Table 2. Description of included studies dealing with the clinical efficacy of techniques used in osteopathy in the cranial field.
| First author | Disease & number of participants | Intervention and comparison | Primary study outcome & result | Other outcomes & results | |
|---|---|---|---|---|---|
| Low risk of bias | Elden [42] | Pelvic Girdle Pain: 123 | EG “standard treatment + craniosacral therapy” / “standard treatment” G | Sick leaves & pain intensity in the morning and the evening. Results showSSD but no MCID for pain intensity in the morning in favour of EG (VAS increased by 7mm in CG and decreased by 0.5mm in EG after treatment) | None |
| Haller [44] | Non specific neck pain: 54 | EG “craniosacral therapy protocol” / PG “sham of the craniosacral therapy protocol” | Pain intensity.Results showSSD & MCID 3 months after treatment for the pain intensity in favour of EG (-21 and -16.8mm after 8 and 20 weeks, respectively) | • 32 criteria (16 outcomes immediately after treatment and at 3 months). 1. Pain on movement (Pain on Movement Questionnaire). 2. Maximum pressure pain sensitivity : point of maximum pain, levator scapulae, trapezius and semispinalis capitis muscles (algometer). 3. Functional disability (Neck Disability Index). 4. Quality of life (through two subscales of the 12-item Short Form Health Survey). 5. Well-being (16-item Questionnaire for Assessing Subjective Physical Well-being). 6. Anxiety and depression (Hospital Anxiety and Depression Scale). 7. Stress perception (Perceived Stress Questionnaire). 8. Pain acceptance (through the subscale “Positive life constrution Scale” of the Emotional/Rational Disease Acceptance Questionnaire). 9. Body connection (through two subscales “body awareness” and “body dissociation” of the Scale of Body Connection). 10. Global impression of improvement (Patients’ ratings of their Globa Impression of Improvement). • Results show SSD to 7 outcomes after treatment and 5 outcomes at three months in favor of the EG group**. |
|
| Castro-Sànchez [45] | Non specific low back pain: 64 | EG “craniosacral therapy”/ CG “Classic massage” | Roland Morris Disability Questionnaire. Results show no SSD | • 32 criteria (16 outcomes immediately after treatment and one month later). 1. Low back pain disability (Oswestry Low Back Pain Disability Index). 2. Pain intensity (10-point numeric pain rating scale). 3. Kinesiophobia (Tampa Scale of Kinesiophobia). 4. Hemoglobin oxygen saturation, systolic blood pressure, diastolic blood pressure and hemodynamic (cardiac index) (Electro Interstitial Scanner). 5. Interstitial levels of sodium, serum potassium, chloride, phosphate, ionized or free calcium, magnesium and lactic acid (Electro Interstitial Scanner). 6. Isometric endurance of trunk flexor muscles (McQuade test). 7. Lumbar mobility in flexion (finger-to-floor distance). • Results show SSD to 6 outcomes after treatment and 3 outcomes one month later in favour of CST group**. |
|
| Major doubt on risk of bias | Hanten [33] | Tension-type headache : 60 | EG “CV-4 technique as described by Upledger and Vredevoodg”/ untreated G(1)/ resting position G(2) | None |
2 criteria (VAS for Pain intensity and Pain affect) immediately after treatment. Results showdifference between pretest and post-test for Pain intensity [untreated G : 7.8 mm ; resting position G : 11.2 mm; EG : 19.3 mm] and Pain affect [untreated G : 2.9 mm; resting position G : 7.6 mm ; EG : 14.9 mm] |
| Hayden [34] | Infantile colic : 28 | EG “standard cranial osteopathic techniques” / untreated G | None | 3 criteria immediately after treatment, that are Crying and sleeping daily durations (parent reporting) andDuration of parent holding and rocking (parent reporting). Results show SSD for all criteria (daily amount of crying : −1h, sleeping time : −1.17h and helding or rocking time : −0.7h) after treatment in favor of the EG. | |
| Nourbakhsh [36] | Lateral epicondylitis : 23 | EG “The OEMT [Oscillating-energy Manual Therapy] (V-spread) was administered based on the standard method described in many osteopathic texts.”/ PG | None | • 7 criteria (4 outcomes immediately after treatment and 3 outcomes at 6 months). 1. Grip strength (Jamar dynamometer). 2. Functional level (Patient-Specific Functional Scale). 3. Pain intensity (11-point scale). 4. Pain limited activity (11-point scale). Results show differences immediately after treatment for grip strength (PG: -1.9; EG: +12.3), functional level (PG: +4.7; EG: +14.5), pain intensity (PG: -0.5; EG: -3.1) and pain limited activity (PG: -0.1; EG: +3.3) and no SSD at 6 months for functional level, pain intensity and pain limited activity. |
|
| Sandhouse [37] | Myopia & hyperopia : 29 | EG “The specific OMT technique performed was balanced membranous tension”/ PG | None | • 12 criteria immediately after treament. 1. Presence of a cranial dysfunction (manual evaluation). 2. Visual acuity (right and left) (distance visual acuity testing). 3. Accomodation amplitude (right and left) (Donder push-up testing). 4. Stereoscopic visual acuity (local stereoacuity testing). 5. Pupillary size (right and letft ; under bright light and dim light) (Pupillary testing). 6. Ocular deviation (Cover test with prism neutralization). 7. Near point of convergence (break point and record point) (distance in cm). Results show SDD for 1 criterion out of 12 between EG and PG : the left pupillary size measured under bright light with respectively +0.13mm and -0.40mm of difference between after and before intervention for EG and PG, respectively. |
|
| Castro-Sánchez [38] | Fibromyalgia : 92 | EG “a craniosacral therapy protocol”/ PG | None | • 75 criteria (25 outcomes immediately after treatment and 2 months and 1 year later). 1. Body composition (extracellular, cellular and lean mass analysed with bioelectrical impendance). 2. Pain at 18 tender point sites (pressure algometer). 3. Heart rate, temporal standard deviation of RR segments (HRV) and root mean square deviation of HRV index (Holter). 4. Clinical global impression of improvement (7-level Likert scale). • Results : number of criteria above 20*. |
|
| Matarán-Peñarrocha [39] | Fibromyalgia : 104 | EG “a craniosacral therapy protocol”/ PG | None | • 54 criteria (18 outcomes immediately after treatment, 6 months and 1 year later). 1. Pain intensity (VAS). 2. Quality of life (SF-36 : one outcome for each of the 8 questionnaire sections − thus 8 outcomes). 3. Sleep quality (Pittsburgh Sleep Quality Index : one outcome for each of the 6 questionnaire sections − thus 6 outcomes). 4. Depression state (Beck depression inventory). 5. Trait anxiety and state anxiety (2 outcomes) (State Trait Anxiety Inventory). • Results : number of criteria above 20*. |
|
| Amrovabady [40] | Attention deficit hyperactivity disorder : 24 | EG “Craniosacral therapy”/ standard treatment G | None | 10 criteria immediately after treatment[the Conners Parents Rating Scale 48-question version (divided into 5 sub-outcomes and the Child Symptoms Inventory-4th (divided into 5 sub-outcomes)]. Results show SSD for all results in favor of the EG with, for instance, a total CPRS difference of +0.58 in the standard treatment G vs. +7.5 in the EG. | |
| Árnadóttir [41] | Migraine : 20 | Cross-over range on 12 wks with 2 G(“Upledger Craniosacral therapy” vs. no treatment) | HIT-6 questionnaire. Results show SSD immediately after treatment (effect size : 0.48) and 1 mo after treatment (effect size : 0.43). | None | |
| Bialoszewski [43] | Non specific low back pain : 55 | EG “Craniosacral therapy”/ trigger point therapy G | None | • 8 criteria immediately after treatment. 1. Pain severity (VAS). 2. Pain intensity (modified Laitinen questionnaire). 3. Pain frequency (modified Laitinen questionnaire). 4. Analgesic use (modified Laitinen questionnaire). 5. Functional impact of pain (modified Laitinen questionnaire). 6. Lombosacral mobility (Schober test). 7. Resting tension of the multifidus muscle (right and left) (Electromyography). Results show no SSD after treatment for all criteria. |
|
| High risk of bias | Mehl-Madrona [35] | Chronic asthma : 89 | CST G “standard craniosacral therapy treatments in accordance with the protocol taught at the Upledger Institute in Michigan”/ acu G / CST + acu G/ PG/ waiting list | None | • 21 criteria (7 outcomes at 2 weeks, 2 months and 6 months after treatment). 1. Pulmonary function (no more information). 2. Quality of life (Asthma Quality of Life and SF-36). 3. Mood state (Profile of Mood State). 4. Depression state (Beck Depression Inventory). 5. Medication use over the past year (dose and frequency). • Results : Selective reporting of results. Number of criteria above 20*. |
| Raith [46] | Preterm infants : 30 | EG “standardised craniosacral therapy”/ standard treatment G | General Movement Assessment. Results show no SSD. | 1 criterion immediately after treatment (General Movement Optimality Score).Results show no SSD. |
Legend. EG: experimental group; G: group; SSD: significant statistic difference; CST: craniosacral therapy; acu: acupuncture; PG: placebo group; VAS: visual analogic scale; MCID: minimal clinically important difference.
*Considering the risk of inflated alpha value and for sake of clarity, the results of the studies that both had not chosen primary study outcomes and had used more than 20 criteria were not reported.
** No detail is given for sake of clarity.