| 1. |
- Holy, Marek, et al.
(författare)
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Operative treatment of cervical radiculopathy : anterior cervical decompression and fusion compared with posterior foraminotomy: study protocol for a randomized controlled trial
- 2021
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Ingår i: Trials. - : BioMed Central (BMC). - 1745-6215. ; 22:1
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Tidskriftsartikel (refereegranskat)abstract
- Background; Cervical radiculopathy is the most common disease in the cervical spine, affecting patients around 50-55 year of age. An operative treatment is common clinical praxis when non-operative treatment fails. The controversy is in the choice of operative treatment, conducting either anterior cervical decompression and fusion or posterior foraminotomy. The study objective is to evaluate short- and long-term outcome of anterior cervical decompression and fusion (ACDF) and posterior foraminotomy (PF) Methods: A multicenter prospective randomized controlled trial with 1:1 randomization, ACDF vs. PF including 110 patients. The primary aim is to evaluate if PF is non-inferior to ACDF using a non-inferiority design with ACDF as "active control." The neck disability index (NDI) is the primary outcome measure, and duration of follow-up is 2 years. Discussion: Due to absence of high level of evidence, the authors believe that a RCT will improve the evidence for using the different surgical treatments for cervical radiculopathy and strengthen current surgical treatment recommendation.
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| 2. |
- Kontakis, Michael G., et al.
(författare)
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Artificial disc replacement and adjacent-segment pathology : 10-year outcomes of a randomized trial
- 2022
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Ingår i: Journal of Neurosurgery. - : AMER ASSOC NEUROLOGICAL SURGEONS. - 1547-5654 .- 1547-5646. ; 36:6, s. 945-953
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 3. |
- MacDowall, Anna, et al.
(författare)
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Anxiety and depression affect pain drawings in cervical degenerative disc disease
- 2017
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Ingår i: Upsala Journal of Medical Sciences. - : TAYLOR & FRANCIS LTD. - 0300-9734 .- 2000-1967. ; 122:2, s. 99-107
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Pain drawings have been frequently used in the preoperative evaluation of spine patients. Until now most investigations have focused on low back pain patients, even though pain drawings are used in neck pain patients as well. The aims of this study were to investigate the pain drawing and its association to preoperative demographics, psychological impairment, and pain intensity. Methods: We carried out a post hoc analysis of a randomized controlled trial, comparing cervical disc replacement to fusion for radiculopathy related to degenerative disc disease. Preoperatively the patients completed a pain drawing, the Hospital Anxiety and Depression Scale (HADS), and a visual analogue scale (VAS). The pain drawing was evaluated according to four established methods, now modified for cervical conditions. Comparisons were made between the pain drawing and age, sex, smoking, and employment status as well as HADS and VAS. Results: Included were 151 patients, mean age of 47 years, female/male: 78/73. Pain drawing results were not affected by age, sex, smoking, and employment status. Patients with non-neurogenic pain drawings according to the modified method by Ransford had higher points on HADS-anxiety, HADS-depression, and HADS-total. Patients with markings in the head region had higher score on HADS-depression. Markings in the neck and lower arm region were associated with high values of VAS-neck and VAS-arm. Conclusions: Pain drawings were affected by both pain intensity and anxiety/depression in cervical spine patients. Therefore, the pain drawing can be a useful tool when interpreting the patients' pain in correlation to psychological impairment and pain location.
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| 4. |
- MacDowall, Anna, et al.
(författare)
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Artificial disc replacement versus fusion in patients with cervical degenerative disc disease and radiculopathy : a randomized controlled trial with 5-year outcomes
- 2019
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Ingår i: Journal of Neurosurgery. - 1547-5654 .- 1547-5646. ; 30:3, s. 323-331
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVEThe method of artificial disc replacement (ADR) has been developed as an alternative treatment to fusion surgery after decompression for cervical degenerative disc disease (DDD) with radiculopathy. Preserving the motion of ADR devices aims to prevent immobilization side effects such as adjacent-segment pathology (ASP). However, long-term follow-up evaluations using MRI are needed to investigate if this intent is achieved.METHODSThe authors performed a randomized controlled trial with 153 patients (mean age 47 years) undergoing surgery for cervical radiculopathy. Eighty-three patients received an ADR and 70 patients underwent fusion surgery. Outcomes after 5 years were assessed using patient-reported outcome measures using the Neck Disability Index (NDI) score as the primary outcome; motion preservation and heterotopic ossification by radiography; ASP by MRI; and secondary surgical procedures.RESULTSScores on the NDI were approximately halved in both groups: the mean score after 5 years was 36 (95% confidence interval [CI] 31–41) in the ADR group and 32 (95% CI 27–38) in the fusion group (p = 0.48). There were no other significant differences between the groups in six other patient-related outcome measures. Fifty-four percent of the patients in the ADR group preserved motion at the operated cervical level and 25% of the ADRs were spontaneously fused. Seventeen ADR patients (21%) and 7 fusion patients (10%) underwent secondary surgery (p = 0.11), with 5 patients in each group due to clinical ASP.CONCLUSIONSIn patients with cervical DDD and radiculopathy decompression as well as ADR, surgery did not result in better clinical or radiological outcomes after 5 years compared with decompression and fusion surgery.
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| 5. |
- MacDowall, Anna, et al.
(författare)
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Artificial Disc Replacement versus Fusion in Patients with Cervical Degenerative Disc Disease with radiculopathy : 5-year Outcomes from the National Swedish Spine Register
- 2019
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Ingår i: Journal of Neurosurgery. - 1547-5654 .- 1547-5646. ; 30:2, s. 159-167
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: The long-term efficacy of artificial disc replacement (ADR) surgery compared with fusion after decompression for the treatment of cervical degenerative disc disease and radiculopathy has not previously been investigated in a population-based setting.METHODS: All patients with cervical degenerative disc disease and radiculopathy who were in the national Swedish Spine Registry (Swespine) beginning in January 1, 2006, were eligible for the study. Follow-up information was obtained up to November 15, 2017. The authors compared, using propensity score matching, patients treated with anterior decompression and insertion of an ADR with patients who underwent anterior decompression combined with fusion surgery. The primary outcome was the Neck Disability Index (NDI), a patient-reported function score ranging from 0% to 100%, with higher scores indicating greater disability and a minimum clinically important difference of > 15%.RESULTS: A total of 3998 patients (2018: 1980 women/men) met the inclusion criteria, of whom 204 had undergone arthroplasty and 3794 had undergone fusion. After propensity score matching, 185 patients with a mean age of 49.7 years remained in each group. Scores on the NDI were approximately halved in both groups after 5 years, but without a significant mean difference in NDI (3.0%; 95% CI -8.4 to 2.4; p = 0.28) between the groups. There were no differences between the groups in EuroQol-5 Dimensions or in pain scores for the neck and arm.CONCLUSIONS: In patients with cervical degenerative disc disease and radiculopathy, decompression plus ADR surgery did not result in a clinically important difference in outcomes after 5 years, compared with decompression and fusion surgery.
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| 6. |
- MacDowall, Anna, 1976-
(författare)
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Cervical Radiculopathy : Studies on Pain Analysis and Treatment
- 2018
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Background: Knowledge about how to interpret pain-analyzing tools such as the pain drawing test and the visual analog scale (VAS) in cervical spine patients are sparse; hence, they have never been validated for this subgroup of patients. The method of artificial disc replacement (ADR) has been developed as an alternative treatment to fusion surgery after decompression for cervical degenerative disc disease (DDD) with radiculopathy. Preserved motion of ADR devices aims to prevent immobilization side effects such as stiffness, dysphagia and adjacent segment pathology. Long-term follow-ups of these devices compared with the gold standard treatment are needed to create future guidelines.Objectives: This thesis aims at (1) validating the pain drawing as an investigational tool for the cervical spine, (2) validating the VAS for the cervical spine regarding the measurement noise and the minimum clinically important difference (MCID), (3) comparing ADR with fusion surgery at 5-years of follow-up regarding outcome and complications in a randomized controlled trial (RCT) as well as in the Swedish spine (Swespine) registry, and (4) investigating possible predictors to outcome after surgical treatment of cervical radiculopathy.Methods: An RCT with 153 patients undergoing surgery for cervical radiculopathy was performed. Baseline data, the Neck disability index (NDI), two sets of VAS-neck and VAS-arm scores, the EQ-5D, Hospital anxiety and depression scale (HADS), Dysphagia short questionnaire and a pain drawing test were gathered preoperatively and after 5 years. Radiographs in flexion/extension and MRIs were done preoperatively and at follow-up. All patients registered in Swespine since January 1st, 2006 with cervical DDD and radiculopathy treated with ADR or fusion surgery, were included. Baseline data, the NDI, EQ-5D, and VAS-neck and VAS-arm scores were analyzed at 1, 2, 5 and 10-years of follow-up as well as the information regarding secondary surgeries.Results: Pain drawings interpreted with the simple body region method showed good inter-rater reliability in cervical spine patients. Markings in the upper arm region on the pain drawing predicted surgical treatment outcome and markings in the head region predicted depression. The measurement noise was ~10 mm and the MCID was ~20 mm on a 100 mm pain VAS. In both the RCT and Swespine register the outcome after ADR surgery were comparable with fusion at 5 years of follow-up, except for an elevated risk regarding secondary surgery on the index level in the ADR group. Fifty percent of the patients in the RCT, allocated to ADR surgery had preserved motion of less than 5°, at the 5-year follow-up, and 25%, mostly men were spontaneously fused. Preserved motion did not prevent adjacent segment pathology. High values of preoperative HADS scores were negative predictors of outcome.Conclusions: In patients with cervical DDD and radiculopathy both the pain drawing test and the VAS are validated tools to interpret the patients’ pain. Preoperative mental distress affects long-term outcome much more than the allocated treatment, ADR or fusion surgery in patients with cervical radiculopathy.Clinical Trial Registration: ISRCTN, registration number: 44347115.
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| 7. |
- MacDowall, Anna, et al.
(författare)
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Effects of preoperative mental distress versus surgical modality, arthroplasty, or fusion on long-term outcome in patients with cervical radiculopathy
- 2018
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Ingår i: Journal of Neurosurgery. - : AMER ASSOC NEUROLOGICAL SURGEONS. - 1547-5654 .- 1547-5646. ; 29:4, s. 371-379
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE Several efforts have been made to investigate the long-term efficacy of artificial disc replacement surgery compared with that of fusion after decompression for the treatment of cervical degenerative disc disease and radiculopathy. However, research on the impact of mental distress on surgical treatment outcome has been sparse. The aim of the authors was to investigate the potential predictive value of preoperative risk factors in determining long-term outcome. METHODS A total of 153 patients (mean age 47 years) with single-or double-level cervical degenerative disc disease and radiculopathy were randomly assigned to undergo either anterior cervical discectomy and fusion (n = 70) or artificial disc replacement (n = 83). The primary outcome was the Neck Disability Index (NDI) score, a patient-reported function score that ranges from 0% to 100%; higher scores indicate greater disability. Preoperative variables such as sex, age, smoking status, employment status, having a strenuous job, neck pain duration, arm pain duration, amount of regular exercise, Hospital Anxiety and Depression Scale (HADS) score, NDI score, whether surgery was performed on 1 or 2 levels, and allocated treatment were analyzed in multiple linear regression models with the 5-year NDI score as the outcome. RESULTS A total of 47 (31%) patients had either a HADS anxiety or HADS depression score of 10 points or higher. High values on the preoperative HADS were a negative predictor of outcome (p = 0.009). Treatment allocation had no effect on 5-year NDI scores (p = 0.32). CONCLUSIONS Preoperative mental distress measured with the HADS affects long-term outcome in surgically treated patients with cervical radiculopathy.
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| 8. |
- MacDowall, Anna, et al.
(författare)
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Pain drawings predict outcome of surgical treatment for degenerative disc disease in the cervical spine
- 2017
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Ingår i: Upsala Journal of Medical Sciences. - : Uppsala Medical Society. - 0300-9734 .- 2000-1967. ; 122:3, s. 194-200
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Pain drawings have been frequently used in the preoperative evaluation of spine patients. For lumbar conditions comprehensive research has established both the reliability and predictive value, but for the cervical spine most of this knowledge is lacking. The aims of this study were to validate pain drawings for the cervical spine, and to investigate the predictive value for treatment outcome of four different evaluation methods.METHODS: We carried out a post hoc analysis of a randomized controlled trial, comparing cervical disc replacement to fusion for radiculopathy related to degenerative disc disease. A pain drawing together with Neck Disability Index (NDI) was completed preoperatively, after 2 and 5 years. The inter- and intraobserver reliability of four evaluation methods was tested using κ statistics, and its predictive value investigated by correlation to change in NDI.RESULTS: Included were 151 patients, mean age of 47 years, female/male: 78/73. The interobserver reliability was fair for the modified Ransford and Udén methods, good for the Gatchel method, and very good for the modified Ohnmeiss method. Markings in the shoulder and upper arm region on the pain drawing were positive predictors of outcome after 2 years of follow-up, and markings in the upper arm region remained a positive predictor of outcome even after 5 years of follow-up.CONCLUSIONS: Pain drawings were a reliable tool to interpret patients' pain prior to cervical spine surgery and were also to some extent predictive for treatment outcome.
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| 9. |
- MacDowall, Anna, et al.
(författare)
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Posterior foraminotomy versus anterior decompression and fusion in patients with cervical degenerative disc disease with radiculopathy : up to 5 years of outcome from the national Swedish Spine Register
- 2020
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Ingår i: Journal of Neurosurgery. - : American Association of Neurological Surgeons. - 1547-5654 .- 1547-5646. ; 32:3, s. 344-352
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: The long-term efficacy of posterior foraminotomy compared with anterior cervical decompression and fusion (ACDF) for the treatment of degenerative disc disease with radiculopathy has not been previously investigated in a population-based cohort.METHODS: All patients in the national Swedish Spine Register (Swespine) from January 1, 2006, until November 15, 2017, with cervical degenerative disc disease and radiculopathy were assessed. Using propensity score matching, patients treated with posterior foraminotomy were compared with those undergoing ACDF. The primary outcome measure was the Neck Disability Index (NDI), a patient-reported outcome score ranging from 0% to 100%, with higher scores indicating greater disability. A minimal clinically important difference was defined as > 15%. Secondary outcomes were assessed with additional patient-reported outcome measures (PROMs).RESULTS: A total of 4368 patients (2136/2232 women/men) met the inclusion criteria. Posterior foraminotomy was performed in 647 patients, and 3721 patients underwent ACDF. After meticulous propensity score matching, 570 patients with a mean age of 54 years remained in each group. Both groups had substantial decreases in their NDI scores; however, after 5 years, the difference was not significant (2.3%, 95% CI -4.1% to 8.4%; p = 0.48) between the groups. There were no significant differences between the groups in EQ-5D or visual analog scale (VAS) for neck and arm scores. The secondary surgeries on the index level due to restenosis were more frequent in the foraminotomy group (6/100 patients vs 1/100), but on the adjacent segments there was no difference between groups (2/100).CONCLUSIONS: In patients with cervical degenerative disc disease and radiculopathy, both groups demonstrated clinical improvements at the 5-year follow-up that were comparable and did not achieve a clinically important difference from one another, even though the reoperation rate favored the ACDF group. This study design obtains population-based results, which are generalizable.
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| 10. |
- MacDowall, Anna, et al.
(författare)
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Validation of the Visual Analogue Scale in the Cervical Spine
- 2018
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Ingår i: Journal of Eurosurgery. - Charlottesville, Virginia. - 1547-5654 .- 1547-5646. ; 28:3, s. 227-235
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The Visual analogue scale (VAS) is frequently used to measure treatment outcome in patients with cervical spine disorders. The minimum clinically important difference (MCID) is the smallest change in a score that has clinical importance to the patient. Although it has been established for other medical fields, knowledge of the VAS MCID for the cervical spine is sparse, and it has rarely been considered in relation to measurement noise. The goals in this study were as follows: 1) to validate the VAS-neck and VAS-arm instruments for the cervical spine (e.g. repeatability); 2) to investigate the possible influence of predictive factors and the Hospital Anxiety and Depression Scale (HADS) score on repeatability; and 3) to compute the MCID with five different methods.Methods: A post hoc analysis of a prospective randomized controlled trial with 151 patients undergoing surgery for cervical radiculopathy due to degenerative disc disease (DDD) was performed. Information on age, sex, smoking habits, exercise and employment status, HADS score, and VAS-neck and VAS-arm scores was gathered before surgery and after 1 year. The VAS was applied twice on every occasion with 15 minutes in-between. Repeatability and the association with predictors and HADS score were analyzed using the one-sample t-test, linear regression models and Spearman correlation. The MCID was calculated with the following methods: average change, change difference, receiver operating characteristic curve, effect size, and minimum detectable change (MDC).Results: The repeatability in VAS-neck was 8.1 mm and in VAS-arm 10.4 mm. Less consistent values on the VAS correlated to female sex and higher values on HADS. For VAS-neck the MCID ranged from 4.6 to 21.4 and for VAS-arm it ranged from 1.1 to 29.1. The highest MCID came from the MDC method, which was the only method that gave values above the measurement noise in both VAS-neck and VAS-arm.Conclusions: Measurement noise in VAS-neck and VAS-arm for the cervical spine was influenced by female sex and HADS score. The only method to compute MCID that consistently gave results above the measurement noise in VAS-neck and VAS-arm was the MDC.
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