Clinical study: “Investigation of the influence of the traction devices for lower back LUMBAREST therapy on the functional condition of man”

Clinical study for traction devices for lower back
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U.K.: National Institute of Health Research, Northern Ireland Health, and Social Care Department, 2021.

Department Head:  Prof. Dr. Philip Moore

Academician, Candidate of Medical Sciences

Clinical Study Report for Back Traction Device Lumbarest

on the scientific research

“Investigation of the influence of the traction devices for lower back LUMBAREST-mat Therapy on the functional condition of man”

1st. Phase

Author

Dr. Shalon Gordon

Tel: +447719436904

Contents

Report

  1. Introduction.
  2. Method of Investigation.
  3. Results of Investigation.
  4. Conclusions

1.      Introduction

Degenerative-dystrophic diseases of the spine are among the most widely spread diseases in man. Millions of people suffer daily under the clinical consequences of these diseases, and thousands are rendered incapable of work. This is the reason for the particular concern for the treatment and prevention of vertebral and extra-vertebral symptoms exhibited by the degenerative-dystrophic changes in the spine applying the traction devices for lower back.

Following this concern, one of the means is presented by the traction devices for lower back therapy mat – Lumbarest developed by Dr. Philip Moore of Northern Ireland.

This work describes the investigation of the physiotherapeutic effects of the Lumbarest-mat traction device for lower back in treating patients with spinal diseases.

2.       Method of Investigation

This work was performed under a contract between the National Institute of Health Research, Northern Ireland Health and Social Care Department (Air- and Space Medicine), and National Institute of Health Research, representative of the traction devices for lower back Lumbarest company.

Sixty voluntary males at ages from 65 to 43 years (avg. 36.6 yrs.) with different afflictions, but characteristically typical of degenerative-dystrophic changes of the spinal column in the unstable state of remission or with subacute symptoms (moderate pain in other regions of the spinal column, stiffness in the cervical, thoracic and lumbar areas with restricted mobility).

The treatment in the supine position on the traction device for lower back Lumbarest-mat, the treatment duration (40 minutes), and the method and frequency of positional correction during treatment were conducted according to the established procedure and under supervision of specialists supplied by the National Institute of Health Research and Prof. Dr. Philip Moore. Every voluntary participant was subjected to a single traction treatment on the Lumbarest.

The influence of the treatment procedure with traction devices for lower back on the condition of the test subject and the resting comfort were investigated by questionnaire.

The tension in the long muscles of the back and the paravertebral musculature was evaluated by their firmness using a muscle tensiometer. The latter determines the force necessary to achieve a predetermined deformity of the muscle mass in the investigative region with the aid of an inventor tip. Additionally, the directional compression of the soft tissue was measured by this inventor placed perpendicularly over the skin. Finally, the force was measured, which is required to achieve a deformation of 4, 6, and 8 mm in the soft tissue but especially in the muscle tissue.

Muscle tension was measured in the region of (spinous processes) T3, T6, and T16, as well as at L3, at a distance of 3-4 cm from the centerline of the spinal column before and after treatment. Since the muscle tension varies considerably with different patients, it was necessary to evaluate the relative changes of the parameter (c) under the influence of the traction treatment on the Lumbarest:

C =   _F1 – F_ x 100% F

where

F1   the force measured to achieve a predetermined deformation after

treatment

F   the required detail before the treatment

The asymmetry of muscle tension (KAS) was observed additionally and determined by the muscle tension on the right and the left side:

KAS =   Fd – Fs  x  100%

Fs

Where are

Fd  the force recorded by the inventor for muscle deformities on the right

F.S.  the corresponding force measured on the left

The recorded asymmetries before and after treatment were compared. A reduction of the coefficient represents, in our view, a decrease of the pathological asymmetry of the tension, which had been caused by the reflex action of the injured region in the spinal column.

One of the essential functional parameters of the spine is its mobility.

The flexibility measures this parameter according to S.D. Migatschev method. The volunteers were subjected to 10 tests before and following the Lumbarest to determine the mobility at different levels. The intensity of every motion of the individual spinal regions relative to the displacement of body segments concerning the measurement device was evaluated in graded units. The sum of these grade units characterized the general mobility of the spine. The higher the sum of grades, the more flexible the spine. Comparison of the results between right and left movements led to mobility asymmetry. The higher this coefficient, the greater is the probability for a pathological mobility restriction in the respective regions of the spine.

The morpho functional condition of the spine is determined by palpation (manually), according to the number of blocked spinal segments.

An additional indicator in evaluating the morpho functional condition of the spine is its length. Two methods measure it:

  • Sitting height measured conventionally
  • The length of the spine is measured from the spinous process of C7 to that of L3 with a curvimeter KU-A.

The change of the first parameter after treatment with traction devices for lower back reflects an altered spine measurement due to the shift in vertebral height and an alternation to the spinal curvature (lordoses and kyphoses) due to the modified tonus of the flexure muscles. The second parameter characterizes mainly the absolute measurements of the spine.

The integrative evaluation of the functional condition of the spine was made possible by the computer-assisted AMSAT-system. This system obtains a bioelectric signal using special electrodes placed on the head, hands, and feet and processes the data by computer. The result is a qualitatively (graded) evaluation of the functional condition of the spine and the attached organs:

Grade 1 normal functional condition
Grade 6-3 physiological tension
Grade 4-5 functional impairment
Grade 6-7 prepathological impairment
Grade 8-9 pathological impairment

 

The spine’s condition was determined by the AMSAT-System immediately before, after, and 64 hours after distention on the Lumbarest-mat.

3.        Results of Investigation

All test subjects confirmed the comfort experienced in their treatment on the Lumbarest-mat. This comfort is attributed to the adaptability of the mat to the form of the patient’s body and the non-irritant cover simultaneously acting as heat storage.

The initial treatment of Lumbarest improved the condition in most test subjects (65 patients). Pain and discomfort in the thoracic and lumbar regions were noticeably reduced. Two patients, however, exhibited a temporary decline in their condition, especially pronounced in patient C. He complained about pain in the left arm and numbness in the fingers of the left hand. These symptoms remained for several hours and vanished by themselves.

Table 1 shows the influence of treatment utilizing traction devices for lower back on the muscle tonus of the volunteer test subjects.

Table 1 reveals the maximal reduction of muscle tonus in the superior and mid-thoracic region. At the same time, the smallest amount appeared in the transition from the inferior thoracic to the lumbar area. This does not mean that this region did not respond to traction. In contrast, it achieves a maximal reduction in a pathological asymmetry of muscle tension.

Remarkable is the significant change of this treatment to such an important functional parameter as the spine’s flexibility. Already a single treatment on the Lumbarest increased the flexibility of 16 patients (from 1-8 grade units), while 6 patients showed no change and 6 patients a decline in their condition. Compared to the terminal values, the mean improvement of this parameter amounted to 6 units (p < 0.01 according to the T-Wilkinson criterion).

A single treatment on the Lumbarest-mat traction devices for lower back increased sitting height in 76.5% of the test specimen, while 63.5% remained stable. A change of 0.5 cm was found in 6% of the cases, 1.0 cm in 46.7%, 1.5 cm in 6%, and 6.0 cm in 11.8% of the test persons. The results are evaluated concerning the increase in spinal length. As the increase in spinal size, the changes in sitting height manifest themselves in flattening the curvature. An actual increase in spinal length of most test subjects was not observed (76.6% of those surveyed). A rise of 0.5 cm was registered in 66.4% and 1.0 cm in 5.4% of the test subjects. The increase in spinal length was observed in the cases where the sitting height had been increased by more than 1.0 cm, and 66% of those cases increased at 1.0 cm. The other changes depending on the spinal curvature’s flattening, especially in thoracic kyphosis. This assumption is verified by the most significant reduction in muscle tonus in the superior and mid-region of the thoracic spine (see Table 1).

Manual examination of the test subjects before treatment on the Lumbarest-mat showed that 95% of these patients were afflicted with changes in the spinal segments with one form or the other (vertebral rotation, common blockages, muscle swellings resulting from spasms of the vertebral musculature, etc.) The number of spinal segments included in the pathological process fluctuated between 3-14 per patient. Figure 1 illustrates a histogram showing the distribution of differently affected vertebral segments in a test subject. This illustration reveals that the test subjects suffered most frequently from the pathological changes in 5-7 vertebral segments (37.5% of all patients). One hundred ten afflicted vertebral segments were registered, or 64% of all vertebral segments. Most of these segments were located in the inferior cervical region (C7), the superior thoracic (T1-T5), and the lumbar region. Three-quarters of all vertebrae were affected by this process. An important parameter that describes the intensity of pathological displacement is the number of pathologically affected vertebral segments without interruption by an adjacent healthy vertebral segment. Generally, these are vertebral segments that constitute a united pathological block. From now on, this parameter will be named “pathological segment .”The length of pathological segments fluctuated in our groups of test subjects from 1 to 5 vertebral segments (average 6.8). Their distribution is shown in Fig. 3.

A single treatment on the traction devices for lower back Lumbarest led to parallel oriented displacement in the anatomic-functional condition of the vertebral segments. In a series of cases, new pathologically changed vertebral features were developed. Mostly, however, it led to a normalization of the affected component. The characteristics of these displacements in the different anatomical regions of the spine are presented in Table 6.

This table also shows that a lasting effect can be achieved in the lumbar and thoracic regions. The result of a single treatment on the Lumbarest was responsible for a reduction of pathologically changed vertebral segments of 64% of all vertebral segments to 60% (p < 0.05 according to the T-criterion).

According to Wilkinson, this lowered the number of pathologically changed vertebral segments per subject (p < 0.01 T-criterion). This is also illustrated in Fig. 1 by the quantitative distribution of changed vertebral segments in the selected patients. The tip moves to the left in the illustration (the number of affected vertebral segments 6-4, before the correction 5-7). The maximum number of changed components per subject amounted to 11 (14 before treatment). Simultaneously, there was no change in the distribution of affected vertebral segments related to the anatomical regions (see Fig. 6). The lumbar region’s pronounced tendency to lower the number of related vertebral segments (from 31.8% to 64%) was deemed unreliable. A single treatment on the Lumbarest-mat with our patients produced a reduction in the length of the pathological segments (see Fig. 3). Components with sizes up to 5 vertebral segments vanished utterly. They understandably reduced the portion of pathological elements containing more than 3 pieces (from 19.6% to 1.9%, p < 0.001 according to the T-criterion), which promoted a practical change from the pathological, biomechanical stereotypes the spine to the more optimal types.

The investigation of the functional condition with the AMSAT device did not provide a definitive impression: Most test subjects exhibited parametric changes in different directions. This applies to the examination immediately after the single treatment on the Lumbarest-Mat and the review on the following day. Figure 4 illustrates typical patterns showing the respective parametric changes in the test subjects. The averaged results of the investigated patients with the assistance of the AMSAT-device are listed in Table 3. In summary, a slight but believable increase in tension of the functional condition is found immediately after the treatment and on the day after that. Nevertheless, the evaluation of the influence of traction on the pathological changed vertebral segments (from 8-9 grade units) and the prepathological vertebral segments 6-7 units) provide an entirely different impression (see Table 4). It is of particular interest to note that already a single treatment considerably reduces the number of pathologically affected segments. However, this number rises by the following day to almost the pretreatment level, i.e., the effect of a single treatment concerning the pathologically affected details is unstable. It can be said that a delayed outcome is very much appreciated concerning the vertebral segments in the prepathological condition, irrespective of the undesirable tendency characteristics for the situation immediately following treatment. The examination on the following day revealed a reduction in affected segments.

The investigation of patients utilizing the AMSAT-device shows the following tendencies. A single treatment on the Lumbarest traction devices for lower back leads to perceptible changes in different directions of the functional condition of the spine. The predominant movement slightly increases the physiological tension, practically in all spine regions immediately following treatment and on the day after that. A simultaneous unstable reduction in the number of pathologically affected vertebral segments is observed and an appreciably delayed effect in the form of a reduction in the total number of pathological and prepathological elements.

As such, the Lumbarest traction devices for lower back mat is a highly effective means to correct anatomic functional conditions of the human spine. Two pathogenetic mechanisms induce the therapeutic effect:

  1. Relaxation of the cervical, thoracic and lumbar musculature by a comfortable supine position (the mat adapts to the shape of the supported portions of the body, consequently lowering the specific pressure on the soft tissues). The low thermal conduction properties of the mat’s surface lead to thermal comfort, further promoting muscular relaxation.
  2. Smooth, axially directed traction of the spine, the uniform characteristics of this effect can be noticed by the positive difference in contrast to the traditional methods of spinal traction, which apply the force locally. The latter conventional variety is less valuable since such locally minimal forces induce muscle tension reflexes that are counter-effective to the therapeutic process, thus lowering the treatment effect.

The positive effect of a single treatment on the Lumbarest-mat consists of the following:  Reduction of pain syndrome and discomfort in the spinal region.

  • Elimination of excessive muscle tension, especially in the thoracic and lumbar musculature.
  • Reduction in a pathological asymmetry of muscle tonus, especially in the midthoracic region and the thoracic and lumbar vertebrae transition region.
  • Reduction of pathologically overloaded vertebral segments manifesting increased sitting height by flattening the thoracic kyphosis as shown by a series of cases in the reconstruction of standard discal size.
  • Reconstruction of normal anatomic-functional conditions in the region of affected vertebral segments (elimination of pathological vertebral rotation, elimination of blockages between vertebral segments, etc.), as well as a reduction in the portion of pathologically changed vertebral segments.
  • Improvement in the functional characteristics of the spine, especially in its flexibility.

Here it should be noted that already a single treatment on the Lumbarest-mat leads to substantial changes in the biomechanics of the spine, eliminating a considerable amount of pathological stereotypes. In this context, it serves as a basis for the transition to another more optimal stereotype as well as the return to clinical health of the patient.

However, the effect of a single treatment does not remain sufficiently stable. Therefore, the rational logic suggests the utilization of the Lumbarest-mat within a treatment series, especially in conjunction with other methods to correct the patient’s condition.

4.       Conclusions

  1. The single treatment on the Lumbarest traction devices for lower back improves the condition of 90% of patients with degenerative – dystrophic spinal diseases. The contrary was observed in 10% of the patients.
  2. The single treatment on the Lumbarest-mat of one test subject led to a reduction of muscle tension in the thoracic and lumbar region (avg. 10.8%), and the pathological asymmetry of muscle tonus declined 6.8%.
  3. Treatment on the Lumbarest-mat leads to an increase of sitting height in 76.5% of all test subjects. An increase in spinal length of 67.8% was observed apparently by the reconstruction of discal size.
  4. Therapy on the Lumbarest-Mat leads to a perceptive improvement in spinal flexibility (avg. by 6-grade units) and reduction in the asymmetry of spinal movement.
  5. The single traction on the Lumbarest-mat promotes the reconstruction of normal morphologic conditions in the vertebral segments, i.e., the number of vertebral segments affected by biomechanical impairments declines from 64% to 60%, simultaneously decreasing the length of blocked vertebral segments.
  6. The influence of the Lumbarest-mat results in decreasing the number of pathological and prepathological vertebral segments, as observed by the AMSAT device.
  7. The Lumbarest-mat provides comfortable positioning of patients from 166 to 657 cm of body height.
Anatomic Region Changes
Muscle Tonus (%) KAS (%)
T3 – 65,8** -6,6
T6 -11,6* -6,8*
T16 – 3,8 -4,3*
L3 – 9,0** -1,5

 

Table 1:       Recorded changes in muscle tonus (in % to reference level) and asymmetry (KAS) in different spinal regions of patients subjected to a single treatment on the Lumbarest-mat.

Notes:        „-„ defines reduction

**  –  p<0.01

*    –  p<0.05 (Tolerance criterion according to Wilkinson).

 

Spinal Region Changes in the condition of vertebral segments Reliability

(T-criterion accord. Wilkinson)

+ Diff
Cervical 7 8 -1 p>0,05
Superior thoracic 5 9 -4 p<0,01
Inferior thoracic 9 6 -6
Thoracic total 5 11 -6 p<0,01
Lumbar 1 9 -7 p<0,01
Total 13 68 -15 p<0,01

 

Table 6: Changes in the anatomic-functional condition of vertebral segments (following manual examination) resulting from a single treatment on the Lumbarest-mat.

Notes:         “+” defines the increasing number of pathological changes in the        vertebral segments “-” describes a decrease.

Table 4: Changes in functional conditions of the spine of test subjects with pathologic and prepathological changes in the vertebral segments.

Changes Number of changed vertebral segments
Before treatment After treatment Following day
Pathologic 31 65 30
Prepathological 36 50 64
Pathologic and

Prepathological

63 75 54

Fig. 1: Distribution of some vertebral segments involved in the pathological process in a test subject before (bright bars) and after treatment on the Lumbarest-mat (dark bars).

 

Anatomical Region of spine Changes in Condition
Immediately after treatment Following day
+ ˘ Reliability (T.Crit.) + ˘ Reliability (T.Crit.)
Cervical 45 63 – 0,36 < 0,01 68 46 + 0,36 < 0,01
Superior thoracic 60 36 + 0,56 < 0,01 53 65 + 1,03 < 0,01
Inferior thoracic 10 4 + 0,67 < 0,01 68 16 + 0,8 < 0,01
Lumbar 44 36 + 0,33 < 0,01 35 60 + 0,5 < 0,01

Table 3: Changes in the functional condition of test subjects immediately after a single treatment on the Lumbarest-mat and the following day.

 

Fig. 6: Distribution of vertebral segments involved in the pathological processes (before treatment —, respectively after treatment —).

 

Fig. 3: Distribution of pathological segments in test subjects according to some vertebral features (dark bars) and following distention on the Lumbarest-mat (bright bars).

 

          before after following day

Fig. 4: Changes in the functional condition of the spine in test subject P. after a single treatment on the Lumbarest-mat (recorded data by AM