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Clinical Rehabilitation 2011; 25: 25–35 A randomized controlled trial investigating the effects ofcraniosacral therapy on pain and heart rate variability infibromyalgia patients Adelaida Marı´a Castro-Sa´nchez Department of Nursing and Physical Therapy, University of Almerı´a,Guillermo A Matara´n-Pen˜arrocha Health District Ma´laga Norte, Malaga, Nuria Sa´nchez-Labraca Department of Nursingand Physical Therapy, University of Almerı´a, Jose´ Manuel Quesada-Rubio Department of Statistics, University of Granada,Jose´ Granero-Molina Department of Nursing and Physical Therapy, University of Almerı´a and Carmen Moreno-LorenzoDepartment of Physical Therapy, University of Granada, Spain Received 9th February 2010; returned for revisions 10th April 2010; revised manuscript accepted 16th April 2010.
Context: Fibromyalgia is a prevalent musculoskeletal disorder associated withwidespread mechanical tenderness, fatigue, non-refreshing sleep, depressed moodand pervasive dysfunction of the autonomic nervous system: tachycardia, posturalintolerance, Raynaud’s phenomenon and diarrhoea.
Objective: To determine the effects of craniosacral therapy on sensitive tenderpoints and heart rate variability in patients with fibromyalgia.
Design: A randomized controlled trial.
Subjects: Ninety-two patients with fibromyalgia were randomly assigned to anintervention group or placebo group.
Interventions: Patients received treatments for 20 weeks. The intervention groupunderwent a craniosacral therapy protocol and the placebo group received shamtreatment with disconnected magnetotherapy equipment.
Main measures: Pain intensity levels were determined by evaluating tender points,and heart rate variability was recorded by 24-hour Holter monitoring.
Results: After 20 weeks of treatment, the intervention group showed significantreduction in pain at 13 of the 18 tender points (P50.05). Significant differencesin temporal standard deviation of RR segments, root mean square deviation oftemporal standard deviation of RR segments and clinical global impression ofimprovement versus baseline values were observed in the intervention group butnot in the placebo group. At two months and one year post therapy, the interven-tion group showed significant differences versus baseline in tender points at leftocciput, left-side lower cervical, left epicondyle and left greater trochanter andsignificant differences in temporal standard deviation of RR segments, root meansquare deviation of temporal standard deviation of RR segments and clinical globalimpression of improvement.
Conclusion: Craniosacral therapy improved medium-term pain symptoms inpatients with fibromyalgia.
Address for correspondence: AM Castro-Sa´nchez, Carretera deSacramento s/n, Departamento de Enfermerı´a y Fisioterapia,Universidad de Almerı´a, 04120 Almerı´a, Spain.
e-mail: [email protected] ß The Author(s), 2011.
Reprints and permissions: http://www.sagepub.co.uk/journalsPermissions.nav Thus, Vaeroy et al.13 and Elam et al.14 reporteda lower peripheral sympathetic response to acous-tic stimulation, cooling and muscle contraction in In fibromyalgia, the perception of pain is known fibromyalgia patients than in healthy controls.
to be related to modifications in the central nervous system that result in the amplification of reported to produce significant improvements in nociceptive impulses.1–3 This phenomenon, known pain intensity and range of movement in fibromy- as ‘central sensitization’, has been attributed to algia patients.15–19 The technique known as cra- neuronal synaptic plasticity in response to previ- niosacral therapy is based on a study by Hack ous pain episodes. Differences in the degree of cen- et al.,20 who reported that the rectus capitis poste- tral sensitization would explain the variations in rior minor muscle of the head was bound to the dura mater at the atlanto-occipital joint, with a patients.1–3 The four main sites in the pain system that are potentially susceptible to modifi- between the two structures. It was subsequently cation are peripheral tissue, brain, descending reported that lesions or stress affecting this con- nection may be a potentially important factor in It has not been scientifically demonstrated that the onset of chronic pain, among other symptoms.
pain is generated solely by upper areas of cortical Thus, a dysfunction in the rectus capitis posterior activity.4 In fibromyalgia, abnormal levels of sub- minor muscle triggers a central sensitization phe- stance P and serotonin in brain and in spinal cord nomenon that promotes hypertonia in paraverteb- at nerve root level produce abnormalities in neu- roendocrine and nociceptive functions that can Various studies have demonstrated the efficacy cause sleep disruption, enhanced pain perception of alternatives and complementary therapies to Both fibromyalgia and chronic fatigue syn- However, we could find no studies that address drome appear to be associated with alterations in the effects of craniosacral therapy in tender autonomic function.6,7 The most common forms points and heart rate variability. The purpose of of dysautonomia, observed in one-third of fibro- this investigation, therefore, was to assess the ther- myalgia patients, are neuromediated hypotension apeutic effects of craniosacral therapy on tender and orthostatic tachycardia syndrome. Patients points and heart rate variability in these patients.
have an exaggerated increase in heart rate in We hypothesized that craniosacral therapy would response to exercise.8 Dysautonomia is often asso- ciated with intense fatigue. A study using heartrate variability analysis and head-upright tilttable test demonstrated that autonomic nervoussystem dysfunction is frequent in patients with fibromyalgia and that dysautonomia may play acentral role in the pathogenesis of this disease.
The present investigation was a randomized con- Hence, fibromyalgia may be a pain syndrome trolled trial. A sample of 135 patients was selected that is maintained by the sympathetic nervous by non-probabilistic accidental sampling from system.9,10 Researchers using 24-hour Holter mon- among all patients with fibromyalgia (n ¼ 250) itoring to study the circadian behaviour of the autonomic nervous system reported sympathetic Torrecardenas Hospital (Almeria, Spain) who hyperactivity in fibromyalgia patients throughout were receiving protocolized pharmacological treat- the 24-hour period.11 Dysautonomia, used here to ment. Figure 1 depicts the recruitment process.
describe a sympathetic nervous system that is per- Study inclusion criteria were diagnosis of fibromy- sistently hyperactive but at the same time hypor- algia, age of 16–65 years, and signing of informed eactive to stress, is detected in fibromyalgia consent to study participation. Exclusion criteria patients by means of heart rate variability analysis were impaired skin integrity, the practice of any type of regular physical exercise or receipt of any Craniosacral therapy in fibromyalgia patients Total number of patients that potentially could have been recruited (N = 135) Did not meet inclusion criteria (n = 26)Refused to participate (n = 17) Allocated to intervention (n = 46) Allocated to intervention (n = 46) Received allocated intervention (n = 46) Received allocated intervention (n = 46) Flow of patients who participated in the study. None of the 92 randomized patients withdrew because of other non-pharmacological therapies. The study appearing three times (AAABBB, ABABAB, etc.).
was approved by the University of Almeria The sequences assigned to patients were placed in envelopes containing the allocation to each study The final study group of 92 patients (aged 16–65 years) were assigned by a balanced stratified Before application of therapeutic protocol, random assignment method to an intervention baseline data were gathered on pain intensity and group for craniosacral therapy (n ¼ 46 females) heart rate variability. Twice a week for 20 weeks, or a placebo group for sham treatment with dis- the intervention group received a 1-hour session of craniosacral therapy and the placebo group females). Stratified balanced randomization was received a sham treatment protocol with discon- performed to guarantee balance between the nected magnetotherapy equipment on cervical groups in the type of medication they were receiv- ing. The groups were balanced for type of medica- region). A second assessment of the seven vari- tion received, using a stratification system that ables was performed immediately after the final generates a sequence of letters for each combina- treatment session. A third and fourth assessment tion of categories. Sequences were derived from a was performed at two months and 1 year.
table of correlatively ordered permutations of the Craniosacral and magnetotherapy therapists and letters A and B in groups of six, with each letter allocation, although the patients were not aware upper outer quadrant at anterior fold of muscle; that one was a sham treatment. Pain intensity and (14) left gluteal muscle at same localization; (15) heart rate variability were evaluated by a blinded right greater trochanter of the femur, a bony assessor, who did not know whether patients prominence in which piriformis muscles are belonged to the intervention or placebo group.
inserted; (16) left greater trochanter at the same Room temperature was always maintained at localization; (17) right knee at subcutaneous 29.8–34.5C and relative humidity at 39–42% tissue of internal portion above the knee joint line; (18) left knee at same localization.
Scientific Ltd, Maidenhead, UK). In order tocontrol for any seasonal bias, interventions werecarried out in all seasons from 15 April 2006 to15 March 2008.
These were obtained with two recording chan- nels and five Red Dot monitoring electrodes. A Holter device (Rozinn Digital Holter Model RZ153) was used to record the analogue signal (10 bits) over 24 hours. Sampling range was 128 samples and the frequency response filter was esti- attaching electrodes to hands and feet and measur- mated to be between 0.05 and 60 Hz. Electrodes ing the resistance of body tissues to an electrical were attached as follows: channel 1 (À), at right border of the sternal manubrium; channel 1 (þ), at axillary anterior line of sixth left rib; channel 2 (À), at left border of sternal manubrium; channel2 (þ), approximately 1 cm to right of the xyphoidapophysis; and earth channel, at right floating ribson the bony part.
Tender point evaluation (pressure algometry) Pain was assessed at 18 tender point sites in Rheumatology recommendations27 by using aWagner FPI 10 pressure algometer (pressures QRS complexes and deviations from RR intervals from 0.5 to 5 kg at 10 0.5-kg intervals). Sites These were determined by using the Holter com- were as follows: (1) right occiput, posteroinferior puter application. Spectral analysis of RR interval region of head at insertion of right occipital mus- variability was carried out to identify dominating culature; (2) left occiput, posteroinferior region of frequencies in the heart rate variability analysis.
head at insertion of left occipital musculature;(3) right-side lower cervical at anterior aspects ofintertransversal spaces between fifth (C5) and sev-enth (C7) cervical vertebrae; (4) left-side lower cer- vical at same localizations; (5) right trapezius The severity of the patient’s physical condition muscle at midpoint of upper border; (6) left trape- was evaluated by a single researcher (GMP) on zius muscle at same localization; (7) right supras- a Likert scale ranging from level 1 (absence of pinatus muscle at its origin in the upper region of the scapula near internal border; (8) left supraspi-natus muscle at same localization; (9) second rightrib at closest point to the sternum; (10) second leftrib at same localization; (11) right lateral epicon- Clinical global impression of improvement dyle at the humeral bone bridge where forearm The improvement perceived by the patient was extensor muscles begin; (12) left lateral epicondyle assessed on a Likert scale ranging from level 1 at same localization; (13) right gluteal muscle, in (very much improved) to level 7 (extremely ill).28 Craniosacral therapy in fibromyalgia patients Three experimental factors were considered: group factor, with two components (craniosacral therapy Craniosacral therapy is a manual therapeutic group and sham therapy group); time factor, with method to assess and treat problems affecting the four components (baseline time, immediate post- craniosacral system.22,24,25 The rhythm of the cra- therapy, two months post therapy and one year niosacral system can be considered similar to that post therapy) and individual factor (46 in placebo of the cardiovascular and respiratory systems, group and 46 in intervention group). The group among other rhythmic systems. Palpation methods and time factors had fixed crossed effects, while can be used for functional observations and for the the individual factor had randomized effects treatment of dysfunctions. The most accessible areas of this system are the cranial bones, Treatment efficacy was analysed by using a sacrum and coccyx, since these are associated t-test for paired samples. Independent t-tests with membranes containing cerebrospinal fluid.
were applied to baseline scores to determine This liquid is generated and reabsorbed within the system, producing a palpable rhythm with a adequately controlled for baseline demographic frequency of 6–12 cycles/min and providing a differences. Changes in variables within each dynamic communication cycle within a semi- group were measured using the paired t-test for closed hydraulic system. Information on the state independent samples. The Pearson correlation of the craniosacral system can be obtained by pal- coefficient was applied to establish correlations pitating the frequency, fullness, symmetry and among variables. Data were stored in a database quality of the craniosacral rhythm. Evaluation constructed with SPSS for Windows version 17.0 and treatment of the craniosacral system is achieved by means of very light lifting or tractionforce Treatment is aimed at removing the restrictive obstacle and returning the system to its naturalstate.22 The craniosacral therapy protocol in this study established the following sequence of manip- Out of 135 candidate patients, 109 were selected ulative therapy24,25: still point (in feet), pelvic dia- for the study (105 women, 4 men), aged 38–64 phragm release, scapular girdle release, frontal lift, (mean age: 52.532 Æ 11.658 years old). Seventeen parietal lift, compression–decompression of sphe- patients withdrew from the study before random- ized assignation, yielding a final study sample of fascia, compression–decompression of temporo- 92 patients (Figure 1). Demographic characteris- mandibular joint and evaluation of dural tube tics are shown in Table 1. Baseline characteristics were similar between the intervention and placebogroups except in the temporal standard deviationof RR segments (P50.024) and root mean squaredeviation of temporal standard deviation of RR segments (P50.049) (Table 2). The number of ten- der points did not significantly differ (P50.178) Levene test, obtaining a 95% confidence level between the intervention (650) and placebo (641) and P-value40.05 and confirming variance equal- groups. No significant intragroup differences in ity. After performing descriptive statistics of body composition were detected in any of the variables at baseline, the normal distribution of four analyses performed during the study, and variables was determined using the Kolmogorov– no significant differences in body composition Smirnov test, expressing continuous data as means were found between the study groups at any time with standard deviation (SD) in the text and point (baseline: cellular mass P50.889, extracellu- lar mass P50.840, lean mass P50.424; 20 weeks: Temporal changes in the scores were examined by using a two-way repeated measures ANOVA.
P50.816, lean mass P50.416; 2 months: cellular Demographic characteristics of the groups P-value 50.05 (95% confidence interval).
mass P50.885, extracellular mass P50.833, lean mass P50.427; 1 year: cellular mass P50.732, extracellular mass P50.829, lean mass P50.532) At baseline, significant correlations were found (Pearson correlation coefficient) in the presence of tender points between right and left supraspinatus muscles (r ¼ 0.381; P ¼ 0.015), right and left trape- zius muscles (r ¼ 0.625; P ¼ 0.006), right and left left lower cervicals (r ¼ 0.512; P ¼ 0.008).
Results immediately after 20 weeks of therapy Pressure algometry analyses showed significant reductions in the number of tender points in the intervention group versus placebo group in the right occiput (P50.044), left occiput (P50.035), right-side lower cervical (P50.035), left-side lower (P50.018), left trapezius muscle (P50.040), second rib (P50.040), right lateral epicondyle (P50.017), left lateral epicondyle (P50.023), left gluteal muscle (P50.033), right greater trochanter (P50.044) and left greater trochanter (P50.031).
No reduction in the number of tender points was observed in the placebo group (Tables 3 and 4).
The intervention group showed a significant Craniosacral therapy in fibromyalgia patients Differences between groups in numbers of patients with painful tender points (nine tender points I) *P-value 50.05 (95% confidence interval).
Values are presented as numbers of patients with painful tender points.
PTP, painful tender points; IG, intervention group; PG, sham group; Pre T, pre therapy; 1st PT, post therapy (immediately after20 weeks of treatment); 2nd PT, post therapy (two months after treatment); 3rd PT, post therapy (1 year after treatment); RO,right occiput; LO, left occiput; LCR, lower cervicals (righ-side); LCL, lower cerivicals (left-side); RTM, right trapezius muscle;LTM, left trapezius muscle; RSM, right supraspinatus muscle; LSM, left supraspinatus muscle; 2nd RR, second right rib.
Differences between groups in numbers of patients with painful tender points (nine tender points II) *P-value50.05 (95% confidence interval).
Values are presented as numbers of patients with painful tender points.
PTP, painful tender points; IG, intervention group; PG, sham group; Pre T, pre therapy; 1st PT, post therapy (immediately after20 weeks of treatment); 2nd PT, post therapy (two months after treatment); 3rd PT, post therapy (1 year after treatment);2nd LR second left rib; RLE, right lateral epicondyle; LLE, left lateral epicondyle; RG, right gluteal muscle; LG, left glutealmuscle; RGT, right greater trochanter, LGT, left greater trochanter; RK, right knee; LK, left knee.
reduction in pain at 13 of the 18 tender points in right lateral epicondyle, P50.026); left lateral epi- comparison with baseline values: right occiput, condyle, P50.033); left gluteal muscle, P50.026); P50.028); left occiput, P50.026); right-side right greater trochanter, P50.042); and left lower cervical, P50.033); left-side lower cervical, greater trochanter, P50.023). Repeated-measures P50.042); right trapezius muscle, P50.026); left ANOVA showed a significant time  groups inter- trapezius muscle, P50.042); right supraspinatus action for right occiput (F ¼ 8.326; P50.023); left muscle, P50.042); left second rib, P50.042); occiput (F ¼ 7.543; P50.029); right-side lower cervical (F ¼ 5.722; P50.035); left-side lower cer- global impression of severity values (P50.059).
vical (F ¼ 4.123; P50.019); right trapezius muscle Repeated-measures ANOVA showed a significant [right occiput (F ¼ 6.745; P50.044), left occiput muscle (F ¼ 5.045; P50.009); left lateral epicon- (F ¼ 7.522; P50.029), left-side lower cervical dyle (F ¼ 7.945; P50.031); right gluteal muscle (F ¼ 8.326; P50.023), right supraspinatus muscle (F ¼ 7.836; P50.034); right greater trochanter (F ¼ 8.276; P50.023) and left greater trochanter (F ¼ 7.631; P50.030), left greater trochanter (F ¼ 10.489; P50.047), clinical global impression No significant differences in heart rate variabil- of improvement (F ¼ 9.629; P50.043) and clinical ity versus baseline were observed in either group.
However, the intervention and placebo groups sig- nificantly differed in temporal standard deviationof RR segments (P50.043) and in root meansquare deviation of temporal standard deviationof RR segments (P50.046) (Table 2). Clinical global impression of improvement (P50.033) At one year after therapy, the intervention group showed significant differences versus base- (P50.042) values were significantly improved in line at left occiput (P50.019), left-side lower cer- the intervention group versus baseline but not vical (P50.026), left epicondyle (P50.035) and in the placebo group (clinical global impression left greater trochanter (P50.044) and significant of improvement, P50.064 and clinical global differences versus baseline in temporal standard impression of severity, P50.081 versus baseline) deviation of RR segments (P50.026), root mean (Table 2). Repeated-measures ANOVA showed a square deviation of temporal standard deviation of RR segments (P50.035) and clinical global P50.043) and clinical global impression of sever- groups significantly differed in tender points at left occiput (P50.025), left-side lower cervical (P50.030), left lateral epicondyle (P50.035) andleft greater trochanter (P50.040) and in temporalstandard deviation of RR segments (P50.035), root mean square deviation of temporal standard The groups significantly differed in number of deviation of RR segments (P50.047), and clinical tender points at the right occiput (P50.035), left global impression of improvement (P50.048).
Repeated-measures ANOVA showed a significant (P50.044), left trapezius muscle (P50.044), time  groups interaction for tender points (left right lateral epicondyle (P50.025), left lateral occiput (F ¼ 8.932; P50.046), left lateral epicon- dyle (F ¼ 5.923; P50.048), and clinical global impression of improvement (F ¼ 6.956; P50.040).
(P50.048). At two months, significant differencesin temporal standard deviation of RR segments(P50.047) and root mean square deviation oftemporal standard deviation of RR segments (P50.031) versus baseline values were observedin the intervention group but not in the placebo After a twice-weekly programme of craniosacral group. Clinical global impression of improvement therapy for 20 weeks, pressure algometry measure- values were significantly higher in the intervention ments demonstrated a significant reduction in group than in the placebo group (P50.046), but tender points in this series of patients with fibro- the groups did not significantly differ in clinical myalgia. Pain reduction was recorded at all Craniosacral therapy in fibromyalgia patients studied sites with the exception of the right gluteal with no muscle training or clinical symptoms of Ziljstra et al.29 found a significantly lower Physical therapeutic techniques can be consid- number of tender points in fibromyalgia patients ered as complementary to drug therapies and may at two and three months after a six-month pro- be used in combination with other non-drug ther- gramme of talasotherapy combined with exercise, apies in a multidisciplinary approach. Thus, cog- education and recreational activities. Multimodal nitive therapy can make a major contribution39 treatment programmes have produced significant and meditation and hypnosis achieve important reductions in painful tender points, which per- reductions in the sensory perception of pain via sisted up to six months after the treatment.30 indirect effects on areas of the brain that deal Significant reductions in tender points were with sensations and reactions to pain.40,41 A multi- reported after a combined six-week programme disciplinary therapeutic approach has been shown of aerobic exercise, biofeedback assisted group to improve the levels of pain intensity perceived by We found no significant differences between Manual therapies appear to be widely used by mean heart rate variability values before and fibromyalgia patients32,33 and to offer them pain after the therapy, as also reported by previous relief and an enhanced quality of life. Craniosacral therapy was found to contribute to a better quality patients have lower than average cardiovascular of life in fibromyalgia patients, improving their and aerobic capacity, and their muscular system mood, nocturnal rest, and physical function.34 makes inefficient use of oxygen. Their conse- Baranowsky et al.35 and Singh et al.17 reported quently reduced functional capacity can have a that manual therapy and acupuncture significantly negative effect on cardiovascular and peripheral improved the quality of life of these patients, prob- ably because osteomuscular pain is a cardinal Our findings indicate that craniosacral therapy symptom of this disease.36 Younger patients with improves medium-term pain symptomatology in a background of anxiety and depression are also fibromyalgia patients. The improvement observed increasingly turning towards alternative and com- at two months dissipated over the one-year fol- plementary therapies for a solution to their health low-up, underscoring the need for this manual therapy treatment to be sustained in order to Another manual therapy technique used in these remain effective. We cannot report on its effects patients is ischaemic compression therapy, devel- on the autonomic nervous system, since no signif- oped by Travell and Simons.37 Its application to icant changes in heart rate variability were sensitive zones followed by spinal manipulations detected. According to these results, craniosacral in alternate sessions reduced the number of therapy can be considered a complementary ther- tender points determined by applying 4 kg of pres- apeutic approach to fibromyalgia that diminishes sure with a pressure algometer.38 These beneficial the patient’s perception of pain. This therapy effects persisted for one month after one month should be included as part of the multimodal ther- without treatment, improving the health of patients and supporting the use of the two tech- Although the examiners who measured the out- niques. The effectiveness of ischaemic compression come variables were blinded to the group assign- therapy and craniosacral therapy can be under- ment of the patients, the therapists were not. The stood in terms of the physiopathological processes patients themselves were evidently aware of the of the fascia.37 Traditional medicine limits its type of therapy received but were not aware that assessment of muscular function to contractile one was a sham treatment. A further study limita- capacity. 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