Assessing pain intensity following SCI 1 Assessing pain intensity following spinal cord injury: should rating scales measure ‘overall’ or ‘maximal’ values? Short title (running head): Assessing pain intensity following SCI Andrew O. Frank, FRCP ¹, Fotios Spyridonis, PhD 2 and Gheorghita Ghinea, PhD 2 ¹ College of Health and Life Sciences, Brunel University, UK ² College of Engineering, Design and Physical Sciences, Brunel University, UK Corresponding Author: Andrew O. Frank, Mary Seacole Building, College of Health and Life Sciences, Brunel University, Uxbridge, UB8 3PH, UK. Email: andrew.frank1@btinternet.com Tel/Fax: +44 (0)1895 269853 Declaration of Interest None declared Source of funding None declared Assessing pain intensity following SCI 2 Abstract Rating scales (RSs) are important for the assessment of pain intensity (PI) following a spinal cord injury (SCI). Using a Graphic Rating Scale (GRS), this pilot study measured an ‘overall’ level of PI repeated about 2-hourly over one day and compared it with maximal PI scores reported previously. Patients were categorised into severity groups according to the overall GRS score at initial assessment (T0). Eight men and six women (mean age 53.1; range 28-75) participated. Comparison of the overall PI scores and their changes over time with the maximal PI scores reported previously showed loss of patients in the severe group and less pronounced PI changes over time. Conclusion: RSs used in SCI services should measure maximal pain experienced ‘right now’ to eliminate potential averaging out of pain over time, which might allow physicians to assist patients in understanding their pain and begin their adjustment. Keywords: clinical significance; comparison study; pain assessment; rating scales; rehabilitation; spinal cord injury Assessing pain intensity following SCI 3 Introduction Pain remains ‘the main problem’ following spinal cord injury (SCI) for many experiencing this condition (Lofgren & Norrbrink 2012). Its measurement remains a major target for health professionals in this area and rating scales (RSs) are widely used for the assessment of pain intensity (PI) (Alexander et al. 2009; Cuff et al. 2014; Jensen et al. 2010). Pain management in clinical practice remains problematic (Lofgren & Norrbrink 2012), with patients finding the medical professions’ obsession with medication frustrating, particularly the complications of drug therapy (Lofgren & Norrbrink 2012). Patients report unsatisfactory pain outcomes and the need for rehabilitation professionals to help them develop individual coping methods and not rely on medication (Lofgren & Norrbrink 2012). A novel approach in the assessment of post-SCI pain in the rehabilitation situation has recently been reported, where PI is measured approximately 2-hourly during the day to facilitate finding pain triggers and improve strategies for its alleviation (Frank et al. 2013). A RS was used, which showed clinically significant changes in PI, providing clues for pain management. That study measured the maximal PI, but suggested that traditional use of a RS may mask important PI peaks (Frank et al 2013). Current descriptors used in RSs include: pain experience ‘right now’ or current pain (Cuff et al 2014; Heutink et al. 2012); average PI (Finnerup et al. 2014; Heutink et al 2012), average PI - ‘last seven days including today’ (Widerstrom-Noga et al. 2014), overall PI (Ullrich et al. 2013); and worst ever (Heutink et al 2012) or maximal PI (Frank et al 2013). It is unclear whether it is more helpful to utilise the worst ever/maximal or average/overall PI descriptors during clinical or research use of RSs. Assessing pain intensity following SCI 4 Objective: To measure an ‘overall’ level of PI repeated about 2-hourly over one day and compare it with maximal PI scores reported previously. Methods A consecutive cohort of 16 individuals admitted to a SCI unit between July-October 2010 was asked to participate in the pilot study. Participants had experienced a SCI, were aged 20 years or greater and experiencing pain during hospitalization. Two patients not experiencing pain were excluded; 14 agreed to participate. At initial interview (time zero – T0), written informed consent was obtained. The following data were recorded at T0: Demographic: date of birth and gender; Clinical: level of lesion, AIS grade, walking ability (able to walk or not); First admission or readmission for rehabilitation Pain assessment Data were collected at T0 and entered into a laptop computer. Most patients utilised the research assistant to complete forms, because of upper limb weakness. PI was assessed using standard marked GRS from 0-90 that had ends marked “no pain” and “worst pain you can imagine”. Patients reporting pain between one number and the next (e.g. between 60-70) were averaged (e.g. 65); Overall GRS score at T0 was categorised as follows: No pain (GRS= 0); Mild pain (GRS=1-44); Moderate pain (GRS=45-74); Severe pain (GRS=75 or more) (Jensen et al 2003). Assessing pain intensity following SCI 5 T0 was about 08.30h and three further measurements were recorded at approximately 2-3h intervals (concluding around 17.00h) over a period of one day and labelled T1, T2 and T3. Patients were unable to see their previous score(s) and were asked to score the current level (right now) of PI. Measurements took approximately 20 minutes. Clinically significant changes in pain Patients whose maximal scores only varied between 0-33 on the GRS were deemed not to experience clinically significant changes. Those reporting a maximal score of 34 or more were deemed to have a clinically significant change in their pain if the difference between the maximal and minimum scores was 33% or more (Jensen et al 2003). Overall PI was compared with the maximal PI reported previously (Frank et al 2013).The study was approved by North London 1 Research Ethics Committee. Results and Discussion Participants Fourteen individuals with SCI were studied (mean age 53; range 28-75): eight men (mean age 47; range 28-75) and six women (mean age 61; range 46-72) (Table 1). Ten patients were admitted for their initial rehabilitation (new patients) and were assessed a mean of 3.6 (range 0.9 – 7) months following SCI. Four were follow-up admissions assessed a mean of 150 (range 10-336) months following SCI. Nine lesions were complete and five incomplete, resulting in the ability of three patients to be able to walk to some extent. Suggest insert Table 1 about here Assessing pain intensity following SCI 6 Assessment of pain All 14 patients experienced some pain during the period of study. The range of PI recorded at any time between T0-T3 varied from 0-90. Further data have been reported previously (Frank et al 2013). Overall PI at T0 The mean overall GRS was 42 (range 10-70, sd 18) for the new patients and 64 (range 50-80, sd 13) for the follow-up patients (Figures 1a & 1b). These differences were not statistically significant. Six patients were in the moderate group, and five in the mild group. Three patients were pain-free. No patients’ overall PI exceeded 75 (severe pain). Seven patients (two in the moderate group and five in the no pain-mild group) demonstrated clinically significant changes in pain between T0-T3. Five showed clinically significant rise and two a clinically significant fall. Those with clinically significant rises were in the no pain-mild group. Those with clinically significant falls were in the moderate group. A comparison between the overall and maximal PI is shown in Table 2. Suggest insert Figures 1a & 1b and Table 2 about here The portrayal of PI using maximal and overall scores shows notable differences, shifting patients into different pain groups (Jensen et al 2003), which may influence clinical or research practice e.g. if protocols suggest intensity of therapy dependent on pain groups. Thus, comparing the maximal PI with the overall PI showed: Assessing pain intensity following SCI 7 Loss of the severe pain group (75-90), i.e. six patients (P13, 14, 12, 1, 3, 2) moved to the moderate group; The no pain-mild group increased in size; The number of patients with clinically significant changes fell from 9 (Maximal) to 7 (Overall); Patients might have interpreted the overall PI as the average PI between ‘right now’ and the time of the previous measurement; however, this cannot be true for the overall PI at T0. The use of the overall PI did not change the thrust of previous work showing that those with high PI in the mornings tended to improve, whilst those with low PI tended to deteriorate (Frank et al 2013). The overall PI probably hides variations experienced in different body sites – with therapeutic implications (Frank et al 2013). We recommend descriptors for measuring PI are ‘right-now’ and the ‘maximal’ pain experienced. Limitations of the study Our small sample lacked those with lumbar spine lesions. Use of the GRS has limitations, but remains widely used in clinical and research practice (Frank et al 2013). Recordings were only made during one day. Assessing pain intensity following SCI 8 Acknowledgements The patients who kindly gave their time and energy to support this work. Dr Jan Gawronski who facilitated this study and enabled it to happen; Dr Angela Gall and Dr Maya DeSouza for allowing us to study patients under their care; Emma Linley, Head Occupational Therapist for advice on many aspects of this study; Staff of the Spinal Cord Injuries Unit at the Royal National Orthopaedic Hospital at Stanmore without whose cooperation this study could not have been performed. 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Overall GRS over time for Moderate Group 10 Assessing pain intensity following SCI 11 Table 1 Participants Patient Level Of Injury (AIS Age Sex Diagnosis Number Months since Initial injury repeat** Range Overall GRS Grade *) P1 63 F Vascular SCI C1-4 AIS A 55 3 1 P2 70 F Traumatic SCI C5-8 AIS D 44-55 1 1 P3 41 M Traumatic SCI C1-4 C 44-67 5 1 P4 69 M Epidural abscess C1-4 C 0-22 7 1 P5 28 M Traumatic SCI T1-S5 A 22-55 2 1 P6 61 M Traumatic SCI T1-S5 A 0-55 336 2 P7 46 F Disc prolapse T1-S5 A 22-33 5 1 P8 32 M Spinal neurofibroma C5-8 D 55-67 22 2 P9 75 M Traumatic SCI C1-4 D 0-44 1 1 P10 39 M Traumatic SCI C5-8 A 0-44 6 1 P11 66 F Traumatic SCI C5-8 A 0-11 1 1 P12 72 F Epidural abscess T1-S5 A 44-78 5 1 P13 47 F Traumatic SCI T1-S5 A 66-89 233 2 P14 34 M Traumatic SCI T1-S5 A 11-73 10 2 *AIS= Association impairment scale ** 1=Initial admission, 2= Repeat admission Assessing pain intensity following SCI 12 Table 2 Comparison of overall pain intensity scores with maximal pain intensity scores (Frank et al 2013) Maximal (T0-T3) Overall (T0-T3) Severe 6 0 Moderate 5 6 Mild 3 5 Pain-free 0 3 Group(n=14) 45.7 39.9 New (n=10) 52.5 36.1 70 49.3 9 7 No. of patients Mean GRS scores Old (n=4) Clinically significant changes