI score. Neurological outcomes improved over time in patients undergoing surgery for CR with no between-group differences., However, persistent neurological impairments were common, and associated with poorer outcome for patient-reported neck disability.Clinical registration: clinicaltrial.gov NCT01547611, 08/03/2012, Title: Outcome of physiotherapy after surgery for cervical disc disease: a prospective multi-centre trial.

Dizziness and balance outcomes after two different postoperative rehabilitation approaches following neck surgery: analyses of a multicenter randomized controlled trial.

BACKGROUND: Dizziness and balance problems are common symptoms in patients with cervical radiculopathy. OBJECTIVE: To evaluate the effect of neck surgery postoperatively combined with either structured rehabilitation or standard approach in patients with cervical radiculopathy and dizziness and/or balance problems, and investigate factors influencing dizziness and balance at 6-month follow-up. METHODS: Individuals (n = 149) with cervical radiculopathy and dizziness and/or balance problems were randomized preoperatively to structured postoperative rehabilitation or standard postoperative approach. Outcomes were intensity of dizziness and subjective balance, and clinical measures of balance. RESULTS: Self-reported measures improved at three months (p ˂ 0.001 to p = .007) and the standing balance at six months (p = .008). No between-group differences. Baseline values, neck pain, and physical activity level explained 23-39% of the variance in 6-month outcomes for self-reported measures. Baseline values and physical activity level explained 71% of the variance in walking balance, and lower baseline scores were significantly associated with standing balance impairments (OR 0.876). CONCLUSION: Patients improved significantly in dizziness and subjective balance intensity shortly after surgery, and in standing balance at 6 months, independent of postoperative rehabilitation. Neck pain, physical activity, and neck muscle function influenced dizziness and balance, although preoperative values and neck pain were of most importance for 6-month outcomes.

Artificial disc replacement and adjacent-segment pathology: 10-year outcomes of a randomized trial.

OBJECTIVE: Artificial disc replacement (ADR) is designed to preserve motion and thus protect against adjacent-segment pathology (ASP) and act as an alternative treatment to fusion surgery. The question remains, how well do ADR devices perform after 10 years of follow-up compared with fusion surgery in terms of patient satisfaction, sustainability, and protection against ASP? METHODS: This was the 10-year follow-up study of 153 participants who underwent ADR or fusion surgery after anterior decompression due to cervical degenerative radiculopathy (ISRCTN registration no. 44347115). Scores on the Neck Disability Index (NDI), EQ-5D, and visual analog scale for neck and arm pain were obtained from the Swedish Spine Registry and analyzed using ANCOVA. Information about secondary surgical procedures was collected from medical records and presented as Kaplan-Meier curves. MRI and flexion-extension radiography were performed, and ASP was graded according to the Miyazaki classification system. RESULTS: Ten participants were lost to follow-up, which left 143 participants (80 underwent ADR and 65 underwent anterior cervical discectomy and fusion). There were no differences between groups in terms of patient-reported outcome measures (10-year difference in NDI scores 1.7 points, 95% CI -5.1 to 8.5, p = 0.61). Nineteen (24%) participants in the ADR group compared with 9 (14%) in the fusion group underwent secondary surgical procedures. The higher reoperation rate of the ADR group was mainly due to 11 female participants with device loosening. The rates of reoperation due to ASP were similar between groups, which was confirmed with MRI assessment of ASP that also showed no differences between the groups (p = 0.21). CONCLUSIONS: This was the first 10-year follow-up study to compare ADR with fusion surgery and to provide MRI information for the assessment of ASP. The authors found no benefit of ADR over fusion surgery after anterior decompression for cervical degenerative radiculopathy.

Larger pain extent is associated with greater pain intensity and disability but not with general health status or psychosocial features in patients with cervical radiculopathy.

ABSTRACT: Pain as a result of cervical radiculopathy (CR) can be widespread, nondermatomal and individually specific, but the association between pain extent and other clinical features has never been explored. The objective of this study is to investigate whether pain extent relates to clinical variables including pain intensity in addition to health indicators including disability, general health, depression, somatic anxiety, coping strategies or self-efficacy.An observational cohort study was conducted. Participants were recruited from 4 hospital spinal centres in Sweden. Pain extent was quantified from the pain drawings of 190 individuals with cervical disc disease, verified with magnetic resonance imaging (MRI) and compatible with clinical findings (examined by a neurosurgeon), that show cervical nerve root compression. Pain extent was evaluated in relation to neck pain, arm pain, and headache intensity. Multiple linear regression analysis were then used to verify whether pain extent was associated with other health indicators including disability, health-related quality of life, depression, somatic anxiety, coping strategies and self-efficacy.Pain extent was directly related to neck, arm and headache pain intensity (all P < .01). Multiple linear regression revealed that pain extent was significantly associated only to the level of perceived disability (P < .01).Increased pain extent in people with CR is associated with higher headache, neck and arm pain intensity, and disability but not measures of general health, depression, somatic anxiety, coping strategies or self-efficacy.

Clinical and radiological evaluation of Trabecular Metal and the Smith-Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up.

A prospective, randomized, controlled study was carried out to compare the radiological and clinical outcomes after anterior cervical decompression and fusion (ACDF) with Trabecular Metal (TM) to the traditional Smith-Robinson (SR) procedure with autograft. The clinical results of cervical fusion with autograft from the iliac crest are typically satisfactory, but implications from the donor site are frequently reported. Alternative materials for cervical body interfusion have shown lower fusion rates. Trabecular Metal is a porous tantalum biomaterial with structure and mechanical properties similar to that of trabecular bone and with proven osteoconductivity. As much as 80 consecutive patients planned for ACDF were randomized for fusion with either TM or tricortical autograft from the iliac crest (SR) after discectomy and decompression. Digitized plain radiographic images of 78 (98%) patients were obtained preoperatively and at 2-year follow-up and were subsequently evaluated by two senior radiologists. Fusion/non-fusion was classified by visual evaluation of the A-P and lateral views in forced flexion/extension of the cervical spine and by measuring the mobility between the fused vertebrae. MRI of 20 TM cases at 2 years was successfully used to assess the decompression of the neural structures, but was not helpful in determining fusion/non-fusion. Pain intensity in the neck, arms and pelvis/hip were rated by patients on a visual analog scale (VAS) and neck function was rated using the Neck Disability Index (NDI) the day before surgery and 4, 12 and 24 months postoperatively. Follow-ups at 12 and 24 months were performed by an unbiased observer, when patients also assessed their global outcome. Fusion rate in the SR group was 92%, and in the TM group 69% (P < 0.05). The accuracy of the measurements was calculated to be 2.4 degrees . Operating time was shorter for fusion with TM compared with autograft; mean times were 100 min (SD 18) and 123 min (SD 23), respectively (P = 0.001). The patients' global assessments of their neck and arm symptoms 2 years postoperatively for the TM group were rated as 79% much better or better after fusion with TM and 75% using autograft. Pain scores and NDI scores were significantly improved in both groups when compared with baseline at all follow-ups, except for neck pain at 1 year for the TM group. There was no statistically significant difference in clinical outcomes between fusion techniques or between patients who appeared radiologically fused or non-fused. There was no difference in pelvic/hip pain between patients operated on with or without autograft. In our study, Trabecular Metal showed a lower fusion rate than the Smith-Robinson technique with autograft after single-level anterior cervical fusion without plating. There was no difference in clinical outcomes between the groups. The operative time was shorter with Trabecular Metal implants.

Sagittal Alignment After Laminectomy Without Fusion as Treatment for Cervical Spondylotic Myelopathy: Follow-up of Minimum 4 Years Postoperatively.

OBJECTIVES: The aims of this study were to evaluate the incidence of sagittal malalignment including kyphosis following cervical laminectomy without fusion as treatment for cervical spondylotic myelopathy and to assess any correlation between malalignment and clinical outcome. STUDY DESIGN: Retrospective cohort study. METHODS: In all, 60 patients were followed up with conventional radiography at an average of 8 years postoperatively. The cervical lordosis (C2-C7 Cobb angle), C2-C7 sagittal vertical axis (cSVA) and C7 slope were measured on both preoperative and postoperative images. Patients completed a questionnaire covering Neck Disability Index (NDI), visual analogue scale for neck pain, and general health (EQ-5D). RESULTS: Mean C2-C7 Cobb angle was 8.6° (SD 9.0) preoperatively, 3.4° (10.7) postoperatively and 9.6° (14.5) at follow-up. Ultimately, 3 patients showed >20° cervical kyphosis. Mean cSVA was 16.3 mm (SD 10.2) preoperatively, 20.6 mm (11.8) postoperatively, and 31.6 mm (11.8) at follow-up. Mean C7 slope was 20.4° (SD 8.9) preoperatively, 18.4° (9.4) postoperatively, and 32.6° (10.2) at follow-up. The preoperative to follow-up increase in cSVA and C7 slope was statistically significant (both P < .0001), but not for cervical lordosis. The preoperative to follow-up change in cSVA correlated moderately with preoperative cSVA (r = 0.43, P = .002), as did the corresponding findings regarding C7 slope (r = 0.52, P = .0001). A comparison of radiographic measurements with clinical outcome showed no strong correlations. CONCLUSIONS: No preoperative to follow-up change in cervical lordosis was found in this group; 5.0% developed >20° kyphosis. No clear correlation between sagittal alignment and clinical outcome was shown.

Probing the mechanisms underpinning recovery in post-surgical patients with cervical radiculopathy using Bayesian networks.

BACKGROUND: Rehabilitation approaches should be based on an understanding of the mechanisms underpinning functional recovery. Yet, the mediators that drive an improvement in post-surgical pain-related disability in individuals with cervical radiculopathy (CR) are unknown. The aim of the present study is to use Bayesian networks (BN) to learn the probabilistic relationships between physical and psychological factors, and pain-related disability in CR. METHODS: We analysed a prospective cohort dataset of 201 post-surgical individuals with CR. In all, 15 variables were used to build a BN model: age, sex, neck muscle endurance, neck range of motion, neck proprioception, hand grip strength, self-efficacy, catastrophizing, depression, somatic perception, arm pain intensity, neck pain intensity and disability. RESULTS: A one point increase in a change of self-efficacy at 6 months was associated with a 0.09 point decrease in a change in disability at 12 months (t = -64.09, p < .001). Two pathways led to a change in disability: a direct path leading from a change in self-efficacy at 6 months to disability, and an indirect path which was mediated by neck and arm pain intensity changes at 6 and 12 months. CONCLUSIONS: This is the first study to apply BN modelling to understand the mechanisms of recovery in post-surgical individuals with CR. Improvements in pain-related disability was directly and indirectly driven by changes in self-efficacy levels. The present study provides potentially modifiable mediators that could be the target of future intervention trials. BN models could increase the precision of treatment and outcome assessment of individuals with CR. SIGNIFICANCE: Using Bayesian Network modelling, we found that changes in self-efficacy levels at 6-month post-surgery directly and indirectly influenced the change in disability in individuals with CR. A mechanistic understanding of recovery provides potentially modifiable mediators that could be the target of future intervention trials.

Clinical predictive modelling of post-surgical recovery in individuals with cervical radiculopathy: a machine learning approach.

Prognostic models play an important role in the clinical management of cervical radiculopathy (CR). No study has compared the performance of modern machine learning techniques, against more traditional stepwise regression techniques, when developing prognostic models in individuals with CR. We analysed a prospective cohort dataset of 201 individuals with CR. Four modelling techniques (stepwise regression, least absolute shrinkage and selection operator [LASSO], boosting, and multivariate adaptive regression splines [MuARS]) were each used to form a prognostic model for each of four outcomes obtained at a 12 month follow-up (disability-neck disability index [NDI]), quality of life (EQ5D), present neck pain intensity, and present arm pain intensity). For all four outcomes, the differences in mean performance between all four models were small (difference of NDI < 1 point; EQ5D < 0.1 point; neck and arm pain < 2 points). Given that the predictive accuracy of all four modelling methods were clinically similar, the optimal modelling method may be selected based on the parsimony of predictors. Some of the most parsimonious models were achieved using MuARS, a non-linear technique. Modern machine learning methods may be used to probe relationships along different regions of the predictor space.

Neck-Related Headache in Patients With Cervical Disc Disease After Surgery and Physiotherapy: A 1-Year Follow-up of a Prospective Randomized Study.

STUDY DESIGN: A prospective randomized multicenter trial. OBJECTIVE: To investigate the effects of surgery with either structured postoperative physiotherapy or standard postoperative approach on neck-related headache in patients with cervical radiculopathy. Secondary, to investigate associations between change in neck-related headache and change in neck muscle endurance, neck mobility, or neck pain. SUMMARY OF BACKGROUND DATA: The effect of physiotherapy on individuals with neck-related headache after surgery for cervical radiculopathy due to magnetic resonance imaging-verified disc disease is unknown. METHODS: One hundred six patients with neck-related headache and participating in a randomized controlled trial evaluating the additional effects of physiotherapy after surgery for cervical radiculopathy were included. Patients were randomized preoperatively to structured postoperative physiotherapy (n = 51) or the standard postoperative approach (n = 55). Outcome measures were headache intensity and neck pain intensity, neck muscle endurance, and neck mobility. Measures were obtained preoperatively and at 6 weeks, 3 months, 6 months, and 1 year postoperatively. RESULTS: Headache intensity significantly changed from baseline to 1 year postoperatively (P < 0.001) in both groups. Post-hoc tests showed a significant difference between baseline and 6 weeks (P ≤ 0.05). No significant differences were found between groups (P > 0.05) or between-group differences in changes over time (P > 0.05). The change in current headache intensity over time was associated with a change in current neck pain intensity over time (P = 0.003, ß = 0.40). CONCLUSION: There was a significant improvement in headache intensity 1 year postoperatively in patients with cervical radiculopathy and neck-related headache, but there were no differences between groups over time. Change in current headache intensity was only associated with a change in current neck pain intensity. LEVEL OF EVIDENCE: 2.

Postoperative structured rehabilitation in patients undergoing surgery for cervical radiculopathy: a 2-year follow-up of a randomized controlled trial.

OBJECTIVE: Information about postoperative rehabilitation for cervical radiculopathy (CR) is scarce. The aim of this study was to investigate the additional benefits of structured postoperative rehabilitation (SPT), which was performed in all patients, compared with a pragmatic standard postoperative approach (SA), in which rehabilitation was used as needed and patients sought physiotherapy on their own without a referral, in patients with MRI evidence of disc herniation and concomitant clinical signs who underwent surgery for CR. METHODS: Patients (n = 202) were randomized to receive SPT or SA. Included key variables in the present study were primary and selected secondary outcomes of a prospective randomized controlled multicenter study. The main outcome was the Neck Disability Index (NDI) score. The NDI score, pain variables, self-efficacy, and health-related quality of life were investigated at baseline and 3, 6, 12, and 24 months postoperatively. RESULTS: SPT provided no additional benefits over SA (p = 0.08 to p = 0.99) at the postoperative 2-year follow-up. Both groups improved over time (p < 0.0001), with no reported adverse effects. CONCLUSIONS: One can conclude that SPT offered no additional benefits over SA; however, patients tolerated postoperative neck exercises without any negative side effects. These findings are important for the development of future active and neck-specific postoperative rehabilitation interventions for patients with CR.Clinical trial registration no.: NCT01547611 (clinicaltrials.gov).

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.

INTRODUCTION: Patients 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 ANALYSIS: This 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 CONSIDERATIONS: This 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 muscle soreness. Both randomisation groups will receive care that is expected to relieve pain, although the group receiving NSE is expected to demonstrate a greater and more cost-effective improvement versu s the PPA group. Any significant harm or unintended effects in each group will be collected by the test leaders. All questionnaires and test materials are coded by the research group, with code lists stored in locked, fireproof file cabinets, housed at the university in a room with controlled (card-based) access. Only individuals in receipt of a unique website address posted by the researchers can access the programme; patients can neither communicate with each other nor with caregivers via the programme.Study participation might lead to improved rehabilitation versus non-participation, and might therefore be of benefit. The results of this study should also contribute to more effective and flexible rehabilitation, shorter waiting times, lower costs and the possibility to implement our findings on a wider level. DISSEMINATION: If effective, the protocols used in this study can be implemented in existing healthcare structures. The results of the study will be presented in scientific journals and popular science magazines of relevance to health. The findings will also be presented at local, regional, national and international conferences and meetings, as well as in the education of university students and at public lectures. Information about the results will be communicated to the general population in cooperation with patient organisations and the media. TRIAL REGISTRATION: NCT03036007.

Artificial disc replacement versus fusion in patients with cervical degenerative disc disease and radiculopathy: a randomized controlled trial with 5-year outcomes.

In BriefIn this study the authors compare cervical arthroplasty with fusion surgery in a randomized controlled trial using patient-reported outcome measures and MRI after 5 years of follow-up. Because the main purpose of arthroplasties is to prevent adjacent-segment pathology, it is important to investigate if that is actually realized in practice.

Structured postoperative physiotherapy in patients with cervical radiculopathy: 6-month outcomes of a randomized clinical trial.

OBJECTIVE Structured physiotherapy has been suggested as treatment before as well as after surgery to improve clinical outcomes in patients with cervical radiculopathy (CR), but randomized clinical trials to inform evidence-based clinical guidelines for the treatment of patients with CR after surgery are lacking. The aim of this study was to compare the results of structured postoperative physiotherapy combining neck-specific exercises with a behavioral approach to a standard postoperative approach in patients who had undergone surgery for cervical disc disease with CR at 6 months after surgery. METHODS Patients with cervical disc disease and persistent CR who were scheduled for surgery were randomized preoperatively to structured postoperative physiotherapy (n = 101) or a standard postoperative approach (n = 100). The latter included pragmatic physiotherapy in accordance with the usual Swedish postoperative care. Outcome measures included patient-reported neck disability as measured with the Neck Disability Index (NDI), intensity and frequency of neck and arm pain, global outcome of treatment, and expectation fulfillment, as well as enablement. RESULTS Patients who received structured postoperative physiotherapy reported greater expectation fulfillment (p = 0.01), and those who attended at least 50% of the treatment sessions reported less neck pain frequency (p = 0.05), greater expectation fulfillment (p = 0.001), and greater enablement (p = 0.04) compared with patients who received the standard postoperative approach. No other difference between treatment groups was found (p > 0.15). The NDI and neck and arm pain intensity were improved in both groups at 6 months after surgery (p < 0.001). Additional use of postoperative physiotherapy was reported by 61% of the patients who received the standard postoperative approach. CONCLUSIONS The results from this first randomized clinical trial of postoperative physiotherapy showed only minor additional benefit of structured postoperative physiotherapy compared with standard postoperative approach 6 months postoperatively in patients who underwent surgery for cervical disc disease with CR. Patients who received structured postoperative physiotherapy reported higher expectation fulfillment, and many patients in the standard postoperative approach group perceived a need for additional treatments after surgery, suggesting that patients with CR are in need of further postoperative support. The results confirm that neck-specific exercises are tolerated postoperatively by patients with CR, but more studies of postoperative physiotherapy are needed to inform clinical guidelines for this patient group. Clinical trial registration no.: NCT01547611 (clinicaltrials.gov).