preliminary study

6 Springer-Verlag 2005 Printed in Austria

Lumbar spinal decompression with a pneumatic orthesis (orthotrac):

preliminary study

V. Dallolio

Department of Neurosurgery, Santa Corona Hospital, Pietra Ligure (SV), Italy

Summary

Aim. We present a preliminary study on the conservative treat- ment of chronic low back pain (LBP) using an easy to manage and extremely practical orthesis. It consists of a pneumatic custom made lumbar vest (Orthotrac), which permits both support-stabilisation and decompression. This system is versatile since the patient is not impeded and can perform any activity while wearing it.

Material. The study included 41 patients (23 males and 18 females, aged between 19 and 25 years) with radicular pain due to degenera- tive discopathy including: dark disc, discal protrusion with neural foramina involvement, stenosis of the foramina, syndrome of the facets, Grade 1 listhesis.

Patients had to wear the Orthotrac vest according to a precise protocol, 60 minutes 3 times a day for 5 weeks.

Results. 32 patients (78%) have showed a significant subjective and clinical improvement with subsequent better quality of life. All pa- tients referred a decrease or disappearance of radicular pain. Out- come measures were evaluated according to SF-36 system which is used in clinical practice and research. As in any innovative therapy, selection of patients is extremely important. The pneumatic vest is not indicated in all patients, but it can play an important role in non- surgical therapy for LBP.

Conclusion. The system seems to give an e¤ective spinal decom- pression and deserves a careful consideration when lumbar discal disease is treated conservatively. Further multicenter and interdisci- plinary studies on a greater number of patients are obviously needed to confirm these preliminary results.

Keywords: Traction; degenerative discopathy; auto-traction; low back pain; SF-36 health survey.

Introduction

LBP is an extremely frequent clinical manifestation is continuously increasing in industrial countries; the high social cost due to missed working days and the increase of periodical or permanent disabilities justify the high interest in research on the treatment. LBP is

responsible for the loss of 12 million working days a year in the UK. In the US in 1990 the cost due to LBP was around 0.5% of the gross national product (GNP).

In the US it is the second common cause of illness.

Although the causes are di¤erent, only the under- standing of the pathophysiology of the intervertebral disc and the lumbar rachis will allow a rational treat- ment in patients with LBP. Up to now the major cause responsible for LBP is the degenerative discopathy with loss of intradiscal pressure, of the necessary ten- sion of the lumbar anulus fibres and consequent pos- terior overload with degeneration and hypertrophy of the articular facetsjoints: the concept of the ‘‘degener- ative cascade’’ introduced by Kirkaldy-Willis.

It is well known that 80% of population su¤er LBP

at least once and that 35% develop a hernia of the disc

and 0.1% will undergo surgery. The remaining per-

centage will be treated conservatively. With overload

being one of the main causes of lumbar degenerative

discopathy, we have scrutinized the literature for the

various treatments of chronic LBP. We found many

therapeutic approaches and this demonstrates the high

rate of chronic LBP and the great interest in its treat-

ment due to the high social cost. These approaches

range from surgery with few or many but more and

more innovative instruments to various conservative

treatments, sometimes questionable. Among the con-

servative treatments, the use of lumbar vests is the

most frequent. In order to better understand our ther-

apeutic proposal, it should be remembered what hap-

pened to surgical treatment of lumbar diseases over

time. In the 70s the trend was to demolish, while in the

80s fusion with pedicle screw cages was up-to-date in

order to improve results. In the 90s the transitional syndrome was understood and the discs (natural stress- breakers) were replaced using prostheses or inter- spinous stress-breakers made of metal alloys or bio- polymers. In 2000 it was found that the best way was to repair the disc and where possible to restore its spe- cific functions in di¤erent ways (injection of polymers, hydrogel, BMPs, staminal cells) to regain the integrity and height of the disc.

The challenge of biological repair (combined use of genic therapy on tissue engineering) of the interverte- bral disc is still open.

Each specialist o¤ers a di¤erent solution for LBP, not in pathologies with neurological damage or in severe stenosis or instability where surgery is out of question, but in those more frequent forms which should be treated conservatively.

Among the conservative treatment modalities, we wanted to study a reproducible method, e‰cacious and easy to apply. Treatments with reduction of load are the traction techniques which lighten the weight on the lumbar segments. Lumbar traction which we define as dynamic support is taking over the lumbar support with elasticised corsets with rigid sticks which we could define as static.

In the literature it is shown that traction induces a flattening of the lumbar lordosis, a distraction of the vertebral bodies, an increase in height of the inter- vertebral spaces, lengthening of the spinal muscles and ligaments, and widening of the conjugation foramens.

Traction is based on the application of a force along the axis of the spine. The traction used since ancient times (Fig. 1) has recently been rediscovered with the introduction of new techniques of extreme e‰cacy: the

Fig. 1. History of traction

auto-traction introduced by Lind in 1974 and further modified by Natchev in 1984 [5].

We analyzed about 150 papers about lumbar trac- tion in di¤erent forms for chronic LBP treatment and we found 10 di¤erent types of lumbar traction. The majority of papers judged negatively the utility of traction in treating LBP, while a great number of pa- pers were in favour of using lumbar traction. When analysing the papers, we realized that the indications were not homogeneous, the traction techniques and traction times were di¤erent and in the vast majority of the studies traction was applied in patients with acute LBP. This necessitates further studies. We all agree that if the human body was not subjected to gravity or if it could live all the time in water or air (without body weight) there would not be the problem of degenera- tive discopathy and therefore LBP. It should be re- marked that the common feature of all these types of conventional traction (gravitational, auto-traction, in water, passive) is that the patient body is immobilised or constrained by the traction systems. All these sys- tems influence the time and frequency of application of traction and the use is limited due to the discomfort of these distractional methods.

There was the need for a traction system which al- lowed lumbar distraction whilst permitting free move- ment. This could be achieved by applying a distrac-

tional force unconditioned by external constraints but linked to the body itself of the patient and so to permit free movement.

The pneumatic vest (Orthotrac) (Fig. 2) meets these characteristics. It is a vest which by means of pneu- matic pistons transfers a load of 30–50% of the body weight from the spine to the iliac crests. It should be worn 3 hours a day (also intermittently) for a period of 5 weeks.

This type of traction could be defined as ‘‘dynamic walking traction’’, to be opposed to the traction with lumbar support vest which could be defined as ‘‘static’’

(Fig. 3).

The philosophy of the treatment with Orthotrac Pneumatic Vest coincides with recent research on in- terspinous devices to reduce both the intradiscal pres- sure and the pressure on the articular facets. Spinal surgery tends to improve its technology since it is clear that it is necessary not only to demolish and remove but also to reconstruct and recover function. Already the intersomatic cages recovered the disc height, sup- ported the neural foramina, tensioned, where possible, the anulus fibres. Surgeons understood that it was in- correct to fuse and fix only with instruments. For this reason stress breaking systems of ‘‘dynamic fusion’’

were proposed which recover height, tension the annulus fibres with restoration of a partially stress

Fig. 2. Orthotrac Pneumatic Vest

breaking e¤ect. In this study the e‰cacy of the pneu- matic Orthotrac vest has been studied by testing the changes in pain and quality of life with the SF-36 questionnaire.

Material and methods

Candidates to Orthotrac are those patients with mechanical LBP, defined as lumbar or radicular pain which changes upon postures and activities; previous surgery is not contraindication. Further- more, those patients in which LBP did not improve after conven- tional conservative treatments and pain was present for at least 3 months with or without irradiation to the lower limb were included in this study. Hernia or disc protrusion at one or more levels, listhesis with spondylolysis or degenerative listhesis documented by CT or MRI can be associated.

Exclusion criteria are: tumors, infective or metabolic causes of LBP, indications for surgery due to neurological ingravescent deficit, osteoporosis and pregnancy.

Patients included in the study:

41 Patients with chronic LBP with age between 19 and 65 years, 23 males and 18 females. 9 (22%) patients a¤ected by disc hernia at one level with pain present for more than 3 months; 11 (27%) patients with 1st degree listhesis: 14 (34%) patients with multilevel discopathies and dark disc with Modic 1 and 2 signs; 7 (17%) with

stenosis of the lumbar spine. Each of the 41 patients, following an appropriate information and consensus, had a custom made Or- thotrac vest for a minimum of 40–60 minutes three times a day 5 weeks. The correct recommended use of Orthotrac is to start the treatment with a distraction force corresponding to 30% of the body weight for the first 2 weeks which should be increased up to 50% in the remaining weeks. The patients had to fill in 2 outcome ques- tionnaires (according to SF-36 Health Survey); the first question- naire (baseline) before the treatment and the second one (follow-up) at the end of treatment.

Both questionnaires included 2 scales to measure the following symptomatologic variables:

Neurogenic Symptoms Score: this scale included 6 scores to measure pain of the lower limb

Pain/Disability Score: this scale included 11 score to measure quality of life in all its aspects.

Results

The results of the questionnaires were as follows:

2 Patients (5%) were excluded from the study because they were not collaborative.

7 Patients (17%) had no improvement and subjectively they referred unchanged symptoms.

The remaining 32 patients (78%) had noticed a de- crease in pain with percentages between 15 and 66%.

Orthotrac seems to reduce pain more in elderly pa- tients; the group of younger patients complained about the vest due to discomfort and di‰culty in driving (Tables 1 and 2).

Fig. 3. Ambulatory treatment

Table 1. Pain/disability scale results

41 patients treated with Orthotrac Pain / Disability Scale

23%

31% 15%

31%

No Reduction; Minimal Reduction; Moderate Reduction;

Significant Reduction

Conclusion

Following the indication of less invasiveness, un- constrained traction while walking (similarly to walk-

ing in water without the constraint of water) could be an important further therapeutic support alone or as- sociated with other procedures in order to regain as much as possible the initial characteristics of the inter- vertebral disc.

References

1. Geraldine L, Pellecchia MA (1994) Lumbar traction: a review of the literature. JOSPT 20: 5

2. Jo¤e D, Watkins M, Steiner L (2002) Treadmill ambulation with partial body weight support for the treatment of low back and leg pain. JOSPT 32: 5

3. Krause M, Refshauge KM, Dessen M (2000) Lumbar spine trac- tion: evaluation of e¤ects and recommended application for treatment. Man Terapy 5 (2): 72–81

4. Tekeoglou I, Adak B (1998) Distraction of lumbar vertebrae in gravitational traction. Spine 23 (9): 1061–1064

5. Tesio L, Merlo A (1993) Autotraction versus passive traction: an open controlled study in lumbar disc herniation. Arch Phis Med Rehab 74: 871–876

Correspondence: Villiam Dallolio, Via Movedo 4, 23900 Lecco, Italy. e-mail: [email protected]

Table 2. Neurogenic symptoms scale results

41 patients treated with Orthotrac Neurogenic Symptoms Scale

29%

21% 7%

43%

No reduction; Minimal Reduction; Moderate Reduction;

Significant Reduction