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Validation of the Visual Analogue Scale in the Cervical Spine
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.ORCID iD: 0000-0002-9231-7608
Institutionen för lärande, informatik, management och etik. Department for learning, informatics, management and ethics, Karolinska institutet, Stockholm, Sweden.ORCID iD: 0000-0001-9901-6886
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.ORCID iD: 0000-0002-2724-6372
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.ORCID iD: 0000-0002-2111-6868
2018 (English)In: Journal of Eurosurgery : Spine, ISSN 1547-5654, E-ISSN 1547-5646, Vol. 28, no 3, p. 227-235Article in journal (Refereed) Published
Abstract [en]

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. 

Place, publisher, year, edition, pages
Charlottesville, Virginia, 2018. Vol. 28, no 3, p. 227-235
Keywords [en]
Visual analogue scale, Minimum clinically important difference, Cervical degenerative disc disease, Surgical treatment, Hospital anxiety and depression scale.
National Category
Orthopaedics
Research subject
Orthopaedics
Identifiers
URN: urn:nbn:se:uu:diva-327266DOI: 10.3171/2017.5.SPINE1732ISI: 000426297500001OAI: oai:DiVA.org:uu-327266DiVA, id: diva2:1129943
Projects
Cervical radiculopathy: Studies on pain analysis and treatmentAvailable from: 2017-08-07 Created: 2017-08-07 Last updated: 2019-02-08Bibliographically approved
In thesis
1. Cervical Radiculopathy: Studies on Pain Analysis and Treatment
Open this publication in new window or tab >>Cervical Radiculopathy: Studies on Pain Analysis and Treatment
2018 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

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.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2018. p. 111
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1442
Keywords
Cervical radiculopahy, Artificial disc replacement
National Category
Orthopaedics
Research subject
Orthopaedics
Identifiers
urn:nbn:se:uu:diva-345977 (URN)978-91-513-0272-0 (ISBN)
Public defence
2018-05-05, Gustavianum, Akademigatan 3, Uppsala, 13:00 (Swedish)
Opponent
Supervisors
Available from: 2018-04-10 Created: 2018-03-13 Last updated: 2018-04-10

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MacDowall, AnnaRobinson, YohanOlerud, Claes

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