Tratamiento de la Cefalea Tensional Mediante técnicas de Tejido Blando VS técnicas de estimulación Del Vago.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 42
- Locations
- 4
- Primary Endpoint
- Change in Pain intensity
Study Overview
Brief Summary
A treatment based on manual therapy and vagus nerve stimulation is more effective than manual therapy only to reduce frequency, intensity and pressure pain threshold in patients with tension type headache.
Detailed Description
Participants will be randomly assigned to two groups:
- Experimental group, to which soft tissue techniques and vagus nerve stimulation techniques will be applied.
- Control group, to which only soft tissue techniques are applied. Treatment will consist of four sessions, with an interval of seven days between them, for both study groups. Each session with a duration of 20 minutes for both groups.
In the control group, treatment using soft techniques will consist of the application of manual techniques that have already been shown to have some efficacy in other studies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients diagnosed with episodic or chronic tension type headache
Exclusion Criteria
- •Pregnant women
- •Patients who have received in the previous 3 months some type of treatment for headache
- •Recent history of syncope or seizures
- •Heart / cardiovascular disease
- •Electrical or neurostimulation devices
- •History of intracranial / carotid aneurysm or bleeding; brain tumors / lesions; significant head trauma.
- •Change in prophylactic medication type or dose <1 month before the intervention
Outcomes
Primary Outcomes
Change in Pain intensity
Time Frame: Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
The strength with which the participants subjectively feel their headache. It will be measured with the following degrees: mild, moderate or severe. The Headache Disability Inventory will be used to measure pain intensity.
Secondary Outcomes
- Change in Impact of pain(Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).)
- Change in Headache frequency(Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).)
- Change in Pain threshold(Day 1 (before the intervention), Day 28 (after the last intervention).)
- Change in Cervical Range of Motion(Day 1 (before the intervention), Day 28 (after the last intervention).)
Investigators
Lucia Trullenque Espallargas
STUDIENT
University of Alcala