Mastercare - A Scientific Study of Low Back Pain

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A Scientific Study of Low Back Pain

Mastercare® Back-A-Traction®

Effects of gravity-facilitated traction of the lumbar spine
in persons with chronic low back pain at the workplace.

Authors:
MD; PhD Lennart Dimberg
Physiotherapist Lars-Göran Josefsson
PhD Bo Eriksson© Mastercare AB/Nordisk Rygghälsa AB

Dr Dimberg treating a patient

Abstract

Measurements

Results

Statistical methods

Conclusion

Results

Introduction

Drop-outs

Aims of the study

Discussion

Material and methods

Conclusion

Inclusion criteria

References

Exclusion criteria

Baseline parameters© M a s terc a re A B On l y to b e u s ed for
M as terc are p rod u c ts .
P lea s e note: Stu d i es n ot val i d for "s i m i l ar"
p rod u c ts d u e to th e b i g d i fferen c e i n fu n c ti on
and us age.

Abstract
A 12-month study was conducted to determine if gravity inversion at theworkplace could prevent low back pain disorders from worsening. Employeeswith chronic low back pain disorders (LBP) were included. The participants
were stratified by age, sex and worker category and randomized into three

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groups. Group 1 used the Swedish Mastercare Inversion System (SMIS) withinversion (head down) of 15 and 30 and a brief training program for 10
minutes daily; group 2 used it for 10 minutes twice daily and group 3 served as
the control group. A questionnaire was used to obtain information on pain
levels in a visual analogue scale and about sick days and sick-periods. The
questionnaire was used at baseline, after 3 months and after 12 months. Backmobility was measured at baseline and after 3 months.
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Results
116 persons were enrolled for the study. Of these, 108 (93%) completed the first
three months and 92 (79%) completed the full 12 month schedule. At the start
the participants averaged 44.1 years of age and 77% were men. A significant
dose-related reduction in pain was noted for the training groups as compared tothe control group after 3 and 12 months. Sick-leave due to LBP fell an averageof 7.9 days per individual in the training groups compared to the year prior to
the study, whereas control-group absenteeism increased. Forward flexion
measured by finger-to-floor distance indicated increased backflexion, compared
to baseline in the training groups but not in the control group.
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Conclusion
Regular gravity inversion demonstrated a plausible remedial effect on low backpain and sick-leave was reduced. Key-words Low-back pain, inversion therapy,
prospective study tilt table.
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Introduction
In 1987 there were 14 million paid sick-days for low back pain (LBP) in
Sweden, a nation with 8 million inhabitants (13). However, 70% of the sickperiods were shorter then 10 days ( 1). Out of 66 000 filed worker’s
compensation claims in 1988, 41 000 were due to LBP (13). An estimated 15%of all sick-days in the USA in the early 1980s was due to LBP (13). Obviously
LBP is a problem of major proportions for society and industry.
For Volvo Aero Corporation, with about 3 000 employees and 3 800 sick-days ayear for LBP (1), an estimated $150 per sick-day means a loss of $570 000 per
annum. If this absenteeism could be reduced by 10%, a net savings of $57 000
would be the result.
Inversion therapy of LBP has been used since the days of Hippocrates when thepatient was hung upside down with his feet tied to the rungs of a ladder which
was hoisted and dropped, imparting an abrupt tractive force to the spine (7).
Since that time, various forms of traction equipment have been used andclaimed to be effective in alleviating LBP (11). Frederick Sheffield designed atiltable table with a highly-polished slippery top on which the patient was
attached by a pelvic harness. By tilting the table head down 90 , he could adjust
the traction from zero to 50% of the patient’s own body weight (14). Gravity
inversion as self-treatment for LBP by means of inversion boots was
popularized in the movie American Gigolo (9). Other traction equipment thathas been used in scientific tests is the Backtrac, and the Back-On-Track (2). Yetanother principle of back traction not involving inversion, is illustrated by theGravitational Lumbar Traction System developed by the Sister Kenny Institute.
Here the user is suspended upright by a corset-like vest worn around the rib

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cage. The weight of the lower part of the body supplies the traction force (2),much like the common practice of hanging from a door to relieve LBP.
Most studies we have reviewed focused on the basic working principles ofequipment, side effects and case reports but we have not been able to find any
controlled prospective study on the clinical outcome of inversion therapy. The
Swedish Mastercare Inversion system (SMIS) or Back-A-Traction® is a selfusable table which pivots on a tubular steel frame and is tiltable to 15 and 30(figure 1). It suspends its user from padded rollers clasping the ankles. The
ankle support is adjustable to body lengths of 150-215 cm. The manufacturer
claims it is easy to handle, safe, inexpensive and especially suitable for aworkplace setting to alleviate the low back pain of employees with suchproblems. If regular use of the SMIS were to have a significant effect, it would
be an efficient and cheap prophylaxis that would improve employee health andpossibly reduce sick-day costs for the employer.
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Aims of the study
A randomized, controlled trial with two training groups and one control group
was conducted with the aim of assessing the effect of regular SMIS training on
the pain level, back mobility and sickness absenteeism of chronic LBP patients.
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Material and methods
Volvo Aero Corporation in Trollhättan, Sweden, manufactures, overhauls andrepairs aircraft engines. Operations also include development and production
covering space vehicle components, hydraulics, diesel engine components andboat heaters. In 1992 the company employed nearly 3 000 persons, allnaturalized Swedish citizens. About 1/3 were white collar workers andapproximately 15 % were women. Most employees (90%) used the company
medical facility for their medical problems.
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Inclusion criteria
Employees that had undergone medical treatment for LBP at the company
medical department during the last 3 years with 1. on-going LBP and/or 2. LBP
more than 3 months during the previous 3 years and/or 3. LBP more than 1
week more than once during the previous 3 years.
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Exclusion criteria
Unwillingness or lack of time to participate. On-going full-time sick-leave at
the start of ale study. Other concomitant severe medical condition.
Employees with the above criteria were drawn from the medical appointment
statistics and randomized into 3 groups: group 1 used the inversion system forten minutes once daily on paid working time, group 2 used the system for ten
minutes twice daily and group 3 served as the control group. The groups werestratified based on three criteria: age, gender and worker category (blue- or
white collar). Invitations to participate were mailed to the workplace of fifty
individuals for each group, also asking them to attend briefings tailored to eachgroup, explaining the study in detail and what was expected from each individual.
After the briefing they voluntarily signed on to participate in the study. All
employees using the SMIS were first given detailed instructions including

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certain exercises, by a Mastercare representative who monitored the training
during the first week. Each treatment consisted of 15 inversion for 5 minutes
including exercises and then 30 for another 5 minutes relaxation. Fifteen tables
were set up in the company gym, available any time of day, within 10 minutes
walking distance from the most distant part of the company. All training wasrecorded on each visit by personal punchcard. Patients training once daily
usually did so in conjunction with their lunch (11 am to 1 pm) and thosetraining twice daily usually did their second round at the end of the work day(3-5 pm). However, they were given considerable freedom to schedule training
at their convenience. The program started on August 1, 1992. An in-depth
follow up was carried out after 3 months (this period was mandatory), and a
final follow up was carried out in late September, 1993.
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Measurements
Since the participants were drawn from the medical files, all had beenpreviously examined for their back complaints by the occupational physicians
and were x-rayed to exclude malignancy. At baseline, information was gatheredby questionnaire (1) under a nurse’s supervision concerning age, sex, worker
category, pain level (previous week’s pain on a scale of 0 to 10) using a Visual
Analogue Scale (5), functional level, medication and other treatment, sick-leave
during the previous six months and other medical complaints. Also compiled
were the frequency of headache on a Visual Analogue Scale (from 0=none to
10=very often), neck/shoulder problems and pain level, and the frequency ofother locomotor pain during the previous month. A pain drawing was also
completed (15). The result was classified into two variables. The first was codedby pain distribution: local back pain only, rhizopathy in leg and a combinationof the two with other locomotorpain.
The second variable was coded by pain modality: 1 equals one modality; 2equals two and 3 equals three or more modalities. Measurements of hackmobility were taken in a semi-randomized fashion out of group order, using thestandardized Mildenberg finger-floor method and the Schober test (12). The
Schober test was conducted as follow: with the patient standing upright, a markwas made on the skin at the level of the dimples of Venus, which approximates
L5. A second mark was made 10 cm above and a third mark 5 cm below the
first mark. Then the patient bent forward with the knees straight, reaching as far
as possible towards the toes. The increase between the upper and lower markwas taken as a measurement of lumbar flexion. The finger-floor measurements
were taken on both sides upon the first attempt of the patient to bend forwardwith extended knees until stopped by pain or muscle spasm. Blood pressure in
the supine position and intraocular pressure by applanation tonometry werescreened with norms at systolic of <160 and diastolic<100 mm Hg, and <20 mm
Hg respectively.
After 3 months the above procedure was repeated and information on thenumber of training episodes was compiled. Subjective impression of theequipment, side-effects and free comments were also gathered at this time. The
nurse was blinded to the previous measurements of back mobility, but due tofamiliarity with the patients it was impossible to blind her from who weretraining or not. But, to avoid inter-observer variability the same nurse always
handled the same patient.
After one year there was a follow up including the number of training episodes,
number of sick-days and periods for low back pain, changes in medication over

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the previous 9 months, subjective impression of the effect of training on wellbeing and pain parameters of the different parts of the locomotor system theprevious month on the Visual Analogue Scale described previously. No
mobility measurements were taken.
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Statistical methods
Comparisons of the groups were made using conventional statistical tests. Inchange comparisons, adjustments were made for age, sex, working category andinitial value. The analysis reference was made for both group 1 and 2 together(combined training group). All tests were two-sided. Statistical significance wastaken as p<0.05 unless otherwise stated.
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Results
Of the 150 persons that were asked, 116 enrolled in the study, and 108 (93%)
completed the mandatory 3 month study. The distribution of these participants
and the baseline parameters are shown in table 1. Ninety-two persons (79%)
completed the 12 month study.
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Drop-outs
Eight persons entered the study but did not complete the treatments. Two ofthese experienced more pain after some initial inversion treatments, two feltdizziness near fainting after the inversion and two did not have time to come tothe treatments. In addition, two individuals from the control group refused tocome to the follow up. The drop-outs did not significantly differ from the otherparticipants with regard to sex, age, or worker category.
No severe concomitant disease was found, All patients had normal bloodpressure (<160/90). One patient had a slightly elevated intraocular pressure but
was cleared by his ophtalmologist for the study.
All results after 3 months are presented in table 2 and after 12 months in table 3.
The average variables ”pain last week” and ”pain affecting daily activities”
decreased significantly for group 2 and the combined training group after threemonths compared to baseline, and increased slightly for group3 (control group)
as is evident in figure 2. The finger-floor distance decreased in the training
groups indicating increased back-mobility after 3 months, and was different
from the control group, where it increased somewhat as illustrated in figure 3.
”Low back pain last month” after 12 months decrease significantly more for the
combined group compared to the control group.
Average sick-days per participant and month for low back pain and totally 6months prior to the study (baseline) and during the 12 months of the study are
shown as percentages of baseline values in figure 4. After 12 months there wasa slight increase in sick-days for LBP in group 1, training once daily, a clear
decrease in group 2 training twice daily, and an increase in group 3, thecontrols, as compared to baseline. In the combined training group the difference
from baseline in lost sick-days per month due to low back pain during the
12month study was 7.9 days per participant. A downward trend was shown for
average length of sick-periods for LBP after 12 months in both training groups
as opposed to the control group, figure 5. The 12-month changes in sick-periods
and sick-days were significant between group 1 and 2 and the control group.

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Seventy-one percent of the participants in group 1 and eighty-six percent ingroup 2 reported a positive effect from SMIS therapy.
The most common reasons for not continuing regular use of the equipment inspite of the good effects reported were lack of time, laziness (20 participants),
healed back (5 persons) and negative effects - worse back or ankle and muscle
pain - (9 persons).
No serious negative side-effects were reported.
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Discussion
This study has shown a significant, dose-related reduction of pain index for the
training groups compared to the control group, an increase in lumbar flexion as
finger-floor distance after 3 months and a reduction of ”low back pain lastmonth”. The increase of back mobility shown by reduction of finger-floor
distance compared to baseline was not supported by an increase in the Schober
test. This may indicate that the mobility increase was mainly from thehamstrings. Over the years, there has been considerable discussion on themechanisms of spinal traction- what does it do and how does it relate to pain?
This is not an easy question to answer especially since, according toNachemson, a clear diagnosis for about 70 % of the patents with low back pain
will never be established (13). Kane (8) relates studies involving x-ray of thelumbar spine before and after traction showing a lumbar segment separation of
1-2 mm using 35-150 kg traction. Other studies have shown reduction ofherniated discs on CAT scan and confirmed vertebral distraction after
autotraction (11, 3, 6). Whether the proposed effect of traction in this study wasdue to this or an increase in intervertebral foramina height enlarging space fornerve roots or degenerative joints (3), or stretching of the paraspinal lumbar
muscles when the cause of pain is muscle spasm, or the anterior or posterior
longitudinal ligaments (14), or a general relaxation effect or a combination ofthese is pure speculation. No-one has shown how large a vertebral separation isneeded to give a therapeutic effect and it seems reasonable to assume that the
distraction of vertebrae is a continuous variable and not an ”all or nothing”
phenomenon. In addition to this, all patients using the SMIS also performed aset of motions tailored to enhance the effect of the traction. The participants inthis study had chronic LBP from various causes, discogenic and nondiscogenic, and it has not been the aim of this study to prove exactly which of
the above hypothesized effects were working for fee individual patient.
Over the 12 month period there was an insignificant increase in sick-days for
LBP in group 1, a more pronounced reduction in group 2, and an increase ingroup 3. This dose-response tendency in relation to the control group may
support a real relationship. However, the finding must be interpreted withcaution. Reporting in sick is influenced by many other factors such as social
attitudes to work, type of work and life style, and there may be otherexplanations to the findings than the effects of treatment (1). From our previous
work in sickness absenteeism it is our experience that the number of sickperiods has been a better measurement of treatment effect than the number ofsick-days, due to the fact that a few patients with very long sick-periods may
throw off the average number of sick-days per participant. The change of sickperiods shown in figure 5 is consistent, with a significant reduction in LBP forgroup 1, which also supports the finding that this could be an effect of thetreatment.
It may be argued that it is impossible to decide whether the suggested effect on

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low back pain by SMIS was due to the inverse traction itself or to the training
program that was also conducted and that such an effect might be obtained by
the exercise program alone. According to Nachemson, however, no back school
has been proven to be effective thus far(13). On the other hand the effect might
be due to a combination of the traction and training, and it must be emphasizedthat the special pivotal design of the table was essential to the effectiveness ofthe training.
Caution has been suggested for the following patient populations: increased
intraocular pressure, hypertension, uncompensated heart failure, carotid arterystenosis, hiatal hernia or spinal instability and people receiving anticoagulants,
chronic headache, artificial hip replacements, motion sickness and chronicsinusitis (9, 10, 4, 16, 8).
In our study we have not included any patients with high blood pressure. The
most common side-effects have been dizziness, orthostatic reaction (2 patients),
pain in ankles, knees or muscles (4 patients) and increased back pain (4patients). No serious side-effects were documented.
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Conclusion
A significant dose-dependent effect on pain reduction in employees withchronic low back pain problems was noted after daily self-training with theSwedish Mastercare Inversion System (SMIS).
A significant reduction of finger-floor distances at forward bending withextended knees indicative of increased back flexion mobility was also seen in
the training groups at the 3 month follow up but the Schober test did not
substantiate this finding. A significant effect on sick-leave was noted for bothtraining groups at 12 months: group 1 for sick-periods for LBP and group 2 fortotal sick-days. An average reduction of sick-leave due to low back pain for thetwo training groups was 7.9 days per participant compared to the year before thestudy as opposed to an increase for the control group.
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References
1. Dimberg L, Olafsson A, Stefansson E et al: Sickness absenteeism in anengineering industry - an analysis with special reference to absence for neckand upper extremity symptoms. Scand JSoc Med 17:77-84, 1989.
2. Gianakopoulos G, Waylonis G, Grant P: Inversion devices: their role inproducing lumbar distraction. Arch Phys Med Rehabil 66:100-102, 1985.
3. Gianakopoulos G, Waylonis G, Grant P: Inversion devices: their role inproducing lumbar distraction. Arch Phys Med Rehabil 68:100-102, 1985.
4. Goldman RM, Tarr RS, Pinchuk BG et al: More on gravity inversion, West J
Med 141, 1984.
5. Huskinsson EC: Visual Analogue Scales in Melzach R (Ed): Pain
measurement and assessment. Raven Press, 1983, pp 33-37).
6. Judovich BD: Lumbar traction therapy and dissipated force factors. J Lancet
74:411-414, 1954.

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7. Kane M, Karl R. Swain J: Effects of gravity-facilitated traction onintervertebral dimensions of the lumbar spine. JOSPT6(5):281-288, 1985.
8. Klatz RM, Goldman RM, Tarr RS: Gravity inversion therapy. West J Med
11:538-540, 1983.
9. Klatz R, Goldman R, Pinchuck B et al: Effects of gravity inversion on
hypertensive subjects. The physician and sports medicine 13 (3):85-89, 1985.
10. London GM, Levenson JA, Safar ME et al: Hemodynamic effects of headdown tilt in normal subjects and sustained hypertensive patients. Am J
Physiol 245:194-202, 1983.
11. Mathews J: Dynamic discography: a study of lumbar traction. Ann Phys
Med 9:275-279, 1968.
12. Mildenberg F: Back mobility. Compendium, Skönvik Rehabcenter, 35-44,
1991.
13. Nachemson A: Low Back Pain - a societal problem, The Swedish Council
on Tecnology Assessment in Health Care, 1-200, 199l.
14. Sheffiel F: Adaptation of tilt table for lumbar traction. Arch Phys Med
Rehabil 14:469-472, 1964.
15. Sivik T, Gustafsson E, Klingberg K: Differential diagnosis of low-backpain patients. A simple quantification of the pain drawing. Nord J
Psychiatry 46: 55 - 62, 1992.
16. Zito M: Effects of two gravity inversion methods on heart rate,systolicbrachial pressure, and ophtalmic artery pressure. Therapy 68:20-25,
1968.
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Baseline parameters
Group 1 training once daily, group 2 training twice daily, group 3 is thecontrol group. Figures in parentheses are Standard Deviation.
means statistically significant vs control group (p<0.05)

Table 1
Group 1 2 3No 35 34 39
Age 43.4 (11.1) 44.0 (10.9) 45.0 (11.1)% males 86 76 69% blue-collar
workers 66 53 72
Average number ofsick-days per participantand month (last 6 months)
total 0.647 1.931 0.547

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of which for LBP 0.132 1.420 0.128
Average number ofsick-periods per participantand month (last 6 months)
total 0.177 0.184 0.173
of which for LBP 0.025 0.058 0.043
VAS most painful
movement last week
0 = no pain,
10 = intolerable pain 2.3 (2.3) 1.8 (1.9) 1.4 (1.7)
VAS average pain last
week 1.7 (1.9) 1.9 (2.0) 1.0 (1.5)
Pain affecting daily
activities last week
0 = no affection,
5 = can’t do anything 1.9 (0.9) 2.1 (0.9) 1.8 (0.9)
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Table 1 cont 1
Group 1 2 3
Headache last month0 = never, 10 = often 1.9 (2.7) 1.3 (1.4) 1.9 (2.8)
Neck/shoulder problems
last month0 = never. 10 = often 2.9 (3.4) 3.1 (3.9) 3.0 (3.6)
Average neck/shoulder
pain last month0 = no pain, 10 = intolerable pain 2.6 (2.9) 2.1 (2.5) 1.8 (2.0)
LBP last month0 = never, 10 = often 3.5 (3.4) 4.9 (3.5) 3.5 (3.3)
LBP last month0 = no pain,
10 = intolerable pain 3.2 (2.7) 3.7 (2.2) 2.7 (2.9)
Other muscular pain lastmonth 0 = never, 10 = often 1.6 (2.9) 0.8 (1.7) 2.0 (3.2)
Pain distribution (paindrawing) at study start(%)
No LBP 26 9 21
LBP only 29 38 10
LBP and pain in leg 0 6 0
LBP and other pain locations 45 47 69
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Table 1 cont 2
Group 1 2 3

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Low back pain modalities(aching, burning,
numbing, cutting,stitching, cramping)(%)
No pain 26 9 23
One modality 43 29 26
Two modalities 26 41 31
Three or more modalition 5 21 20
Use of pain medication(%)
daily 0 0 3
sometimes 34 41 36
never 66 59 61
Other back treatment
last month (%) 6 21 10
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Table 2Three month follow up
Group 1 trained once daily, group 2 twice daily and group 3 was the control
group. Parentheses are percentages of baseline values.
means statistically significant change to baseline p<0.05 and (*) means
significant change between both training groups together and the control
group and **p<0.0l.
Group 1 2 3No 35 34 39
Average no of
training periods per
participant
total 40 75 0
per week 4.0 8.1 0

Most painful
motion last week
0 = no pain. 10 =intolerable pain 1.5 (65) 0.8 (44) 1.2 (86)
Average pain last
week 0 = no pain,
10 = intolerable pain 1.4 (82)(*) 0.9 (47)** 1.2 (120)
Pain affecting daily
activities last weekfrom 0 = nodisturbance, 5 = can’t
do anything 1.7 (89)(*) 1.4 (67)** 1.7 (94)
Use of pain medication

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%Daily 0 0 0
Rarely 31 35 45
Never 69 65 55
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Table 2 cont 1
Group 1 2 3Other treatment last
3 months%908
Headache last monthfrom 0 = never, 10 =very often 1.5 (79) 1.2 (92) 1.6 (84)Neck/shoulder pain
last monthfrom 0 = never,
10 = very often 1.2 (41) 1.6 (52) 2.2 (73)Neck/shoulder pain
last month from 0 =no pain, 10 = intolerable pain 1.2 (46)** 1.2 (57) 1.8 (100)LBP last
month from 0 = never,
10 = very often 3.4 (97) 2.5 (51) 3.2 (119)
LBP last
month from 0 =no pain, 10 = intolerable pain 2.4 (75) 2.3 (62) 2.5 (93)
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Table 3
12 month follow up.
Group 1 trained once daily, group 2 twice daily and group 3 was the control
group. Within parentheses are the percentage of baselinevalues. * Meanssignificant change to baseline as compared to the control group p<0.05 and**p<0.01. (*) Means significant change between both training groups together
and the control group.
Group 1 2 3No 28 29 35
Average number oftraining periods per
participant during last
9 months
per week 1.9 1.9
Has the training

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affected your wellbeing%
No difference 18 7
Positively 71 86
Negatively 11 7
Has your pain
medication changed
during the last
3 months?
%
no 93 90 94
yes, increased 0 0 0yes, decreased 7 10 6
Headache last month( ) means % of baseline
0 = never, 10 = often 0.7 (41)* 1.4 (100) 1.7 (81)
Table 3 cont 1
Group 1 2 3
Neck/shoulder problems
last month( ) means % of baseline
0 = never, 10 = often 1.4 (48) 1.4 (45) 1.9 (73)
Average neck/shoulder
pain last month( ) means % of baseline
0 = no pain, 10 = intolerable pain 1.2 (46)* 2.2 (110) 2.0 (125)
LBP last month( ) means % of baseline
0 = never, 10 = often 2.7 (71) 2.0 (43)** 3.6 (100)LBP last month( ) means % of baseline
0 = no pain
10 = intolerable pain 2.4 (74)(*) 2.4 (63)(*) 3.4 (123)
Other muscular pain lastmonth( ) means % of baseline
0 = never, 10 = often 0.9 (76) 0.9 (119) 1.7 (92)

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