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ORIGINAL
A semi-rigid thoracolumbar orthosis fitted immediately after
spinal surgery : stabilizing effects and patient satisfaction
Tsuyoshi Goto1, Toshinori Sakai2, Kosuke Sugiura2, Hiroyuki Manabe2, Fumitake Tezuka2, Kazuta Yamashita2,
Yoichiro Takata2, Shinsuke Katoh1, and Koichi Sairyo2
Department of Rehabilitation Medicine, Tokushima University Hospital, Tokushima, Japan
Department of Orthopedics, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan

1
2

Abstract : Purpose : To evaluate the stabilizing effects of a Fit Cure-Spine® semi-rigid thoracolumbar orthosis andwearer satisfaction after lumbar surgery. Methods : In study 1, the spinal angle, spinal motion angle, and distribution of load were measured in 8 adult male volunteers when the orthosis was worn (1) with no custom-madestay (CMS), (2) with a CMS in the prone position (P-CMS), and (3) with a CMS in the prone position and decreased
lordosis (DP-CMS). In study 2, pain scale scores and responses to a questionnaire were recorded in 40 consecutive patients who underwent lumbar spinal surgery in our hospital. Results : In study 1, the mean lumbar lordosis
when standing was similar to that in the prone position. When the trunk was bent forward, loads on the backsupport in P-CMS and DP-CMS were concentrated at the center of the CMS, unlike those for No-CMS. In study
2, there was a significant decrease in postoperative wound pain after wearing the Fit Cure-Spine orthosis for 2
weeks. Most patients who wore the orthosis were satisfied with their pain outcome. Conclusion : Adjustment tolumbar lordosis and the prone position was restricted in volunteers wearing the Fit Cure-Spine with a CMS. J.
Med. Invest. 66 : 275-279, August, 2019
Keywords : Thoracolumbar spine, Orthosis, Low back pain, Range of motion

INTRODUCTION
Low back pain can be caused by many disorders, includingintervertebral disc herniation, spondylosis, spinal canal stenosis, spondylolysis, spondylolisthesis, scoliosis, vertebral fracture,
infection, and malignancy, all of which warrant treatment. Somepatients need surgical intervention, including corrective spinal
fusion surgery (1) while others require conservative treatment.
Regardless of the treatment provided for patients with these
spinal disorders, we often encounter situations where a spinal
orthosis is indicated.
Spinal orthosis is used to restrict movement of the spine tocontrol pain and restore function (2,3,4). In clinical practice,
it is common to encounter patients requiring prompt external
fixation after corrective surgery or following acute vertebral
fracture. However, creating a rigid orthosis that fits a particularpatient usually takes several days to a week. Corrective spinal
fusion surgery is becoming increasingly common. However, ina patient undergoing this procedure, an orthosis molded preoperatively would not fit the trunk postoperatively because of theresulting marked change in posture. Furthermore, patients’general physical status immediately after corrective surgery
is generally such that standing with adequate posture for theduration needed for orthosis molding is impossible. Moreover,postoperative surgical wound pain invariably precludes protracted standing, particularly in older patients. Nevertheless, itis well known that early mobilization is crucial to avoid several
postoperative complications, including cardiovascular events(5), disuse atrophy (6), urologic dysfunction (7), and deep vein
Received for publication December 26, 2018 ; accepted May 8, 2019.
Address correspondence and reprint requests to Toshinori Sakai,
MD, PhD, Associate Professor, Department of Orthopedics, Institute of Biomedical Sciences, Tokushima University Graduate
School, 3-18-15 Kuramoto-cho, Tokushima 770-8503, Japan andFax : +81-88-633-0178.

thrombosis (8).
To resolve this dilemma, we have recently developed asemi-rigid thoracolumbar orthosis that can be fitted immediately
after acute postural change, such as that occurring after traumaor spine surgery. The purpose of this study was to assess theeffectiveness of this orthosis, its stabilizing effect using two different casts molded as stays for insertion during various trunk
movements, and patient satisfaction with use of this orthosis
after lumbar spine surgery.

PATICIPANTS AND METHODS
Study 1
Participants

We enrolled 8 healthy male volunteers with mean age 28.8
(range, 22–33) years, mean height 173.3 (range, 163–179) cm,
and mean body weight 67.4 (range, 55.4–86.4) kg. None of thesubjects had a history of low back pain, musculoskeletal injury,or spinal surgery.

Test material
A cast (splint) is created as a custom-made stay (CMS) fitted
to the lumbar lordosis of the individual patient and is usuallymolded to meet the shape of the patient’s back in the prone position. The device can be made available in approximately 10 min.
After the cast becomes rigid, it is inserted into the back pocket
built into the orthosis. The device is then firmly fixed to the patient’s body using Velcro bands. This orthosis was developed byour team and has been available commercially as the Fit CureSpine® (Alcare Co., Ltd., Tokyo, Japan) since 2017 (Figure 1).
Three types of orthoses were constructed by inserting different types of CMS into the back pocket of the device so that eachsubject would wear the orthosis (1) with no CMS (No-CMS), (2)with a 220 mm × 350 mm CMS made of glass fiber molded to thelumbar lordosis in the prone position (P-CMS), and (3) with the

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T. Goto, et al. Orthosis stability and patient satisfaction

same CMS but with decreased lordosis in the prone position (DPCMS). The CMS was molded to fit the shape of the volunteer’sback in the decreased lordosis condition, which was created byinserting a 10-cm cushion beneath the volunteer’s belly in theprone position to reduce lumbar lordosis.

Figure 1. A custom-made stay (A) fitted to the lumbar lordosis of thepatient is molded to meet the shape of the patient’s back in the prone
position (B). After the cast becomes rigid, it is inserted into the backpocket of the orthosis (C). Fixation is secured by fixing the orthosis tothe patient’s body using Velcro bands (D). This orthosis is available
commercially as the Fit Cure-Spine (E).

Measurement of spinal movement while wearing the orthosis
Spinal movements were measured using a SpinalMouse ®
(Idiag, Volkerswill, Switzerland), which is an electronic computerized device that can measure the sagittal range of motion of
the spine and intersegmental angles in a noninvasive manner.
The device runs paravertebrally along the spine from the seventh cervical (C7) to the third sacral (S3) vertebrae.
First, lumbar lordosis and thoracic kyphosis in the standing
position, in the prone position, and in the prone position with decreased lordosis were compared between the subjects to confirm
the best method by which to mold the CMS (Figure 2). Range of
motion in the sagittal plane from T1 to S1 in the standing position

was then calculated from the angles obtained on full flexion andextension. Measurements were taken while each subject was
wearing the orthosis in the P-CMS and DP-CMS conditions byprojecting the contour of the volunteer’s back onto a wall andplacing marks on the wall (Figure 3). After removal of the orthosis, each volunteer’s body was positioned relative to these marks
and measurements were taken using the SpinalMouse®.

Figure 3. Range of motion in the sagittal plane from T1 to S1during standing was calculated from the angles measured on full
flexion and full extension. Measurements while the subject was
wearing the orthosis under the P-CMS and DP-CMS conditions wereobtained by projecting the contour of the subject’s back onto a walland placing marks on the wall. After removal of the orthosis, theirbody was positioned to align with these marks and measured usinga SpinalMouse®. CMS, custom-made stay; P-CMS, CMS made ofglass fibers fitted to the lumbar lordosis of each subject in the prone
position ; DP-CMS, CMS fitted in the prone position with decreased
lordosis.

Load distribution
Contact pressure exerted by the orthosis on each volunteer’s
body surface was measured using pressure sensors (AMI TechnoCo., Ltd, Tokyo, Japan) on full active flexion/extension of thetrunk while standing with the knees fully extended. The backsurface of the orthosis was divided into 6 × 8 (width × height)
5 × 5-cm square grids, and one pressure sensor was placed oneach square (Figure 4). The value measured by each sensor wasrecorded via connected measurement amplifiers and converted
to a compressive load (N) value (9).

Study 2
Participants
Study 2 included 40 consecutive patients (19 male, 21 female)of mean age 61 (range 13–84) years who underwent various

Figure 2. Lumbar lordosis and thoracic kyphosis of each volunteer
in the standing (A) and prone (B) positions as well as in the prone
position with decreased lordosis (C) were compared to determine theappropriate method of molding the custom-made stay.

Figure 4. Apparatus used for measurement of load. An airpack

placed at the rear of the brace is divided into 6 × 8 (width × height) 5 ×
5-cm square grids, and one pressure sensor is placed on each square.

The Journal of Medical Investigation Vol. 66 August 2019277

lumbar surgeries including posterior lumbar interbody fusion,
extreme lateral lumbar interbody fusion, and direct repair of apars defect, at our hospital from October 2015 to March 2016.

Pain scores and satisfaction questionnaire
Visual analogue scale (VAS) pain scores were recorded at restand during activity immediately following surgery and at 1, 2,
and 3 weeks during the postoperative hospital stay. Orthoses
was fitted in all patients on the second postoperative day. A
questionnaire designed to determine the patients’ perceived easeof use, stability, and comfort, as well as time to wear the orthosis
and overall satisfaction was administered.

Statistical analyses
Friedman test was used to detect statistically significant
differences in measurements obtained at the four assessment
points and post hoc Wilcoxon signed-rank test was used to
identify statistically significant differences in measurements
obtained under the three different wearing conditions. Statistical analyses were performed using SPSS for Windows software(version 22.0; IBM Corp., Armonk, NY). Changes in VAS painscores were analyzed using repeated-measures analysis ofvariance with Bonferroni post hoc test. A p-value < 0.05 wasconsidered statistically significant. Homogeneity of variances
was assessed using the Shapiro-Wilk normality test. Both studies were approved by the Medical Ethics Committee. Informed
consent was obtained from all volunteers in study 1 and all
patients in study 2.

RESULTS

Study 1
Angles of lumbar lordosis
Mean angles of lumbar lordosis under the three wearing
conditions are shown in Table 1. Mean angle in the standing
position was similar to that in the prone position (23.6° ± 6.8°
and 24.6° ± 8.9°, respectively). Mean angle of lumbar lordosis
decreased significantly to 14.4° ± 8.2° after adjustment to decreased lordosis in the prone position.
Table 1. Mean thoracic kyphosis and lumbar lordosis angles foreach orthosis.
No-CMS

P-CMS

DP-CMS

Thoracic kyphosis angel (°)

46.4 ± 8.9

31.9 ± 11.7

24.9 ± 8.9

Lumbar lordosis angle (°)

23.6 ± 6.8

24.6 ± 8.9

14.4 ± 8.2

Figure 5. Graphs showing the mean ranges of motion in flexion andextension of the trunk for each orthosis. *p < 0.05 after Wilcoxon’s
adjustment between each condition. CMS, custom-made stay; P-CMS,
CMS made of glass fibers fitted to the lumbar lordosis of each subject
in the prone position; DP-CMS, CMS fitted in the prone position withdecreased lordosis.

Load distribution on the back support during spinal flexion
The Fit Cure-Spine orthosis is believed to restrict forwardbending of the trunk by providing three-point support at the
lumbar region (by the CMS) and at the thoracic region (by theshoulder and chest belts; Figure 6). In this study, we evaluatedthe extent to which the difference in the type of CMS used influences function by measuring the stress distribution. Figure
7 shows the mean compressive load in each square grid during
spinal flexion. For each volunteer, the trunk was bent forward
and the load on the back support under the P-CMS and DP-CMS
conditions was concentrated on the center of the CMS, which isin contrast with the No-CMS condition.

Study 2
VAS scores
Mean VAS score at rest immediately after surgery was
33.2 ± 28.1 and 36.5 ± 29.8 without and with the Fit Cure-Spinedevice, respectively. At 1 week postoperatively, mean VAS score

Range of motion during spinal flexion and extension
Mean range of trunk motion for each volunteer during flexionand extension under the three wearing conditions is shownin Figure 5. Mean flexion angles under the No-CMS, P-CMS,
and DP-CMS conditions were 88.9° ± 10.3°, 81.6° ± 10.4°, and98.9° ± 6.8°, respectively. There were significant differences inflexion angle between the No-CMS and DP-CMS conditions andbetween the P-CMS and DP-CMS conditions. Mean extension
angles under the No-CMS, P-CMS, and DP-CMS conditions
were 28.6° ± 5.1°, 22.0° ± 5.6°, and 31.9° ± 4.6°, respectively.
There were significant differences between the No-CMS and
P-CMS conditions and between the P-CMS and DP-CMS conditions. Movements were most restricted when the subjects were
wearing the CMS molded to adjust for lumbar lordosis and theprone position.

Figure 6. The Fit Cure-Spine orthosis is thought to provide threepoint support in the lumbar region via the custom-made stay and in
the thoracic region via the shoulder and chest belts.

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T. Goto, et al. Orthosis stability and patient satisfaction

was 21.2 ± 28.1 and 16.2 ± 20.6 with and without the orthosis,
respectively. The respective values were 6.9 ± 11.0 and 6.1 ± 9.9
at 2 weeks and 4.6 ± 9.3 and 3.7 ± 7.9 at 3 weeks postoperatively.
There were no statistically significant differences in mean VAS
scores recorded at rest at any of the time points (Figure 8).

Mean VAS score on activity immediately after surgery was
37.2 ± 25.9 and 57.0 ± 25.4 with and without the Fit Cure-Spinedevice, respectively. At 1 week postoperatively, mean VAS score
was 18.4 ± 19.1 and 25.4 ± 23.0 with and without the orthosis, respectively. The respective values were 8.9 ± 11.7 and 13.3 ± 15.6
at 2 weeks and 4.0 ± 8.1 and 6.6 ± 11.0 at 3 weeks postoperatively. There was a significant difference between the VAS
pain score recorded immediately after surgery and at 1 week
postoperatively.

Comfort and wearability

Figure 7. The mean compressive load in each grid square during
spinal flexion. The volunteer’s trunk was bent forward and the loadon the back support under the P-CMS and DP-CMS conditions wasconcentrated on the center of the CMS, unlike under the No-CMS
condition. CMS, custom-made stay ; P-CMS, CMS made of glass fibers
fitted to the lumbar lordosis of each subject in the prone position ; DPCMS, CMS fitted to each subject in the prone position with decreased
lordosis.

Questionnaire results regarding the comfort and wearabilityof the orthosis are presented in Table 2. Most patients were notconcerned about the orthosis being attached to the body. Overall,approximately 90% of the patients wore their orthosis for ≥ 12 hdaily. Approximately 80% of participants were very satisfied orsatisfied in terms of perceiving the orthosis to be comfortable towear. However, 24% reported difficulty putting the orthosis on
and taking it off and 90% felt that the sensation of having theorthosis on the body and its movement was too strong and somewhat strong. When asked to rate their overall satisfaction withthe orthosis, 14%, 50%, and 36%, reported being very satisfied,satisfied, and undecided, respectively.

DISCUSSION

Figure 8. (A) Mean VAS pain scores at rest immediately after
surgery and at 1, 2, and 3 weeks postoperatively with and without
the Fit Cure-Spine orthosis. There are no statistically significant
differences in scores obtained at rest. (B) Mean VAS pain scoreson activity immediately after surgery and at 1, 2, and 3 weeks
postoperatively with and without the Fit Cure-Spine orthosis. There
was a significant difference in the VAS pain score immediately
after surgery and at 1-week postoperatively. *p < 0.05. VAS, visual
analogue scale.

A spinal orthosis is often used to restrict movement of thespine as part of treatment for several spinal disorders, including postoperatively, to provide mechanical support, enhance comfort, and protect implants from biomechanical forces(2,3,4,9,10,11,12). For the orthosis to be effective, it is importantthat it fits the patient’s trunk and has adequate stiffness; generally, this requires modeling using gypsum with the patient in astanding position and maintaining an ideal posture despite backpain. Furthermore, it takes approximately a week to create acustom-made rigid orthosis. In clinical practice, it is common to
encounter patients postoperatively or post-trauma who need immediate external support. However, until now, there have been
limited orthotic options for these patients.
If an orthosis is modeled before corrective spinal fusion surgery, it will not fit the patient’s trunk because of the change
in posture postoperatively. Furthermore, the patient’s general
physical status may be too poor immediately after such invasive
surgery to maintain a standing position with adequate posturefor the time needed for modeling the orthosis, and postoperative
wound pain adds to this difficulty in older patients. It is known
that early mobilization is important to avoid postoperative complications, in particular cardiovascular events (5), disuse atrophy

Table 2. Evaluation of comfort and ease of wear
Easy to wear

Nomal

Difficult to wear

19

57

24

Too strong

Strong

Fit

33

57

10

Except when bathing

10h

12h

88

7

5

Very satisfied

Satisfied

UndecidedDissatisfied

Perceived comfort (%)

17

62

19

2

Overall satisfaction (%)

14

50

36

Perceived ease of use (%)

Perceived stability (%)

Time spent wearing brace (%)

The Journal of Medical Investigation Vol. 66 August 2019(6), urologic dysfunction (7), and deep vein thrombosis (8). To
address these problems, we have developed a new semi-rigid
thoracolumbar orthosis and validated its clinical effectiveness.
Three-point support with a spinal orthosis is used to treat several common spinal disorders (13). The Fit-Cure Spine semi-rigid
thoracolumbar orthosis used in the present study was developed
taking into account the three-point support theory. This orthosis
supports the trunk via CMS fitted to the lumbar lordosis of theindividual patient, restricts backward bending, and is believed
to restrict forward bending of the trunk by providing three-point
support in the lumbar region via the CMS and in the thoracic
region via the shoulder and the chest belts.
In study 1, we evaluated the effectiveness of the CMS by comparing the orthosis with and without the CMS molded to meetthe shape of the patient’s back in the prone position. We also
assessed the influence of the shape of the CMS by comparing useof the orthosis in the prone position and that with decreased lordosis. Mean angle in the standing position was similar to that in
the prone position, suggesting that the CMS molded in the prone
position would be similar to that molded in the standing position.
However, there was a significant decrease in thoracic kyphosis in
the prone position. This finding may reflect a potential thoracic
flexibility in the volunteers.
Our findings suggest that the CMS may be useful for maintaining good posture and restricting forward/backward bendingof the trunk. A biomechanical study of two alternative semirigid
thoracolumbar orthoses in volunteers performed by Kienie et al.
reported a stabilizing effect (2). In that study, the increased stability was statistically significant despite the inability of either
orthosis to achieve complete immobilization. We believe that thestabilizing effect would be increased only if a CMS was inserted.
The questionnaire responses indicate that patient compliancewith the orthosis was mostly satisfactory. VAS pain scores on
activity decreased significantly immediately after surgery and1 week postoperatively when the orthosis was worn. Our findings indicate that the orthosis has a significant effect within 2
weeks of surgery. However, we do not have any evidence as yet
regarding the local stability of the fusion site, although there wasa significant difference between VAS pain score immediately
after surgery and at 1 week postoperatively. These results showthat the Fit Cure-Spine could significantly decrease surgicalwound pain in the first 2 weeks postoperatively. Therefore, we
recommend the Fit-Cure Spine be prescribed for 2 weeks after
surgery as a temporary orthosis. Ideally, a rigid brace should bemodelled after confirming that wound pain has resolved and thepatient can easily remain in a standing position. The results also
indicate that this orthosis effectively restricts forward bending of
the trunk regardless of the type of CMS used. Thus, we believe
this orthosis would be useful in patients with several types ofthoracolumbar disorders, such as the acute phase of a compression fracture, degenerative disc disease, and infectious discitis.
We acknowledge that this study 1 is limited in that measurements were obtained from healthy adult male volunteers withno history of low back pain, musculoskeletal injury, or spinal
surgery, which may yield different results from those in patientswith lumbar disorders.
In conclusion, we have developed a semi-rigid thoracolumbar
orthosis that can be fitted immediately after an acute posturalchange. We have also confirmed its clinical effectiveness bydemonstrating its stabilizing effects using two different casts
molded as inserted stays during forward/backward bending of
the trunk and by the results of a satisfaction survey in patients
who have undergone various types of lumbar surgery.

279

CONFLICTS OF INTEREST
The authors would like to acknowledge the funding received
from Medical Engineering Laboratory, Alcare Co., Ltd., Tokyo,
Japan.

ACKNOWLEDGEMENTS
The authors thank Hiroyuki Yamada and Takushi Kasashima for providing technical advice regarding the statisticalanalysis.

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