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

NCT ID: NCT06475248

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2024-12-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tension Headaches

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

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.

Group Type PLACEBO_COMPARATOR

Placebo Technique

Intervention Type 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).

Experimental Group

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.

Group Type EXPERIMENTAL

Stretching technique

Intervention Type 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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo Technique

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).

Intervention Type OTHER

Stretching technique

"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.

Intervention Type OTHER

Inhibition of the suboccipital

"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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Escola Superior de Tecnologia da Saúde do Porto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Natália Maria Oliveira Campelo

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Natália MO Campelo, PhD

Role: PRINCIPAL_INVESTIGATOR

Escola Superior da Saúde do Porto

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Escola Superior da Saúde do Porto

Porto, , Portugal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Portugal

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Natália MO Campelo, PhD

Role: CONTACT

+35122 206 1000

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Natália MO Campelo, PhD

Role: primary

938 674 365 ext. +351

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 34537167 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27053061 (View on PubMed)

Hartman, L. S. (2013). Handbook of osteopathic technique. Springer

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OST1_014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cervicogenic Headache Dose-Response
NCT01530321 COMPLETED PHASE1/PHASE2