NCT03555214: MT-Migraine

Efficacy of Manual Therapy for the Treatment of Migraine.

Completed NA Last updated 14 April 2020

What this trial tests

NA trial testing Manual Therapy based on soft tissues in Migraine in 100 participants. Completed in 3 December 2019.

Timeline

30 June 2018

Primary endpoint
30 October 2018

3 December 2019

Quick facts

Lead sponsor	University of Valencia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	treatment
Enrollment	100
Start date	30 June 2018
Primary completion	30 October 2018
Estimated completion	3 December 2019
Sites	1 location across Spain

Drugs / interventions tested

• Manual Therapy based on soft tissues
• Control group — full drug profile →
• Manual Therapy based on structural techniques
• Manual Therapy based on soft tissues and structural techniques

Conditions studied

• Migraine — all drugs for Migraine →

Sponsor

University of Valencia

Who can join

Adults 18 to 60, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction According to the World Health Organization (WHO) at least 47% of adults have suffered from headache in the last year. The headache is not only painful but also disabling, it can be accompanied by social and personal problems, with a decrease in the quality of life and with economic losses. Migraine affects a large number of people and, if the predisposing factors are not controlled, it can become chronic. Once the chronification point of migraine has arrived, it seriously affects the quality of life of people, both in the workplace, social and leisure.

objective Perform the application of a manual therapy treatment based on protocols that include techniques already proven to improve different areas of impact in patients with migraine. To evaluate various aspects, we will include the intensity of pain, the frequency of episodes, anxiety and depression, quality of life, etc ... and the limitations or disability that it produces.

Material and methods This is a prospective, single-blind, randomized study with patients diagnosed with migraine. The sample will be distributed in 4 groups: a) experimental group that will receive combined treatment of soft tissues with techniques evidenced independently; b) Group that will receive independent structural techniques; c) the group that will receive the set of protocols a and b; d) and the placebo control group.

Evaluation An initial assessment will be carried out, another at the end of the treatment and another follow-up one month after the end of the treatment. In addition, the evaluation will include the following instruments: the HDI scale (Headache Disability Inventory), the MIDAS scale (Migraine Disability Assessment Scale), the SF-36 Questionnaire, the EVA Scale (Visual-Analogue Scale), the HIT-6 Questionnaire, the BDI Questionnaire (Beck Inventory Depression), the STAI Questionnaire (The State-Trait Anxiety Inventory), the change perceived after the treatment and medication intake.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Potential Add-On Effects of Manual Therapy Techniques in Migraine Patients: A Randomised Controlled Trial.
   Muñoz-Gómez E, Serra-Añó P, Mollà-Casanova S, Sempere-Rubio N, et al · · 2022 · cited 10× · PMID 36012924 · DOI 10.3390/jcm11164686
2. Effect of a Craniosacral Therapy Protocol in People with Migraine: A Randomized Controlled Trial.
   Muñoz-Gómez E, Inglés M, Aguilar-Rodríguez M, Mollà-Casanova S, et al · · 2022 · cited 10× · PMID 35160211 · DOI 10.3390/jcm11030759