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

Not Applicable

Completed

• Conditions: Quality of Life
• Interventions: Other: Suboccipital inhibitory; Other: Combined treatment; Other: Spinal manipulative; Other: Control group.

• 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

Arm && Interventions

Group	Intervention	Description
Suboccipital inhibitory	Suboccipital inhibitory	Suboccipital inhibitory pressure technique. According to this technique, the suboccipital musculature is palpated until contact is made with the posterior arch of the atlas, and progressive and deep gliding pressure is applied, pushing the atlas anteriorly. The occiput rests on the hands while the atlas is supported by the fingertips. Finger pressure must be maintained for 10 minutes to produce the therapeutic effect of inhibiting the suboccipital soft tissues.
Combined treatment	Combined treatment	Consisted in applying the above two techniques using exactly the same sequence: first the SI technique, and then the SM technique.
Spinal Manipulative	Spinal manipulative	Suboccipital inhibitory pressure technique. This technique is performed along an imaginary vertical line passing through the odontoid process of the axis. No flexion or extension and very little lateroflexion are used. Application is bilateral. First, cephalic decompression is performed lightly, followed by small circumductions. Selective tension is applied to take up tissue slack and create a firm joint barrier. Manipulation is then performed with rotation towards the manipulated side in a helicoidal cranial movement. This technique is designed to correct a generalized dysfunction with the aim of restoring occiput, atlas, and axis joint mobility.
Control group	Control group.	The subjects received no treatment, but attended the same number of sessions, maintaining the resting position for longer than the experimental groups, and underwent the same evaluations (test for arterial compromise, and the three assessments).

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