Francesca Galiano
08/08/2022 - Last update 30/12/2022

Francesco Cerritelli, Eleonora Lacorte, Nuria Ruffini, Nicola Vanacore | Year 2017

Osteopathy for primary headache patients, a systematic review


Primary headache

Type of study:

Systematic review

Date of publication of the study’:



Purpose of the study

  • Obiettivo: to assess the efficacy, effectiveness (clinical efficacy), safety and tolerability of OMT in patients with headache
  • Measured outcomes:
    • Primary: change difference in the number of days per month in which headache occurred between treatment group and control group after at least 4 months of treatment
    • Secondary: adverse effects, pain intensity, frequency of analgesics’ usage, change in drug dosage, patient reported outcome measures (PROM), economic evaluations


  • Articles analyzed: 5
  • Search string: (((((((((((((osteopath* AND manipulat* AND (treatment OR therapy))) OR Manipulation, Osteopathic[MeSH]) OR ((osteopath* AND medicine))) OR ((manual* AND treatment*))) OR ((spinal AND manipulat*))) OR Manipulation, Spinal[MeSH]) OR ((visceral AND manipulat*))) OR (((crani* OR crani* AND sacral OR cranio *sacral) AND osteopat* AND (manipulat* OR manual OR treatment)))) OR (((craniosacral OR cranio-sacral OR cranio sacral)))) OR ((osteopath* AND diagnosis))) OR ((osteopath* AND palpat*))) OR ((osteopath* AND principle* AND practice*)) AND ((headache AND (disease* OR disorder*)))))
  • Criteria of inclusion:
    • studies on patients of all sexes, ethnicities and ages with a clinical diagnosis of headache according to each type of criteria; randomized controlled trials (RCT) and quasi-RCT; use of at least one headache related outcome (e.g. frequency, pain intensity, evaluation scales, use of analgesics); use of validated PROM as primary outcome; use of headache days as secondary outcome
    • use of any type of OMT; use of OMT in combination with standard care; use of sham treatment (similar to OMT but different for at least one essential aspect, e.g. missing somatic dysfunction evaluation), standard care (pharmacology), other treatments (relaxation, physical therapies) or no treatment as control.
  • Criteria of exclusion: descriptive studies; trials with only physiological or laboratory parameters; studies on patients with at least one pathological condition between neurodegenerative, cardiovascular, genetic, respiratory, rheumatological and psychiatric or psychological disorders; evaluation and comparison of different types of OMT only; use of combined manual treatments.

Characteristics of the studies

  • RCT
  • 2 three-arm studies
  • 3 two-arm studies
  • A follow-up visit from 9 to 20 months after the last treatment session, with a study evaluating a further visit after another 3 months
  • The studies ranged from uncertain to high risk of bias (according to the risk of bias – RoB – evaluation method of the Cochrane and the Jadad score)
  • High heterogeneity in relation to both the methodology followed and the results measured (therefore it was not possible to carry out a meta-analysis)


  • Number in the smallest study: 22 people, of which 10 people in the OMT group, 6 people in the control group 1 and 6 people in the control group 2
  • Number in the biggest group: 105 people (69 female and 36 male), of which 35 people in the OMT group, 35 people in the control group 21 and 35 people in the control group 2
  • Total: 265 people, of which 101 people in the OMT group, and 154 in the different control groups
  • Mean age: from 18 to 65 years

Interventions and evaluations

  • In the OMT groups:
    • very variable approaches both in the techniques and in the timing (duration and frequency)
    • variable number of sessions from 1 to 8
    • 1 study with OMT in addition to standard care
  • In the control groups:
    • 2 studies with sham treatment similar to OMT but without the application of any technique
    • 1 study with progressive muscular relaxation
    • 1 study with either palpatory evaluation or rest sessions
    • 1 study with the administration of a questionnaire
  • Only 2 studies reported information on who performed the OMT



  • Primary outcomes: in 3 studies out of 4 reporting the number of days with headache, OMT proved to be able to reduce this outcome in a statistically significant way.


  • Secondary outcomes: OMT showed no adverse effects in the 2 studies that evaluated them.
    In the various studies, has improved statistically significantly the quality of life related to headache (also measured by the Headache Impact Test 6, or HIT-6 scale), in addition to reducing the intensity of headache, work disability and drug use.


OMT appears to improve the quality of life for people with headache, reducing perceived pain, frequency of the episodes and the consequent disability.

Nevertheless, the studies have been carried out on small samples, without an a priori calculation of the sample size, and tend to be at high risk of bias, that is, to have limitations in the methodological design and in the conduct of the study, in particular in the management of possible confounding factors (ie, factors that can alter the results).

In addition, few trials have reported possible adverse effects.
The authors hope for more rigorous studies, in which appropriate recruitment and randomisation procedures are followed and where all the various steps are well specified and explained. Statistical analyses must also improve; first by reporting all the necessary information (e.g. confidence intervals), and then by using appropriate analyses to calculate sample size (the number of people to be recruited) necessary to have reliable results and to assess the impact of possible missing data.

The review of Osteopedia

By Marco Chiera

Strengths: in-depth analysis of the literature and inclusion of the gray literature; assessment of multiple headache-related outcomes.

Limits: non-inclusion of studies other than RCTs (making sense with a view to carrying out a meta-analysis, but still limiting); non-assessment of the different types of headache, which could respond differently.

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