Clinical Neurology and Neurosurgery 129 S1 (2015) S41–S46

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Clinical Neurology and Neurosurgery j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / c l i n e u r o

Is rehabilitation intervention during hospitalization enough for functional improvements in patients undergoing lumbar decompression surgery? A prospective randomized controlled study Chen-Yin Chena, Chia-Wei Changb,c, Shih-Tseng Leed, Yung-Cheng Chena, Simon Fuk-Tan Tange,f, Chih-Hsiu Chengb,c, Yang-Hua Linb,c,* Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital, Linkou, Taiwan Department of Physical Therapy and Graduate Institute of Rehabilitation Science, College of Medicine, Chang Gung University, Taiwan c Healthy Aging Research Center, Chang Gung University, Taiwan d Department of Neurosurgery, Chang Gung Memorial Hospital, Linkou, Taiwan e Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital, Linkou, Taiwan f School of Medicine, Chang Gung University, Taiwan a

b

keywords

abstract

Decompression surgery Perioperative period Physiotherapy rehabilitation Spinal surgery Hospitalization

Objective: Rehabilitation has been reported to improve pain and disability for patients after lumbar surgery. However, studies to investigate the rehabilitation intervention for lumbar decompression surgery during hospitalization are scarce. The aim of this study was to examine outcomes of perioperative rehabilitation intervention for patients who underwent lumbar decompression surgery (LDS). Methods: Patients aged 18-65 years old who received their first LDS were randomized into the perioperative rehabilitation group (PG) or control group (CG). The PG received rehabilitation intervention during hospitalization for lumbar decompression surgery. Pain, functional capacity, Roland-Morris Disability Questionnaire (RMDQ), and Short-Form Health Survey (SF-12) were assessed on admission, at discharge, and at follow-ups one month, three months, and six months after surgery. Two-way repeated measures ANOVAs were used for statistical analysis. Results: A total of 60 patients scheduled for decompression surgery for lumbar stenosis were enrolled into the study. After surgery, the PG showed significant pain relief and improvement of disability as well as quality of life, but there were no significant functional improvements compared with the CG. Conclusions: The findings of this study indicate that the rehabilitation intervention during hospitalization improves pain intensity as well as disability and quality of life, yet has limited effects on the functional performance over time up to six months post-surgery in patients who received LDS. The study suggest that rehabilitation interventions during hospitalization must include regular support for patient adherence to the intervention program and focus on task-oriented programs for lower extremities such as closed-chain exercises in functional postures. © 2015 Elsevier B.V. All rights reserved.

1. Introduction Decompression surgery is the most common operation for the treatment [1-2] of lumbar spinal stenosis. It combines surgical techniques to relieve symptoms caused by compression on the spinal cord and/or nerve roots for degenerative diseases of the lumbar spine. Common techniques for decompression include discectomy, laminectomy, foraminectomy, osteophyte removal, corpectomy, and even fusion of the vertebrae to stabilize the

* Corresponding author at: Department of Physical Therapy and Graduate Institute of Rehabilitation Science, College of Medicine, Chang Gung University, 259, Wen-Hwa 1st Rd., Kwei-shan, Tao-Yuan, Taiwan 333. Tel.: +886-3-2118800; fax: +886-3-2118700. E-mail address: [email protected] (Y.-H. Lin). 0303-8467/© 2015 Elsevier B.V. All rights reserved.

spine. Ideally, surgery is coupled with preoperative education and followed by a planned course of postoperative rehabilitation [3] mediated by a therapist and followed by long-term selfmanagement. Preoperative management is improved in the presence of a basis for establishing rapport for enhanced continuity of care after surgery as well as a mechanism for patient education regarding the scheduled surgery and components of postoperative rehabilitation. Not only patient education but also preoperative evaluation are to identify the patient’s needs, anticipated goals, and expected functional outcomes as a result of the surgery. Preoperative instruction [4] gives the patient an opportunity to become familiar with wound care, any special precautions, and supportive equipment such as a spinal brace or walking aids. Of equal importance, it enables the patient to practice and

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learn postoperative exercises early, without being hampered by postoperative pain or the side effects of pain medication, such as disorientation and drowsiness. The components of preoperative patient education consist of an overview of the plan of care, postoperative precautions, and initial postoperative exercises such as deep breathing and coughing as well as active ankle exercise (pumping exercises) and gentle muscle setting exercises of the immobilized area. During recovery from spinal decompression surgery, rehabilitation such as an instructed physical therapy program may be recommended to exercise the spine in order to regain strength and movement. Usually rehabilitation for spinal surgery starts 4 to 6 weeks post-operation, and sometimes even is suggested to be delayed up to 12 weeks if the surgery involves spinal fusion [5]. Conflicting results have made the effectiveness of rehabilitation intervention unclear. The following positive results have been seen. Patients with a recent history of lumbar microdiscectomy [6] benefited from an exercise program for weak paraspinal musculature and limited functions. Moreover, exercise programs [7] starting 4 to 6 weeks after lumbar disc surgery led to a faster decrease in pain and disability than no treatment. High intensity [7] exercise programs seemed to result in a faster decrease in pain and disability than low intensity programs. There were no significant differences between supervised and home exercises for pain relief, disability, or global perceived effects. On the other hand, the long-term outcomes of rehabilitation in the previous studies after lumbar decompressive surgery with up to two years follow-up were similar to outcomes in those who had not received any intervention as the control group. On the other hand, Mannion’s [8] randomized controlled trial demonstrated that 12 weeks of post-operative physiotherapy did not influence the course of change in pain or disability as long as 24 months after decompression surgery, and advised that keeping active by carrying out physical activities could be as good as undertaking a supervised rehabilitation program of spine stabilization exercises. Similar results were obtained in a prospective study to treat lumbar spinal stenosis with 2-year postoperative follow-up: a routine of postoperative outpatient rehabilitation did not improve functional outcome nor did it have any impact on back and leg pain, satisfaction, and walking ability [5]. As shown in the literature, most rehabilitations start with physical therapy by patient education and instruction. However, a RCT study in 2010 reported that degenerative disease interventions with combined preoperative information and training, patient-controlled epidural analgesia, and intensive postoperative mobilization [9] improved function, shortened hospitalization, and reduced costs in patients who had undergone lumbar spinal surgery. Moreover, perioperative rehabilitation for orthopedic surgery has been reported to accelerate these outcomes. Yet little evidence regarding early rehabilitation interventions during the perioperative [10] period extending from admission for spinal surgery to discharge with a planned program has so far been documented in terms of clinical outcomes. The aim of this study was to examine the outcomes of patients after lumbar decompression surgery (LDS) receiving perioperative rehabilitation. Thus, our study hypothesis was that outcomes would improve by early perioperative rehabilitation, and that patients would experience pain and disability over a shorter time post-operation.

(2) receiving primary LDS, and (3) able to communicate and actively participate in the program. Exclusion criteria were: (1) mental disability, (2) severe neurological disease as well as contraindication to surgery in general, or (3) musculoskeletal or systemic disorders with functional impairments that limit tolerance to testing. All patients who met the inclusion criteria were given oral information and written consent of the study on admission. The patients were randomly allocated to either the perioperative group (PG) or the control group (CG) by a health professional who did not take part in the trial and only had patients fill in a baseline questionnaire. The two patient groups and their healthcare staff were kept separated during the study period; neither were they allowed to discuss the intervention, nor were the healthcare personnel treating the CG aware of the procedures for the PG. The study protocol was approved by the Institutional Review Board/ Chang Gung Memorial Hospital (IRB/ CGMH). All the patients had spinal stenosis due to degenerative disc disease with or without leg pain and received either open or microscopic lumbar decompression surgery at the affected spinal location. Patients may have undergone other procedures, such as discectomy or lumbar interbody fusion, in combination with decompression depending on the decision taken by the surgeon during the operation. The rehabilitation intervention for the PG group was aimed to maximize post-operative engagement and participation in physical therapy and home exercise, to improve functional recovery, and to decrease pain in individuals who had undergone LDS. Both patient education preoperatively and the postoperative program focused on goals of rehabilitation during the hospital stay and after discharge. Patient education to reinforce selfmanagement and gradual intensifying of activities appropriately, postural awareness (i.e., advice given on the importance of good posture especially in sitting and ensuring the patient is independent with mobility preoperatively), mobilization strategies (lying to standing through side-lying), core stability exercises (in lying and in functional positions), and muscle strengthening (trunk and extremity muscles) were included. The education was designed to help participants understand their back problems and how to care for their back after surgery. On admission, the physiotherapist informed the patient about the protocol of the rehabilitation intervention during hospital stay in addition to the usual care and its continuance as a home program following discharge from hospital. As for early postoperative mobilization strategies, the patients were advised to stay active while wearing the lumbar corset and to sit less than 30 minutes at a time for one month after surgery, and they practiced mobility skills including how to move safely in bed or leave bed. Moreover, the physiotherapist mobilized the patients to get out of beds as early as possible and practice the rehabilitative protocol for 30 minutes daily during hospitalization. The rehabilitative protocol included not only deep breathing exercises but also trunk and extremity exercises since maintaining spinal posture and stabilization during activities of daily life was emphasized. The entire protocol was delivered by a researcher (CWC) 30 minutes a day during hospitalization for the PG only. The CG received only instructions concerning post-operative care by the involved neurosurgical team, i.e., the usual care protocol. 3. Outcome measures

2. Materials and methods Patients scheduled for decompression surgery for lumbar stenosis were consecutively invited to participate in the study. Inclusion criteria were: (1) between 18-65 years of age,

Other than participant characteristics and surgical records from medical charts, the outcome measures used in this study were the Visual Analogue Scale (VAS), the Global Rate of Change (GROC) scale, the Roland-Morris Disability Questionnaire



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(RMDQ), and the Short Form (SF)-12 Health Survey. The VAS was used to evaluate pain intensity over the lower back and lower extremities at rest and during activities. The visual analogue scale ranged from 0-10 cm to be equated with pain intensity (0-10 graphic rating scale, for back and leg pain separately). The GROC scale was obtained to determine the patient’s perception of overall improvement as a result of surgery assessed at followup. Satisfaction was assessed using a 5-point scale: very satisfied (=5), satisfied, neither satisfied or dissatisfied, dissatisfied, and very dissatisfied (=1). RMDQ was used to determine patient’s perceived disability associated with back and leg pain, which was used to assess subjective physical impairment and disability due to lower back pain. It contains 24 unweighted items, and the score ranges from 0 (no disability) to 24 (maximum disability). Quality of life was measured at the same points. SF-12, which is a simplified yet highly consistent version of the SF-36, was used to evaluate health status. It contains a physical component summary (PCS) and a mental component summary (MCS) [11]. Furthermore, functional assessments were evaluated for activities of daily life [12] with the exercises of a 15-m walk, 5 sit-to-stands, forward reaching, and 1 minute of going up and down stairs. The sit-to-stand [12] test is a simple and reliable physical performance test that measures the time required for a patient to rise from sitting to standing as quickly as possible five times. The 1 minute of going up and down stairs test measured how many times a patient could climb up and down 10 stairs. If there was any pain or fatigue, the functional assessments were terminated. After registration and inclusion, all patients were assessed for pain and functionality on the day before surgery, at discharge, and at 1-month, 3-month, and 6-month follow-up after discharge. An independent investigator blinded to group allocation assessed outcome measurements. The questionnaire recorded the patients’ demographics (sex, age, body mass index, educational level), medical history (location and types of pain, other conservative treatments), and physical activity. The postoperative follow-up assessment was administered in person to patients visiting the neurosurgical outpatient clinic as scheduled after discharge or accomplished by phone interview if the patients were absent from the appointments. A physiotherapist trained in pain measurement and scoring, interventions, and follow-up performed all assessments. The physiotherapist was not a member of the clinical staff and did not participate in the daily patient care. 4. Statistical analysis Continuous variables were described in terms of mean and standard deviation, while ordinal variables and nominal variables were described in terms of percentage. The Shapiro-Wilk test was used to determine if the data were normally distributed. ANOVAs with repeated measures were used to examine the differences in the outcomes between groups and at the different time points. When non-parametric statistics were for the analyses, the Friedman test and Wilcoxon signed-rank test were performed to compare the change before and after surgery over time within the group. The Mann-Whitney U test was used to compare the difference between the two groups before and after surgery. The significance level was defined with a set at 0.05. Intention to treat (ITT) analysis was conducted, and the mean was used to input a dropout patient’s missing data. Data were analyzed using SPSS for Windows, version 18.0 (SPSS Inc., Chicago, IL, USA). 5. Results From December 2012 through May 2012, 60 patients (30 males, 30 females) were enrolled into this study. The flow chart

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in Fig 1 shows the process of patient recruitment, study design, and timing of data collection. The demographic profiles of the patients were similar in both groups (Table 1). The intraoperative procedures and the use of analgesics were not significantly different between both groups, except for complication rate, which included postsurgical infection and fever (Table 2). Nearly 90% (86.2% in PG; 89.7% in CG) received more than two levels of laminectomy and more than half of the patients had fusion combined with their procedure. Only one-fourth of patients were considered for discectomy. The pain profiles regarding intensity, location, type, and activity-related intensity in both groups are shown in Table 3. In general, all of patients had pain reduced significantly after LDS, which was maintained up to the 6-month follow-up. Along with recovery, pain was decreased significantly more during rest than during activity in both groups. Back pain during activity was apparently more intense than leg pain either at rest or during activity. The PG demonstrated significant decrease in pain at the 1-month follow-up compared with the CG. Postoperative pain varied over time similarly in both PG and CG. In PG, complications had statistically moderate to low correlation with pain of lower extremities along with activity at discharge and at rest one month after surgery (Spearman’s rho = 0.45), which was not observed in the CG or at any other follow-up. The mean RMDQ showed significant improvement in both groups at the 6-month follow-up. Compared with the CG, the PG had greater gain in the quality of life at the 1st month follow-up, yet not for the other two follow-ups later. On the other hand, the CG has demonstrated better scores for both domains of quality of life from the 1-month follow-up onwards. There were statistical differences between the PG and CG. The GROC indicated selfperceived improvements over time in health status of more than 70% of patients in both groups. MCS increased more than PCS did for both groups. All of the patients showed varied changes in functional capacity (Table 2). The main improvement was demonstrated in the 5 repeated sit-to-stands exercise, yet there was no difference between the PG and CG. The PG did not exhibit better performance than the CG over time. 6. Discussion The results demonstrated that perioperative rehabilitation intervention conferred few improvements compared with the convention post-surgical care protocol. Intensive rehabilitation during hospitalization stay in this study showed little advantage over the usual care protocol followed by the CG. Accordingly, patient compliance with the rehabilitation program at home after discharge should be of concern to and closely followed by health professionals. However, in the PG, blood loss and complication rates differed from those in the CG. It could be expected that our intervention group had a higher pain score due to the intensive training program [13]. We may have overlooked differences in the duration of episodes with severe pain because we only asked the patients about the pain level; this could have introduced weakness in the study design. Back pain during activity is a major issue to patients who have undergone LDS. Such pain would be associated with the surgical site along the back, which is stretched by trunk motions during daily activity. The changes in quality of life in the PG were not significant compared with the CG, which might have resulted from high scores at admission. Based on the minimum detectable change thresholds following neural decompression and fusion for symptomatic same-level recurrent stenosis reported in the literature, pain in the back and lower legs as measured by the

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Eligible subjects (n=144)  Refused to join experiment (n=84)  Included subjects (n=60) 

Randomized into two groups    Preoperative assessment (n=60) Intervention group (n=29) 

Control group (n=31) 

Surgery   

Postoperative 1st week follow up 

Postoperative 1st week follow up 

28 Subjects finished (96.6%); 1subject could 

30 Subjects finished (96.8%); 1subject could 

not be contact; 9 subjects did not evaluate 

not be contact; 15 subjects did not evaluate 

functional tests 

functional tests 

Postoperative 1st month follow up 

Postoperative 1st month follow up 

12 Subjects finished (41.3%); 17 subjects 

11 Subjects finished (35.5%); 19 subject could 

could not be contact; 8 subjects did not 

not be contact; 1 Refused to assess due to work; 

evaluate functional tests 

10 subjects did not evaluate functional tests 

Postoperative 3rd month follow up 

Postoperative 3rd month follow up  14 Subjects finished (44.8%); 15 subjects 

12 Subjects finished (38.7%); 18 subject could 

could not be contact; 8 subjects did not 

not be contact; 1 Refused to assess due to work; 

evaluate functional tests 

10 subjects did not evaluate functional tests 

Postoperative 6th month follow up 

Postoperative 6th month follow up  10 Subjects finished (31.0%); 19 subjects  could not be contact; 8 subjects did not 

17 Subjects finished (54.8%); 13 subject could not  be contact; 1 Refused to assess due to work; 12  subjects did not evaluate functional tests 

evaluate functional tests 

Fig. 1. Flow chart.

Table 1 Preoperative demographics of study groups (mean±SD)

PG (n=29)

Table 2 Surgical events of study groups CG (n=31)

Male/female (n) 16/13 14/17 Age (years) 51.8±11.6 52.1±9.9 Education level (%) Elementary school 31.0 32.3 Junior high school 27.6 25.8 Senior high school 24.1 32.3 University 13.7 9.7 162.4±10.5 162.6±7.5 Height (cm) 70.2±9.8 64.5±12.4 Weight (kg) BMI (kg/m2) 26.6±3.4 24.4±4.6 Physical activity (%) 3 times/week 34.5 22.6 1-2 times/week 13.8 6.5 Less 1 times/week 0 3.2 None 51.7 67.7 Conservative treatments (%) Physical therapy 69.0 61.3 Manual therapy 48.3 51.6 Acupuncture 41.9 41.9

p value 0.44 0.40 0.89

0.16 0.22 0.33 0.50

0.53 0.80 0.97

PG: perioperative rehabilitation group, CG: control group, * All betweengroup differences set at a of 0.05; independent t test was used to compare the differences in age, height, weight, BMI between two groups; chi-square test was used to compare the differences in the percentages of sex, education level, and conservative treatments between the two groups.

Surgery type (%) Laminectomy (>2 levels) Foraminectomy Discectomy Fusion Operation time (mean±SD, min) Loss of blood (mean±SD, mL) Postoperative analgesics types (%) Patient-controlled analgesia (PCA) Meperidine HCL

PG (n=29)

CG (n=31)

86.2 89.7 93.1 79.3 24.1 25.0 55.2 51.7 180.8±67.7 164.0±57.0 446.5±462.2 272.5±267.8 34.4 41.4

17.2 51.7

p value 0.69 0.13 0.96 0.79 0.31 0.18 0.23 0.43

PG: perioperative rehabilitation group, CG: control group. * significance between-group differences set at a of .05; independent t test was used to compare the differences in operation time and loss of blood between two groups; chi-square test was used to compare the differences in the percentage of sex, education level, conservative treatment, surgery type, and analgesics type between the two groups.

VAS were closely related to the MDC as well as overall quality of life as measured by the SF-12 [14]. The dropout rate of follow-up appointments was only 5% for the first follow-up clinic visit. After three months, the followup rate was nearly 50% because of patient recovery and limits of



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Table 3 Outcome measures by study group using intention-to-treat analysis (n=60; mean, SD)

Admission PG

CG

Discharge PG

Follow up 1 month

CG

General pain 6.0 6.3 (2.8) (2.2) Back pain Rest – – 2.3† 2.0† (2.0) (1.6) Activity – – 4.5† 3.8† (2.3) (2.1) LE pain Rest – – 2.7*† 1.5† (2.3) (1.6) Activity – – 3.2† 2.7† (2.5) (2.2) 11.7 12.5 – – RMDQ (5.9) (5.3) SF-12 PCS 37.1 34.6 – – (8.6) (7.0) MCS 47.9 43.4 – – (10.5) (12.6) 78.6 73.3 Global rating scale (>0 point, %) Forward reaching 15.6 17.2 13.0* 7.9† (6.2) (6.6) (4.2) (4.3) 19.3 17.2 25.6*† 5 repeated sit-to-stands (sec) 28.9† (9.1) (7.9) (12.2) (7.0) 18.3 20.7 28.3† Timed 15-m walk (sec) 25.8† (6.3) (14.4) (12.4) (8.9) 79.7 77.5 62.6*† 1-minute going up and 48.0† down stairs (stairs) (35.5) (31.7) (26.2) (13.5)

Follow up 3 month

Follow up 6 month

PG

CG

PG

CG

PG

CG

0.4*†‡ (0.6) 2.4*†‡ (1.5)

1.8† (1.0) 3.6† (1.6)

0.8*†‡§ (1.1) 4.5*†§ (1.9)

0.2†‡§ (0.4) 3.2† (1.5)

0.5*†‡ (0.6) 2.5*†‡|| (1.5)

1.1†‡§|| (1.1) 4.2†|| (1.8)

0.8*†‡ (1.0) 1.9*†‡ (1.6) 9.8* (3.5)

1.5† (1.1) 2.8† (1.7) 10.8 (2.1)

0.8*†‡ (1.0) 3.7*†§ (2.1) 10.4* (2.9)

1.1† (1.1) 2.4† (1.5) 9.7†§ (3.5)

0.3†‡§|| (0.5) 3.3*†§ (2.0) 7.6*†§|| (3.5)

0.4†‡§|| (0.9) 1.4†‡§|| (1.8) 5.8†§|| (3.3)

38.2* (6.3) 50.2* (5.8) 100.0 13.6* (1.5) 14.0*†‡ (1.5) 18.3*‡ (1.1) 71.7*‡ (5.0)

36.9 (5.4) 46.2 (6.3) 100.0 28.0†‡ (0.0) 16.4†‡ (0.0) 13.0†‡ (0.0) 88.0‡ (0.0)

33.6*§ (7.1) 46.1*§ (6.9) 92.9 16.0*‡§ (2.5) 16.5*‡§ (3.1) 20.0*†‡§ (3.0) 71.8*‡ (15.3)

37.8† (6.8) 49.1†§ (5.7) 91.7 22.0†‡§ (0.0) 14.3‡§ (0.8) 14.6†‡§ (0.6) 59.7†‡§ (8.6)

40.1*§|| (2.8) 46.0*§ (6.3) 90.0 16.8*‡§|| (1.3) 13.3*†‡§|| (1.2) 18.5*‡§|| (0.4) 70.0*‡§|| (3.8)

41.5†§|| (5.2) 51.3†§|| (6.9) 75.0 23.3†‡§|| (3.7) 12.8†‡§|| (1.6) 14.4†‡§|| (1.2) 89.0‡§|| (12.6)

LE: lower extremities; RMDQ: Roland-Morris disability questionnaire. *Significant difference between two groups (p