An evaluation of the effectiveness of osteopathic treatment on symptoms
Bron : Journal of Medical Engineering & Technology
Datum: Volume 22, Number 1, January/February 1998), pages 1 - 13
R. N. Perrin, J. Edwards and P. Hartleys
Telford Research Institute ‡The School of Prosthetics and Orlhotics §Centre
for Health Studies, University of Salford, Salford, Greater Manchester, M5
The term Myalgic Encephalomyelitis (ME) was initially used in the 1950s .
ME describes a syndrome where there is general muscle pain associated with
evidence of a disturbed nervous system . ME, commonly referred to as
Chronic Fatigue Syndrome (CFS), or post-viral fatigue syndrome is a
condition in which mental and physical fatigue predominate. It is
characterized by gross abnormal muscle fatigue which occurs after relatively
mild activity. Other symptoms regularly complained of include sleep
disturbance, headaches, cognitive dysfunction, feeling depressed, bouts of
low grade fever (not exceeding 38 6°C), increased sensitivity to light, back
and neck pain, sore throat, irritable bowel and bladder . The symptoms of
ME typically become apparent following a viral infection , although other
trigger factors have been noted. Vaccinations against cholera, tetanus,
typhoid and influenza have been associated with the onset of ME . It has
also been observed that any psychological disturbances in ME occur secondary
to, or share a common pathophysiology with an immunological dysfunction .
In many cases there appears to be no apparent triggering factor .
A chance discovery during the past four years of conventional osteopathic
practice of the first author, revealed a plausible correlation between a
mechanical dysfunction of the thoracic spine and the incidence of ME .
Promising results achieved by this author with osteopathic treatment of ME
patients have led to a hypothesis that a cause of ME is a mechanical
dysfunction affecting the upper back which leads to a chronic disturbance of
the sympathetic nervous system. Furthermore, this dysfunction responds
favourably to biomechanical treatment, which involves manipulation of the
intervertebral apophyseal joints of the thoracic spine and massage of the
surrounding soft tissues to increase blood supply and stimulate lymphatic
Treatment advocated for ME in the past has included anti-inflammatory drugs
with muscle relaxants . However anti-viral drugs showed no greater effect
on ME than a placebo . Other studies concluded that treatment should be
based on supportive counselling coupled with psychiatric treatment, and that
the patient should be encouraged to gradually increase everyday activity
[11). Yet, none of these treatments has proved wholly satisfactory and
absence of the ultimate curative drug has led to many alternative treatment
approaches such as oral anti-fungal drugs, and strict exclusion diets. This
use of anti-fungal agents has resulted in some cases of hepatitis .
Alternative treatments have included intramuscular injections of magnesium
sulphate , but at present there still remains much scientific
uncertainty regarding the aetiology, diagnosis and treatment of ME. This has
led to a refusal by many practitioners to admit its very existence and a
recent study in Australia showed that 70 per cent of a group of doctors were
reluctant to make a diagnosis of CFS .
Recent research has alluded to a possible deficit within the central nervous
system . Although there is still a large school of thought that suggests
a viral cause, many new research studies have demonstrated the unlikely
event of viruses being the underlying cause of this disease [16 - 19].
The conventional advice for relief of the symptoms includes psychotherapy,
physiotherapy, exercise programmes, acupuncture, or antidepressants .
Dietary programmes are being investigated, with evidence to suggest that an
essential fatty acid intake must be normalized in the management of ME .
The amount of research into a viable treatment of ME is negligible compared
with world-wide investigation of the actual mechanism causing the disease.
Since the actual existence of the disorder is still a source of controversy,
a universally accepted treatment for ME remains highly unlikely until there
is a change of attitude.
The authors believe that by demonstrating the efficacy of osteopathic
treatment of this disease, more importance will be given to mechanical and
physical aspects of the disease. Since ME as a specific entity has not been
recognized by all the scientific world, and a proven method of diagnosis has
not yet been documented, many previous clinical trials have been flawed in
their claims to have treated the disease.
There has been a long-standing debate over the naming of this disorder. Some
have expressed the opinion that ME is a highly specific disease, whereas CFS
is an umbrella term covering many conditions which exhibit fatigue. It is
our opinion that all the terms used for this disease describe the same basic
disorder. Since this belief, at present, cannot be substantiated, and the
diagnosis cannot be 100 per cent confirmed, the current study has aimed at
evaluating the effect of osteopathic treatment in reducing the main symptoms
associated with ME without categorically stating the diagnosis.
The primary aim of the project was to support the hypothesis that
osteopathic treatment reduces the detrimental effect of the symptoms
associated with ME.
The objectives of this study were:
(a) To determine the strength of correlation between mechanical dysfunction
of the thoracic spine, and the incidence of the symptoms linked with ME.
(b) To demonstrate and evaluate the effectiveness of osteopathy in the
treatment of ME/CFS, by utilizing self report questionnaires, clinical
examination and objective muscle-fatigue tests.
The study involved assessing a total of 58 people with confirmed ME. They
were divided into two groups: a 'PATIENT GROUP' of 34 persons and a 'CONTROL
GROUP' of 24 persons. In order to assess the effectiveness of osteopathic
treatment to reduce the severity of ME symptoms, only those in the patient
group were given osteopathic manipulation, whilst the control group acted as
the base-line for comparison. To this end the control group did not receive
any manual therapy, but were allowed to receive any other treatments
available for this condition. By adopting this arrangement we were able to
demonstrate changes occurring in the patient group, over and above those
which may have occurred in the control group as a result of a natural
recovery process. Furthermore, we were also able to monitor the improvement
of individuals in the patient group with time, as a result of the treatment.
This treatment was maintained for a period of 12 months and both groups were
assessed during this same period.
All subjects in the patient group were selected from patients referred for
treatment of ME to the clinical practice of one of the authors. Each of them
had to satisfy the definition for chronic fatigue syndrome of the Centre for
Disease Control and Prevention (CDC) . This definition is
internationally accepted as the criteria for diagnosis of people suffering
from ME . They also had to satisfy The London Criteria which were
formulated by scientific advisors for the ME Association as well as Action
for ME [1,4], and validated by several groups including the National Task
Force on CFS [24,25]. The latter criteria are more stringent than the CDC
criteria and pay particular attention to two factors when diagnosing ME for
research purposes. Firstly, that many of the symptoms and signs evident in
people suffering from ME could be due to a larger number of other important
conditions. Secondly, ME may run parallel with other diseases having similar
symptoms and signs. Everybody in the control group was chosen from the
membership of the society 'Action for ME'. They had already volunteered to
be involved in any project concerning ME. Selection for the control group
was carried out by representatives of the Society and for ethical reasons
these subjects were not seen by our clinician who treated the patient group.
This was due to the fact that it would be distressing for those in the
control group to know that some patients are receiving treatment not
available to them.
The patient and control group members were all aged between 18 and 55. Both
groups were matched for marital status with a value of 1 allocated to a
single person and 2 if the subject had a partner. Both the patient and
control groups contained slightly more single subjects than married scoring
an identical mean of 1-42 with equal standard deviations of 0 5. The two
groups who completed the year's project were also matched for gender with 17
women and 7 men in the control group compared with 22 women and 11 men in
the patient group. Since the results were affected by the subject's ability
to answer self-report questionnaires, the groups were chosen with a similar
mean educational background. This was determined by a score system from 1 to
7, where 1 = left school without any academic qualifications, and 7=gained a
Ph.D. or equivalent higher degree. The mean score of the control group was
4.5 (SD = 1.5) and the mean score of the patient group was 4.48 (SD = 1.48).
The above results indicate that there was a good match between the patient
and control groups with regard to marital status, gender and educational
Initially, a total of 80 patients volunteered to take part in the project.
They had been diagnosed either by a consultant, or by their GP as suffering
from ME, CFS, or Post-viral fatigue syndrome, and had been excluded from
having any other major untreated pathology. Forty su6'erers had asked to be
control group members and forty had volunteered to be members of the patient
group. They had all seen a notice in the national ME journal 'INTERACTION'
or had heard about the project through word of mouth. All subjects involved
in the project had to satisfy the following criteria to be included in the
(1) Subjects were aged between 18 - 55.
(2) Both groups conformed to our diagnostic criteria (Centre for Disease
Control criteria for Chronic Fatigue Syndrome and the London Criteria for
(3) Members of the patient group were able to afford the X400 of treatment
over the year period at a rate of f.20 per treatment for twenty sessions. If
more treatments were required during the year, they were given free of
(4) Patients to travel to and from the treatment clinics in Salford,
Prestwich or Manchester.
(5) The subjects understood the importance of continuing the treatment until
the end of the year, although they were free to leave the project at any
(6) The patient was willing to be part of a longer follow-up study.
(1) Subjects receiving other treatment for their ME symptoms were excluded
from being part of the patient group, unless they had received the other
treatment as ongoing therapy for at least six months prior to the start of
their participation in the project.
(2) Patient group members receiving any manual treatment for their ME
symptoms other than that from the author were excluded from the study.
Subjects were also eliminated from the project if they had received any
prior physical therapy for their present symptoms.
(3) Control group members receiving any form of manual treatment for their
ME symptoms were also excluded from the trials.
(4) No premorbid symptoms of depression.
(5) If there was a doubt as to the psychiatric state of the patient, or the
subject was experiencing a primary depressive illness, they were excluded.
(6) No psychiatric history in the family.
(7) Subjects were excluded if they tested positive for any other untreated
patho-physiological cause of the symptoms.
(8) A subject who had suffered from any other neurological disorder, was
also excluded from the study.
The experimental procedure involved two types of measurement. The first
involved objective measures carried out in the laboratory to determine the
physical condition of the leg muscles and the mobility of the thoracic
spine. The second involved asking subjects to complete a series of
questionnaires about their symptoms.
It has been demonstrated previously that when a hand was exercised to induce
fatigue, and at the same time blood flow was stopped by inflating a cuff
around the upper arm, there was no recovery of power until the cuff was
released and normal circulation was restored. This was the case even though
the somatic innervation was still functioning . This showed that in
cases of impaired sympathetic function the resulting reduction in blood flow
may precipitate a state of fatigue.
Since fatigue is a common clinical symptom of ME, it was considered
essential to measure whether this fatigue was relieved by the treatment.
Whilst camping out this measurement it was imperative to avoid injury to the
muscle. The knee extensors in the right. thigh were chosen for this
measurement because the fatigue effect of ME is particularly evident in
these muscles. The fatigue test involved isometric measurement of the static
torque exerted about the knee by the extensor muscles of that joint using a
specially designed chair as shown in figure l.
During each measurement the patient was seated with the leg hanging
vertically. A lever attached to a torque transducer at the level of the knee
joint axis was aligned along the lateral side of the leg with a padded
extension that projected across the front of the shin, just above the ankle.
During each test the lever was clamped in a fixed position. The patient was
asked to exert as much force as possible against the padded extension and
the resulting trace of torque at the knee was plotted against time on a pen
recorder. After a set period of time the subject was instructed to stop
Functional electrical stimulation (FES) of the quadriceps might have
provided a more accurate way of measuring fatigue as it. could produce a set
level of stimulation in the muscle . However, it was felt that FES would
have been too painful for these patients to withstand, and for ethical
reasons we preferred to use active contraction controlled by the patient.
Weakness is defined as diminished ability of rested muscle to exert maximal
force. Fatigue, however, is a loss of maximal force-generating capacity that
develops during muscular activity .
The main problem encountered in measuring fatigue of the knee extensors, was
that of achieving maximal force without causing major damage to the patients
muscles. This problem was overcome by carrying out a pre-test in which the
patient was asked to exert force on the leg pad a number of times and then
resting for 3 min before the final test. These preliminary contractions
served a dual purpose. Firstly they allowed patients to accustom themselves
to the machine before applying maximal torque, and secondly they provided an
exercise to induce some preset fatigue in the muscle.
Everyone has an in-built sensation of discomfort which safeguards them
against exerting high levels of muscle force which can damage the muscle
fibres. This is partly psychological and partly due to the physical
sensation of pain. The psychological element of this is variable and will
cause the subject to exert different levels of maximal force on different
occasions. However, on any one occasion, if the subject attempted to
maintain the exertion of muscle force over an extended period of time,
fatigue eventually set in and caused the force to drop whether they wanted
it to or not. Therefore, we found that the rate of decline in muscle force
due to fatigue was more significant than the peak force.
We found that the optimum sequence for the pre-test exercise was ten pushes,
each lasting twenty seconds with an interval of ten seconds between each
push. A typical plot with time of torque exerted about the knee during this
sequence is shown in figure 2.
During the first four pushes after the initial peak, the torque was held
relatively constant until the subject stopped pushing. During pushes 5, 6
and 7, after the initial peak, fatigue caused a gradual drop in torque over
the 20 s time period when the patient was attempting to keep the torque at
maximum. Sometimes, after a 10 s rest, the subject was able to momentarily
achieve a torque as in push no. 8 similar to the original level at push no.
1. However, this was short lived and rapidly fell to a magnitude below push
no. 7. By the tenth cycle of pushes the effect of fatigue had become fully
established. A similar picture of fatigue with exercise pushes was evident
in all the patients, as well as in normals randomly selected from our
University staff. Therefore, ten repeated push cycles was chosen for all our
tests. After completing these ten cycles the subject was allowed three
minutes rest for the muscle to recover. Then the patient was asked to push
as hard as possible again, only this time they were requested to maintain
the maximal push until they could no longer continue. A typical recording
for this final push is shown in figure 3 where the torque about the knee
axis in Newton metres is plotted vertically against time on the horizontal
Newton's second law states: 'the change in linear momentum of a body under
the action of an unbalanced force will be proportional to the product of the
force and the time for which it acts'. This change is known as the impulse.
The area under the pen recorder graph of torque against time was a
measurement of the change in impulse which was directly related to the work
done by the muscle. This was inversely proportional to the fatigue of the
muscle and so was a good method for determining the fatiguability of the
knee extensors. That is, Ft= Impulse and this was defined as the 'Effective
When the subject was asked to press for as long as possible, a difficulty
arose in evaluating exactly what was meant by 'as long as possible'. It was
not the intention of the researcher to cause muscle damage and this would
have added too many subject factors into this experiment, thus increasing
the margin of error. In a pilot study it was noted that the patients could
sustain the final push for at least thirty seconds before relaxing.
Subsequently the first thirty seconds of the final push was the time chosen
to evaluate the fatiguability of the muscle. The patient was then allowed to
stop after this time to prevent any injury.
According to the above definition, in figure 3 the shaded area under the
graph is related to the effective work done by the patient during the final
push of the test. Thus the larger this area, the less was the fatigue of the
muscle over a 30 s time period.
After each test we also recorded the subject's rating in the Borg Scale of
Perceived Exertion. This perceptual effort rating was formulated as a
behavioural and psychological measurement of physical performance and work
capacity. The real value of exertion is proportional to the heart rate of
the patient. (That is if the pulse after exertion was 100 then the real
value of exertion scored 10 on the Borg scale). The patient was asked to
score the perceived amount of strain they felt during the exercise by using
the Borg scale where 6 = minimum effort required and 20 = maximum effort
required . As long as the difference between the real and perceived
exertion during the initial tests did not increase in the final test, then
the torque measurement improvement was shown not to be due to the patient
simply putting more effort in at the end compared to the beginning of the
It has been postulated that irritation of the sympathetic nerves at the
spinal level could lead to adaptive or pathological changes in the tissues
of origin. Altered excitability within the central nervous system may
eventually be caused by the overactive afferent sympathetic supply. This may
effect other tissues in viscera throughout the body leading to disease .
Eased on this hypothesis, it was felt that a method to determine spinal
mobility was needed. If the amount of movement in the thoracic spine was
shown to be proportional to the severity of symptoms, then it could support
the idea of physical irritation of nerve roots involved in the aetiology of
Measurement of spinal mobility requires the shape of the spine to be
recorded at different instants of time during movement of the vertebral
column. In our study, we investigated several shape recording devices
including the use of a flexicurve , as well The MAC Reflex gait study
system (an infrared scanning technique involving automatic computerised
digitization). The latter was found to be too time consuming, and was
impractical because it had to be re-calibrated after each patient. Instead
we chose to use the Salford Biomechanics Workstation. This device digitized
movement of the thoracic spine from video film. The patient was positioned
with the video camera placed laterally and focused on three probes that were
fixed by adhesive tape to specific points on the subject's back overlying
the spine. These points included T1, known as point C; T7 (point T) and L1
(point L). At maximum flexion, the angle CTL was recorded with the
digitizer. This method was painless and required minimal time. Furthermore,
the maximum error of distance measurement with this system was found to be
0-03% in the horizontal view, and 0 9% in the vertical view . The
position of C, T and L were recorded and remained unchanged. For each
individual, the probes were placed exactly over the same segment as in the
previous recording of the spinal movement, thus keeping the distances 0 - C;
C - T and T - L constant for each subject.
Throughout the 12 months treatment period, each patient was also subject to
graded clinical assessment of thoracic spine mobility, and muscular tone of
paravertebral muscles. These assessments utilized palpation and
proprioceptive techniques. In addition, tissue health was graded using a
simple scoring system related to individual segments of the thoracic spine.
This grading system was scored by the researcher and randomly calibrated by
another osteopath. It was carried out as part of a routine clinical visit.
Self report questionnaires
The following nine self-report questionnaires were filled out by all members
of both the patient and control groups. The first two questionnaires were
developed by the author specifically for this study and tested in a pilot
study on nine patients before the start of the clinical trials. The pilot
study's other aim was to evaluate the equipment used for objective
measurements of muscle fatigue and spinal mobility. Questionnaires 3 to 8
were chosen for this project as they had already been validated in previous
research studies, most involving ME. After examining other similar
inventories and reviewing the literature on these questionnaires, they were
deemed as suitable, precise, and easy to use.
Questionnaire no. 1. A General Health questionnaire, was developed
especially for this study. It was based on twenty-six common symptoms
complained of by ME patients. The higher the score, the worse the symptoms.
Questionnaire no. 2. Back pain questionnaire This was developed to examine a
possible correlation between the amount of back pain and the severity of the
other symptoms associated with ME.
Questionnaire no. 3. The revised Beck depression inventory (BDI)  and
Questionnaire no. 4. The Beck anxiety inventory (BAI) . These were
chosen as the most suitable depression and anxiety questionnaires for the
project, as they were short, requiring only 5 - 10 min to complete, easy to
score and had a cut off point. Given that anxiety and depression frequently
coexist [35,36], the results from instruments designed to measure the
severity of anxiety or depression are highly correlated with one another
[34,37]. The BAI was formulated to measure symptoms of anxiety which are
minimally shared with those of depression, and thus it was a suitable
anxiety questionnaire to use with the BDI. Over the last 26 years the BDI
and BAI have become widely accepted instruments for detecting and assessing
the intensity of depression and anxiety in nonpsychiatric patients .
Questionnaire no. 5. The Morgan-Gledhill sleep questionnaire . Sleep
disturbance is one of the most common symptoms of ME. A recent study showed
that many patients with CFS had trouble staying asleep . Actimetering
measuring techniques  were considered for the project but were found to
be too costly and difficult to use. The Morgan-Gledhill sleep questionnaire
was one of only a few established sleep questionnaires, and can be scored to
suit the needs of a particular project.
Questionnaire no. 6. Broadbent's cognitive function questionnaire (42J.
Pronounced and frequent cognitive
deficits have been found in patients with ME when attempting to carry out
mental performance tests . Since no direct contact was made with the
control group by the authors, it was decided to use a cognitive function
self-report questionnaire. The Broadbent's CFQ has been well validated and
is suitable for use in this study as demonstrated by other ME research
projects , and again this questionnaire was easy to complete and score.
Questionnaire no. 7. The Nottingham Health Questionnaire (45J. It was felt
that The Nottingham Health Questionnaire is a quick, simple indicator for
the general symptoms of ME and widely accepted. Also Dr Charles Shepherd,
the medical advisor of 'The ME Association', advised us to include this
questionnaire in the project in order to gain acceptance of our research
findings by his nationally acclaimed group.
Questionnaire no. 8. The profile of fatigue related states (PFRS) . The
PFRS is a multidimensional measure incorporating nearly all the symptoms
associated with ME and was developed at Brunel University especially to
measure the symptoms of illness and to evaluate the effects of treatment
. It is longer than the other questionnaires, but is still quite easy to
complete and not too difficult to score. It has four scales: emotional
stress, cognitive difficulty, fatigue and somatic symptoms.
The control group was chosen by 'Action For ME' from a volunteer group which
met the CDC criteria for Chronic Fatigue and The London Criteria. There were
initially 40 members of this group but the numbers dwindled over the year to
23 by the end of the project.
All members of the control group started in April 1995 and were sent via the
Action For ME, a set of the self report questionnaires every 3 months. With
the above questionnaires they were also sent a general questionnaire to
determine which treatment they had been receiving during the past 3 months.
This gave useful information regarding the efficiency of other therapies in
treating this disorder. After each subject had completed five sets of
questionnaires, they finished their participation in April 1996.
The patients continued to fill out the questionnaires quarterly until the
project was completed.
Forty patients meeting the Centres for Disease Control and Prevention's
working case definition for Chronic Fatigue Syndrome were initially chosen
to be part of the patient group. Five of these were disqualified for failing
the Action for ME questionnaire based on the London Criteria, and one had to
leave the country, unexpectedly. These patients were given code numbers RP01
to RP40 to protect their anonymity. They also received secret code numbers
which were given to them by an independent observer to be used by the
subjects when completing their questionnaires. The identity of the secret
code was kept hidden from the researcher until later on in the project. This
number allowed freedom to answer the questionnaires truthfully without the
researcher influencing the reply. This system was adopted to reduce bias and
thus increase the validity of the questionnaires. Only one subject has
subsequently 'dropped out', leaving thirty-three still having osteopathic
treatment one year after signing on as a research subject.
The treatment of each ME patient consisted of the following techniques:
(1) Soft tissue massage of the paravertebral muscles, the trapezii, levator
scapulae, rhomboids and muscles of respiration.
(2) High and low velocity manipulation of the thoracic and upper lumbar
spinal segments using supine and side-lying combined leverage and thrust
(3) Gentle articulation of thoracic and upper lumbar spine, plus the ribs.
This was achieved by both long and short lever techniques.
(4) Functional techniques to the suboccipital region and the sacrum.
(5) Stimulation of the cranio-sacral rhythm by functional-cranial
(6) Efflourage to aid drainage in thoracic and cervical lymphatic vessels.
(7) Exercises to improve the mobility of the thoracic spine, and to improve
the physical coordination.
All of the above techniques form part of the conventional clinical practice
of osteopathy and are described in more detail in The Handbook of
Osteopathic Techniques, 2nd edn by L. S. Hartman (Chapman and Hall, London,
Osteopathic treatment is not synonymous with manipulation. Many treatments
of numerous conditions were found to be insufficient if they relied on
manual therapy alone . As is standard in osteopathic practice, advice
was also given to help improve general health.
Inflammation is usually combated by prescribing nonsteroidal
anti-inflammatory drugs (NSAIDs) . A more natural method advised by many
osteopaths is a technique known as contrast-bathing. This utilizes warm and
cold compresses to dilate and contract the local blood vessels, thus
stimulating the blood flow and accelerating the natural inflammatory
process. In most cases of ME there is an inflammation of part of the spine
and surrounding tissue. We chose contrast-bathing to reduce the
inflammation, as it acts locally whilst avoiding the side effects of NSAIDs
or steroids. Patients were advised to apply the contrast bathing of warm and
cold compresses to tender areas of their backs, three times a day. In some
severe cases this treatment was prescribed more often, whilst others used it
Initially the patients were also instructed to reduce exercise and physical
activity to half their capability. Once the patients' health had
sufficiently improved to withstand slight physical exertion without any
worsening of symptoms, they were advised to gradually increase walking
activities, and if possible, to do backstroke swimming.
It is important to understand that the entire treatment programme was being
evaluated, and not just the manipulative methods.
The fatiguability and spinal mobility tests were carried out on each member
of the patient group every six months giving three readings over a 12 month
period. They were also asked to fill out the questionnaires 1 - 8 every
three months. The scores of the questionnaires were calculated by the
researcher, and the mean improvement of both patient and control groups were
compared. Questionnaire no. 1 had a minimum possible value of 26 as each
separate complaint scored '1' when symptom free. The back pain questionnaire
(no. 2) scored a minimum of 12, as each section of the back scored '1' if
pain free. Likewise questionnaire no. 8 had a minimum value of 54 based upon
the score of 1 for each symptom free complaint. All the other inventories
scored zero for each symptom free item. The maximum and minimum possible
scores for all the questionnaires are shown in table l.
Figure 4 is a bar chart which plots the mean value obtained for each
questionnaire answered by members of the control group at zero, 3 and 6
months after the start of the project. These values were plotted on the
Table 1. Scoring system of the questionnaires.
Questionnaire No.1 Health 26 104
Questionnaire No.2 Back pain 12 48
Questionnaire No.3 Depression 0 63
Questionnaire No.4 Anxiety 0 63
Questionnaire No.5 Sleep 0 14*
Questionnaire No.6 Cognition 0 100
Questionnaire No.7 Nottingham 0 38
Questionnaire No.8 PFR 54 378
*The sleep questionnaire did not have a maximum limit, since one of the
items evaluated was the time it took to fall asleep which has no upper
limit, and which scored 1 point for every 10 min (e.g. 1 h=6pts). Many of
the patients had severe sleeping problems scoring more than 14.
vertical axis as a percentage severity of symptoms with the questionnaire
number indicated on the horizontal axis, where 0% = Symptom Free and 100% =
Worst symptoms possible (except no. 5 where 100% = 14 points on the sleep
The results for the questionnaire answers of the patient group are plotted
in figure 5, with the severity of symptoms calculated as a percentage (again
where: 0% = Symptom Free and 100% = Worst symptoms (except no. 5).
The final scores of the questionnaires of each individual subject have been
recorded and compared with the scores recorded at the beginning of the
project. These can be seen in the bar charts (figures 6 (a) and 6 (b) ),
On these charts, the total score from all eight of the questionnaires for
each subject is plotted vertically against the case number of the subject on
the horizontal axis. The score values at the beginning of the project are
marked in red while the corresponding values at the end of the project are
marked in green.
For the control group figure 6 (a) shows that the change in score from the
beginning to the end of the project is, in most cases, much smaller than in
figure 6 (b) for the patient group. Furthermore, all the subjects in the
patient group experienced a reduction in score (green bar lower than red),
whilst for nearly 50% of the control group the score was greater at the end
of the project (green bar higher than red).
The percentage change in these scores over the year was calculated for each
subject, and the overall mean for both groups were compared as shown in
table 2. This table shows that the mean score for the patient group improved
by 40% as opposed to a 1% worsening in symptoms for the control group. There
was no overlap in the standard deviations and with a p value of less than 0
0005, the results were highly significant.
Results of laboratory tests
The results of the knee extensor muscle fatiguability test. utilizing the
torque transducer chair were analysed comparing the individual patient
scores at the start of the study to the scores at the end of the project.
These are shown in table 3. An increase in this score measured in Newton
metre seconds represents an improvement in the overall work done by the knee
extensor muscles thus demonstrating a reduction in exercise induced
The mean results of the fatiguability tests were statistically analysed
using a paired T-test comparing the torque x time before and after the year
long study. The mean value at the beginning of the project was 1791 Nms, and
2259 Nms at the completion of the project. The difference in these values
was highly significant with a p value of less than 0.0005.
In some patients the muscles were very weak at the start of the project
(e.g. RP01). As they recovered, their improvement was more noticeable than
those whose rnuscles were quite strong in the first place, e.g. RP07.
To determine spinal mobility, the maximum amount of spinal flexion was
calculated by filming the patients in active full flexion and determining
the minimum angle
Table 2. Comparison of the mean change in symptoms of both groups.
Mean percentage Standard 2-tail
change deviation significance
Patient group 40% 15.8 p< 0.0005
Control group - 1% 22 p< 0.0005
CTL (the smaller the angle the greater the flexion achieved). These results
are shown in table 4 for patients RP01 to RP07 on five test occasions at
three monthly intervals. It demonstrates that the thoracic mobility of these
patients varied very little from the beginning to the end of the project. It
can also be seen that there was no correlation with the improvement of ME
Table 3. Scores of the effective work done in the right knee extensor
muscles (measured in NMS)
Patient Test 1 Test 2
code no. (start of Project) (end of project)
RP01 606 2211
RP02 1077 1767
RP03 512 1255
RP04 716 1783
RP05 732 1182
RP06 1264 1559
RP07 1982 2641
RP11 583 711
RP12 1691 2971
RP13 1917 1366
RP14 5033 5014
RP15 2484 2945
RP16 2653 2990
RP17 1807 2604
RP19 245 704
RP20 518 826
RP21 659 1331
RP23 4776 4670
RP24 475 1179
RP25 1440 1777
RP26 5140 4658
RP27 277 1343
RP28 1793 2118
RP29 1109 1320
RP30 1594 1866
RP31 700 863
RP32 1695 3221
RP33 3002 2927
RP34 3698 3742
RP35 1727 2658
RP36 2757 3476
RP38 1364 1998
RP40 3093 3103
Table 4. Measurement of angle CTL indicating the maximal spinal flexion.
Patients tested: RP01 - RP07.
Test1 Test2 Test3 Test4 Test5
RP01 150.19 150.30 152.51 154.42 144.06
RP02 139.27 151.10 144.76 146.65 146.07
RP03 138.04 144.04 140.05 138.86 140.13
RP04 149.60 145.41 151.42 ***** 150.97
RP05 138.87 3134.99 133.14 ***** 133.57
RP06 139.43 136.62 138.94 ***** 137.17
RP07 137.74 137.67 135 ***** 135.45
Values of angle measured in degrees. ****=No measurement taken
The main objective of this study was to demonstrate whether osteopathic
treatment can reduce the severity of ME symptoms. Our results for the first
6 months confirmed the effectiveness of this treatment. Some of the results
require detailed analysis and explanation. We have postulated that the pain
in the neck and back of these subjects is related to a mechanical
dysfunction, which osteopathic practitioners would expect to relieve by
manual treatment. The questionnaire relating to back pain (no. 2.) showed
that the patient groups' scores (figure 5) improved more than the control
group (figure 4), which was the anticipated result considering the control
group were not able to receive manual treatment for the duration of their
involvement in the project.
The Beck Depression Inventory (Questionnaire no. 3), produced an interesting
result. The scores in figure 4 clearly demonstrate that the depression level
of the control group underwent a steady decrease. This particular result
differs greatly from the other symptoms of the control group, which all
deteriorated during the period of the project, and corroborates the claim
that ME is not a depressive disorder. Otherwise other symptoms would have
shown some improvement as the depression levels dropped. In some of the
control subjects, this may be due to their taking antidepressants. The
patient group's depression score initially improved as the treatment started
to take effect. However, after six months the level of depression was
slightly worse than at the three month period. The reason for this was
possibly due to the fact that the rate of overall improvements in symptoms
had reduced. This is evident from figure 5 which shows a far greater
reduction of symptoms in the first three months than during the second
period. The patients may have lost confidence in the treatment at this
halfway stage, which increased their feeling of depression. This may equally
explain why patient group anxiety levels, and sleep disturbance rose
slightly in the second quarter. However, at the 6 months stage the
depression, anxiety and sleep levels were all less than at the start of the
Broadbent's Cognitive Function Questionnaire, no. 6 produced significant
results. The cognitive abilities of the control group (figure 4) gradually
worsened over the first six months. Whereas the patient score increased
during the same period. This reduction in cognitive ability is very
disturbing for the ME patient. The reasons for this dysfunction have been
studied at length . It is thought to be due to a reduced cerebral blood
flow  which is predominantly controlled by the quantity of hydrogen ions
in the cerebrospinal fluid. The blood flow is raised by an increase of blood
carbon dioxide or by a reduction in the blood oxygen levels. The cerebral
circulatory system has a strong sympathetic innervation that passes upward
from the superior cervical ganglia. This innervation supplies both the large
superficial arteries and the small arteries that infiltrate into the
substance of the brain. It has long been thought that the sympathetic nerves
play no role in regulating cerebral blood flow. Nevertheless, experiments
have shown that the cerebral sympathetic stimulation can, under some
conditions, markedly constrict the cerebral arteries. For instance, when the
arterial pressure rises to a high level during strenuous exercise and other
activities, the sympathetic nervous system constricts the large and
intermediate sized arteries to prevent high blood pressure reaching the
smaller blood vessels, thus preventing strokes. Also sympathetic reflexes
are believed to cause vasospasm in the intermediate and large arteries in
some instances of brain damage, e.g. after a cerebral stroke or in cases of
subdural haematoma, or brain tumour . It is thus feasible that the lack
of normal cognitive function and disturbance of cerebral activity could be
attributed to a dysfunction of sympathetic control mentioned above, which in
turn leads to reduced cerebral circulation.
The results of the final questionnaire no. 8 (The Profile of Fatigue Related
States) are significant, as this was the only established and tested
questionnaire developed specifically for the symptoms associated with ME
. The overall improvement in PFRS scores of the patient group (figure 5)
compared with the control group (figure 4) adequately demonstrated the
validity of the treatment programme.
The tests involving measurement of work done by the knee extensor muscles
(table 3) clearly demonstrated that there was a considerable improvement in
fatigue resistance in the patient group.
A previous study on patients with ME  has demonstrated that the reduced
capacity for dynamic exercise in this case is also associated with reaching
exhaustion more rapidly than in normal subjects, at which point these
patients have relatively reduced intracellular concentrations of ATP. The
study concluded that there was a defect in oxidative metabolism with a
resultant acceleration of glycolysis in the skeletal muscles of an ME
sufferer. If those authors are correct, then impaired blood flow is a
possible explanation for a reduced oxygen supply to the muscle resulting in
the fatigue symptoms of ME.
It should be noted that in the present study, reduced fatiguability of the
quadriceps was not achieved by any direct treatment on the lower extremity,
nor by any exercise regime to improve muscle strength in the patients legs.
The treatment programme was based solely on the hypothesis that by using
manual techniques to reduce disturbed afferent sympathetic impulses, the
overall sympathetic nervous system eventually begins to function normally,
thus improving visceral function and circulation in skeletal muscle.
A major objective of this study was to determine the correlation between the
mechanical dysfunction of the spine, and the incidence of the symptoms
linked with ME. Physiological evidence supports the possibility that the
clinical findings of thoracic spinal dysfunction, may be intrinsically
linked in the pathogenesis of this disorder.
It has been demonstrated that postural changes in the spine produced
alterations in the production of perspiration . A team of physiologists
developed a hypothesis relating to sympathetic nerve involvement in disease
processes. The first conclusions that they reached were as follows.
(a) The manifestations of altered sympathetic activity represent an actual
defect in the patterns of sympathetic activity.
(b) These distortions are due to effects of impulses originating from either
the viscera, or somatic sources.
(c) Other components, such as adaptive or pathological changes and altered
excitability within the central nervous system, may eventually become
involved. This may directly affect local tissue without taking the expected
route of nerve impulses.
Further studies revealed that the areas of altered sympathetic activity
appeared in apparently normal subjects. It was suggested that this was due
to subclinical bombardment of nerve impulses into the spinal cord. These
impulses caused no symptoms themselves but, added to other stimuli affecting
the same spinal segment, they could combine to cause major problems. Long
lasting hyperactivity of innervating sympathetic pathways, seemed to be a
prevailing theme in many clinical conditions. It was also suggested that
spinal dysfunction would lead to disturbances in the muscular fatiguability,
sensory, excitability, immunological mechanisms and endocrine functions due
to an impairment in normal sympathetic efferent flow . If these findings
were correct then we would expect to find that the severity of symptoms
depends upon the amount of spinal mobility. The present results of the
spinal mobility test (see table 4) suggest that there is little correlation
between thoracic spinal movement and ME symptoms.
Our hypothesis, based on clinical evidence, is that following osteopathic
treatment the symptoms are reduced due to stabilizing afferent sympathetic
flow. It is believed by the authors that this equilibrium may be achieved
due to relaxation of soft tissue and an improvement in visceral function
plus increased blood and lymph circulation.
This present study has revealed a demonstrable improvement in ME symptoms as
a result of osteopathic treatment. In future studies we hope to examine
which part of the treatment accounts for the aforementioned improvement.
Also a year after completing the clinical trial, each patient will undergo a
follow-up examination to determine if the improvement in symptoms has been
sustained. It is envisaged that a longer term follow-up on these subjects
will take place over a period of 5 years.
The findings of the present research indicate a need to examine the symptoms
associated with ME from a biomechanical viewpoint.
The authors would like to thank 'Action for ME' for their assistance in this
project. The Department of Elderly Care, Hope Hospital, Salford, for
providing the facilities to conduct our experiments; and The F.O.R. M.E.
Trust for funding this research.
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