Download Flexi:Bak Clinical Trials

Flexi:Bak
Clinical Trials
By
Jason Rosser D.O. & Associates
Introduction
Having designed the flexi:bak using his knowledge of anatomy and biomechanics,
Jason Rosser D.O. carried out a series of tests to measure the pain-relieving effects of
the product and its physical properties. The tests were carried out a) on himself, b) his
associates and then c) on 224 new and long-term patients who attended the Osteopathic
Clinic with a variety of conditions. These results pertain to the 224 patient trials.
Organising the Tests
Patients attending the Osteopathic Clinic were involved on a voluntary basis having
been initially assessed by one of the three Osteopathic Associates. New patients had
their case histories taken and diagnosis made. Patients were then briefed about the
experiment and signed an agreement in which the whole procedure was again detailed.
Acute & Chronic
Acute
Due to the obvious clinical restrictions in accurately diagnosing acute patients,
especially if the condition is the result of a traumatic event or accident, it was decided to
eliminate all acute lower back sufferers from this study.
Initial symptoms of acute pain due to inflammation/swelling/muscle spasm only add to
the complexity of an accurate diagnosis and therefore often ‘mask’ the underlying injury
or disorder. These initial symptoms being short term can be seen as part of the ‘healing
process’. Progress is frequently achieved with little or no therapeutic intervention. To
accurately assess the influence of the flexi:bak on such individuals would be flawed at
the outset.
Chronic
Lower back sufferers make up the majority of patients treated at the Osteopathic Clinic.
The flexi:bak was designed and developed for the chronic sufferer and therefore the
sample of patients involved in this study was limited to the chronic sufferer.
Duration and make up of test
The tests took place between 13 March 1998 and 12 March 1999 and involved 127
women and 97 men.
Assessments
1. As the patients were the ones who would be questioned at the end of the trial, each
was asked to give their subjective opinion of their pain levels.
The scale was
0 = No Pain
1 = Occasional Pain
2 = Recurrent Pain less than 25% of the time
3 = Recurrent Pain more than 25% of the time/Constant Pain
4 = Severe Constant Pain
2. An assessment of specific joint and overall lower back mobility was carried out by
Mr. Rosser and his associates. These used conventional Orthopaedic mobility tests
which were:
The SLR
Schrober
Foraminal Compression
Hands-Feet
Standing SI
Gait-Walking
The tests ascertained Lumbar Strain/Pain, Lumbar Facet Syndrome, Lumbar-Sacral
Strain and Sacro-Iliac Dysfunction. Patients with more than one condition were marked
in more than one category.
This allowed the Assessor when carrying out the tests to give an ‘Active Range of
Movement Figure’ for each test, based both on mobility and quality of movement. Each
patient’s score was again valued 0-4 for each test.
0 = Full and complete mobility taking account of the patients age and overall state
1 = >20% Restriction
2 = >40% Restriction
3 = >60% Restriction
4 = >80% Restriction
3. Assessment of muscular spasm/guarding as an indicator of rate of recovery,
confirmation of patient’s subjective pain report and indicator of soft-tissue state (namely
circulation, swelling, and sensitivity) was also assessed on a grade 0-4.
0 = No muscle spasm in ‘lower triangle’.
1 = Increased muscle tone with increased superficial circulation.
2 = Muscle restriction affecting 1 or 2 lower triangle joints with obvious signs of
inflammation and swelling.
3 = Painful restriction of 3 or 4 lower triangle joints with associated inflammation and
swelling
4 = Severe and extensive muscle restriction affecting 4 or more lower triangle joints
with soft tissue pain.
Patient Pain
Assessment
Muscle
spasm
Foraminal
Compression
Active
Range of
Mobility
Table 1. Overall Test Results 224 Persons
Significant
%
Observable %
Mild
Improvemt
Improvemt
Improvemt
Score =0
Score=1
Score=2
74
33.1 96
43.0 24
%
No
Change
Scor=3/4
10.7 30
%
13.4
86
38.4 87
38.8 24
10.7 27
12.0
71
31.6 68
30.3 61
27.2 24
11.4
87
38.9 104
46.4 23
10.3 10
4.5
Patient Pain
Assessment
Muscle
spasm
Foraminal
Compression
Active
Range of
Mobility
Table 2. Lumbar Sprain/Pain 81 Persons
Significant
%
Observable %
Mild
Improvemt
Improvemt
Improvemt
Score =0
Score=1
Score=2
23
28.3 41
50.6 5
6.2
No
Change
Scor=3/4
12
%
14.8
42
51.8 25
30.9 10
12.3 4
4.9
9
11.1 26
32.1 30
37.0 16
19.7
31
38.2 39
48.1 7
8.6
4.9
Table 3. Lumbar Facet Syndrome 30 Persons
Significant %
Observable %
Mild
Improvemt
Improvemt
Improvemt
Score =0
Score=1
Score=2
14
46.7 10
33.3 4
Patient Pain
Assessment
Muscle
11
spasm
Foraminal
15
Compression
Active Range 12
of Mobility
Patient Pain
Assessment
Muscle
spasm
Foraminal
Compression
Active
Range of
Mobility
%
4
%
No
%
Change
Scor=3/4
13.3 2
6.7
36.6 13
43.3 4
13.3 2
6.7
50.0 8
26.7 5
16.7 2
6.7
40.0 12
40.0 5
16.7 1
3.3
%
No
Change
Scor=3/4
14.5 14
%
Table 4. Lumbar-Sacral Strain 77 Persons
Significant
%
Observable %
Mild
Improvemt
Improvemt
Improvemt
Score =0
Score=1
Score=2
23
30.2 29
38.2 11
18.4
18
23.4 24
31.2 20
26.0 15
19.5
35
45.4 24
31.2 12
15.6 6
7.8
27
35.0 37
48.1 10
13.0 3
3.9
Patient Pain
Assessment
Muscle
spasm
Active
Range of
Mobility
Table 5. Sacroiliac Dysfunction 66 Persons
Significant
%
Observable %
Mild
Improvemt
Improvemt
Improvemt
Score =0
Score=1
Score=2
21
31.8 33
50.0 4
%
6.0
No
Change
Scor=3/4
8
%
12.1
16
24.2 21
31.8 20
30.3 9
13.6
28
42.4 31
46.7 4
6.0
4.5
3
Conclusion
As a whole the group did experience a decrease in symptoms as a result of using the
flexi:bak over the one month trial. The medical conditions of the patients in the study
were of a chronic nature. The device helped these patients with the management of their
pain as well as increased the functional range of motion in their problem areas or joint/s.
By using patients with a chronic condition for this study it is reasonable to assume that
the flexi:bak helped to reduce the related symptoms and findings. It is our belief that
the results obtained in this study warrant further research. It is also important to note
that there were no undesired manifestations as a result of using the flexi:bak