Back to resultsManual Therapy for Tension Headache With Psychological Disorders
Primary Purpose
Tension-type Headache
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
The suboccipital technique
The articulatory technique
Combined treatment
Sponsored by
About this trial
This is an interventional treatment trial for Tension-type Headache focused on measuring Tension-type headache, Depression, Anxiety, Manual therapy, Spinal manipulation, Patients diagnosed with tension-type headache
Eligibility Criteria
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.
Exclusion Criteria:
- Exclusion criteria covered patients with secondary headache suffering from photophobia or phonophobia, nausea or vomiting, cases of headache aggravated by head movements, musculoskeletal disorders, previous neck trauma, vertigo, dizziness, arterial hypertension, arthritis or advanced degenerative osteoarthritis, patients with heart devices, excessive emotional tension, neurological disorders, radiological alterations, pregnancy and a positive vertebral artery test.
Sites / Locations
- Gemma v. Espí López
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
suboccipital technique
The articulatory technique
Combined treatment
Control group
Arm Description
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.
- 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.
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.
Control group. The control group was not applied a treatment technique
Outcomes
Primary Outcome Measures
Change from baseline in Frequency of TTH at week 4 and at week 8
During the study, all subjects completed a weekly register of headaches.
Change from baseline in Intensity of TTH at week 4 and at week 8
During the study, all subjects completed a weekly register of headaches, recording on a daily basis their intensity, using the Visual Analogue Scale (VAS), which measures pain intensity in a 0-10 scale (0=no pain, 10=the most severe pain).
Secondary Outcome Measures
Anxiety
Anxiety was assessed with the State-Trait Anxiety Inventory (STAI-SA and STAI-TA). Scores range from 0 to a maximum of 60 points; scoring above the 50th percentile indicates the presence of anxiety. For men, this percentile correlates with a score of 19 points, both for STAI-state and STAI-trait. For women, scores over 21 for STAI-state and 24 for STAI-trait determine this level.
Depression
Depression, assessed with the Beck Depression Inventory (BDI) , which consists of 21 items with 4 possible answers each; it is intended to assess the severity of depression. It was adapted into Spanish and validated by Conde and Useros, showing very good
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02170259
Brief Title
Manual Therapy for Tension Headache With Psychological Disorders
Official Title
Efficacy of Manual Therapy for the Treatment of Tension-type Headache in Patients With Anxiety and Depressive Disorders. A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-type Headache
Keywords
Tension-type headache, Depression, Anxiety, Manual therapy, Spinal manipulation, Patients diagnosed with tension-type headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
suboccipital technique
Arm Type
Experimental
Arm Description
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.
Arm Title
The articulatory technique
Arm Type
Experimental
Arm Description
- 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.
Arm Title
Combined treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group. The control group was not applied a treatment technique
Intervention Type
Other
Intervention Name(s)
The suboccipital technique
Intervention Description
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
Intervention Name(s)
The articulatory technique
Intervention Description
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
Intervention Name(s)
Combined treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in Frequency of TTH at week 4 and at week 8
Description
During the study, all subjects completed a weekly register of headaches.
Time Frame
Baseline, week 4, and week 8
Title
Change from baseline in Intensity of TTH at week 4 and at week 8
Description
During the study, all subjects completed a weekly register of headaches, recording on a daily basis their intensity, using the Visual Analogue Scale (VAS), which measures pain intensity in a 0-10 scale (0=no pain, 10=the most severe pain).
Time Frame
Basline, week 4 and week 8
Secondary Outcome Measure Information:
Title
Anxiety
Description
Anxiety was assessed with the State-Trait Anxiety Inventory (STAI-SA and STAI-TA). Scores range from 0 to a maximum of 60 points; scoring above the 50th percentile indicates the presence of anxiety. For men, this percentile correlates with a score of 19 points, both for STAI-state and STAI-trait. For women, scores over 21 for STAI-state and 24 for STAI-trait determine this level.
Time Frame
All patients were assessed under the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks).
Title
Depression
Description
Depression, assessed with the Beck Depression Inventory (BDI) , which consists of 21 items with 4 possible answers each; it is intended to assess the severity of depression. It was adapted into Spanish and validated by Conde and Useros, showing very good
Time Frame
All patients were assessed under the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Exclusion Criteria:
Exclusion criteria covered patients with secondary headache suffering from photophobia or phonophobia, nausea or vomiting, cases of headache aggravated by head movements, musculoskeletal disorders, previous neck trauma, vertigo, dizziness, arterial hypertension, arthritis or advanced degenerative osteoarthritis, patients with heart devices, excessive emotional tension, neurological disorders, radiological alterations, pregnancy and a positive vertebral artery test.
Facility Information:
Facility Name
Gemma v. Espí López
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
18331805
Citation
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.
Results Reference
result
Learn more about this trial
Manual Therapy for Tension Headache With Psychological Disorders
We'll reach out to this number within 24 hrs