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

NCT02455323 | Completed

• 1 other identifier: ID004
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Conditions

Quality of Life

Keywords

Efficacy; Tension-type headache; Manual therapy

Outcome Measures

Primary Outcomes (2)

• frequency of pain

  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.

  one month prior to the study

• severity of pain

  These included major aspects for TTH verification, including severity of pain response to the classification of the IHS.

  one month prior to the study

Secondary Outcomes (1)

• quality of life

  8 weeks

Study Arms (4)

Suboccipital inhibitory

EXPERIMENTAL

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

Spinal Manipulative

EXPERIMENTAL

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

Combined treatment

EXPERIMENTAL

Consisted in applying the above two techniques using exactly the same sequence: first the SI technique, and then the SM technique.

Other: Combined treatment

Control group

PLACEBO COMPARATOR

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.

Interventions

Suboccipital inhibitory OTHER

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.

Suboccipital inhibitory

Spinal manipulative OTHER

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

Spinal Manipulative

Combined treatment OTHER

Consisted in applying the above two techniques using exactly the same sequence: first the SI technique, and then the SM technique.

Combined treatment

Control group. OTHER

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).

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Gemma v. Espí López

Valencia, Valencia, 46010, Spain

Location

Related Publications (3)

• Couppe 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. doi: 10.1097/01.ajp.0000210946.34676.7d.

  PMID: 17277641 BACKGROUND

• Toro-Velasco C, Arroyo-Morales M, Fernandez-de-Las-Penas C, Cleland JA, Barrero-Hernandez 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.

  PMID: 19748404 BACKGROUND

• Espi-Lopez GV, Rodriguez-Blanco C, Oliva-Pascual-Vaca A, Benitez-Martinez 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.

  PMID: 24785463 BACKGROUND

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Combined Modality Therapy; Control Groups

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Gemma V Espí-López, PhD

  Department of Physiotherapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: May 27, 2015
• Study Start: March 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

ES (1)