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

• ClinicalTrials.gov Identifier: NCT02455323
• Recruitment Status: Completed
• First Posted: May 27, 2015
• Last Update Posted: May 28, 2015
• Sponsor: University of Valencia
• Information provided by (Responsible Party): GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia

Study Description

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

Condition or disease	Intervention/treatment	Phase
Quality of Life	Other: Suboccipital inhibitory; Other: Spinal manipulative; Other: Combined treatment; Other: Control group.	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Influence of Spinal Manipulation and Suboccipipital Inhibition as a Complementary Therapy for Tension Headache in Quality of Life: A Randomized Controlled Trial
• Study Start Date: March 2013
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: Suboccipital inhibitory; 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. The aim is to suppress spasm of the muscles and in general of the suboccipital soft tissues which are responsible for any dysfunctional mobility of the occiput, atlas, or even the axis.
Experimental: 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.	Other: Spinal manipulative; 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
Experimental: Combined treatment; Consisted in applying the above two techniques using exactly the same sequence: first the SI technique, and then the SM technique.	Other: Combined treatment; Consisted in applying the above two techniques using exactly the same sequence: first the SI technique, and then the SM technique.
Placebo Comparator: 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).	Other: 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).

Outcome Measures

Primary Outcome Measures :

1. frequency of pain [ Time Frame: 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.
2. severity of pain [ Time Frame: 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 :

1. quality of life [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Spain

Gemma v. Espí López

Valencia, Spain, 46010

Sponsors and Collaborators

University of Valencia

Investigators

• Study Director: Gemma V Espí-López, PhD; Department of Physiotherapy

More Information

Publications:

Couppé C, Torelli P, Fuglsang-Frederiksen A, Andersen KV, Jensen R. Myofascial trigger points are very prevalent in patients with chronic tension-type headache: a double-blinded controlled study. Clin J Pain. 2007 Jan;23(1):23-7.

Toro-Velasco C, Arroyo-Morales M, Fernández-de-Las-Peñas C, Cleland JA, Barrero-Hernández FJ. Short-term effects of manual therapy on heart rate variability, mood state, and pressure pain sensitivity in patients with chronic tension-type headache: a pilot study. J Manipulative Physiol Ther. 2009 Sep;32(7):527-35. doi: 10.1016/j.jmpt.2009.08.011.

Espí-López GV, Rodríguez-Blanco C, Oliva-Pascual-Vaca A, Benítez-Martínez JC, Lluch E, Falla D. Effect of manual therapy techniques on headache disability in patients with tension-type headache. Randomized controlled trial. Eur J Phys Rehabil Med. 2014 Dec;50(6):641-7. Epub 2014 Apr 30.

• Responsible Party: GEMMA V ESPÍ LÓPEZ, PhD, PhD, University of Valencia
• ClinicalTrials.gov Identifier: NCT02455323
• Other Study ID Numbers: ID004
• First Posted: May 27, 2015
• Last Update Posted: May 28, 2015
• Last Verified: May 2015

Keywords provided by GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia:

Efficacy; Tension-type headache; Manual therapy

Additional relevant MeSH terms:

Tension-Type Headache; Headache; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases