Journal of Orthopaedic Science: Original Article
Journal of Orthopaedic Science: Original Article
Journal of Orthopaedic Science: Original Article
Original Article
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
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.
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.
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.
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Table 3
Difference of the change of JLEQ score and the effect of two traction modes by pairwise comparison.
Estimatesa
Pairwise Comparisonsc
(I) traction (J) traction Mean Difference (I-J) Std. Error Sig.d 95% CI for Differenced
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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M ¼ MINATO Medical Science, O ¼ OG Wellness Technologies
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