The National Library of Medicine’s Study on Myofascial Release Therapy
The National Library of Medicine, a National Center for Biotechnology Information, conducted a study which proved how significantly beneficial it is for patients with fibromyalgia (FMS) to undergo myofascial release therapy. The study shows how amazing this therapy is in improving pain, anxiety, quality of sleep, depression, and quality of life. The purpose of this study was to determine just that: the benefits of myofascial release therapy on pain, anxiety, quality of sleep, depression, and quality of life in patients with FMS.
The experimental group that received myofascial release therapy in the study showed significant improvements in physical function (), physical role (), body pain (), and social function () versus the baseline group that was placeboed into not receiving myofascial release therapy.
2.1. Study Design
An experimental group (FMS patients who received myofascial release therapy) with a baseline placebo group (FMS patients subjected to a sham protocol of magnotherapy) were used in the randomized controlled trial that was performed. January 1 2009 to January 31 2010 was the period of the study.
2.2. Setting and Patients
FMS was diagnosed in recruited patients (by clinicians who belong to the Almeria Fibromyalgia Association (AFIAL-Spain according to the criteria of the American College of Rheumatology) ). An FMS diagnosis of patients from ages 18 to 65 years (working age range), with no regular physical activity, and an agreement to attend evening therapy sessions, were the inclusion criteria that was required for the study. Nonagreement to study participation, receipt of other nonpharmacologic therapies, presence of hepatic, cardiac or renal insufficiency, cardiovascular event during the previous year, and presence of peripheral venous or arterial insufficiency, physical or psychological hypotension, infection, fever, disease, respiratory alterations limiting treatment application, skin integrity alterations, and failure to comply with prescribed pharmaceutical therapy , were all the exclusion criteria.
Due to incompatibility with their work schedule, 35 patients from the 231 accessible ones with a medical diagnosis of FMS couldn’t participate, and a randomization process was done with the remaining 196 in order to select a sample of 100 patients; the study inclusion criteria was not met by 36 of these 100, and an experimental () or placebo () group was randomly assigned to the remaining 64 by using sealed envelopes. The patients agreed to informed consent, so the ethical criteria established in the Helsinki Declaration, and modified in 2000 for research projects, was fulfilled. The current legislation for clinical trials in Spain is gathered in the Real Decreto 223/2004 of February 6. The University of Almeria’s Ethics and Research Committee gave its approval.
The instruments listed below were used to measure pain, anxiety, depression, quality of sleep, and quality of life.
A Visual Analog Scale (VAS) that assesses the pain intensity and degree of relief experienced by the patient (score of 0 = no pain; 10 = unbearable pain) was used to assess the pain. A pressure algometer (Wagner FPI 10-USA) exerting a pressure of 4 kg was used to assess the painful sensitive points. This instrument consists of a sphere, on which the pressure measurements (10 levels of 0.5 Kg each) are shown, with a rubber end for exertion of the pressure. They evaluated the 18 painful sensitive points that the American College of Rheumatology  describes. 0.56–0.88 for the measurement of the pain VAS  is the index of internal consistency.
The 40-item State-Trait Anxiety Inventory (STAI) determined the anxiety levels, measuring anxiety as a stable dimension of personality (trait or tendency to anxiety) and also including a state subscale to detect anxiety behaviors. In general, for the trait scale, subjects report how they feel at the moment of the completion of the questionnaire for the state anxiety scale. At a specific moment in time, the sensations or feelings of anxiety are indicated by the state anxiety scale (very much so, not at all, somewhat, moderately so, etc.). The frequency with which anxiety is experienced (almost never, sometimes, often, almost always) is indicated in the trait anxiety scale. The following four factors related to the absence or presence of anxiety in each scale were identified by factorial analyses: the absence of state anxiety, presence of state anxiety, absence of trait anxiety, and the presence of trait anxiety. For the measurement of state anxiety, the index of internal consistency is 0.90–0.93 and 0.84–0.91 is for trait anxiety .
The Beck Depression Inventory (BDI), a self-applied 21-item questionnaire that assesses a wide spectrum of depressive symptoms, determined the state of depression. The cognitive components of depression are what it focuses on, thereby representing approximately 50% of the total questionnaire score. 6 of the 21 items refer to somatic-vegetative symptoms and the remaining 15 to ecological-cognitive symptoms; each item has four response options in order of increasing symptom severity . Rather than yield a diagnosis, the aim of the questionnaire is to quantify symptoms. 0 to 63 points is the range of the total questionnaire score, with the usual classifications being the following: no depression: 0–9 points; mild depression: 10–18 points; moderate depression: 19–29 points; severe depression: 30-63 points. The reliability of Chronbach’s alpha coefficient is 0.82  and the BDI is 0.65–0.72.
To study the quality of sleep, the Pittsburgh Quality of Sleep Index Questionnaire (PSQI) was the one used, which is comprised of 24 items; 19 of these items are for the patient-subject to respond to, and the remaining 5 are for someone living in the same place to respond to. On each of seven components of sleep quality, scores are obtained: subjective quality, sleep perturbations, sleep latency, sleep duration, habitual sleep efficiency, daily dysfunction, and use of hypnotic medication. Each component is scored from 0 to 3 (0 = no problems; 3 = severe problems). Hence, ranging from 0 to 21, you get the total score (adding component scores). 0.78 [28, 29] is the reliability coefficient of the PSQI.
Quality of life was assessed with the 36-item SF-36 Quality of Life Questionnaire on functional state, emotional well-being, and general health. Functional state is represented by the dimensions of physical function (10 items), social function (2 items), role limitations due to physical problems (4 items), and role limitations due to emotional problems (3 items). Emotional well-being includes mental health (5 items), vitality (4 items), and pain (2 items). Finally, perception of general health (5 items) and changes in health over time (1 item, not included in the final score) were assessed. For each dimension of the SF-36, items were codified, aggregated, and transformed into a scale ranging from 0 (worst health status) to 100 (optimal health status). Thus, a higher score in the different dimensions indicates a better health status and/or quality of life. The Chronbach’s alpha coefficient for this questionnaire is 0.78–0.96 .
The experimental group was formed by 30 patients and the control group by 29. In all subjects, pain, anxiety, depression, quality of sleep, and quality of life scores were determined before (baseline) and immediately after the 20-week intervention and again at one month and 6 months.
The experimental group underwent a protocol of myofascial release therapy during a weekly 90-minute session for 20 weeks. The treatment was applied by a physiotherapist specialized in myofascial release therapy and aimed to release myofascial restrictions at the sites of the 18 painful points reported by the American College of Rheumatology. The protocol was as follows: myofascial release at insertion of the temporal muscle, release of falx cerebri by frontal lift, release of tentorium cerebelli by synchronization of temporals, assisted release of cervical fascia, release of anterior thoracic wall, release of pectoral region, lumbosacral decompression, release of gluteal fascia, transversal sliding of wrist flexors and fingers, and release of quadriceps fascia .
The placebo group underwent a weekly 30-minute session of disconnected magnetotherapy for 20 weeks. With the patient in a prone position, magnotherapy was applied on the cervical area (15 min) and lumbar area (15 min). Placebo group patients were unaware that they were receiving a sham treatment.
2.5. Data Analysis
SPSS version 18.0 was used for the data analyses. After a descriptive study of the demographic variables, the normal distribution of variables was examined by means of the Kolmogorov-Smirnov test. We calculated an imputed score for standardized scales missing ≤10% of responses. Independent t-tests were used to compare baseline demographic characteristics between participants and drop-outs and between the experimental and placebo groups (randomization test).
Changes in scores for anxiety, pain, depression, and quality of life were analyzed by using a 2 (Groups: experimental and placebo) ×4 (Time points: baseline, immediately post-intervention, at 1 and 6 months) repeated-measures analysis of variance (ANOVA). A Student’s t-test for paired measures was used to determine the effectiveness of treatments. Differences between study groups were analyzed with a Student’s t-test for independent samples and was considered significant in all tests.
Out of the sixty-four patients enrolled in the study, two were lost from the experimental group for starting another treatment and three dropped out of the control group due to family and personal problems (Figure 1). Therefore, the study was completed by 30 patients in the experimental group and 29 in the control group. At baseline, the two groups did not significantly differ in: demographic characteristics (Table 1), mean VAS score for pain (), trait anxiety (), state anxiety (), BDI (), sensitive points, any SF-36 dimension except for emotional role (), or any dimension of the PSQI except for sleep duration .
3.1. Immediately after 20-Week Intervention
Post Intervention, the experimental group showed a significant improvement in VAS score for pain (,) versus baseline and in comparison to the control group (Figure 2). There were significant reductions in sensitive points as measured by pressure algometer at left lower cervicals (), right gluteal muscle (), left gluteal muscle () and right greater trochanter (). No changes were observed in the placebo group. Tables 2 and 3 show the significant differences between the groups.
Comparison between study groups in levels of depression, anxiety, and pain. Values are presented as means with errors bars.
The experimental group also showed a significant improvement in trait anxiety () versus baseline and in comparison to the placebo group. There were no differences in state anxiety or BDI versus baseline or between groups (Figure 2). Among the SF-36 dimensions, the experimental group showed significant improvements in physical function (), physical role (), body pain (), and social function () versus baseline. Table 4 shows the significant differences between groups. No changes were observed in the placebo group. The experimental group showed a significant improvement versus baseline in sleep latency () and sleep duration () in the PSQI, while no changes were observed in the placebo group. Table 5 shows the significant differences between the groups.
3.2. One Month Post-Intervention
One month post-intervention, the experimental group showed a significant improvement in VAS score for pain () versus baseline and in comparison to the control group (Figure 2) and a significant reduction versus baseline in painful sensitive points at left lower cervicals (), right gluteal muscle (), and right greater trochanter (). No changes were observed in the placebo group.
The experimental group showed a significant improvement in trait anxiety () but no significant differences were found between groups (Figure 2). No differences were observed in BDI score versus baseline or between groups. For the SF-36 dimensions, there were significant improvements in physical function (), while no changes were observed in the placebo group. Table 4 shows the significant differences between the groups. For the PSQI items, the experimental group showed a significant improvement in sleep duration versus baseline (), while no changes were observed in the placebo group. Table 6 shows the significant differences between groups. In the experimental group, repeated-measures ANOVA showed a significant time × groups interaction for: VAS score for pain (; ), trait anxiety (; ), physical function (; ), physical role (; ), and body pain (; ) dimensions of the SF-36.
3.3. Six Months Post-Intervention
At 6 months post-intervention, the experimental group showed a significant improvement versus baseline () in sleep duration (PSQI) and for a tender point at right greater trochanter (). Tables 3 and 6 show the significant differences between the groups. No changes were found in the placebo group.
In this study, a 20-week myofascial release therapy program significantly improved the pain, anxiety, quality of sleep, and quality of life in FMS patients. The treatment reduced the sensitivity to pain at sensitive points, mainly at the lower cervicals, gluteal muscles, and right greater trochanter.
Fascial entrapment patterns can appear when a body segment stops receiving appropriate stimuli, establishing a pathological process with deficient circulation and limitation in nutrient supply to the fundamental substance of connective tissue, with its consequent densification. Because dense tissue is hypomobile, this situation leads to movement limitations . Fat accumulation is therefore favored in the affected body segment, altering the properties of the connective tissue and perpetuating the dysfunction if not corrected. Areas of myofascial entrapment are highly sensitive and painful to all type of stimuli .
In the present study, myofascial release therapy produced no changes in BDI scores. A follow-up period of more than six months is probably necessary for a more exhaustive analysis of the bidirectional relationship between pain and depression in FMS. The presence of depression may facilitate the expression of active trigger points and vice versa [17, 18]. Multidisciplinary approaches have achieved significant improvements in depression in FMS patients, attributed to the synergistic action of the different therapies against pain [33–37]. The comorbidity of pain and depression may be linked to central sensitization, in that the persistence of chronic pain and depression may indicate a common pathogenic mechanism attributable to alterations of the hypothalamus-hypophyseal-adrenal axis .
The significant improvements in SF-36 dimensions, physical function, and body pain observed after myofascial release therapy were also reported after aerobic exercise and multidisciplinary interventions in FMS patients [39–44]. These studies underlined the importance of motivation and reinforcement through health education to reduce body pain and improve quality of life perception. We could find no published reports of a significant improvement in state anxiety through the application of manual therapy alone, and this was also true in the present study. However, a multimodal approach has yielded improvements in state anxiety levels [45, 46], which may be explained by their positive impact on psycho-emotional factors . Anxiety and stress can affect proteoglycan synthesis and metabolism, hence interfering with the mechanical properties of connective tissue. If perpetuation of this phenomenon is combined with immobility phenomenon, fascial entrapment areas appear, triggering the emergence of painful points . The improvements obtained in the PSQI by applying myofascial release therapy were similar to those obtained by the manipulation of conjunctive tissue . The release of fascial restrictions, correcting visceral fascial dysfunction at intestinal level, may facilitate sleep by favoring the secretion of serotonin by platelets. A large number of these patients have intestinal problems or diseases, which may be due to neuroendocrine disorders that can affect serotonin secretion .
One study limitation is the exclusion of 35 of the 231 eligible participants due to incompatibility with their work schedules. A further limitation is that patients with less severe pain may have been able to improve more rapidly.
This study demonstrated that myofascial release therapy reduces the sensitivity to pain at tender points in patients with fibromyalgia, improving their pain perception. The physical role, sleep quality, and physical function are all improved in these patients and their anxiety levels are also reduced, all by the release of fascial restrictions in them. Myofascial release therapy is an alternative and complementary therapy that achieves transient improvements in the symptoms of these patients.
6. On the House Advice and Recommendation
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