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

NCT06475248 | Not Yet Recruiting DMC

• 1 other identifier: OST1_014
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tension Headaches

Keywords

Tension headaches; Trapezius Stretching; sternocleidomastoid Stretching; Suboccipital Inhibition; Manual Therapy; Osteopathy; HIT-6

Outcome Measures

Primary Outcomes (1)

• Change in the intensity and frequency of pain after the three treatment sessions;

  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.

  One month after the first intervention

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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.

Other: Placebo Technique

Experimental Group

EXPERIMENTAL

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.

Other: Stretching technique; Other: Inhibition of the suboccipital

Interventions

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).

Control Group

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.

Experimental Group

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Study Sites (1)

Escola Superior da Saúde do Porto

Porto, 4200-072, Portugal

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Natália MO Campelo, PhD

  Escola Superior da Saúde do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natália MO Campelo, PhD

CONTACT

+35122 206 1000; nmc@ess.ipp.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 11, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

PT (1)