Efficacy of Manual Therapy for the Treatment of Tension-type Headache in Patients With Anxiety and Depressive Disorders. A Randomized Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tension-type Headache
- Sponsor
- University of Valencia
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Change from baseline in Intensity of TTH at week 4 and at week 8
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
GEMMA V ESPÍ LÓPEZ, PhD
PhDr
University of Valencia
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.
Outcomes
Primary Outcomes
Change from baseline in Intensity of TTH at week 4 and at week 8
Time Frame: 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
Time Frame: Baseline, week 4, and week 8
During the study, all subjects completed a weekly register of headaches.
Secondary Outcomes
- 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).)
- 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).)