Manual Therapy for Tension Headache With Psychological Disorders

NCT ID: NCT02170259

Last Updated: 2016-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-01-31

Brief Summary

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Introduction. Tension-type headache is a highly prevalent disorder with a significant socio-economic impact, affecting psychological aspects. This study aims to assess aspects pertaining to anxiety, depression, headache frequency and pain intensity.

Subjects and methods. A clinical trial was conducted on 84 participants suffering from tension-type headache, divided into 4 groups, the mean age being 39.76 years (SD 11.38). The first group received suboccipital soft tissue treatment (ST); the second group was treated with articulatory technique (AT); the third group was applied a combination of both techniques (ST and AT) and a forth group which served as control group. Treatment sessions were administered during four weeks, with a post-treatment assessment, and follow-up after one month. The investigators conducted Repeated measures Analysis of Covariance (RM-MANCOVA) to evaluate the effect of treatment on between and within-subject conditions and their interaction on reported depression, anxiety, and headache pain frequency and intensity.

Detailed Description

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Conditions

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Tension-type Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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suboccipital technique

The suboccipital technique (ST) aims to release the spasm of the muscles affected in tension-type headaches and in general of suboccipital soft tissues, as they are responsible for the mobility dysfunction of the occiput-atlas-axis joint; this releases the facial restriction of this region.

Group Type EXPERIMENTAL

The suboccipital technique

Intervention Type OTHER

The suboccipital technique (ST) aims to release the spasm of the muscles affected in tension-type headaches and in general of suboccipital soft tissues, as they are responsible for the mobility dysfunction of the occiput-atlas-axis joint; this releases the facial restriction of this region. Patients lied on the stretcher, in supine position, with their occiput resting against the physiotherapist's hands. Fingertips slide until contacting the posterior arch of atlas so that it "hangs" from the fingers. A deep and progressive pressure is applied, perpendicularly to muscle fibers, until the therapist perceives that muscle tone decreases. Approximate duration of ST is 10 minutes and it is performed with patients' eyes closed because of the connection between craniocervical muscle tone and eye movements

The articulatory technique

\- The articulatory technique (AT) was administered to correct and restore the mobility of joints between occiput, atlas and axis - correcting a global joint dysfunction. This technique was performed in supine position, in the same manner as the preceding technique, bilaterally and in two phases.

Group Type EXPERIMENTAL

The articulatory technique

Intervention Type OTHER

The articulatory technique (AT) was administered to correct and restore the mobility of joints between occiput, atlas and axis - correcting a global joint dysfunction. This technique was performed in supine position, in the same manner as the preceding technique, bilaterally and in two phases. First, a gentle head decompression is applied, followed by small circumduction searching for the joint barrier in rotation through selective tension. Second, the manipulation is performed by a cranial rotation towards the same side as the circumduction and around a vertical axis passing through the axis, without cervical flexion or extension and very little bending

Combined treatment

Combined treatment (ST and AT). Combination treatment consisted of the application of the two preceding treatments in the same sequence: first, treatment with ST and then AT.

Group Type EXPERIMENTAL

Combined treatment

Intervention Type OTHER

Combined treatment (ST and AT). Combination treatment consisted of the application of the two preceding treatments in the same sequence: first, treatment with ST and then AT, thereafter maintaining the resting position for five minutes

Control group

Control group. The control group was not applied a treatment technique

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The suboccipital technique

The suboccipital technique (ST) aims to release the spasm of the muscles affected in tension-type headaches and in general of suboccipital soft tissues, as they are responsible for the mobility dysfunction of the occiput-atlas-axis joint; this releases the facial restriction of this region. Patients lied on the stretcher, in supine position, with their occiput resting against the physiotherapist's hands. Fingertips slide until contacting the posterior arch of atlas so that it "hangs" from the fingers. A deep and progressive pressure is applied, perpendicularly to muscle fibers, until the therapist perceives that muscle tone decreases. Approximate duration of ST is 10 minutes and it is performed with patients' eyes closed because of the connection between craniocervical muscle tone and eye movements

Intervention Type OTHER

The articulatory technique

The articulatory technique (AT) was administered to correct and restore the mobility of joints between occiput, atlas and axis - correcting a global joint dysfunction. This technique was performed in supine position, in the same manner as the preceding technique, bilaterally and in two phases. First, a gentle head decompression is applied, followed by small circumduction searching for the joint barrier in rotation through selective tension. Second, the manipulation is performed by a cranial rotation towards the same side as the circumduction and around a vertical axis passing through the axis, without cervical flexion or extension and very little bending

Intervention Type OTHER

Combined treatment

Combined treatment (ST and AT). Combination treatment consisted of the application of the two preceding treatments in the same sequence: first, treatment with ST and then AT, thereafter maintaining the resting position for five minutes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients participating in this study had been diagnosed in primary healthcare centers with frequent episodic tension-type headache (ETTH) or chronic tension-type headache (CTTH) as described by the International Headache Society (IHS). Participants presented pericranial tenderness evolving over a period greater than six months and all were pharmacologically stable.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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GEMMA V ESPÍ LÓPEZ, PhD

PhDr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gemma v. Espí López

Valencia, Valencia, Spain

Site Status

Countries

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Spain

References

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Penacoba-Puente C, Fernandez-de-Las-Penas C, Gonzalez-Gutierrez JL, Miangolarra-Page JC, Pareja JA. Interaction between anxiety, depression, quality of life and clinical parameters in chronic tension-type headache. Eur J Pain. 2008 Oct;12(7):886-94. doi: 10.1016/j.ejpain.2007.12.016. Epub 2008 Mar 10.

Reference Type RESULT
PMID: 18331805 (View on PubMed)

Other Identifiers

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UVtensiontype

Identifier Type: -

Identifier Source: org_study_id

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