Efficacy of Manual Therapy in Migraine

MIGRAINE Clinical Trial

— MTHDIQMi  

Official title:

DO SOFT TISSUE TECHNIQUES HAVE A POSITIVE EFFECT ON DISABILITY AND QUALITY OF LIFE IN MIGRAINE SUFFERERS?: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02446275
• Other study ID #: ID005
• Status: Completed
• Phase: N/A
• First received: March 20, 2015
• Last updated: May 15, 2015
• Start date: January 2014
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Objective: The aim of this study was to determine the efficacy of suboccipital inhibitory manual therapy treatment in migraine compared to treatment based on Myofascial Trigger Points (MTrPs) and their stretching, often being hypersensitive in patients with migraine.

Material and methods: 27 patients in two groups participated in the study: a) the control group received combined techniques based on MTrPs and bilateral stretching in the trapezius and sternocleidomastoid muscle (SCM); b) the experimental group was applied the same techniques as those applied in the control group plus suboccipital inhibition. The treatment lasted for 8 weeks and the impact, disability and quality of life were assessed in both groups.

Description:

Introduction Migraine is a highly prevalent disorder entailing substantial costs. Manual therapy offers an attractive option as an alternative to medical treatment or used in combination therewith. Treatment focused on the soft tissues of the suboccitpital region has been studied in other types of headaches but not in migraine.

Objective: The aim of this study was to determine the efficacy of suboccipital inhibitory manual therapy treatment in migraine compared to treatment based on Myofascial Trigger Points (MTrPs) and their stretching, often being hypersensitive in patients with migraine.

Material and methods: 27 patients in two groups participated in the study: a) the control group received combined techniques based on MTrPs and bilateral stretching in the trapezius and sternocleidomastoid muscle (SCM); b) the experimental group was applied the same techniques as those applied in the control group plus suboccipital inhibition. The treatment lasted for 8 weeks and the impact, disability and quality of life were assessed in both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Patients were diagnosed according to the criteria established by the IHS

Exclusion Criteria:

• Patients were excluded if they presented with other headache types, if their headache was triggered by neck movement, or if they presented with dizziness, hypertension, emotional stress, psychological disorders, cardiovascular disease or pregnancy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• MIGRAINE
• Migraine Disorders

Intervention

Other:
• Sternocleidomastoid MTRP and stretching
The sternocleidomastoid was treated with ischemic compression. The patient's head was passively moved into contralateral rotation and the patient was asked to relax completely. Sustained pressure was then applied to the sternocleidomastoid muscle until the pain threshold was reached. During the application of pressure, pain decreases so the pressure was gradually increased over a duration of 1 minute. The pressure was then reduced progressively.
• Trapezius MTRP and stretching
The central MTRP of the trapezius was treated as described above for the sternocleidomastoid. Subsequently stretching was performed, whereby the therapist supported the patient's head and performed passive contralateral inclination and ipsilateral rotation of the head. The therapist placed one hand over the patients shoulder while the other hand performed the stretching and simultaneously controlled the position of the head to achieve suitable stretching

Locations

Country	Name	City	State
Spain	Gemma v. Espí López	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Becker C, Brobert GP, Almqvist PM, Johansson S, Jick SS, Meier CR. Migraine incidence, comorbidity and health resource utilization in the UK. Cephalalgia. 2008 Jan;28(1):57-64. Epub 2007 Nov 6. — View Citation

Calandre EP, Hidalgo J, García-Leiva JM, Rico-Villademoros F. Trigger point evaluation in migraine patients: an indication of peripheral sensitization linked to migraine predisposition? Eur J Neurol. 2006 Mar;13(3):244-9. — View Citation

Fernández-de-las-Peñas C, Dommerholt J. Myofascial trigger points: peripheral or central phenomenon? Curr Rheumatol Rep. 2014 Jan;16(1):395. doi: 10.1007/s11926-013-0395-2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	The Visual Analogue Scale (VAS)25 was used to rate the patients average pain intensity using a 0-10 scale (0=no pain, 10=the most severe pain).	4 weeks	No
Secondary	The impact of headache (HIT-6)	The Headache Impact Test (HIT-6) (Yang et al., 2011) provides an overall measure of the adverse impact of headaches. This questionnaire consists of 6 items measuring the impact of pain on social functioning, role functioning, vitality, cognitive functioning and psychological distress, and provides a measure of the severity.	4 weeks	No
Secondary	Disability (MIDAS)	. Disability caused by migraine was assessed by the MIDAS questionnaire (Adenis Silva et al., 2008) based on 5 questions and the score obtained from the sum of the days lost due to headaches registered in the questions.	4 weeks	No