Influence of Osteopathic Intervention on Cervical Muscles in Tension Headaches in Women

NCT06475248 — Not applicable, Not yet recruiting, 43 participants, Escola Superior de Tecnologia da Saúde do Porto

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Influence of Osteopathic Intervention on Cervical Muscles in Tension Headaches in Women: Randomized Controlled Trial

Registry	NCT06475248
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	43 (Estimated)
Sponsor	Escola Superior de Tecnologia da Saúde do Porto (Other)
Conditions	Tension Headaches
Interventions	Placebo Technique, Stretching technique, Inhibition of the suboccipital (Other)
Dates	start 2026-09-01 (estimated), primary completion 2026-12-01 (estimated), completion 2026-12-11 (estimated), first posted 2024-06-26, last updated 2026-06-25
Locations	1 site in Portugal

-Summary

This study aims to understand whether there is any relationship between the intervention on the trapezius, sternocleidomastoid and suboccipital muscles in patients with chronic tension headaches.

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+Detailed description

It is expected to find an improvement in the symptoms and frequency of tension headaches.

In this study, the investigators intend to see the effects of trapezius and sternocleidomastoid "stretching techniques", and "suboccipital inhibition" on tension headaches. To collect data, volunteers were asked to fill out the Headache Impact Test (HIT-6).

+Arms and interventions

Arm	Type	Interventions	Description
Control Group	Placebo comparator	Other: Placebo Technique	Each volunteer selected in this group will complete a scale, in this case Hit-6, to collect data and evaluate the evolution. Then a placebo technique will be used, which consists of imitating the contacts of the techniques without compressing or pulling the tissue, lasted 6 minutes. This procedure will be repeated for two more sessions. One month after the first evaluation, the volunteers filled out the Hit-6 scale again.
Experimental Group	Experimental	Other: Stretching technique; Other: Inhibition of the suboccipital	After each volunteer completes the Hit-6 scale, one of the researchers will perform the "trapezius and sternocleidomastoid stretching techniques", and "suboccipital inhibition". The techniques performed will only be done once, lasted 6 minutes. This procedure will be repeated for two more sessions. One month after the first evaluation, the volunteers filled out the Hit-6 scale again.

Placebo Technique (Other): For the technique performed in the control group, the researcher will come into contact with the volunteers' chests. This contact will be maintained for the same period of time as the experimental group (6 minutes).
Stretching technique (Other): "Stretching technique" for the upper trapezius and sternocleidomastoid: the volunteer will be in supine position on the couch, the researcher will perform the technique from the contralateral side of the muscle to be treated, the hand will contact the ipsilateral shoulder to stabilize, meanwhile, with the other hand, contact the upper trapezius and perform a rhythmic pull in contralateral rotation. This technique is performed bilaterally.
Inhibition of the suboccipital (Other): "Inhibition of the suboccipital": the participant is in the supine position, the researcher will position himself behind the patients head. In this technique, contacts will be made on the suboccipital area with the 2nd, 3rd and 4th fingers of both hands. Make a slight pull with your body backwards and wait that there is relaxation of muscular tensions.

+Outcome measures

Primary outcomes

Change in the intensity and frequency of pain after the three treatment sessions; [One month after the first intervention]: The scale Hit-6 will be the instrument used to evaluate the level the intensity and frequency of tension headache. This instrument consists of six questions about the characteristics of headaches, with each question presenting five choices. The answers range from never to always. This data will be collected immediately before the first investigation and one month after the first evaluation, through the volunteers filling out the scale.

+Eligibility

Sex: Female, ages: 18 Years to 60 Years, accepts healthy volunteers

Inclusion Criteria:

* Tension headaches;
* Being over eighteen years of age;

Exclusion Criteria:

* Loss of mobility of cervical;
* Cervical and shoulder pain during episodes;
* Other headaches (migraine, cervicogenic headache...)
* Other interventions and/or pharmacological treatment a few days before the intervention;
* Epilepsy;
* Trauma.

+Locations (1)

Facility	City	Country	Status
Escola Superior da Saúde do Porto	Porto	Portugal

+Publications

Cumplido-Trasmonte C, Fernandez-Gonzalez P, Alguacil-Diego IM, Molina-Rueda F. Manual therapy in adults with tension-type headache: A systematic review. Neurologia (Engl Ed). 2021 Sep;36(7):537-547. doi: 10.1016/j.nrleng.2017.12.005. Epub 2020 Apr 7. PMID 34537167
Lebedeva ER, Kobzeva NR, Gilev DV, Olesen J. The quality of diagnosis and management of migraine and tension-type headache in three social groups in Russia. Cephalalgia. 2017 Mar;37(3):225-235. doi: 10.1177/0333102416642603. Epub 2016 Jul 11. PMID 27053061
Hartman, L. S. (2013). Handbook of osteopathic technique. Springer

+Investigators

Natália MO Campelo, PhD, Principal investigator, Escola Superior da Saúde do Porto