Manual Therapy for Tension Headache With Psychological Disorders

Not Applicable

Completed

• Conditions: Tension-type Headache

• Registration Number: NCT02170259
• Lead Sponsor: University of Valencia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-12
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-23
• Study Completion: 2016-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-05
• Last Update Posted: 2016-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change from baseline in Intensity of TTH at week 4 and at week 8	Basline, week 4 and 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).
Change from baseline in Frequency of TTH at week 4 and at week 8	Baseline, week 4, and week 8	During the study, all subjects completed a weekly register of headaches.

Secondary Outcome Measures

Name	Time	Method
Anxiety	All patients were assessed under the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks).	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	All patients were assessed under the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks).	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

Trial Locations

Locations (1)

Gemma v. Espí López; 🇪🇸 Valencia, Spain