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Keywords:

  • Alternative medicine;
  • cranial osteopathy;
  • craniosacral therapy;
  • effectiveness;
  • systematic review

Abstract

  1. Top of page
  2. Abstract
  3. Background
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. References

Aim

Craniosacral therapy (CST) is a popular treatment for a wide range of conditions. This systematic review evaluates the evidence of effectiveness for CST for any human condition.

Method

An electronic search for relevant studies was conducted across three databases; this was complemented by extensive hand-searching of departmental files and bibliographies. Articles were included if they reported RCTs of CST for any human condition. Data were extracted according to predefined criteria and trial quality was determined using the Jadad score.

Results

Six studies were included. Except for one, all were associated with a high risk of bias. Low quality studies suggested positive effects, while the high-quality trial failed to demonstrate effectiveness.

Conclusion

The notion that CST is associated with more than non-specific effects is not based on evidence from rigorousRCTs.


Background

  1. Top of page
  2. Abstract
  3. Background
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. References

Craniosacral therapy (CST) was developed in the 1970s by the osteopath John E Upledger. The Upledger Institute International, based in Florida, USA, currently describes CST as ‘a gentle, hands on approach that releases tensions deep in the body to relieve pain and dysfunction and improve whole-body health and performance’.[1]Practitioners of CST ‘release restrictions in the soft tissues that surround the central nervous system’ by using gentle touch.[1] The CST practitioner:

‘uses his or her own hands to evaluate the craniosacral system by gently feeling various locations of the body to test for the ease of motion and rhythm of the cerebrospinal fluid pulsing around the brain and spinal cord. Soft-touch techniques are then used to release restrictions in any tissues influencing the craniosacral system.’[1]

Today, CST is practised mostly by osteopaths and chiropractors. These practitioners advocate CST for a wide variety of diseases, including migraines and headaches, chronic neck and back pain, stress and tension-related disorders, motor-coordination impairments, infant and childhood disorders, brain and spinal cord injuries, chronic fatigue, fibromyalgia, temporomandibular joint disorder, scoliosis, central nervous system disorders, learning disabilities, attention deficit hyperactivity disorder, post-traumatic stress disorder, orthopaedic problems and many other conditions.[1] Yet, the evidence for such claims is not convincing; it is based mostly on assumptions, anecdotes, experience or uncontrolled outcome studies.[2-8]Moreover, only vague andunproven theories exist about the mode of action of CST.[9]

This systematic review therefore set out to evaluate the evidence of effectiveness for CST for any human condition based only on data from RCTs.

Methods

  1. Top of page
  2. Abstract
  3. Background
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. References

An electronic literature search was carried out using MEDLINE, EMBASE and The Cochrane Library for the following keywords: craniosacral, craniosacral therapy and cranial osteopathy. The author's departmental files and bibliographies were hand-searched also. No limits regarding date or language of publication were imposed.

Studies were included if they were RCTs examining the effectiveness of craniosacral therapy for the treatment of any condition. Studies with healthy volunteers were excluded.[10-12]Non-randomised trials, case series or case reports were also excluded. The methodological quality of all included studies was determined using the Jadad score.[13] Key data from all included RCTs were extracted according to predefined criteria. A meta-analytical approach was considered but had to be abandoned due to the clinical heterogeneity of the primary studies.

Results

  1. Top of page
  2. Abstract
  3. Background
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. References

The search identified 102 articles, of which six met the inclusion criteria (Figure 1). Details of these studies are summarised in Table 1. The following text provides an additional description and critique of each study.

figure

Figure 1. Flow chart of included studies. CST, craniosacral therapy.

Download figure to PowerPoint

Table 1. Description of included studies of craniosacral therapy
First author (year)Study design (Jadad score)PatientsExperimental intervention (A)Control intervention (B)Main outcome measureMain findingsa
  1. a

    described by the authors.

  2. CST, craniosacral therapy; db, double-blind; pc, placebo controlled.

Hanten (1999)[14]RCT, open, three parallel arms (2)60 patients with tension-type headacheOne session of CST (10 min)

1) Sham CST (10 min)

2) Rest (10 min)

Pain (VAS)CST was significantly superior to controls
Hayden (2006)[15]RCT, open, two parallel arms (2)28 infants with colicOne CST session (30 min) per week for 4 weeksAttention control with no physical treatment (same time schedule)Duration of crying, mean hours sleepingCrying decreased 63% in A and 23% in B. Sleep improved 11% in A and 2% in B.
Matarán-Peñarrocha (2011)[16]RCT, pc, db, two parallel arms (3)84 patients with fibromyalgiaTwo CST sessions (60 min) per week for 25 weeksTwo weekly sham ultrasound sessions (30 min) for 25 weeksAnxiety, pain, sleep quality, depression, QoL (at 10 min, 6 months, 12 months)Significant improvements in most outcomes at 6 months of A vs. B (at 12 months only sleep quality showed such improvements)
Castro-Sánchez (2011)[17]RCT, pc, db, two parallel arms (3)92 patients with fibromyalgiaTwo CST sessions (60 min) per week for 20 weeksTwo weekly sham magnet-therapy sessions (30 min) for 25 weeksPain, heart-rate variability (at 2 months, 5 months, 12 months)Significant superiority of A vs. B for both endpoints
Curtis (2011)[18]RCT, two parallel arms (3)65 patients with migraineEight weekly CST sessions8 weekly sessions of low-strength magnet therapyCredibility of interventionControl treatment was deemed less credible than CST
Wyatt (2011)[19]RCT, two parallel arms (4)142 children with cerebral palsySix sessions of CSTWaiting list with partial attention controlMotor function (blinded assessors), QoL after 6 months plus a range of secondary endpointsNo inter-group difference in motor function or secondary endpoints (but cores in A were more likely than those in B to report improvements in global health of the children)

Hantenet al.[14]published the first RCT of CST. The investigators randomised 60 patients with tension-type headache into three groups: a single 10-min session of CST, one session of sham CST, or simple rest. At the end of the treatment, there was a significant inter-group difference in pain intensity in favour of real CST.

This study was small, not blinded and further limited by the single-therapy session design. Other potential flaws included an inappropriate randomisation procedure, possible baseline differences between groups and lack of detail on the study methodology. Consequently, there was a high risk of bias, which might have produced a false negative result.

Hayen and Mulligen[15] randomised 28 infants with colic into one group receiving four weekly sessions of CST and one receiving no treatment. The two outcome measures were time spent crying and time spent sleeping. Both variables favoured CST over no treatment.

This study was even smaller than Hantenet al.[14]and made no attempt to control for placebo or other non-specific effects. Further, the outcome measure was subjective and not validated. The findings are therefore less than reliable.

Matarán-Peñarrochaet al.[16]assigned 84 patients with fibromyalgia to either regular CST or sham ultrasound for 25 weeks. The effects of these interventions on a range of parameters were quantified after 10 min, 6 months and 1 year. At the end of each treatment period, anxiety, pain, QoL and sleep quality all improved in the experimental group compared to controls. At 1-year follow-up, this was evident only for sleep quality.

This study[16] had several flaws. Although it was labelled as ‘double-blind' by its authors, it seems that neither the patients nor the therapists were blinded. The trial had no named primary endpoint, no ITT analysis, no correction for multiple statistical comparisons and no adequate randomisation procedure. Most importantly, the sessions of the placebo group were only half as long as those in the CST group. Thus, the observed outcomes could be unrelated to any specific effects of CST and entirely due to context effects.

In another study, the same research group randomised 92 patients with fibromyalgia to either CST or sham magnetotherapy.[17] This study used a similar design as the previous RCT,[16] though the control intervention and clinical outcome measures were marginally different. The results of this trial[17] were also positive.

The flaws of this study[17] were essentially the same as those of the one previously mentioned.[16] One also has to wonder how one research group could recruit nearly 200 fibromyalgia patients for two trials published in the same year.

Curtiset al.[18]tested the credibility of low-strength static magnet therapy in comparison to CST. The investigators randomised 65 patients with migraines to weekly CST or magnet therapy for 8 weeks. At the end of the 8-week period, patients noted that the control intervention was less credible.

This RCT was not designed to test the effectiveness or efficacy of CST. Instead, the authors wanted to develop a credible control intervention. Therefore, this study does not contribute to our knowledge about the therapeutic value of CST.

Wyattet al.[19]randomised 142 children with cerebral palsy into two groups. One received six sessions of CST, while the other one was put on a waiting list with partial attention control. Motor function, as assessed by a blinded physiotherapist, served as the primary endpoint. The results showed no inter-group differences in motor function, pain, sleep or QoL. However, carers in the CST group were nearly twice as likely to report that their children's global health had improved 6 months later.

This pragmatic trial[19] was carefully designed and is the only CST study that was well reported. Even though blinding could only be partial, there was an attempt to control for non-specific effects. This study shows in exemplary fashion the discrepancy between objectively quantified outcomes (which all demonstrated the absence of CST-induced effects) and the global impressions of carers (which, in a study of this nature, is likely to be positive).

Discussion

  1. Top of page
  2. Abstract
  3. Background
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. References

This review shows that several RCTs of CST have recently emerged. In 1999, a systematic review had found not a single controlled clinical trial of CST,[20] while in 2011 a systematic review included eight studies.[21] However, the latter article was limited in that it included observational studies and studies recruiting healthy volunteers; it also excluded several RCTs reported in the present review. The conclusion of the authors of the 2011 review was that the evidence is ‘insufficient to draw definitive conclusions’.[21]

The present review also shows that the evidence from rigorous RCTs of CST does not lend strong support to the therapeutic value of CST. The studies by Hanten[14]and Hayden[15] were both fatally flawed and their results are likely false positives. The two Spanish studies[16, 17]of strikingly similar design yielded positive results, but they were both too flawed to generate firm conclusions. The only well-designed and well-reported RCT[19] did not support the effectiveness of CST but demonstrated that the impressions of unblinded carers about clinical outcomes can be unreliable.

The assumptions underpinning CST[1] are not biologically plausible.[9, 22, 23]When these assumptions were put to the test, the results tended to be negative. Downeyet al.[24]investigated whether CST does, as claimed, lead to changes in intra-cranial pressure and found no such effect. Moran and Gibbons[25] investigated whether the cranial rhythmic changes postulated by CST practitioners are in fact detectable, and found no intra-or inter-examiner reliability of the diagnostic ability of experienced therapists.

In defence of CST, some advocates might claim that it is harmless and might help some patients through placebo or other non-specific effects. Wyattet al.[19]have elegantly shown that the impression of a benefit can be wrong. More importantly, perhaps, it is erroneous to assume that any ineffective treatment would be harmless. Serious harm can, of course, occur when a gravely ill patient does not receive effective therapy.[26]

This review has several limitations. There is no certainty that all relevant articles were retrieved. Publication bias, which is particularly rife in areas of alternative medicine,[27] might mean that negative trials were never published. The low quality and quantity of RCTs is a further drawback. Collectively, these limitations prevent firm conclusions from being drawn.

Conclusion

  1. Top of page
  2. Abstract
  3. Background
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. References

In conclusion, very few RCTs of CST exist. Most of these trials are seriously flawed. Therefore, there is insufficient evidence to suggest that CST has therapeutic effects beyond placebo.

Conflict of interest None declared.

References

  1. Top of page
  2. Abstract
  3. Background
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. References
  • 1
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