Table 2.
Summary of included studies.
| Study | Analysis plan (intention to treat vs. per protocol) | Sample size (experimental/control) | Experimental intervention | Control intervention | Outcome | Risk of bias | Results |
|---|---|---|---|---|---|---|---|
| Accorsi et al. (57) | Per-Protocol | 28 (14/14) | Craniosacral Therapy | Conventional Care | ADHD Treatment | High | Multivariate linear regression showed that OMT was positively associated with changes in the Biancardi-Stroppa Test accuracy and rapidity scores. |
| Bagagiolo et al. (58) | Intention-to-Treat | 96 (48/48) | OMT (including Craniosacral Therapy) + Repositioning Therapy | Sham Treatment + Repositioning Therapy | Neonate Cranial Asymmetry Treatment | Low | Multivariate logistical regression showed that OMT was positively associated with a reduction in ODDI scores |
| Castejón-Castejón et al. (59) | Per-Protocol | 54 (29/25) | Craniosacral Therapy | No Treatment | Infantile Colic Treatment | High | ANCOVA with a Bonferroni post-hoc correction showed that craniosacral therapy was positively associated with a reduction in crying hours, an increase in hours of sleep, and a decrease in colic severity measured by the Infantile Colic Severity Questionnaire |
| Castro-Sánchez et al. (60) | Per-Protocol | 92 (46/46) | Craniosacral Therapy | Sham Treatment | Fibromyalgia Treatment | High | Paired two-sample t-tests showed that craniosacral therapy was positively associated with a reduction in pain of tenderpoints, temporal standard deviation of RR segments, root mean square deviation of temporal standard deviation of RR segments, and clinical global impression of improvement |
| Castro-Sánchez et al. (61) | Intention-to-Treat | 64 (32/32) | Craniosacral Therapy | Massage Therapy | Chronic Low Back Pain Treatment | Low | ANCOVA showed no significant difference in the Roland Morris Disability Questionnaire results |
| Cerritelli et al. (62) | Intention-to-Treat | 110 (55/55) | OMT (including Craniosacral Therapy) + Conventional Care | Conventional Care | Length of Stay in Hospitals for Premature Infants | Low | A generalized linear model showed that OMT was positively associated with a length of hospital stay reduction in premature infants |
| Duncan et al. (63) | Per-Protocol | 55 (19/17/19) | Group 1: OMT (including Craniosacral Therapy) Group 2: Acupuncture Treatment | No Treatment | Cerebral Palsy Treatment | High | Hierarchical linear regression models showed a positive association for OMT but not acupuncture treatment in improved Gross Motor Function Measurement score and the mobility domain in the Functional Independence Measure score |
| Elden et al. (64) | Intention-to-Treat | 123 (63/60) | Craniosacral Therapy + Conventional Care | Conventional Care | Pelvic Girdle Pain Treatment and Sick Leave Time in Pregnant Women | High | Mann–Whitney U-tests showed that OMT combined with conventional care had a positive association with a reduction in pelvic girdle pain in the morning but a non-significant impact in a reduction of pelvic girdle pain in the evening or sick leave time |
| Haller et al. (65) | Intention-to-Treat | 54 (27/27) | Craniosacral Therapy | Sham Treatment | Chronic Neck Pain Treatment | Low | Univariate analysis of covariance showed that craniosacral therapy was positively associated with a reduction of neck pain intensity |
| Hanten et al. (66) | Intention-to-Treat | 60 (20/20/20) | Group 1: Resting Position Technique Treatment Group 2: Craniosacral Therapy | No Treatment | Tension-type Headache Treatment | High | One-way MANCOVA followed by univariate and post-hoc tests showed that craniosacral therapy but not resting position technique treatment had a positive association with a reduction in pain intensity during an attack |
| Hayden et al. (67) | Per-Protocol | 28 (14/14) | Craniosacral Therapy | No Treatment | Infantile Colic Treatment | High | Paired two-sample t-tests showed that craniosacral therapy was positively associated with a reduction in hours spent crying and an increase in hours spent sleeping |
| Herzhaft Le Roy et al. (68) | Intention-to-Treat | 97 (49/48) | OMT (including Craniosacral Therapy) | Sham Treatment | Neonate Biomechanical Suckling Ability | Low | Longitudinal regression models showed that OMT was positively associated with an improvement in LATCH scores |
| Matarán-Peñarrocha et al. (69) | Per-Protocol | 84 (43/41) | Craniosacral Therapy | Sham Treatment | Fibromyalgia Treatment | High | Paired two-sample t-tests showed that craniosacral therapy was positively associated with a reduction in pain and an improvement in Pittsburgh Sleep Quality Index, short form-36 health survey, Beck depression inventory, and State Trait Anxiety Inventory scores |
| Mazreati et al. (70) | Per-Protocol | 59 (30/29) | Craniosacral Therapy | Sham Treatment | Chronic Back Pain Treatment in Nurses | High | ANCOVA showed that craniosacral therapy had a positive association with an improvement in McGill Pain Questionnaire scores |
| Muñoz-Gómez et al. (71) | Intention-to-Treat | 50 (25/25) | Craniosacral Therapy | Sham Treatment | Migraine Treatment | Some Concern | Two-factor mixed MANCOVA showed that craniosacral therapy was positively associated with a reduction in pain and pain medication intake as well as an improvement in Headache Disability Index and Patients’ Global Impression of Change scores |
| Philippi et al. (72) | Intention-to-Treat | 32 (16/16) | OMT (including Craniosacral Therapy) | Sham Treatment | Neonate Postural Asymmetry Treatment | Low | Independent t-tests showed that OMT was positively associated with an improvement in standardized asymmetry scores |
| Raith et al. (73) | Intention-to-Treat | 25 (12/13) | Craniosacral Therapy | Conventional Care | Neurological Development in Premature Neonates | Low | First order autoregressive covaraince structure calculations showed no significant difference in global General Movement Assessment scores |
| Rolle et al. (74) | Per-Protocol | 40 (21/19) | OMT (including Craniosacral Therapy) | Sham Treatment | Frequent Episodic Tension-type Headache Treatment | High | 2-way ANOVA followed by a multiple comparison Tukey test showed that OMT was positively associated with a reduction in headache frequency |
| Sandhouse et al. (76) | Per-Protocol | 89 (47/42) | Craniosacral Therapy | Sham Treatment | Visual Function | High | Hierarchical ANOVA showed that craniosacral therapy was positively associated with an effect on pupillary size under bright light in the left eye and in near point of convergence break but no significance was found with pupillary size under bright light in the right eye, pupillary size under dim light in both eyes, best-corrected distance visual acuity testing in both eyes, Donder pushup testing in both eyes, near point of convergence recovery, or the cover test with prism neutralization |
| Sandhouse et al. (75) | Per-Protocol | 29 (15/14) | Craniosacral Therapy | Sham Treatment | Visual Function | High | Hierarchical ANOVA showed that craniosacral therapy was positively associated with an effect on pupillary size under bright light in the right eye but no significance was found with pupillary size under bright light in the left eye, pupillary size under dim light in both eyes, best-corrected distance visual acuity testing in both eyes, Donder pushup testing in both eyes, near point in convergence break and recovery, or the cover test with prism neutralization |
| Terrell et al. (77) | Intention-to-Treat | 84 (15/15/13/15/14/12) | Parkinson’s Patients: Group 1: “Whole-body” OMT (including Craniosacral Therapy) Group 2: “Neck-down” OMT Group 3: Sham Treatment | Healthy age-matched controls: Group 1: “Whole-body” OMT (including Craniosacral Therapy) Group 2: “Neck-down” OMT Group 3: Sham Treatment | Parkinsonian Gait Treatment | High | Paired two-sample t-tests and waveform analysis show that craniosacral therapy in conjunction with OMT but not OMT alone or the sham treatment was positively associated with reduced hip extension in the mid-to-late stance phase and reduced knee extension in the stance phase in Parkinsons patients compared to controls but craniosacral therapy in conjunction with OMT, OMT alone, and the sham treatmet had no significance on saggital hip, knee, or ankle angles througout the gait cycle in Parkinsons patients compared to controls |
| Vandenplas et al. (78) | Per-Protocol | 28 (15/13) | OMT (including Craniosacral Therapy) | Sham Treatment | Obstructive Apnea Treatment in Neonates | Some Concern | Mann–Whitney U-tests showed that OMT was positively associated with a decrease in obstructive apneas measured via polysomnographs |
| Wahl et al. (79) | Intention-to-Treat | 90 (24/22/22/22) | Group 1: OMT (including Craniosacral Therapy) with Sham Echinacea Treatment Group 2: Echinacea Treatment with Sham OMT Treatment Group 3: OMT (including Craniosacreal Therapy) with Echinacea Treatment | Sham OMT and Sham Echinacea Treatment | Recurrent Otitis Media Treatment in Young Children | High | Mann- Whitnet U-tests showed no significance with OMT and the reduction of risk of acute otitis media, no significant interaction between OMT and Echinacea treatment, and that Echinacea treatment was negatively associated with a reduction of risk of acute otitis media |
| Wyatt et al. (80) | Intention-to-Treat | 142 (71/71) | Craniosacral Therapy | No Treatment | Cerebral Palsy Treatment | Some Concern | Generalized linear modeling procedures and analysis showed no significance with OMT and change in Gross Motor Function Measure-66 and Child Health Questionnaire PF50 scores |