Fibromyalgia (FM) is a chronic musculoskeletal disease of unknown aetiology and is characterised by pain diffused throughout the body and hyperalgesia. Patients with FM also have functional and emotional disorders, including persistent fatigue, sleep disturbances, paresthesia, cognitive disorders, and mood disturbance [1
]. Until 2016, the diagnostic criteria for fibromyalgia included the assessment of pain at 19 sites and a 4-item symptom severity scale from which an overall fibromyalgia severity score, the polysymptomatic distress (PSD) scale, could be calculated [2
]. In 2016, a modification added a widespread pain criterion and clarified scoring (2016 criteria) [3
]. The new criteria for diagnosis combines the concept of generalised chronic pain (such as a generalised pain index covering 19 regions) with the presence of an additional measure for fatigue, sleep, cognitive symptoms, mood symptoms, and other sources of pain. The symptom severity score and the combination of the generalised pain index provides a maximum score of 31. For diagnosis, patients should score a minimum of 3 or higher on the generalised pain index, with a total score of 12 when combined with the symptom severity score [3
]. Studies have found prevalence lower than 1% in Denmark, 2% in Spain, and an estimated 2% to 3.3% in North America [4
]. Generally, it is believed that FM affects between 2% and 4% of the world’s population, and the prevalence is higher among women aged between 50 to 80 years, reaching 7% [5
In the absence of definitive pathology, the critical aspect for evaluating FM patients relies upon patients to report the presence and degree of symptoms [6
]. Because of the symptoms, it has been observed [7
] that FM can affect daily functioning, both physically and psychologically.
While fatigue is a common complaint for individuals with fibromyalgia, pain is the defining characteristic for diagnosing it [9
]. One of the most challenging aspects of fibromyalgia is the variable nature of pain. It can be associated with morning stiffness as well as increasing pain throughout the day [6
]. Patients with fibromyalgia exhibit dysregulated functioning of the hypothalamus–pituitary–adrenal–cortex axis [11
] and central sensitisation [12
], which leads to increased pain sensitivity. Pain in individuals with fibromyalgia has been associated with greater disease severity, reduced function, and symptoms of fibromyalgia [13
]. Thus, pain is a significant symptom that may affect physical functioning.
Poor sleep is reported by almost 80% of patients with fibromyalgia [11
]. Epidemiological studies indicate that lower sleep quality is a risk factor for fibromyalgia; poor sleep is strongly and dose-dependently associated with symptom severity [14
] in the fibromyalgia population. As part of the American College of Rheumatology (ACR) 2010 diagnostic criteria for fibromyalgia, “waking unrefreshed” is one of the symptoms [11
]. There are interactions between sleep disorders, neuroendocrine and immune disorders, and clinical symptoms present in FM. Therefore, sleep disturbances can be both a cause and a consequence of FM [16
]. Poor sleep quality and pain can have a significant impact on the overall quality of life of FM patients [11
]. It has been seen that quality of sleep can be an important mediator of the relationship between pain, distress, emotional functioning [14
], and anxiety [17
]. Some authors point out that pain by itself does not directly produce emotional distress [14
Anxiety, which is a key symptom in fibromyalgia, is associated with higher levels of pain and neuropsychological disorders in these patients [18
]. It is also associated with higher fibromyalgia impact, and patients with high levels of anxiety usually present an increased risk of severe fibromyalgia. Some research suggests that the prevalence of depressive and anxiety disorders in FM patients is significantly higher compared to the prevalence in the general population; this prevalence is 20–80% and 13–63.8% of cases, respectively [19
Severe anxiety and/or depression can impede the ability to comply with nonpharmacological therapy, which is why interactions with chronic pain and fatigue can become cyclical and self-perpetuating. In FM, it is known that a negative mood can lead to a poor perception of physical health [20
]. Depression can increase the perception of pain, producing a vicious cycle of depression/pain/depression [21
The complex symptomatology of FM mainly involves three areas: aspects of physical health (musculoskeletal system), pain regulation mechanisms (neuroendocrine system), and factors related to psychological well-being and mental health [22
]. Despite the fact that in recent years some studies have explored the complex relationships between the different aspects and symptoms of the disease [14
], it is still necessary to deepen both the explanatory mechanisms that affect its severity and the most appropriate treatments to minimize its main symptoms. According to clinical practice guidelines, there are various forms of treatment for FM, from patient education, drug treatment, physical therapy, and psychology, to some alternative therapies such as yoga, taichi, or acupuncture [24
]. In most patients, a multidisciplinary approach, combining nonpharmacological and pharmacological treatments, is needed [17
Randomised controlled trials have shown that multiple nonpharmacological treatments such as psychotherapy, exercise therapy, education, and physiotherapy are effective in the reduction of FM symptoms [24
]. The main causes for patients to seek medical care are musculoskeletal pain and sleep disorders [25
]. Patients often seek relief from their symptoms [26
]. Physical exercise treatment has been shown to show promising results for this population [27
Manual therapy has been defined in different ways, one of them as the manipulation of soft tissues and joints using the hands and another as the systematic mapping of soft tissue with rhythmic pressure to prevent, develop, maintain, rehabilitate, or increase physical function or relieve pain [28
]. In physiotherapeutic practise, manual therapy plays an important role in the treatment of patients with musculoskeletal disorders. Chronic back pain, migraines, anxiety, hypertension, depression, and many other physical and psychological conditions have been shown to respond positively to manual therapy [29
]. Connective tissue massage is considered an important element of manual therapy, dealing with the skin and subcutaneous tissue. However, most of the literature reports the beneficial effects of manual therapy on healthy people and there are very few studies that report these effects in FM patients.
Despite this, Cimmino et al. has observed that massage is the therapeutic modality used by 75% of patients with fibromyalgia [30
]. However, there is only moderate evidence (level B) to recommend this therapy for FM patients because the massage can be extremely painful; however, many of the patients prefer it because the benefits reward them later. According to Roberts [29
], the intensity of the massage should be moderate to save excessive pain and be beneficial.
The application of different types of massage in FM patients, including connective tissue massage, has benefits in terms of improving FM symptoms, especially pain, anxiety, and depression [31
], however Swedish massage is not recommended for FM patients [31
]. Connective tissue in patients with chronic inflammation becomes dense [32
]. Therefore, in the present study, we wanted to study the effect of moderate pressure massage on the dense connective tissue at the back of the neck and not Swedish massage. Ekici et al. [33
] also support the application of connective tissue massage, among other manual therapies, and conclude that they improve pain, health status, and quality of life, so it could be used in the treatment of FM patients.
Furthermore, with the intention to improve knowledge about FM symptoms and its management, the aim of the study was to assess the effectiveness of a manual therapy technique performed with moderate digital pressure in FM patients on the variables of fatigue, pain, sleep, anxiety, and mood. This was done to provide another alternative treatment to pharmacological therapies for FM patients and to provide new evidence on the effects of manual therapy in FM patients.
Thirty-six women were recruited for the present study and 36 were assessed for eligibility. Of these, four did not meet the inclusion criteria, one declined to participate, and another did not want to participate for other reasons, leaving 30 participants who were randomly allocated into the manual therapy group (MTG) and placebo group (PG). Over the follow-up period, six participants withdrew from the trial, one from the MTG and five from the PG. Therefore, 24 women were included in the analysis. Both groups of women did not differ on demographic variables. All withdrawals were due to personal reasons (Figure 1
shows descriptive statistics before and after the intervention, as well as the baseline comparison between groups (basal and post-intervention). It can be observed that the general sample presented homogeneous values at the initial assessment, with the exception of the fatigue variable (mean differences, MD: 0.9, p
presents the summary statistics of the ANCOVA analysis. The main analysis of the present study shows that there was a significant training × group difference (p
< 0.001; η2
= 0.093) in the pain scale. The post hoc analysis showed a decrease between pre- and post-intervention in the manual therapy group (MD: 4.223, p
< 0.001, ES: 2.072). In addition, inter-group differences were found (Figure 2
) after the intervention (MD: 2.9, p
= 0.044, ES: 0.593) in favour of the manual therapy group. However, no significant effects were found in any other variable.
The analysis of the correlations between all participants and each variable are shown in Table 3
. A significant positive correlation was observed between fatigue and sleep (R = 0.411; p
= 0.046). A significant positive association was also observed between the pain variable and the anger–hostility subscale of the POMS (R = 0.436; p
= 0.033). Except the significant associations between the POMS questionnaire and its own subscales, significant correlations between variables were not identified.
The aim of this study was to analyse the effectiveness of a manual therapy performed with moderate pressure on the variables of muscle fatigue, pain, sleep, and mood state in women with fibromyalgia. The effectiveness of a manual therapy in healthy people seems evident [35
], however the literature shows little evidence of the effects of manual therapy in relation to the most characteristic symptoms suffered by FM patients [26
]. Now, conclusions can be drawn on what the characteristics of manual therapy should be for FM patients—painless, progressive, and the intensity should gradually increase [26
] from session to session depending on the patient’s symptoms. It has been observed [29
] that the therapeutic benefit is greater than a direct deep application without any kind of light pre-pressure as a warm-up.
In terms of the benefits of manual therapy for patients, it promotes restful sleep, decreases anxiety and depression, and reduces the immediate and delayed perception of pain [25
]. Regarding number of sessions, it is suggested to do at least 1–2 times per week [26
], although the reason why this should be 2 and not a greater or lesser number of sessions is not clear.
It seems necessary to provide conclusive data to allow the use of manual therapy by health professionals as an alternative technique to other treatments with greater disadvantages such as drug treatments [49
]. This research provides new insight into the use of manual therapy in FM; the treatment area. The manual therapy was carried out in the sensitive points of diagnosis, corresponding to the cervical area, where the patients experienced more pain. As in other investigations, a vibration manual therapy [51
] was carried out with the fingertips, with moderate pressure [54
] on the sensitive diagnostic points corresponding to the cervical area [55
] for 15 min, twice a week for 4 weeks [26
]. Moderate pressure is able to stimulate pressure receptors, which will lead to an increased vagal activity which seems to mediate the various benefits observed for manual therapy [56
It is necessary to emphasise the importance of performing the massage with moderate pressure as described in the methodology and also to reach this pressure in an increasing way, as recommended by other authors [29
]. The significant result of this study may be thought to be related to the pressure applied in the massage. Other studies where its application is not recommended, because of its moderately positive results, refer to the unpleasant pain that was experienced by the subjects due to the massage [57
]. In the same direction as the results of our work, in the study carried out by Oliveira et al. [58
], the effects of a massage therapy programme on cortisol concentration, pain intensity, quality of life, and perceived stress index of fibromyalgia patients were investigated. Subjects were treated with massage twice a week for three months. They suggest that the treatment improved quality of life, reduced the index of perceived stress, and reduced pain in these volunteers [58
Based on the results of the FSS, the state of fatigue was not significantly reduced after the intervention. Fatigue is a factor that can be associated with morning stiffness [59
]. The current limited number of treatment options for fatigue in FM patients has contributed to the increased level of disability in patients without apparent medical explanation [7
]. In previous research, different methods have been used to measure muscle fatigue [9
], for example, by examining static contractions of a single muscle in the upper or lower limb or by performing simultaneous contractions of several muscles. It has been observed that people with fibromyalgia have less muscle strength and voluntary resistance than sedentary controls [9
]. This is why some people with fibromyalgia perceive a higher level of fatigue during activities of daily living (e.g., folding clothes, drying hair, or dressing). Therefore, it is suggested that the effect of moderate pressure manual therapy on the posterior cervical muscles does not seem helpful in improving the performance of household tasks due to the significant effect found for the reduction of fatigue.
One of the main reasons why FM patients seek medical care is musculoskeletal pain, along with sleep disorders [25
]. As observed in the present study, after the intervention, pain decreased significantly based on the EVA scale. Other research [35
] has also concluded that manual therapy is effective in improving health by reducing chronic back pain, migraines, and many other physical and psychological conditions in healthy patients. This clinical research is very helpful for understanding the benefits of manual therapy and accepting the technique as a treatment modality among health professionals [35
]. More evidence is needed for FM patients to choose nonpharmacological treatments [60
]. As previously observed, chronic neck pain is an unpleasant sensory experience that can have a negative psychological impact [62
]. Patients with chronic neck pain experienced sleep deprivation, even when taking analgesics. Further, poor sleep quality is known to precede the onset of a depressed mood [63
]. Therefore, it is suggested that if patients have experienced improvements in lower neck pain with massage therapy, they will also have experienced improvements in sleeping disorders.
Although manual therapy has been shown to promote restful sleep in FM patients [26
], no significant results were obtained in the present study. Variables such as sleep and mood in the experimental group were positive but not significant. The systematic review by Choy [17
] and others [16
] suggests that exercise, cognitive behavioral therapy, and balneotherapy may improve sleep, but the data are low-quality evidence. Future research should determine the benefits of each of these treatments and evaluate their cost-effectiveness.
Persons with chronic pain are more likely to have depressive symptoms than those without pain [64
]. FM patients who have a negative mood may have a poor perception of health [20
]. This may be because psychosocial factors are known as risk factors for neck pain [65
], and Blozik et al. [66
] suggests depression and anxiety as major determinants of neck pain. Although this cannot be justified by the results obtained for mood state variables, future research will need to evaluate this adaptation because it is estimated that mood disorders are more than three times higher in FM subjects than in the general population [60
Limitations of this study include the small sample size and the short-term assessment. In addition, while all attempts were made to standardize the delivery of the massage routine provided in this study, we did not control for the amount of pressure provided. This would be an important consideration for future studies, given that there is evidence that different amounts of pressure can elicit unique responses [35
]. In other studies [35
], the force applied by the therapist’s fingers was measured with ConTact type C500 sensors (Pressure Profile Systems, Los Angeles, CA, USA), which were pre-molded to fit the fingers of the massaging therapist and were fixed using latex cradles. The force data were collected with an imaging test, specifically electromyography. With this test, a digital pressure of 100 Hz was determined for the analysis. In addition, the scales of evaluation variables were self-reported measures, not objective measurements. It has not been possible to monitor directly with heart rate variability or muscle relaxation recording devices; therefore, this may have some influence on the final result. In addition, the impossibility of generalizing the results to the FM population should also be considered because the study included no men and the sample size is not a representation of the whole Spanish population with FM. Further, it has not been possible to control the duration of the disease and compare the efficacy of this type of therapy with other non-pharmacological ones. Finally, new lines of research are needed to shed more light on whether the benefits of manual therapy in FM patients could be sustained over time after treatment or whether they are only short-term benefits.