RESEARCH ARTICLE
Physiotherapeutic Rehabilitation Following Lumbar Total Disc Replacement: A Retrospective Study Adeline Green1,2, Philippa Gilbert1,2, Matthew Scott-Young3 & Allan Abbott1,4,5* 1
Faculty of Health Science and Medicine, Bond University, Queensland, Australia
2
Physiomax, Gold Coast, Australia
3
Gold Coast Spine, Gold Coast, Australia
4
Department of Physiotherapy, Karolinska University Hospital, Stockholm, Sweden
5
Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Stockholm, Sweden
Abstract Background and Purpose. This study sought to answer the following questions: What are the outcomes of physiotherapy post lumbar total disc replacement (LTDR) compared with patient self-mediated rehabilitation? Is a difference in outcomes related to the number of physiotherapy sessions? Methods. This is a retrospective observational study of 600 patients post TDR. Patient outcomes for self-mediated rehabilitation (Group 1), 1–3 sessions of clinicbased physiotherapy (Group 2) and ≥4 sessions of clinic-based physiotherapy (Group 3) were analysed. Outcomes measures included the Oswestry Disability Index (ODI), Roland Morris Disability Questionnaire (RMQ), Short Form-36 Physical (SF-36 PCS) and Mental Subscale Components (SF-36 MCS), Visual Analogue Scale (VAS) for back and leg pain intensity. Patient’s pre-operative baseline measures and post-operative follow-up measures at 3, 6, 12 and 24 months post-operatively were analysed. Results. Oswestry Disability Index and RMQ had significantly lower scores in Group 3 compared with Group 1 at 3, 6, 12 and 24 months follow-up. Significantly lower scores for Group 2 compared with Group 1 were observed for the ODI at 3 months follow-up and for the RMQ at 3 and 6 months follow-up. Significantly lower scores were observed in Group 3 compared with Group 1 for VAS back pain at 3 months and VAS leg pain at 6 months follow-up. Significantly higher scores in Group 3 compared with Group 1 were also observed in the SF-36 PCS at 6, 12 and 24 months. Significantly higher scores in Group 2 compared with Group 1 were observed at 6 months follow up. These trends were also observed when investigating the percentage of patients with a greater 50% improvement in the outcome measure. Conclusions. Physiotherapy post-LTDR produces statistically significant and possibly clinically important improvements in functional disability, pain and quality of life outcomes compared with self-mediated rehabilitation. Copyright © 2015 John Wiley & Sons, Ltd. Received 23 January 2014; Revised 20 October 2014; Accepted 25 February 2015 Keywords orthopaedics; outcome measures; physiotherapy; spinal surgery *Correspondence Allan Abbott, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, 4229, Australia. Email: [email protected]
Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/pri.1630
Physiother. Res. Int. (2015) © 2015 John Wiley & Sons, Ltd.
A. Green et al.
Physiotherapeutic Rehabilitation Following TDR
Introduction Lumbar total disc replacement (LTDR) is an alternative surgical technique to spinal fusion for the treatment of degenerative disc disease and other causes of back pain (van den Eerenbeemt et al., 2010; Jacobs et al., 2012). The purpose of this surgical technique is to relieve pain in addition to restoring and preserving spinal segment motion, which is believed to prevent adjacent level degeneration (van den Eerenbeemt et al., 2010; Jacobs et al., 2012; Wang et al., 2012). In the presence of multilevel degenerative disc disease, the use of multilevel LTDR or a hybrid combination of LTDR and fusion on separate intervertebral levels has also been reported (Erkan et al., 2009). Despite the recent increase in this surgical technique, there has been little research on the effectiveness of physiotherapy on patient outcomes after LTDR surgery. As with any spinal surgery, the importance of rehabilitation after LTDR has been mentioned previously as a key factor for clinical success (Cinotti et al., 1996; Guyer and Ohnmeiss 2003; Siepe et al., 2007; Canbulat et al., 2011). In a radiographic analysis, one study demonstrated that patients who began exercises 1 week after surgery had greater mobility at the operated levels (11°) than those who wore a corset for 3 months (6°; P < 0.05) (Cinotti et al., 1996). Similarly, early and active rehabilitation following LTDR is advocated by Guyer and Ohnmeiss (2003), Siepe et al., (2007) and Canbulat et al., (2011), who emphasise its criticalness for achieving favourable treatment outcomes. A systematic review with meta-analysis investigated the effectiveness of rehabilitation specifically after first-time lumbar disc surgery and concluded that exercise programmes starting 4 to 6 weeks post-operatively appear to result in a faster decline in pain and disability compared with no treatment (Oosterhuis et al., 2014). In addition, high intensity exercise programmes seem to lead to a more rapid reduction in pain and disability compared with low intensity programmes. No significant differences were found between supervised and home exercises for pain relief or disability in the review. Furthermore, there was no indication that active rehabilitation programmes increase the re-operation rate after first-time lumbar surgery (Oosterhuis et al., 2014). Studies investigating physiotherapy after lumbar fusion surgery have also shown positive outcomes of interventions focusing on physical exercise combined with cognitive behavioural therapies (Christensen et al., 2003; Abbott et al., 2010; Monticone et al., 2013). No
controlled trials have however investigated rehabilitation post-LTDR, and it is unclear as to whether existing spinal surgery rehabilitation literature can be generalized to patients after LTDR surgery. Because of the lack of published research on rehabilitation post-LTDR, research in this area is warranted. It is hypothesized that physiotherapy would be more effective in improving patient outcomes for pain, function and quality of life compared with patient selfmediated rehabilitation. It was also hypothesized that patients who had ≥4 sessions of clinic-based physiotherapy would have improved pain, functional and quality of life outcomes compared with those who had 1–3 clinic-based physiotherapy sessions. Therefore, the aim of this study is to analyse pain, functional and quality of life-related outcomes of patients post-LTDR who have received 1–3 physiotherapy clinic-based sessions, ≥4 physiotherapy clinic based sessions or selfmediated rehabilitation.
Methods Design The study is a retrospective observational study of preoperative baseline measures and post-operative measures for pain, function and quality of life at 3, 6, 12 and 24 months after LTDR or hybrid surgery (LTDR and adjacent level fusion). The Bond University Human Research Ethics Committee approved this study (RO1611). Subjects The primary diagnosis and selection of patients for LTDR or hybrid surgery was assessed and determined by an orthopaedic spinal surgeon at Gold Coast Spine. The patients recruited received surgery during the years 1997 to 2008. A total of 600 patients received LTDR or hybrid surgery. The orthopaedic spinal surgeon from Gold Coast Spine performed all surgeries and recorded patient characteristics (Table 1). Intervention Surgeries were performed with the patient in a supine trendelenburg position. Either a horizontal or vertical incision was used along with a midline rectus split with a right or left-sided retroperitoneal approach. Complete discectomy was then performed and removal of the cartilaginous endplate. Insertion of the artificial Physiother. Res. Int. (2015) © 2015 John Wiley & Sons, Ltd.
A. Green et al.
Physiotherapeutic Rehabilitation Following TDR
Table 1. Background patient data
Patient characteristics*
Group 1: Self-mediated rehabilitation (n = 202)
Group 2: 1–3 sessions post-op physiotherapy (n = 123)
Group 3: ≥4 sessions post-op physiotherapy (n = 275)
92 (45.5) 110 (54.5) 49.4 ± 10.1
36 (29.3)† 87 (70.7)† 47.8 ± 9.5
109 (39.6)‡ 166 (60.4)‡ 46.1 ± 11.0†
171 (84.7) 14 (6.9) 12 (5.9) 4 (2.0) 1 (0.5)
85 (70.7) 17 (13.8) 16 (13.0) 3 (2.4) 0 (0)
200 (72.7) 42 (15.3) 29 (10.5) 4 (1.5) 0 (0)
75 (37.1) 56 (27.7) 7 (3.5) 49 (24.3) 13 (6.4) 0 (0) 2 (1)
42 (34.1) 50 (40.7) 2 (1.6) 22 (17.9) 7 (5.7) 0 (0) 0 (0)
90 (32.7) 95 (34.5) 6 (2.2) 58 (21.1) 25 (9.1) 1 (0.4) 0 (0)
6 (7.9) 68 (89.5) 2 (2.6)
3 (5.1) 54 (91.5) 2 (3.4)
14 (11.1) 112 (88.9) 0 (0)
76.4 ± 19.5 63.3 ± 29.8 50.1 ± 15.7 16.9 ± 4.4 28.2 ± 8.7 35.7 ± 14.3
69.9 ± 22.8† 48.0 ± 30.6† 45.2 ± 15.7† 15.7 ± 5.2 29.9 ± 7.9 41.5 ± 15.2†
72.1 ± 23.4 53.1 ± 32.0† 45.9 ± 15.6 16.0 ± 4.8 28.9 ± 8.4 40.2 ± 14.0†
Female Male Age (years ± SD) LTDR type Charité Inmotion Maverick Flexicore Min T Surgical Technique One-level LTDR One-level LTDR + One Level ALIF One-level LTDR + Two Level ALIF Two-level LTDR Two-level LTDR + One Level ALIF Two-level LTDR + Two Level ALIF Three-level LTDR Hybrid TDR: location of ALIF level Above the LTDR level Below the LTDR level Above and below the LTDR level Outcomes at Baseline (mean ± SD) VAS back pain VAS leg pain Oswestry Disability Index Roland Morris Disability Questionnaire SF-36 Physical Component Scale SF-36 Mental Component Scale *
Presented as number of patients (percent of patients) unless stated otherwise.
† ‡
Significantly different compared with Group 1 p < 0.05. Significantly different from Group 2.
VAS = visual analogue scale; SF-36 = Short Form 36; LTDR = lumbar total disc replacement.
disc prosthesis was performed according to the recommended surgical technique. In the case of multisegmental degenerative disc disease, multilevel LTDR or LTDR in combination with adjacent level anterior lumbar interbody fusion was performed with an interbody cage and bone graft. For all patients during the first days after surgery, the physiotherapists instructed respiratory and circulatory exercises, training of transfers, walking and other activities of daily living relevant for the patient discharge from hospital. A total of 398 patients chose to receive clinic-based physiotherapy, while 202 patients chose not to participate in an organized clinic-based physiotherapy rehabilitation programme. The clinic-based physiotherapy rehabilitation programme was initiated within 4 weeks of surgery and included education regarding surgery, pain and healing, initial activity, post-operative Physiother. Res. Int. (2015) © 2015 John Wiley & Sons, Ltd.
rehabilitation, pain coping strategies, ergonomics and body awareness. When required, pain management including electro/cryo/acupuncture therapies, manual therapy and relaxation techniques were implemented. Physical interventions included gait training, postural alignment training, stretching of lower limb musculature and lumbar neural glide mobilisation techniques. Pilates and theraband strengthening exercises were implemented, focusing specifically on spinal, abdominal and pelvic-stabilizing muscle activation during the whole body exercise. Exercises encouraging controlled, progressive motion of the spine and general conditioning were also implemented. Extension of the lumbar spine was avoided in the early stages to ensure proper healing of the surgical anterior incision wound. Typically, spinal stabilization exercises in neutral position were introduced first, followed by flexion exercises,
A. Green et al.
Physiotherapeutic Rehabilitation Following TDR
followed by rotation and lateral movements and finally, extension. Behavioural strategies were also implemented for reinforcement of wellness behaviour and ignore sick behaviour, and goal setting as well as quotas/pacing were used for promotion of physical activities in daily living. In subsequent clinic-based sessions, the exercise quotas and pacing of the programme was therefore progressed and tailored to meet patient goals and willingness to attend outpatient clinic-based physiotherapy sessions and adapted to a home exercise programme, as the physiotherapist deemed appropriate.
d = M1 – M2/ ((SD1 + SD2)/2). Cohen’s d effect size measure d = 0.20 is considered a small effect, d = 0.50 is a medium effect and d = 0.80–infinity is a large effect size (Cohen 1992). A responder analysis was also performed where the percentage of patients reporting a more than 50% level of improvement in the outcome variables. IBM SPSS Version 21 was used for all data analyses. A p-value of 0.05 (two-tailed) was considered statistically significant.
Results Patient characteristics
Outcome measures All the patient’s background, demographic and outcome data were collected from Physiomax and Gold Coast Spine medical record systems. The following outcome measures were analysed for pre-operative, 3,6,12 and 24 months post-operative time points: Oswestry Disability Index (ODI), Short Form-36 Physical (SF-36 PCS) and Mental Subscale Components (SF-36 MCS), the Roland Morris Disability Questionnaire (RMQ) and Visual Analogue Scale (VAS) for both back pain and leg pain intensity. The ODI Version 2.1 (Fairbank et al., 1980; Fairbank and Pynsent, 2000) is presented as a 0 to 100 score, where lower scores represent lower levels of low back pain disability. Both the SF-36 PCS and SF-36 MCS were used to measure mental and physical health. Each subscale is presented as a 0–100 score, with higher scores representing better mental or physical health. The VAS for both back pain and leg pain intensity have a scoring range from 0 for no pain to 100 for maximal pain experienced in the previous week.
Data analysis The patient data were grouped as followed: self-mediated rehabilitation (Group 1), 1–3 sessions of clinic-based physiotherapy rehabilitation (Group 2) and ≥4 sessions of clinic-based physiotherapy rehabilitation (Group 3). For demographical variables, an analysis of variance (ANOVA) was conducted. For categorical variables, a Chi-squares test was used. For tests of main effects between groups, an analysis of covariance (ANCOVA) with Sidak comparison and adjustments for sex, age, surgical technique and questionnaire scores at baseline was utilized. Effect sizes from baseline for each group were calculated with the following formula: Cohen’s
Demographic and baseline measurement data are presented in Table 1. Variability in patient characteristics for the three groups at baseline was found with a significantly lower mean age (p < 0.05) in Group 3 (46.1 ± 11.0) compared with Group 1 (49.4 ± 10.1). Analyses for gender revealed significantly more women (p < 0.05) in Groups 1 (45.5%) and 3 (39.6%) compared with Group 2 (29.3%). A significant difference at baseline (p < 0.05) was found with lower VAS back pain in Group 2 (69.9 ± 22.8) compared with Group 1 (76.4 ± 19.5). For VAS leg pain at baseline, significantly lower scores (p < 0.05) were found for Group 2 (48.0 ± 30.6) and Group 3 (53.1 ± 32.0) compared with Group 1 (63.3 ± 29.8). Comparison of the ODI at baseline found a significantly lower score (p < 0.05) in Group 2 (45.2 ± 15.7) compared with Group 1 (50.1 ± 15.7). For SF-36 MCS, a significantly lower score (p < .05) for Group 1 (35.7 ± 14.3) compared with Group 2 (41.5 ± 15.20) and Group 3 (40.2 ± 14.0). To take into account these baseline differences between groups and the alternative surgical techniques used, statistical adjustment was carried out between groups by using these variables as covariates in subsequent between-group statistical comparisons. Outcomes measures Mean score changes (standard deviations) from baseline and effect sizes for each group, as well as between group mean differences, including 95% confidence intervals and ANCOVA for outcomes, are shown in Table 2. For analyses of ODI, there was a statistically significant difference (p = 0.004) between Groups 1 and 3 at 3 months, with the mean of Group 3 being 4 points lower. This trend continued at 6, 12 and 24 months (p = 0.002, p = 0.001 and 0.021, respectively). A statistically significant mean Physiother. Res. Int. (2015) © 2015 John Wiley & Sons, Ltd.
Physiother. Res. Int. (2015) © 2015 John Wiley & Sons, Ltd.
(27.2) (26.9) (28.2) (29.8)
(35.6) (35.9) (34.7) (35.7)
(18.0) (17.3) (18.7) (19.3)
(6.2) (6.1) (5.6) (5.9)
(12.7) (12.5) (11.7) (13.1)
(15.2) (14.9) (14.1) (18.3)
49.4 52.1 52.8 49.2
41.3 43.5 44.5 42.4
25.1 29.4 31.8 29.3
9.0 10.6 11.7 11.1
12.7 13.3 16.9 14.1
12.7 14.6 16.2 13.7
0.91 1.09 1.29 1.66
1.31 1.33 1.82 1.32
1.81 2.22 2.49 2.34
1.61 1.96 2.13 1.89
1.55 1.67 1.73 1.60
2.45 2.62 2.61 2.32
Mean change Effect from baseline (SD) size‡
Group 1: Self-mediated rehabilitation (n = 202)
(12.9) (12.5) (11.3) (12.0)
(7.2) (6.3) (6.0) (6.5)
(21.1) (19.5) (19.7) (19.5)
(36.3) (35.3) (34.4) (33.8)
(30.6) (29.7) (27.4) (27.8)
8.9 (15.3) 10.4 (15.0) 10.4 (16.2) 6.0 (18.6)
13.5 15.7 17.9 15.7
10.0 11.4 11.7 11.1
25.5 28.5 30.5 28.0
31.4 32.1 33.2 29.5
48.1 48.8 49.4 46.3
Mean change from baseline (SD)
11.7 11.9 12.9 8.4
13.7 17.0 19.2 17.1
10.5 12.0 12.8 11.6
27.0 30.6 32.6 29.1
35.9 38.7 37.8 33.3
51.3 52.2 52.6 48.3
(15.9) (15.5) (15.3) (18.5)
(13.4) (13.2) (11.6) (11.5)
(6.6) (6.1) (6.2) (6.1)
(19.2) (18.2) (19.3) (19.5)
(36.0) (35.2) (37.4) (36.6)
(28.4) (27.8) (30.4) (29.5)
Mean change from baseline (SD)
0.86 0.92 1.05 1.39
1.41 1.76 2.17 1.86
1.95 2.58 2.79 2.57
1.74 2.10 2.28 2.02
1.30 1.45 1.41 1.23
2.33 2.41 2.38 2.18
Effect size‡
Group 3: ≥4 sessions post-op physiotherapy (n = 275)
1.2 1.8 1.2 3.2
0.7 2.3 2.2 2.1 to 9.4) to 8.0) to 1.8) to 6.8)
to 8.9) to 7.0) to 7.3) to 8.0)
0.8 ( 0.5 ( 1.6 ( 2.9 (
1.9 ( 3.4 ( 2.1 ( 2.4 (
2.1 2.2 0.7 0.3
4.4 5.9 4.3 5.0
to 3.6) to 3.2) to 3.9) to 6.2)
to 0.5) to 0.9) to 0.1) to 0.2)
1.7 (0.5 to 3.0) 1.5 (0.4 to 2.6) 0.8 ( 0.3 to 1.9) 0.8 ( 0.3 to 2.0)
3.6 (0.2 to 7.1) 2.3 ( 0.9 to 5.5) 2.6 ( 0.5 to 5.7) 2.2 ( 1.2 to 5.6)
4.1 ( 3.1 ( 3.4 ( 1.8 (
4.1 ( 2.3 ( 2.6 ( 2.9 (
Mean difference (95% CI)†
0.601 0.731 0.172 0.075
0.127 0.008* 0.057 0.065
0.006* 0.010* 0.139 0.144
0.039* 0.366 0.098 0.211
0.133 0.221 0.142 0.478
0.094 0.322 0.285 0.253
ANCOVA p-value
Between group (1–2)
1.5 ( 0.4 ( 0.1 ( 1.3 (
1.1 ( 3.8 ( 2.5 ( 3.2 (
to 2.8) to 2.7) to 2.4) to 2.0)
3.8 to 0.8) 2.6 to 1.7) 1.8 to 2.0) 1.2 to 3.8)
3.0 to 0.9) 5.8 to 1.8) 4.2 to 0.8) 5.2 to 1.2)
1.8 (0.8 1.9 (1.0 1.6 (0.8 1.1 (0.2
to 6.8) to 6.3) to 6.5) to 5.8)
1.1 to 7.3) 0.3 to 7.9) 1.1 to 6.5) 3.9 to 4.1)
4.0 (1.3 3.8 (1.4 4.1 (1.6 3.2 (0.5
3.1 ( 4.1 ( 2.7 ( 0.1 (
5.0 (1.2 to 8.9) 3.5 ( 0.2 to 7.3) 3.8 ( 0.1 to 7.7) 2.9 ( 1.1 to 7.0)
Mean difference (95% CI)†
0.210 0.709 0.936 0.311
0.288
Physiotherapeutic Rehabilitation Following Lumbar Total Disc Replacement: A Retrospective Study Adeline Green1,2, Philippa Gilbert1,2, Matthew Scott-Young3 & Allan Abbott1,4,5* 1
Faculty of Health Science and Medicine, Bond University, Queensland, Australia
2
Physiomax, Gold Coast, Australia
3
Gold Coast Spine, Gold Coast, Australia
4
Department of Physiotherapy, Karolinska University Hospital, Stockholm, Sweden
5
Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Stockholm, Sweden
Abstract Background and Purpose. This study sought to answer the following questions: What are the outcomes of physiotherapy post lumbar total disc replacement (LTDR) compared with patient self-mediated rehabilitation? Is a difference in outcomes related to the number of physiotherapy sessions? Methods. This is a retrospective observational study of 600 patients post TDR. Patient outcomes for self-mediated rehabilitation (Group 1), 1–3 sessions of clinicbased physiotherapy (Group 2) and ≥4 sessions of clinic-based physiotherapy (Group 3) were analysed. Outcomes measures included the Oswestry Disability Index (ODI), Roland Morris Disability Questionnaire (RMQ), Short Form-36 Physical (SF-36 PCS) and Mental Subscale Components (SF-36 MCS), Visual Analogue Scale (VAS) for back and leg pain intensity. Patient’s pre-operative baseline measures and post-operative follow-up measures at 3, 6, 12 and 24 months post-operatively were analysed. Results. Oswestry Disability Index and RMQ had significantly lower scores in Group 3 compared with Group 1 at 3, 6, 12 and 24 months follow-up. Significantly lower scores for Group 2 compared with Group 1 were observed for the ODI at 3 months follow-up and for the RMQ at 3 and 6 months follow-up. Significantly lower scores were observed in Group 3 compared with Group 1 for VAS back pain at 3 months and VAS leg pain at 6 months follow-up. Significantly higher scores in Group 3 compared with Group 1 were also observed in the SF-36 PCS at 6, 12 and 24 months. Significantly higher scores in Group 2 compared with Group 1 were observed at 6 months follow up. These trends were also observed when investigating the percentage of patients with a greater 50% improvement in the outcome measure. Conclusions. Physiotherapy post-LTDR produces statistically significant and possibly clinically important improvements in functional disability, pain and quality of life outcomes compared with self-mediated rehabilitation. Copyright © 2015 John Wiley & Sons, Ltd. Received 23 January 2014; Revised 20 October 2014; Accepted 25 February 2015 Keywords orthopaedics; outcome measures; physiotherapy; spinal surgery *Correspondence Allan Abbott, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, 4229, Australia. Email: [email protected]
Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/pri.1630
Physiother. Res. Int. (2015) © 2015 John Wiley & Sons, Ltd.
A. Green et al.
Physiotherapeutic Rehabilitation Following TDR
Introduction Lumbar total disc replacement (LTDR) is an alternative surgical technique to spinal fusion for the treatment of degenerative disc disease and other causes of back pain (van den Eerenbeemt et al., 2010; Jacobs et al., 2012). The purpose of this surgical technique is to relieve pain in addition to restoring and preserving spinal segment motion, which is believed to prevent adjacent level degeneration (van den Eerenbeemt et al., 2010; Jacobs et al., 2012; Wang et al., 2012). In the presence of multilevel degenerative disc disease, the use of multilevel LTDR or a hybrid combination of LTDR and fusion on separate intervertebral levels has also been reported (Erkan et al., 2009). Despite the recent increase in this surgical technique, there has been little research on the effectiveness of physiotherapy on patient outcomes after LTDR surgery. As with any spinal surgery, the importance of rehabilitation after LTDR has been mentioned previously as a key factor for clinical success (Cinotti et al., 1996; Guyer and Ohnmeiss 2003; Siepe et al., 2007; Canbulat et al., 2011). In a radiographic analysis, one study demonstrated that patients who began exercises 1 week after surgery had greater mobility at the operated levels (11°) than those who wore a corset for 3 months (6°; P < 0.05) (Cinotti et al., 1996). Similarly, early and active rehabilitation following LTDR is advocated by Guyer and Ohnmeiss (2003), Siepe et al., (2007) and Canbulat et al., (2011), who emphasise its criticalness for achieving favourable treatment outcomes. A systematic review with meta-analysis investigated the effectiveness of rehabilitation specifically after first-time lumbar disc surgery and concluded that exercise programmes starting 4 to 6 weeks post-operatively appear to result in a faster decline in pain and disability compared with no treatment (Oosterhuis et al., 2014). In addition, high intensity exercise programmes seem to lead to a more rapid reduction in pain and disability compared with low intensity programmes. No significant differences were found between supervised and home exercises for pain relief or disability in the review. Furthermore, there was no indication that active rehabilitation programmes increase the re-operation rate after first-time lumbar surgery (Oosterhuis et al., 2014). Studies investigating physiotherapy after lumbar fusion surgery have also shown positive outcomes of interventions focusing on physical exercise combined with cognitive behavioural therapies (Christensen et al., 2003; Abbott et al., 2010; Monticone et al., 2013). No
controlled trials have however investigated rehabilitation post-LTDR, and it is unclear as to whether existing spinal surgery rehabilitation literature can be generalized to patients after LTDR surgery. Because of the lack of published research on rehabilitation post-LTDR, research in this area is warranted. It is hypothesized that physiotherapy would be more effective in improving patient outcomes for pain, function and quality of life compared with patient selfmediated rehabilitation. It was also hypothesized that patients who had ≥4 sessions of clinic-based physiotherapy would have improved pain, functional and quality of life outcomes compared with those who had 1–3 clinic-based physiotherapy sessions. Therefore, the aim of this study is to analyse pain, functional and quality of life-related outcomes of patients post-LTDR who have received 1–3 physiotherapy clinic-based sessions, ≥4 physiotherapy clinic based sessions or selfmediated rehabilitation.
Methods Design The study is a retrospective observational study of preoperative baseline measures and post-operative measures for pain, function and quality of life at 3, 6, 12 and 24 months after LTDR or hybrid surgery (LTDR and adjacent level fusion). The Bond University Human Research Ethics Committee approved this study (RO1611). Subjects The primary diagnosis and selection of patients for LTDR or hybrid surgery was assessed and determined by an orthopaedic spinal surgeon at Gold Coast Spine. The patients recruited received surgery during the years 1997 to 2008. A total of 600 patients received LTDR or hybrid surgery. The orthopaedic spinal surgeon from Gold Coast Spine performed all surgeries and recorded patient characteristics (Table 1). Intervention Surgeries were performed with the patient in a supine trendelenburg position. Either a horizontal or vertical incision was used along with a midline rectus split with a right or left-sided retroperitoneal approach. Complete discectomy was then performed and removal of the cartilaginous endplate. Insertion of the artificial Physiother. Res. Int. (2015) © 2015 John Wiley & Sons, Ltd.
A. Green et al.
Physiotherapeutic Rehabilitation Following TDR
Table 1. Background patient data
Patient characteristics*
Group 1: Self-mediated rehabilitation (n = 202)
Group 2: 1–3 sessions post-op physiotherapy (n = 123)
Group 3: ≥4 sessions post-op physiotherapy (n = 275)
92 (45.5) 110 (54.5) 49.4 ± 10.1
36 (29.3)† 87 (70.7)† 47.8 ± 9.5
109 (39.6)‡ 166 (60.4)‡ 46.1 ± 11.0†
171 (84.7) 14 (6.9) 12 (5.9) 4 (2.0) 1 (0.5)
85 (70.7) 17 (13.8) 16 (13.0) 3 (2.4) 0 (0)
200 (72.7) 42 (15.3) 29 (10.5) 4 (1.5) 0 (0)
75 (37.1) 56 (27.7) 7 (3.5) 49 (24.3) 13 (6.4) 0 (0) 2 (1)
42 (34.1) 50 (40.7) 2 (1.6) 22 (17.9) 7 (5.7) 0 (0) 0 (0)
90 (32.7) 95 (34.5) 6 (2.2) 58 (21.1) 25 (9.1) 1 (0.4) 0 (0)
6 (7.9) 68 (89.5) 2 (2.6)
3 (5.1) 54 (91.5) 2 (3.4)
14 (11.1) 112 (88.9) 0 (0)
76.4 ± 19.5 63.3 ± 29.8 50.1 ± 15.7 16.9 ± 4.4 28.2 ± 8.7 35.7 ± 14.3
69.9 ± 22.8† 48.0 ± 30.6† 45.2 ± 15.7† 15.7 ± 5.2 29.9 ± 7.9 41.5 ± 15.2†
72.1 ± 23.4 53.1 ± 32.0† 45.9 ± 15.6 16.0 ± 4.8 28.9 ± 8.4 40.2 ± 14.0†
Female Male Age (years ± SD) LTDR type Charité Inmotion Maverick Flexicore Min T Surgical Technique One-level LTDR One-level LTDR + One Level ALIF One-level LTDR + Two Level ALIF Two-level LTDR Two-level LTDR + One Level ALIF Two-level LTDR + Two Level ALIF Three-level LTDR Hybrid TDR: location of ALIF level Above the LTDR level Below the LTDR level Above and below the LTDR level Outcomes at Baseline (mean ± SD) VAS back pain VAS leg pain Oswestry Disability Index Roland Morris Disability Questionnaire SF-36 Physical Component Scale SF-36 Mental Component Scale *
Presented as number of patients (percent of patients) unless stated otherwise.
† ‡
Significantly different compared with Group 1 p < 0.05. Significantly different from Group 2.
VAS = visual analogue scale; SF-36 = Short Form 36; LTDR = lumbar total disc replacement.
disc prosthesis was performed according to the recommended surgical technique. In the case of multisegmental degenerative disc disease, multilevel LTDR or LTDR in combination with adjacent level anterior lumbar interbody fusion was performed with an interbody cage and bone graft. For all patients during the first days after surgery, the physiotherapists instructed respiratory and circulatory exercises, training of transfers, walking and other activities of daily living relevant for the patient discharge from hospital. A total of 398 patients chose to receive clinic-based physiotherapy, while 202 patients chose not to participate in an organized clinic-based physiotherapy rehabilitation programme. The clinic-based physiotherapy rehabilitation programme was initiated within 4 weeks of surgery and included education regarding surgery, pain and healing, initial activity, post-operative Physiother. Res. Int. (2015) © 2015 John Wiley & Sons, Ltd.
rehabilitation, pain coping strategies, ergonomics and body awareness. When required, pain management including electro/cryo/acupuncture therapies, manual therapy and relaxation techniques were implemented. Physical interventions included gait training, postural alignment training, stretching of lower limb musculature and lumbar neural glide mobilisation techniques. Pilates and theraband strengthening exercises were implemented, focusing specifically on spinal, abdominal and pelvic-stabilizing muscle activation during the whole body exercise. Exercises encouraging controlled, progressive motion of the spine and general conditioning were also implemented. Extension of the lumbar spine was avoided in the early stages to ensure proper healing of the surgical anterior incision wound. Typically, spinal stabilization exercises in neutral position were introduced first, followed by flexion exercises,
A. Green et al.
Physiotherapeutic Rehabilitation Following TDR
followed by rotation and lateral movements and finally, extension. Behavioural strategies were also implemented for reinforcement of wellness behaviour and ignore sick behaviour, and goal setting as well as quotas/pacing were used for promotion of physical activities in daily living. In subsequent clinic-based sessions, the exercise quotas and pacing of the programme was therefore progressed and tailored to meet patient goals and willingness to attend outpatient clinic-based physiotherapy sessions and adapted to a home exercise programme, as the physiotherapist deemed appropriate.
d = M1 – M2/ ((SD1 + SD2)/2). Cohen’s d effect size measure d = 0.20 is considered a small effect, d = 0.50 is a medium effect and d = 0.80–infinity is a large effect size (Cohen 1992). A responder analysis was also performed where the percentage of patients reporting a more than 50% level of improvement in the outcome variables. IBM SPSS Version 21 was used for all data analyses. A p-value of 0.05 (two-tailed) was considered statistically significant.
Results Patient characteristics
Outcome measures All the patient’s background, demographic and outcome data were collected from Physiomax and Gold Coast Spine medical record systems. The following outcome measures were analysed for pre-operative, 3,6,12 and 24 months post-operative time points: Oswestry Disability Index (ODI), Short Form-36 Physical (SF-36 PCS) and Mental Subscale Components (SF-36 MCS), the Roland Morris Disability Questionnaire (RMQ) and Visual Analogue Scale (VAS) for both back pain and leg pain intensity. The ODI Version 2.1 (Fairbank et al., 1980; Fairbank and Pynsent, 2000) is presented as a 0 to 100 score, where lower scores represent lower levels of low back pain disability. Both the SF-36 PCS and SF-36 MCS were used to measure mental and physical health. Each subscale is presented as a 0–100 score, with higher scores representing better mental or physical health. The VAS for both back pain and leg pain intensity have a scoring range from 0 for no pain to 100 for maximal pain experienced in the previous week.
Data analysis The patient data were grouped as followed: self-mediated rehabilitation (Group 1), 1–3 sessions of clinic-based physiotherapy rehabilitation (Group 2) and ≥4 sessions of clinic-based physiotherapy rehabilitation (Group 3). For demographical variables, an analysis of variance (ANOVA) was conducted. For categorical variables, a Chi-squares test was used. For tests of main effects between groups, an analysis of covariance (ANCOVA) with Sidak comparison and adjustments for sex, age, surgical technique and questionnaire scores at baseline was utilized. Effect sizes from baseline for each group were calculated with the following formula: Cohen’s
Demographic and baseline measurement data are presented in Table 1. Variability in patient characteristics for the three groups at baseline was found with a significantly lower mean age (p < 0.05) in Group 3 (46.1 ± 11.0) compared with Group 1 (49.4 ± 10.1). Analyses for gender revealed significantly more women (p < 0.05) in Groups 1 (45.5%) and 3 (39.6%) compared with Group 2 (29.3%). A significant difference at baseline (p < 0.05) was found with lower VAS back pain in Group 2 (69.9 ± 22.8) compared with Group 1 (76.4 ± 19.5). For VAS leg pain at baseline, significantly lower scores (p < 0.05) were found for Group 2 (48.0 ± 30.6) and Group 3 (53.1 ± 32.0) compared with Group 1 (63.3 ± 29.8). Comparison of the ODI at baseline found a significantly lower score (p < 0.05) in Group 2 (45.2 ± 15.7) compared with Group 1 (50.1 ± 15.7). For SF-36 MCS, a significantly lower score (p < .05) for Group 1 (35.7 ± 14.3) compared with Group 2 (41.5 ± 15.20) and Group 3 (40.2 ± 14.0). To take into account these baseline differences between groups and the alternative surgical techniques used, statistical adjustment was carried out between groups by using these variables as covariates in subsequent between-group statistical comparisons. Outcomes measures Mean score changes (standard deviations) from baseline and effect sizes for each group, as well as between group mean differences, including 95% confidence intervals and ANCOVA for outcomes, are shown in Table 2. For analyses of ODI, there was a statistically significant difference (p = 0.004) between Groups 1 and 3 at 3 months, with the mean of Group 3 being 4 points lower. This trend continued at 6, 12 and 24 months (p = 0.002, p = 0.001 and 0.021, respectively). A statistically significant mean Physiother. Res. Int. (2015) © 2015 John Wiley & Sons, Ltd.
Physiother. Res. Int. (2015) © 2015 John Wiley & Sons, Ltd.
(27.2) (26.9) (28.2) (29.8)
(35.6) (35.9) (34.7) (35.7)
(18.0) (17.3) (18.7) (19.3)
(6.2) (6.1) (5.6) (5.9)
(12.7) (12.5) (11.7) (13.1)
(15.2) (14.9) (14.1) (18.3)
49.4 52.1 52.8 49.2
41.3 43.5 44.5 42.4
25.1 29.4 31.8 29.3
9.0 10.6 11.7 11.1
12.7 13.3 16.9 14.1
12.7 14.6 16.2 13.7
0.91 1.09 1.29 1.66
1.31 1.33 1.82 1.32
1.81 2.22 2.49 2.34
1.61 1.96 2.13 1.89
1.55 1.67 1.73 1.60
2.45 2.62 2.61 2.32
Mean change Effect from baseline (SD) size‡
Group 1: Self-mediated rehabilitation (n = 202)
(12.9) (12.5) (11.3) (12.0)
(7.2) (6.3) (6.0) (6.5)
(21.1) (19.5) (19.7) (19.5)
(36.3) (35.3) (34.4) (33.8)
(30.6) (29.7) (27.4) (27.8)
8.9 (15.3) 10.4 (15.0) 10.4 (16.2) 6.0 (18.6)
13.5 15.7 17.9 15.7
10.0 11.4 11.7 11.1
25.5 28.5 30.5 28.0
31.4 32.1 33.2 29.5
48.1 48.8 49.4 46.3
Mean change from baseline (SD)
11.7 11.9 12.9 8.4
13.7 17.0 19.2 17.1
10.5 12.0 12.8 11.6
27.0 30.6 32.6 29.1
35.9 38.7 37.8 33.3
51.3 52.2 52.6 48.3
(15.9) (15.5) (15.3) (18.5)
(13.4) (13.2) (11.6) (11.5)
(6.6) (6.1) (6.2) (6.1)
(19.2) (18.2) (19.3) (19.5)
(36.0) (35.2) (37.4) (36.6)
(28.4) (27.8) (30.4) (29.5)
Mean change from baseline (SD)
0.86 0.92 1.05 1.39
1.41 1.76 2.17 1.86
1.95 2.58 2.79 2.57
1.74 2.10 2.28 2.02
1.30 1.45 1.41 1.23
2.33 2.41 2.38 2.18
Effect size‡
Group 3: ≥4 sessions post-op physiotherapy (n = 275)
1.2 1.8 1.2 3.2
0.7 2.3 2.2 2.1 to 9.4) to 8.0) to 1.8) to 6.8)
to 8.9) to 7.0) to 7.3) to 8.0)
0.8 ( 0.5 ( 1.6 ( 2.9 (
1.9 ( 3.4 ( 2.1 ( 2.4 (
2.1 2.2 0.7 0.3
4.4 5.9 4.3 5.0
to 3.6) to 3.2) to 3.9) to 6.2)
to 0.5) to 0.9) to 0.1) to 0.2)
1.7 (0.5 to 3.0) 1.5 (0.4 to 2.6) 0.8 ( 0.3 to 1.9) 0.8 ( 0.3 to 2.0)
3.6 (0.2 to 7.1) 2.3 ( 0.9 to 5.5) 2.6 ( 0.5 to 5.7) 2.2 ( 1.2 to 5.6)
4.1 ( 3.1 ( 3.4 ( 1.8 (
4.1 ( 2.3 ( 2.6 ( 2.9 (
Mean difference (95% CI)†
0.601 0.731 0.172 0.075
0.127 0.008* 0.057 0.065
0.006* 0.010* 0.139 0.144
0.039* 0.366 0.098 0.211
0.133 0.221 0.142 0.478
0.094 0.322 0.285 0.253
ANCOVA p-value
Between group (1–2)
1.5 ( 0.4 ( 0.1 ( 1.3 (
1.1 ( 3.8 ( 2.5 ( 3.2 (
to 2.8) to 2.7) to 2.4) to 2.0)
3.8 to 0.8) 2.6 to 1.7) 1.8 to 2.0) 1.2 to 3.8)
3.0 to 0.9) 5.8 to 1.8) 4.2 to 0.8) 5.2 to 1.2)
1.8 (0.8 1.9 (1.0 1.6 (0.8 1.1 (0.2
to 6.8) to 6.3) to 6.5) to 5.8)
1.1 to 7.3) 0.3 to 7.9) 1.1 to 6.5) 3.9 to 4.1)
4.0 (1.3 3.8 (1.4 4.1 (1.6 3.2 (0.5
3.1 ( 4.1 ( 2.7 ( 0.1 (
5.0 (1.2 to 8.9) 3.5 ( 0.2 to 7.3) 3.8 ( 0.1 to 7.7) 2.9 ( 1.1 to 7.0)
Mean difference (95% CI)†
0.210 0.709 0.936 0.311
0.288
