An evaluation of the effectiveness of osteopathic treatment on symptoms

associated with Myalgic Encephalomyelitis. A preliminary report

 

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=9491353

 

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

4WT, UK

 

Introduction

------------

 

The term Myalgic Encephalomyelitis (ME) was initially used in the 1950s [1].

ME describes a syndrome where there is general muscle pain associated with

evidence of a disturbed nervous system [2]. 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 [3]. The symptoms of

ME typically become apparent following a viral infection [4], although other

trigger factors have been noted. Vaccinations against cholera, tetanus,

typhoid and influenza have been associated with the onset of ME [5]. It has

also been observed that any psychological disturbances in ME occur secondary

to, or share a common pathophysiology with an immunological dysfunction [6].

In many cases there appears to be no apparent triggering factor [7].

 

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 [8].

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

drainage.

 

Treatment advocated for ME in the past has included anti-inflammatory drugs

with muscle relaxants [9]. However anti-viral drugs showed no greater effect

on ME than a placebo [10]. 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 [12].

Alternative treatments have included intramuscular injections of magnesium

sulphate [13], 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 [14].

 

Recent research has alluded to a possible deficit within the central nervous

system [15]. 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 [20].

Dietary programmes are being investigated, with evidence to suggest that an

essential fatty acid intake must be normalized in the management of ME [21].

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.

 

Patient selection

-----------------

 

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) [22]. This definition is

internationally accepted as the criteria for diagnosis of people suffering

from ME [23]. 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

background.

 

Inclusion criteria

------------------

 

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

trials.

 

(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

ME).

 

(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

charge.

 

(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

time.

 

(6) The patient was willing to be part of a longer follow-up study.

 

Exclusion criteria

 

(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.

 

Method

------

 

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.

 

Laboratory measurements

-----------------------

 

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 [26]. 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

pushing.

 

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 [27]. 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 [28].

 

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

axis.

 

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

Work Done'.

 

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 [29]. 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

project.

 

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 [30].

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

ME.

 

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 [31], 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 [32]. 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) [33] and

 

Questionnaire no. 4. The Beck anxiety inventory (BAI) [34]. 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 [38].

 

Questionnaire no. 5. The Morgan-Gledhill sleep questionnaire [39]. Sleep

disturbance is one of the most common symptoms of ME. A recent study showed

that many patients with CFS had trouble staying asleep [40]. Actimetering

measuring techniques [41] 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 [43]. 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 [44], 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) [46]. 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

[47]. 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.

 

Control group

-------------

 

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.

 

Patient group

-------------

 

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.

 

Treatment

---------

 

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

techniques.

 

(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

techniques.

 

(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,

1994).

 

Other advice

------------

 

Osteopathic treatment is not synonymous with manipulation. Many treatments

of numerous conditions were found to be insufficient if they relied on

manual therapy alone [48]. 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

less frequently.

 

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.

 

Results

-------

 

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.

------------------------------------------------------------

                                          Minimum     Maximum

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

questionnaire).

 

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

fatiguability.

 

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

symptoms.

 

 

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

 

 

Discussion

----------

 

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

project.

 

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 [49]. It is thought to be due to a reduced cerebral blood

flow [50] 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 [51]. 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

[46]. 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 [52] 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 [53]. 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 [30]. 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.

 

Conclusion

----------

 

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.

 

Acknowledgements

----------------

 

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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