Clinical Outcomes Study of Fibromyalgia Patients Treated With EEG-Driven Stimulation and Myofascial Physical Therapies at Myosymmetries International Inc. (Edmonton)

Dr. Horst H. Mueller, CPsych
Myosymmetries International Inc. (Edmonton)
Clinic Director

January 1998

A study of 17 consecutive FMS patients treated between October 1996 and December 1997 at the Edmonton Myosymmetries International clinic was recently completed.

Patient Data. Patients were 14 females and 3 males, aged 50 ± 13 years. All were physician diagnosed with fibromyalgia syndrome (n = 15) or chronic fatigue syndrome (n = 2) and all fully met the American College of Rheumatology classification criteria for FMS (ACR 1990). The mean chronicity for these patients was 4.8 ± 3.4 years.

All had complaints of generalized soft tissue pain, disturbed and nonrestorative sleep, cognitive clouding, and persistent fatigue. Other problems included: headache (6), hysterectomy (6), depression (5), irritable bowel (5), myofascial pain (4), anxiety (3), hypertension (3), nausea (3), whiplash (3), asthma (3) hypothyroid (2), osteoarthritis (2), premenstrual syndrome (2), restless leg syndrome (2), diabetes (1), epilepsy (1), and obsessive-compulsive disorder (1).

At the time of intake, 10 patients were off work on short-term or long-term disability benefits, 3 were "not in the workforce", 2 were fully "retired" and 1 was retired but working part-time, and 1 was working part-time.

Intake Assessment. At intake all patients were seen for a brief intake and medical history interview, all patients completed a number of self-report questionnaires including the Fibromyalgia Impact Questionnaire (FIQ) and the Symptom Check List 90-R (SCL 90-R), all patients underwent an EEG brain mapping procedure, and all patients were seen by a chartered physical therapist for an examination that included palpation of the ACR-defined 18 tender point locations as well as algometer readings of pain sensitivity and pain tolerance.

On initial quanitative EEG brain mapping, all 17 patients showed a pattern of excess amplitude delta/theta or theta/alpha EEG activity with reduced ranging of the dominant frequency above 12 Hz from four or more recording sites— most frequently from frontal, prefrontal and sensorimotor cortex sites.

On physical therapy examination, all patients fully met the ACR (1990) classification criteria for fibromyalgia with a minimum of 11 positive tender points at palpation pressures of =3.0 kg/cm2.

Therapy. These 17 patients underwent an average of 35 EDS sessions (range = 27-44) followed by an average of 8 physical therapy/neuromuscular retraining therapy sessions. All seven demonstrated clear reductions in slow wave EEG over the course of EDS treatment and all but one reported significant improvement in mental clarity, sleep, depression, anxiety, and pain symptoms. The one exceptional patient improved significantly in mental clarity and sleep but experienced little reduction in anxiety, fatigue and pain.

What is EEG-Driven Stimulation? EEG-Driven Stimulation (EDS), originally developed by Dr. Len Ochs at the University of California in Los Angeles in 1990, is a new EEG-driven photic stimulation biofeedback procedure that is being used to research treatment of central nervous system functioning problems. The EDS system consists of proprietory DOS software that links together the J&J I-330 EEG module 201 with the Synectic Systems Synergizer board installed in an IBM compatible 486DX66 computer and a pair of special darkened eyeglasses with green LED lights built into the lenses. EDS carries out real-time spectral analysis of EEG using a fast-fourier technique and applies this information to constantly adjust the frequency and duration of gently flashing lights which stimulate the subject’s optic nerve through the closed eye and, in turn, influence a change in the frequencies of the subject’s brain waves. The flashing lights are housed in a special pair of dark glasses worn by the subject.

SCL 90-R Results. Table 1 shows pretreatment versus posttreatment scores on Symptom Check List 90-R (SCL90-R), a self-rating questionnaire of psychological and emotional adjustment that asks patients to rate the extent, over the previous 7 days, to which they were distressed by each symptom (from 0 = not all to 4 = extremely). Scores for each item are combined into 9 clinical scales as well as a grand total score indicating overall level of distress. Scores are compared to T-score norms for "normal" males or females. T-score values over 60 are considered clinically significant (T60 = 84%tile; T70 = 98%tile; T80 = >99%tile). T-score values between 40-60 are normal. T-scores below 40 are not readily interpretable. The 9 clinical scales are as follows:

Somatization (12 items): Reflects distress arising from perceptions of bodily dysfunction. Complaints focus on cardiovascular, gastrointestinal, respiratory and pain and discomfort of the gross musculature.

Obsessive-Compulsive (10 items): Reflects distress arising from thoughts, impulses and actions experienced as unremitting and irresistable. Also includes a number of items reflecting concern with cognitive performance deficits.

Interpersonal Sensitivity (9 items): These items focus on distress related to feelings of inadequacy and inferiority; self-depreciation and self-doubt.

Depression (13 items): Reflects distress related to manifestations of clinical depression. Includes both cognitive-affective items as well as vegetative items.

Anxiety (10 items): Reflects symptoms that are frequently general signs of anxiety.

Hostility (6 items): Reflects thoughts, feelings or actions that are characteristic of the negative affect state of anger.

Phobic Anxiety (7 items): Reflects irrational and persistent fears of specific things.

Paranoid Ideation (6 items): Reflects feelings and thoughts of loss of autonomy, hostility, suspiciousness, and distrust.

Psychoticism (10 items): Reflects distress related to interpersonal alienation, feelings of social isolation, as well as more frank hallucinations and delusional behaviour associated with schizoid thinking.

Global Severity Index (mean of all 90 items): Reflects overall level of psychological and emotional distress.

Positive Symptom Total (count of all non-zero items): Simply a reflection of the total number of symptoms endorsed by the patient.

Positive Symptom Distress Index: Reflects the average level of distress reported for the symptoms that were endorsed. Functions as a measure of response style— high scores are indicative of augmentation of distress. Non-patient adult males rarely score above T50 and nonpatient adult females rarely score above T60.

Table 1 (below) shows that treatment resulted in significant reductions in self-reported symptoms and distress on the majority of SCL 90-R scales. This is especially the case for those scales that most strongly reflect the neurosomatic symptoms most frequently associated with FMS/CFS.

SCL 90-R Special Scales Results. By summing patient responses to specific items of the SCL90-R and dividing by the number of items summed, 5 new "special scales" were created. These scales were not developed by the SL90-R’s authors and have no published norms. Mean scores for each scale can vary from 0.0 to 4.0. The following SCL90-R Special Scales were created:

Vegetative Depression: Combines all items reflecting apathy and withdrawal of life interest, loss of vital energy, poor appetite, poor sleep and other somatic indicators of depression.

Sleep Quality: Combines all items that reflect disturbed sleep.

Chronic Fatigue: Combines all items that reflect reduced mental and physical energy and motivation.

Cognitive Dysfunction: Combines all items that reflect reduction of cognitive functioning or mental clarity.

Body Pain: Combines all items that reflect body muscular pain.

Table 2 below shows that treatment resulted in statistically significant reductions in reported distressing symptoms on all five Special Scales. The greatest changes were obtained with respect to improved sleep and reduced body pain.

Patient Self-Ratings of Symptom Status. Patients were asked to rate the following symptoms at each therapy session using a 0-10 cm Visual Analog Scale (VAS): Current Pain Intensity, Quality of Previous Night’s Sleep, Current Level of Fatigue, Current Level of Cognitive Clouding, Current Level of Depression, and Current Level of Anxiety. Except for Quality of Sleep, patient’s rated their symptoms from 0 = no problem to 10 = most severe ever. Quality of sleep was reversed with 0 = no sleep and 10 = best sleep ever. The mean of the first 10 ratings for each symptom for each patient was calculated and used as the "pretreatment" measure. These were compared to the mean of the last 10 ratings for each synptom for each patient (i.e., the posttreatment measure).

Table 3 above shows pretreatment versus posttreatment VAS scores. All scores showed significant change with treatment; with all changes in the direction of improvement. Clearly, patients perceived themselves as having improved with respect to pain intensity, sleep quality, fatigue, cognitive functioning, feelings of depression and anxiety.

Pre- vs Post-Treatment EEG Results. Table 4 (next page) shows data comparing the pretreatment to posttreatment mean amplitudes in microvolts of Delta (1-4 Hz), Theta (4-8 Hz), Alpha (8-12 Hz), low Beta (12-16 Hz), and High Beta (16-20 Hz) activity as recorded from 21 cortical sites using a single electrode referenced to the left ear (A1) and taking 18 second samples with eyes closed from each location in the following sequence: FP, FP1, F7, T3, T5, O1, O2, T6 T4, F8, FP2, F3, C3, P3, P4, C4, F4, FZ, CZ, PZ, OZ. Data was collected over the course of approximately 30 minutes.

Although excessively high amplitude delta and theta activity were most commonly found in only the following 11 locations in this sample of FMS/CFS patients— namely, FP, FP1, FP2, FZ, F3, F4, F7, F8, CZ, C3, C4— Figure 4 shows the mean amplitudes for each waveband calculated over all 21 sites assessed. Despite the fact that calculating pre- versus posttreatment mean amplitudes based on all 21 sites will tend to reduce the size of changes, statistically significant reductions in Delta and Theta (p <.05) were obtained. No significant changes were noted for Alpha, Low Beta or High Beta wavebands.

Fibromyalgia Impact Questionnaire Data. The Fibromyalgia Impact Questionnaire (FIQ) was completed by all patients at the beginning of their treatment and was sent out for them to complete again 6 months after their discharge from treatment. Of the 17 patients in this study, there is 6-month follow-up data available for 9 patients at this time.

NOTE: At the time of intake, only 4 of the 17 patients had actually worked in the previous week. Of the 9 patients for which follow-up data was obtained, 6 were working.

Work Status Data. At the time of their intake, 10 patients were off work on short-term or long-term disability benefits, 3 were "not in the workforce", 2 were fully "retired" and 1 was retired but working part-time, and 1 was working part-time. Within one month of completing treatment, 6 of the 10 patients (60%) on STD or LTD had returned to work (4 F/T, 2 P/T) and 4 of the 10 patients (40%) on STD or LTD had not returned to work. The one individual who was working part-time at the time of her intake, returned to full-time work.

Conclusions. Broadly speaking, all 17 patients demonstrated significant, although somewhat varying, improvement in a number of symptoms. Most frequently patients reported significant improvements in mood, restorative sleep, and mental clarity and ability to focus and maintain attention. The EDS treatment also appeared to have an impact on the majority of the patients’ pain experience in that, over the course of sessions, patients tended to report experiencing a reduction in their "all-over" body pain and an increase in specific localized aches and pains. As well, with this apparent movement from a non-localized more systemic pain experience to a more localized or regional type of pain, patients also seemed better able to describe their pain sensations in specific as opposed to vague terms.

As part of our treatment protocol for FMS/CFS patients, we use this change in pain perception as an indicator to begin physical therapies focused on reduction and management of these now more localized pains. It is our clinical experience that a combination of therapeutic deep-tissue massage, various myofascial triggerpoint and release therapies, sEMG guided neuromuscular retraining, specific muscle stretching and strengthening exercises, and biomechanical and postural re-education will be effective in reducing pain and dysfunction in these patients once their pain experience has become localized again. Prior to EDS therapy, these patients’ experience of severe sleep disturbance, depressed and hyperirritable mood, significant cognitive clouding, and vague "all-over-body" pain simply fails to respond to physical therapies.

Relevant Further Reading

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