The Influence of Manual Therapy in the Quality of Life in Tension-Type Headache

Not Applicable

Completed

• Conditions: Quality of Life

• Registration Number: NCT02455323
• Lead Sponsor: University of Valencia

Brief Summary

The present study aims to assess the quality of life of patients suffering from tension-type headache (TTH) treated for 4 weeks with different manual therapy-based techniques. The study design involved a factorial, randomized, double-blind, controlled study

Detailed Description

Object: The present study aims to assess the quality of life of patients suffering from tension-type headache (TTH) treated for 4 weeks with different manual therapy-based techniques.

Methods: The study design involved a factorial, randomized, double-blind, controlled study of 76 subjects. They were divided into 4 groups: suboccipital inhibitory pressure was applied to the first group; suboccipital spinal manipulation was applied to the second group; a combination of the two treatments was applied to the third group; and the fourth group was a control group. Quality of life was assessed using the SF-12 questionnaire (both overall and in its different dimensions) at the beginning and at the end of treatment, and after one month as a follow-up.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-05
• Study Completion: 2013-12
• Study First Submitted: 2015-03-20
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-27
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• diagnosed by a neurologist, with headache characteristics as established by the International Headache Society and Controlled pharmacologically.

Exclusion Criteria

• Patients with infrequent ETTH, or with probable frequent and infrequent forms of TTH They can never have vomiting or headache episodes during the treatment ETTH patients may experience very occasionally photophobia or phonophobia during their episodes of headache, CTTH patients may experience very occasionally photophobia, phonophobia or mild nausea during headache episodes. Pain aggravated by movement of the head, Metabolic or musculoskeletal problems with similar headache symptoms, Previous trauma to the cervical spine, Active vertigo history Poorly controlled hypertension, Joint stiffness, atherosclerosis, or advanced osteoarthritis, Patients undergoing pharmacological adaptation, Excessive emotional stress, Patients with heart devices Joint instability, Neurological disorders, Laxity of cervical soft tissues, Radiographic abnormalities Generalized hyperlaxity or hypermobility, Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
frequency of pain	one month prior to the study	These included major aspects for TTH verification, including frequency of noted pain (less than 15 days monthly = ETTH; more than 15 days monthly = CTTH) response to the classification of the IHS.
severity of pain	one month prior to the study	These included major aspects for TTH verification, including severity of pain response to the classification of the IHS.

Secondary Outcome Measures

Name	Time	Method
quality of life	8 weeks	To assess the subject's quality of life, we applied the health status questionnaire SF-12v2 (Short Form 12 Health Survey) which has shown to be highly reliable. This questionnaire has been adapted to the Spanish context by Alonso et al. and Monteagudo et al.

Trial Locations

Locations (1)

Gemma v. Espí López; 🇪🇸 Valencia, Spain