NCT02446275

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
Last Updated

May 18, 2015

Status Verified

May 1, 2015

Enrollment Period

10 months

First QC Date

March 20, 2015

Last Update Submit

May 15, 2015

Conditions

MIGRAINE

Keywords

efficacy, manual therapy, migraine, quality of life

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • The impact of headache (HIT-6)

    4 weeks

  • Disability (MIDAS)

    4 weeks

Study Arms (2)

Sternocleidomastoid MTRP and stretching

EXPERIMENTAL

The sternocleidomastoid was treated with ischemic compression.

Other: Trapezius MTRP and stretching

Trapezius MTRP and stretching

EXPERIMENTAL

The central MTRP of the trapezius was treated as described above for the sternocleidomastoid.

Other: Sternocleidomastoid MTRP and stretching

Interventions

Sternocleidomastoid MTRP and stretchingOTHER

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
Trapezius MTRP and stretchingOTHER

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

Sternocleidomastoid MTRP and stretching

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gemma v. Espí López

Valencia, Valencia, 46010, Spain

Location

Related Publications (3)

  • Fernandez-de-las-Penas 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.

    PMID: 24264721BACKGROUND

  • 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. doi: 10.1111/j.1468-2982.2007.01469.x. Epub 2007 Nov 6.

    PMID: 17986274BACKGROUND

  • Calandre EP, Hidalgo J, Garcia-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. doi: 10.1111/j.1468-1331.2006.01181.x.

    PMID: 16618340BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD

Study Record Dates

First Submitted

March 20, 2015

First Posted

May 18, 2015

Study Start

January 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

May 18, 2015

Record last verified: 2015-05

Locations

ES(1)