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Journal of Orthopaedic Science 26 (2021) 953e961

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Journal of Orthopaedic Science


journal homepage: http://www.elsevier.com/locate/jos

Original Article

Immediate effect of mechanical lumbar traction in patients with


chronic low back pain: A crossover, repeated measures, randomized
controlled trial
Hideki Tanabe a, Masami Akai b, *, Tokuhide Doi c, Sadao Arai d, Keiji Fujino e,
Kunihiko Hayashi f, for Low back-pain Traction Therapy (LTT) Study
a
Tanabe Orthopaedic Clinic, 3-2-16 Narimasu, Itabashi-ku, Tokyo 175-0094, Japan
b
Graduate School, International University of Health and Welfare, 4-1-26 Akasaka, Minato-ku, Tokyo 107-8402, Japan
c
Geriatric Care Facility Narita Tomisato Tokushu-en, 1-1-1 Hiyoshi-dai, Tomisato-shi, Chiba 286-0201, Japan
d
Arai Orthopaedic Clinic, 1-19-7 Asumigaoka Midori-ku, Chiba-shi, Chiba 267-0066, Japan
e
Fujino Orthopaedic Clinic, 2-15-12 Johoku, Naka-ku, Hamamatsu-shi, Shizuoka 432-8011, Japan
f
Department of Statistical Epidemiology, School of Health Sciences, Gunma University, 3-39-22 Shouwa-machi, Maebashi-shi, Gunma 371-8514, Japan

a r t i c l e i n f o a b s t r a c t

Article history: Background: Lumbar traction is a treatment method traditionally used for chronic low back pain (CLBP)
Received 5 June 2020 in many countries. However, its clinical effectiveness has not been proven in medical practice. The
Received in revised form purpose is to conduct a multi-center, crossover, randomized controlled trial (RCT) to prove the efficacy
22 September 2020
and safety of traction on CLBP patients, using equipment capable of precise traction force control and of
Accepted 28 September 2020
Available online 27 March 2021
reproducibility of the condition based on the previous biomechanical and pre-clinical studies.
Methods: Ninety-five patients with non-specific CLBP from 28 clinics and hospitals were randomly
assigned to either the intermittent traction with vibration (ITV) first group (A: sequence ITV to ITO) or
the intermittent traction only (ITO) first group (B: sequence ITO to ITV); the former was treated with
repeated traction and vibration force added to preload. All patients were followed up weekly for 2 pe-
riods after study-initiation. The primary outcome measures were disability level including pain and
quality of life (based on Japan Low back pain Evaluation Questionnaire; JLEQ), and JLEQ was measured
repeatedly. Statistical analysis was performed using linear mixed model.
Results: Comparing to pre-traction data, both traction modes significant improvement except the first
intervention of ITO treatment. The differences in JLEQ scores over time showed significant improvements
in the treatment to which vibrational force was added in contrast to the conventional traction treatment;
Mean difference was significant to compare ITV treatment and ITO treatment (1.75 (p ¼ 0.001), 95%
CI; 2.69 to 0.80). However, neither difference between the two sequences (p ¼ 0.884) nor carryover
effect (p ¼ 0.527) was observed.
Conclusions: Altogether, the results indicate that lumbar traction was able to improve the pain and
functional status immediately in patients with CLBP. This study contributes to add some evidence of the
efficacy of lumbar traction.
© 2021 The Authors. Published by Elsevier B.V. on behalf of The Japanese Orthopaedic Association. This is
an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/
4.0/).

1. Introduction

Chronic low back pain (CLBP) is a common and major cause of


distress and disability among the working population in industri-
alized countries [1,2]. The prevalence of low-back pain (LBP) in
* Corresponding author. Fax: þ81-3-5574-3901. Japan is the highest among other health problems according to the
E-mail addresses: [email protected] (H. Tanabe), [email protected]. statistics by the Government [3].
jp (M. Akai), [email protected] (T. Doi), [email protected] (S. Arai),
[email protected] (K. Fujino), [email protected] (K. Hayashi).

https://doi.org/10.1016/j.jos.2020.09.018
0949-2658/© 2021 The Authors. Published by Elsevier B.V. on behalf of The Japanese Orthopaedic Association. This is an open access article under the CC BY-NC-ND license
(http://creativecommons.org/licenses/by-nc-nd/4.0/).

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H. Tanabe, M. Akai, T. Doi et al. Journal of Orthopaedic Science 26 (2021) 953e961

Among several conservative treatments for CLBP at the present, neurologic deficits, satisfying the following criteria: angle of more
which have been updated repeatedly, conclude that mechanical than 70 during straight leg-raising test, negative femoral nerve
lumbar traction is not effective for treating nonspecific LBP [4,5]. A stretching test, no superficial sensory deficits, and no muscle
previous Cochrane systematic review concluded that traction, weakness less than 4/5 based on manual muscle testing.
either alone or in combination with other treatments, has little or
no impact on pain intensity, functional status, global improvement, 2.1.2. Criteria for exclusion
and return to work [6]. A systematic review concluded that wide Patients who had low back pain due to tumors, infections, or
variability in intervention method might call into question the fractures; patients who had previous back surgery, severe osteo-
conclusion that lumbar traction has little no or value on clinical porosis, psychiatric disorders such as depression or others, liver and
outcomes [7]. renal dysfunction, pregnancy, medication for cardiac failure, and a
However, lumbar traction is still a widely accepted and popular history of cerebrovascular accident and/or myocardial infarction
treatment for patients with CLBP in many countries, and many within 6 months before the day of agreement to enter the trial.
clinicians or physical therapists continue to use it, primarily as an The attending physicians for all patients provided an informa-
additional modality [8,9]. For example, expert clinical opinion, tion leaflet about the trial and obtained written informed consent
theoretical models, and some research evidence suggest that a for participation and randomization. They also filled out their pa-
certain group of patients with LBP respond positively to traction tients’ information sheets to check for the inclusion and exclusion
[10]. criteria. The completed sheets were sent via facsimile to an
Such controversial findings might be because of (1) the lack of administrative office to recheck the eligibility and allocation to the
in vivo biomechanical confirmation of the mechanism of lumbar treatment groups.
traction that occurs at the lumbar spine; (2) the lack of a precise
delivery system for traction force; (3) the lack of standard treat- 2.2. Ethics approval and consent to participate
ment protocol and, subsequently, the lack of reproducibility; and
(4) few randomized controlled trials proving the effectiveness and Written informed consent was obtained from all participants,
utility of lumbar traction [11]. and this research has been approved by the institutional review
With the devices able to provide precise traction with constant board of the authors’ affiliated institution.
lumbar position, we conducted a clinical biomechanical study in
combination with the finite element method (FEM). We confirmed 2.3. Source of funding
that the distraction force lineally responded to the movement of
the traction unit at the pelvic girdle and lower body. When applying This study was a joint project of the two Academic Societies,
vibration force in addition to preloading, the distortion gauge which contracted with two companies, to conduct a clinical trial to
showed proportional vibration of shifting distance without an assess the clinical utility of lumbar traction treatment.
obvious phase lag. The FEM provided a shifting distance of at least The fund provided by these societies and companies mainly
3 mm at the lumbar spine under 100 mm of body traction between served to cover the fees of consumable research supplies, such as
two body parts [11]. strain gauge or electrodes in the previous study and the running
We got answers to the two problems that had become a wall in fees of the administration office for the random allocation and
proving the effectiveness of traction treatment, so we decided to management of participant in the current trial. The traction devices
carry out the remaining RCT this time based on previous study, are owned by the participating facilities.
which proposed towing conditions.
This is the nationwide, multi-center, randomized controlled trial 2.4. Trial registration
(RCT) to investigate the effectiveness of lumbar traction on CLBP
with the help of recently developed traction devices. Our working Trial registration was done as a whole (Low-back pain traction
hypothesis of this study is that precisely reproducible delivery therapy: LTT study), including our previous biomechanical and pre-
system for lumbar traction proves its effectiveness in clinical trial. clinical studies, at the UMIN (University of Medicine Information
Network) - CTR (Clinical Trials Registry).
2. Materials and methods
2.5. Delivery of precise traction force
2.1. Study design and participants
We used two types of traction devices sold in the market under
This multi-center, crossover, randomized controlled trial was set the same category of classification (MINATO Medical Science, ST-
in 28 clinics and hospitals, which were distributed all over Japan. 2L/2CL and OG Wellness Technologies, OL-6500/6000) (Fig. 1).
Only orthopaedic surgeons, who are board-certificated and use the The devices consist of two main parts; holding part for the upper
following two traction devices, joined in this study. body with arm holders and moving part for the lower body incor-
Considering following two points; (1) relatively less fluctuated porating the 90/90 position of the lower extremities [11] (Fig. 2).
condition from CLBP, and (2) immediate response of lumbar trac- Traction force was automatically added and maintained using
tion, which is proved with the previous study [11], we chose a computer regulation. Both devices are made with the same
crossover design for this clinical trial. concept, and are able to provide the same intervention in view of
maintaining posture, load applied, and traction conditions
2.1.1. Criteria for inclusion controlled by the feedback system.
All adults aged 20e64 years who consulted their orthopedic
surgeons with non-specific CLBP of more than 3 months’ duration 2.6. Study protocol
and who were able to give informed written consent. LBP was
defined as the pain localized below the L1 spinal process and above A crossover design with two groups, the intermittent traction
the inferior gluteal folds without sciatica (radicular pain). A chro- only (ITO) first group and intermittent traction with vibration (ITV)
nologic fluctuation of the pain was not considered if the pain itself first group was set up for 1 week. We added a so-called “run-in
continued for more than 3 months. The patients included had no period” for 1 week before the beginning the application of traction
954

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Fig. 1. Two types of traction devices. The upper body unit automatically measures the height of the arm pit to maintain the counter force against traction. The lower body unit
produces a position of 90/90 traction adjusting the thigh length.

Fig. 2. Mechanics of traction device. These two main components were separately moved on the rail with a help of actuator connected with a load cell. When a user sits on the
device, it falls backwards and finally reaches a tilt position as shown in the Figure. This figure is taken from our previous literature; Tadano et al. BMC Musculoskeletal Disorders
2019; 20:155.

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H. Tanabe, M. Akai, T. Doi et al. Journal of Orthopaedic Science 26 (2021) 953e961

for (1) obtaining informed consent, (2) physical examination and X- JLEQ is a self-administered, disease-specific measure, consisting
rays of the lumbar spine, (3) checking the chronic nature of their of 30 items, which covers wide range of items from pain, discomfort
complaint, and (4) treatment with non-steroidal anti-inflammatory and other patients’ feeling to, limitation of ADL and social partici-
plaster to cover this period, if necessary. pation. Its validity and reliability have already been proved with
A trial administration office was organized at the Clinical psychometric analysis [12].
Research Center belonging to an author's institute. A random Since we planned repeated measures, we used a single scale
computer-generated table produced the random allocation of repeatedly rather than using multiple scale measures.
crossover sequence. Each participating clinic and hospital faxed
patients' entry sheets to the above office. The office managed the 2.9. Sample size and power analysis
patient registration, including confirmation of the eligibility
criteria, randomization to an allocated treatment, and data man- Sample size and Power was calculated for the primary outcome,
agement. The information on the allocation was then faxed back to JLEQ score changes, using GLMPOWER procedure in SAS, especially
the participating clinics and hospitals. SAS 9.4M6 (STAT 15.1). We set alpha level of significance 0.05 and
Patients were randomly assigned to either the A group nominal power 0.9.
(sequence ITV to ITO) or the B group (sequence ITO to ITV).
3.10. Statistical analysis
2.6.1. Intermittent Traction with vibration (ITV) mode
Traction for 10 min to which a vibration function was added. Among the patients' demographic data, gender was analyzed
Cycles of traction for 30 s and suspension for 5 s were repeated. with the Chi-square test at the baseline. Other data, such as age,
Load of traction: 40% of the body weight. Vibration was added height, weight, and body mass index (BMI) were analyzed using the
with a frequency of 0.1 Hz and amplitude of 30% of the applied load. Student's t-test. The differences in changes of JLEQ scores over time
Three days a week for 1 week with 2 days (Saturday and Sunday) between the two groups were estimated and analyzed using a
as a washout period between the 2 sequences. The patients were generalized linear model (GLM) for repeated measurement.
asked to visit the physician's office at least twice a week to The 95% confidence interval (CI) for the means of each outcome
encourage their compliance. measure was also calculated. Statistical analyses were undertaken
with SPSS ver. 23.0 (IBM Corp., Armonk, NY, USA) and SAS 9.4 (SAS
Institute Inc. Cary, North Carolina, USA).
2.6.2. Intermittent Traction only (ITO) mode
Traction for 10 min with repeated cycles of traction for 30 s and
3. Results
suspension for 5 s.
Load of traction: 40% of the body weight.
Of the potential 95 participants who were registered at the
Three days a week for 1 week with 2 days (Saturday and Sunday)
administrative office between December 2016 and March 2017, all
as a washout period between the 2 arms. The patients were also
participants were eligible and consented to randomization (49
asked to visit the physician's office at least twice a week.
allocated to the A group: sequence ITV to ITO and 46 to the B group:
These stimulation conditions, especially those for vibration
sequence ITO to ITV). Fig. 3 shows the progression through the trial.
traction, are derived from the previous research [11].
Since standard deviation of JLEQ in a preliminary test was 9.6,
And at the stage of preparation of the protocol, there is un-
and nominal power 0.9 and alpha 0.05, sample size determination
published data among us comparing the traction force of 30%, 40%,
was 92 for each treat of ITV and ITO. And we confirmed there were
and 50% of body weight. In 50%, there were cases that back pain was
neither new prescriptions for NSAID plaster nor no changes to
worse after the traction, and 40% was the optimum traction force.
previous treatments.

2.7. Allowed additional treatment 3.1. Comparison at the baseline

Commonly used NSAIDs plasters were allowed to be used in a As the baseline between two modes, the comparison was per-
case that patients requested as pain control, and treatments, such formed for 94 participants after one drop-out between the periods
as local injection or per os NSAIDs, to control the symptoms directly 1 and 2. Table 1 shows the baseline characteristics of patients who
were prohibited. entered the trial. There were no statistically significant differences
Adverse events such as exacerbation of pain and the appearance with respect to the sex, age, body height, body weight, BMI, and
of neurological symptoms would be reported to the trial adminis- JLEQ scores between the A and B group.
tration office and countermeasures such as discontinuation of the
traction would be taken. 3.2. Data on primary outcomes

2.8. Outcome measures During the two weeks of observations, we conducted 6 check-
points (total sample ¼ 94  6 ¼ 564) which resulted in a total of
Patients’ characteristics and related data were collected during 16,920 (¼ 94 cases  6 times  30 question items) items assessed.
the run-in period. Outcomes were measured at 0-week ("pre" of Missing data were only 1 out of 564 and 26 out of 16,920, and these
intervention), 1-week: period 1 (twice at "post" of interventions), deficits were compensated by the estimated values using preceding
and 2-week: period 2 ("pre" and twice at "post" of interventions). figures (last observations carry forward).
These measurements were performed when the patients visited There was no statistically significant difference with respect to
their attending physicians, who were requested to keep the results the population mean of JLEQ scores at baseline (p ¼ 0.998).
of the trial confidential until completion.
Disability including pain and quality of life (QOL) as assessed by 3.3. Carry-over effect: comparison between crossover sequences
the previously validated Japan Low-back pain Evaluation Ques-
tionnaire (JLEQ) [12], and we asked the patients to fill out JLEQ by Table 2 shows the results of repeated measurement on JLEQ
themselves. score for two traction modes.
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Fig. 3. Flow diagram of patients according to the CONSORT statement expanding to cover a crossover trial.

Carryeover effect between period 1 and 2 was calculated using 3.4. Comparison between the two towing modalities
GLM procedure in SAS; its calculated result was p ¼ 0.527 and not
significant. Table 3 shows difference of the change of JLEQ score and the
Calculated result of actual power was 0.901 and better than 0.80, effect of two traction modes by pairwise comparison. Comparison
which is generally accepted value. using linear mixed model revealed that the ITV mode showed
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Table 1
Baseline characteristics of participants.

A (ITV to ITO) B (ITO to ITV)

Male: Femalea 24:25 19:27 Chi-Square p ¼ 0.398


Age 41.7 (38.5e44.9) 42.3 (38.7e45.9) t-test for Equality of Means p ¼ 0.879
Height (cm) 164.4 (162.1e166.7) 164.1 (161.7e166.4) p ¼ 0.829
Weight (kg) 61.4 (58.5e64.3) 61.9 (58.2e65.6) p ¼ 0.843
Body mass index 22.6 (21.8e23.5) 22.9 (21.8e24.1) p ¼ 0.372
JLEQ score 19.4 (16.4e22.4) 19.4 (16.3e22.6) p ¼ 0.998

Mean (95% Confidence Interval for mean).


a
As the baseline comparison between two sequences, the comparison was performed including one drop-out case (n ¼ 95).

Table 2 supposed mechanisms of effectiveness, which we discussed in our


JLEQ score at the (0) to (5) time points for two traction modes and the effect of time previous experimental article [11].
course by pairwise comparison. We conducted a preliminary biomechanical clinical study, and
Traction mode Period Time JLEQ score 95% CI for mean confirmed that the distraction force lineally correlated to the
movement of the traction unit at the pelvic girdle of the lower body.
Mean (S.E) Upper bound Lower bound
We could also confirm the immediate effect of lumbar traction in a
ITV 1 0 23.21 (1.93) 19.39 27.02
previous study which is compatible to the impression of orthopedic
1 15.67 (1.93) 11.85 19.48
2 13.04 (1.93) 9.23 16.85 surgeons. However, there was no difference between ITV mode and
2 3 15.65 (1.97) 11.75 19.54 ITO mode according to the analysis of self-report treatment diary
4 13.23 (1.97) 9.34 17.13 [11]. Therefore, we planned an RCT to investigate the difference
5 12.23 (1.97) 8.34 16.13 between the two traction modes with or without vibration.
ITO 1 0 23.21 (1.97) 19.32 27.11
1 20.10 (1.97) 16.21 24.00
The current trial was a nationwide, multi-center, crossover
2 18.67 (1.97) 14.77 22.56 randomized clinical trial to examine the immediate effect of lumbar
2 3 15.65 (1.93) 11.83 19.46 traction for chronic low back pain. Altogether, this study demon-
4 13.40 (1.93) 9.58 17.21 strated that lumbar traction using stretching with adding vibration
5 12.48 (1.93) 8.66 16.30
was more efficacious than that using the conventional constant
Pairwise Comparisonsb stretching method, as measured by JLEQ.
Traction (I) (J) Mean Difference Sig.c 95% CI for Differencec
mode time time (J-I)
Lower Upper 4.1. Crossover trial
Bound Bound

ITV 0 1 7.542a <0.001 10.985 4.098 CONSORT statement expanded to cover a crossover trial and
0 2 10.167a <0.001 13.610 6.723 provided 20 checkpoints [17]. And Li et al. investigated 83 crossover
0 4 9.974a 0.006 18.216 1.732
0 5 10.974a 0.002 19.216 2.732
trials and reported that issues affecting the risk of bias, such as
1 2 2.625 0.374 6.068 0.818 carryover, period effects and missing data, were often ignored [18].
3 4 2.413 0.653 5.930 1.104 We followed such guideline and carefully checked power analysis
3 5 3.413 0.066 6.930 0.104 or carry-over effect.
4 5 1.000 1.000 4.517 2.517
ITO 0 1 3.109 0.141 6.626 0.409
0 2 4.543a 0.002 8.061 1.026
4.2. Outcome measures
0 4 9.817a 0.008 18.059 1.575
0 5 10.731a 0.002 18.982 2.480
1 2 1.435 1.000 4.952 2.083 Chronic back pain is not simple lasting pain, but has several
3 4 2.250 0.817 5.693 1.193 aspects of activity limitation.
3 5 3.164 0.110 6.629 0.301 JLEQ is reliable enough to evaluate the function and QOL of
4 5 0.914 1.000 4.379 2.551
Japanese CLBP patients [12,19]. As in the current trial, a core set of
Based on estimated marginal means 95% CI: 95% Confidence Interval. outcome measures including pain, function, and QOL has been
a
The mean difference is significant at the 0.05 level.
b recommended for back pain trials [12].
Dependent Variable: JLEQ.
c
Adjustment for multiple comparisons: Bonferroni.

4.3. Targeted patient groups and traction devices


significantly better improvement than the ITO mode in the mean
In a clinical setting, targeted disorders are not strictly identified
difference of the estimated marginal means for JLEQ scores
even in large-scale systematic reviews, such as the Cochrane
was 1.75 (p ¼ 0.001). The 95% CI for the difference of means be-
Database Systematic review wherein low back pain with or without
tween the two traction modalities was from 2.69 to 0.80.
sciatica has been analyzed together [6]. Even for the treatments
focused on lumbosacral radicular syndrome (sciatica), available
4. Discussion evidence states that there is no difference regarding pain and
disability at short term follow-up [20].
From the current trial, the differences in changes of JLEQ scores We used 90/90 position to cause minimal lordosis of the lum-
over time showed significant improvements in the treatment to bar spine in the current study. However, Diab et al. reported the
which vibrational force comparing to the conventional traction efficacy of lumbar extension traction [21]. This means there is other
treatment. possibility to apply different body position and different traction
Biomechanical or imaging studies on lumbar spine have been mode. Several studies have reported that there are subgroups with
conducted for the last several decades [13e16]. There are several low back pain that show positive response to mechanical traction
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Table 3
Difference of the change of JLEQ score and the effect of two traction modes by pairwise comparison.

Estimatesa

traction Mean Std. Error 95% CI

Lower Bound Upper Bound

ITV 15.504 1.291 12.943 18.065


ITO 17.251 1.291 14.690 19.812

Pairwise Comparisonsc

(I) traction (J) traction Mean Difference (I-J) Std. Error Sig.d 95% CI for Differenced

Lower Bound Upper Bound

ITV ITO 1.747b 0.482 <0.001 2.694 0.800

Based on estimated marginal means 95% CI: 95% Confidence Interval.


a
Dependent Variable: jleq. 95% CI: 95% Confidence Interval.
b
The mean difference is significant at the 0.05 level.
c
Dependent Variable: JLEQ.
d
Adjustment for multiple comparisons: Bonferroni.

[22,23]. Positioning of the participants and more precise mea- 5. Conclusion


surement of the focused area may help further resolve issues [24].
Lumbar traction is able to provide immediate effect in terms of
the pain intensity and functional status in patients with CLBP, and a
traction method added vibrational force on preload seemed to be
4.4. Adding vibration mode
promising. This study contributes to add some evidence of the ef-
ficacy of lumbar traction.
Machado et al. published a systematic review on proper placebo
intervention used in clinical trials for low back pain and mentioned
the ineffectiveness of weak traction forces as placebo [25]. The
Declarations
current study adopted two types of lumbar traction with 40% of the
body weight. That figure does not mean weak traction forces, but it
Ethics approval and consent to participate
is necessary to prepare two different interventions for comparison
as a clinical trial.
All procedures performed in studies involving human partici-
For the last several decades, vibration stimulus with lower fre-
pants were conducted in accordance with the ethical standards of
quency to human body has been widely investigated, especially as a
the institutional and/or national research regulations, and with the
topic in work-related, industrial health problems. Majority of such
1964 Helsinki declaration and its later amendments or comparable
reports cover the negative aspect of vibration stimuli, such as low-
ethical standards.
back pain in vocational car drivers, or upper arm disorders in forest
Written informed consent was obtained from all participants,
workers induced by chain saw [26,27].
and the institutional review board of the Japanese Clinical Ortho-
Since the current study is a clinical trial, trial methods basically
paedic Association (#2015e01) approved all study protocols.
follow the conditions prevailing in the clinical setting. However,
vibration stimuli used in this study provided a more effective
biomechanical intervention for low back pain. We speculate that
Source of funding
distraction force with additional vibration may induce stronger
stimulation on the somatosensory input system.
This study was a joint project of the Japanese Clinical Ortho-
It is the first step to prove the efficacy of traction therapy in
paedic Association (JCOA) with the Japanese Society for Musculo-
humans, so further studies are required to investigate the most
skeletal Medicine, which contracted with two companies, MINATO
effective conditions of vibrations in the future [28,29].
Medical Science and OG Wellness Technologies, to conduct a clin-
ical trial to assess the clinical utility of lumbar traction treatment
(Recipient: Hideki Tanabe, #2014-SP-1).
4.5. Limitations in this study

First, this study has a short follow-up period of 2 weeks. How- Trial registration
ever, in this trial, our purpose was focused on the immediate effects
of mechanical lumbar traction. Further studies with longer follow University Hospital Medical Information Network-Clinical Trial
up durations will be required. Registration: UMIN-CTR #000024329 (dated to open, October 24,
Second, intensive multidisciplinary, bio-psycho-social rehabili- 2016).
tation including psychological assessment, might have proved to be
more effective in improving pain and function for patients with
CLBP [30]. Therefore, intervention as single physical modality Consent for publication
might be not sufficient to resolve all the complications associated
with LBP. This paper has not been published elsewhere or not under
This article will be the first step in demonstrating the effec- consideration. All authors agreed to submit it and will agree to
tiveness of traction therapy and will lead to the resolution of many transfer the copyright to the publisher, in case the manuscript is
questions in the future. accepted. (Please see Copyright Agreement Form).
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H. Tanabe, M. Akai, T. Doi et al. Journal of Orthopaedic Science 26 (2021) 953e961

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and assumes final responsibility for the decision to submit for
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All authors of this study designed, conducted, analyzed, inter- agement of low back pain: results of a survey of physiotherapists in the United
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preted the present study, and participated in the data analysis and [9] Madson TJ, Hollman JH. Lumbar traction for managing low back pain: a survey
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not been omitted. lumbar traction. Eur Spine J 2009 Apr;18(4):554e61.
MA and KH mainly prepared the study protocol. HT received the [11] Tadano S, Tanabe H, Arai S, Fujino K, Doi T, Akai M. Lumbar mechanical
traction; a biomechanical assessment of change at the lumbar spine. BMC
fund, and HT, SA and KF organized the study network, recruited the
Muscoskel Disord 2019 Apr 9;20(1):155.
participants and measured outcome in their outpatient clinics. TD [12] Shirado O, Doi T, Akai M, Fujino K, Hoshino Y, Iwaya T. An outcome measure
and MA performed data analysis. MA prepared the first draft, and for Japanese people with chronic low back pain: an introduction and valida-
tion study of Japan Low Back Pain Evaluation Questionnaire. Spine 2007 Dec
all members of authors contributed to writing, and have seen and
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approved the final version. [13] Kurutz M. In vivo age- and sex-related creep of human lumbar motion seg-
ments and discs in pure centric tension. J Biomech 2006 Jan 1;39(7):1180e90.
Declaration of competing interest https://doi.org/10.1016/j.jbiomech.2005.03.021.
[14] Simmerman SM, Sizer PS, Dedrick GS, Apte GG, Brisme e J-M. Immediate
changes in spinal height and pain after aquatic vertical traction in patients
We declare that we have no conflict of interest. The device with persistent low back symptoms: a crossover clinical trial. PM & R 2011
providers had no role in the study design, data collection, data May;3(5):447e57.
[15] Park WM, Kim K, Kim YH. Biomechanical analysis of two-step traction therapy
analysis, data interpretation, or writing of the manuscript. in the lumbar spine. Man Ther 2014 Dec;19(6):527e33.
[16] Chow DHK, Yuen EMK, Xiao L, Leung MCP. Mechanical effects of traction on
Acknowledgements lumbar intervertebral discs: a magnetic resonance imaging study. Muscu-
loskelet Sci Pract 2017 Jun;29:78e83. https://doi.org/10.1016/
j.msksp.2017.03.007.
We thank two academic societies (Japanese Clinical Orthopaedic [17] Dwan K, Li T, Altman DG, Elbourne D. CONSORT 2010 statement: extension to
Association (JCOA) and Japanese Society for Musculoskeletal Med- randomised crossover trials. BMJ 2019 Jul 31;366:l4378.
[18] Li T, Yu T, Hawkins BS, Dickersin K. Design, analysis, and reporting of cross-
icine) and two medical device companies (MINATO Medical Science
over trials for inclusion in a meta-analysis. PloS One 2015 Aug 18;10(8):
and OG Wellness Technologies) for their help for this project. We e0133023.
also thank all of the orthopaedic surgeons, their staffs, and the [19] Shirado O, Doi T, Akai M, Hoshino Y, Fujino K, Hayashi K, Marui E, Iwaya T.
Multicenter randomized controlled trial to evaluate the effect of home-based
patients who willingly participated in this study. The following 28
exercise on patients with chronic low back pain: the Japan Low Back Pain
hospitals and clinics anticipated in this project; Exercise Therapy Study. Spine 2010 Aug 1;35(17):E811e9.
Akashi Orthopedic Clinic (M), Arai Orthopaedic Clinic (M), Chosi [20] Luijsterburg PA, Verhagen AP, Ostelo RW, van Os TA, Peul WC, Koes BW.
Clinic (M), Fujino Orthopedic Clinic (M), Fujino Orthopaedics (O), Effectiveness of conservative treatments for the lumbosacral radicular syn-
drome: a systematic review. Eur Spine J 2007 Jul;16(7):881e99.
Harada Orthopedic Hospital (O), Hasegawa Orthopaedic & Reha- [21] Diab AA, Moustafa IM. The efficacy of lumbar extension traction for sagittal
bilitation (M), Iizuka Orthopaedic Clinic (M), Imazato Inagaki Or- alignment in mechanical low back pain: a randomized trial. J Back Musculoskelet
thopaedics (M), Karaki Orthopaedics (M), Kazusa Orthopaedics (M), Rehabil 2013 Jan 1;26(2):213e20. https://doi.org/10.3233/BMR-130372.
[22] Fritz JM, Thackeray A, Childs JD, Brennan GP. A randomized clinical trial of the
Koike Orthopedic Clinic (M), Kubota Clinic (M), Matsuda Orthope- effectiveness of mechanical traction for sub-groups of patients with low back
dics Clinic (M), Minezaki Orthopaedic Clinic (M), Miyake Ortho- pain: study methods and rationale. BMC Muscoskel Disord 2010 Apr 30;11:81.
paedic Clinic (M), Miyata Clinic (M), Nakada Hospital (M), [23] Thackeray A, Fritz JM, Childs JD, Brennan GP. The effectiveness of mechanical
traction among subgroups of patients with low back pain and leg pain: a
Narashinodai Orthopedics & Internal Medicine Clinic (M), Noguchi randomized trial. J Orthop Sports Phys Ther 2016 Mar;46(3):144e54.
Hospital (M), Osada Orthopedic Clinic (O), Ryusoh Orthopaedic [24] Stokes IAF, Gardner-Morse M. A database of lumbar spinal mechanical behavior
Hospital (O), Suzuki Orthopaedic Clinic (M), Tana Orthopedic Clinic for validation of spinal analytical models. J Biomech 2016 Mar;49(5):780e5.
[25] Machado LA, Kamper SJ, Herbert RD, Maher CG, McAuley JH. Imperfect
(M), Tanabe Orthopaedic Clinic (M), Uehara Orthopedic Clinic (M),
placebos are common in low back pain trials: a systematic review of the
Ueno Orthopaedics (M), Wada Clinic (M). literature. Eur Spine J 2008 Jul;17(7):889e904.
Abbreviations indicate the type of traction device used at each [26] Bovenzi M, Schust M, Mauro M. An overview of low back pain and occupa-
tional exposures to whole-body vibration and mechanical shocks. Med Lav
facility:
2017 Dec;108(6):419e33.
M ¼ MINATO Medical Science, O ¼ OG Wellness Technologies
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H. Tanabe, M. Akai, T. Doi et al. Journal of Orthopaedic Science 26 (2021) 953e961

[27] Hagberg M. Clinical assessment of musculoskeletal disorders in workers [29] Perraton L, Machotka Z, Kumar S. Whole-body vibration to treat low back
exposed to hand-arm vibration. Int Arch Occup Environ Health 2002 pain: fact or fad? Physiother Can 2011 Winter;63(1):88e93.
Jan;75(1e2):97e105. [30] Guzm an J, Esmail R, Karjalainen K, Malmivaara A, Irvin E, Bombardier C.
[28] Wang S, Wang L, Wang Y, Du C, Zhang M, Fan Y. Biomechanical analysis of Multidisciplinary bio-psycho-social rehabilitation for chronic low back pain.
combining head-down tilt traction with vibration for different grades of Cochrane Database Syst Rev 2002;(1):CD000963. https://doi.org/10.1002/
degeneration of the lumbar spine. Med Eng Phys 2017 Jan;39:83e93. https:// 14651858.CD000963.
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