Tension-type Headache Clinical Trial
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
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | January 2016 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Gemma v. Espí López | Valencia |
Lead Sponsor | Collaborator |
---|---|
University of Valencia |
Spain,
Peñacoba-Puente C, Fernández-de-Las-Peñas C, González-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: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, week 4, and week 8 | No |
Primary | 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). | Basline, week 4 and week 8 | No |
Secondary | 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. | All patients were assessed under the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). | No |
Secondary | 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 | All patients were assessed under the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05517200 -
Pilot Study for a Machine Learning Test for Migraine
|
||
Not yet recruiting |
NCT05906901 -
Effects of Osteopathic Treatment in Patients With Tension Type Headache
|
N/A | |
Completed |
NCT02264340 -
Effects of Exercise and Relaxation Techniques on Tension Headache Pain Parameters of University Students
|
N/A | |
Terminated |
NCT00276952 -
Gonyautoxin in the Treatment of Chronic Tension-Type Headache
|
Phase 2 | |
Recruiting |
NCT04867967 -
Yoga and MBSR for TTH
|
N/A | |
Active, not recruiting |
NCT06112587 -
Muscle Function and Strength Training of the Neck and Shoulder in Migraine and Tension-type Headache Patients. A Singel Arm Open Label Trial
|
N/A | |
Recruiting |
NCT04857671 -
Botulinum Toxin A in Frequent and Chronic Tension-type Headache
|
Phase 3 | |
Completed |
NCT04523311 -
An Evaluation of Brief Online Hypnosis for Migraine and Tension-type Headaches
|
N/A | |
Recruiting |
NCT06108180 -
Effectiveness of the Dry Needling Approach in Patients With Tension-Type Headache
|
N/A | |
Completed |
NCT03056131 -
Diacutaneous Fibrolysis, Effects on Tension Type Headache
|
N/A | |
Recruiting |
NCT05153876 -
An Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients
|
||
Not yet recruiting |
NCT06065969 -
Photobiomodulation Dosimetry s in Patients With Orofacial Pain
|
N/A | |
Recruiting |
NCT05431335 -
Exercise Treatment in Tension Type Headache
|
N/A | |
Recruiting |
NCT06050382 -
Progressive Relaxation Training Effect On Pain, Activity And Social Participation In Women With Tension-Type Headache And Migraine
|
N/A | |
Recruiting |
NCT05893004 -
German Translation and Cross-cultural Adaptation of the Headache Screening Questionnaire (HSQ) Followed by a Test-retest Reliability Study.
|
N/A | |
Completed |
NCT02269501 -
Exercise in Migraine and Co-existing Tension-type Headache and Neck Pain
|
N/A | |
Not yet recruiting |
NCT05689944 -
Dance-therapy and Chronic Pain
|
N/A | |
Completed |
NCT02984826 -
Muscle Strength in Shoulder and Neck Muscles in Tension Type Headache Patients. Effect of Specific Strength Training
|
N/A | |
Completed |
NCT00315666 -
Prophylactic Effect of Memantine in Chronic Tension-Type Headache
|
Phase 3 | |
Recruiting |
NCT05430776 -
Laser Therapy on Tension-type Cephalea and Orofacial Pain in Post-covid-19 Patients
|
N/A |