Effectiveness of the Treatment of Tension-type Headache With Manual and Manipulative Therapy

Not Applicable

Completed

• Conditions: Tension-type Headache
• Interventions: Other: Manual Therapy; Other: placebo treatment

• Registration Number: NCT01601015
• Lead Sponsor: University of Valencia

Brief Summary

Background. Tension-type headache (TTH) is the most common form of primary headache and it is a real problem for the subjects suffering from it. Until now, physiotherapy treatments have included different techniques combined together, without establishing which of them is more effective.

Objective. The purpose of this study is to know the effectiveness of manipulative and manual therapy treatments, with regard to pain perception and neck mobility in patients with tension-type headache.

Methods: A double-blind, randomized clinical trial was conducted, with 84 patients diagnosed with tension-type headache, divided into three treatment groups -manual therapy, manipulative therapy, and a combination of both techniques-, and a placebo control group. Four treatment sessions were administered during four weeks, with post-treatment assessment, and follow-up at one month. Cervical ranges of motion were assessed (CROM device), as well as pain perception (McGill Pain Questionnaire), and frequency and intensity of headaches (weekly register).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-12
• Study Completion: 2011-12
• Status Verified: 2012-05
• Study First Submitted: 2012-05-11
• Study First Submitted QC: 2012-05-16
• Last Update Submitted: 2012-05-16
• Study First Posted: 2012-05-17
• Last Update Posted: 2012-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Subjects aged between 18 and 65 years

• Diagnosis of frequent ETTH and CTTH

• Having headache episodes on more than 1 day per month

• Headache episodes lasting from 30 minutes to 7 days

• Headaches having at least 2 of the following characteristics:

  • Bilateral location of pain
  • Pressing non pulsating quality
  • Mild or moderate intensity
  • Not aggravated by physical activity

• Sufferers may present photophobia, phonophobia, nausea or vomiting

• Headache may be associated with pericranial tenderness

• Suffering from TTH for over 3 months

• Subjects being under pharmacological control

Exclusion Criteria

• Patients with infrequent ETTH, and patients with probable TTH in its frequent and infrequent forms.

  • Headache that is aggravated by head movements.
  • Metabolic or musculoskeletal disorders with symptoms similar to headache
  • Previous neck trauma
  • Vertigo, dizziness, arterial hypertension.
  • Joint stiffness, arteriosclerosis or advanced degenerative osteoarthritis
  • Patients with heart devices
  • Patients in process of pharmacological adaptation
  • Excessive emotional tension
  • Neurological disorders
  • Laxity of neck soft tissues
  • Radiological alterations
  • General hypermobility or hyperlaxity
  • Joint instability
  • Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Manual therapy	Manual Therapy	Manual therapy of Suboccipital soft tissue Inhibition treatment aims to release the suboccipital muscle spasm that maintains the occiput-atlas-axis joint dysfunction.
Occiput-atlas-axis joint manipulation	Manual Therapy	Is bilaterally administered. The aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction
Combined treatment	Manual Therapy	The group receiving combined treatment received the two previous techniques exactly with the same sequence.
Control group	placebo treatment	Control group not receive treatment and stayed in this position for 10 minutes

Primary Outcome Measures

Name	Time	Method
An individual clinical interview was conducted to collect socio-demographic data and characteristics of headache in a one-month base period (the previous 4 weeks)	up to 4 weeks	Firstly, socio-demographic data and characteristics of headache were collected during the four weeks prior to the treatment through individual clinical interview carried out by a physiotherapist who did not participate in the outcome assessment nor in the administration of treatments. It included age and sex, location of pain, side dominance of pain, type of pressure, connection with physical activity, frequency, severity of pain, associated symptoms and pain intensity, rated by the patient on the 0-10 Visual Analogue Scale (VAS) (0 = no pain, 10 = most severe pain).

Secondary Outcome Measures

Name	Time	Method
Multidimensional perception of pain, assessed by the McGill Pain Questionnaire	up to 8 weeks	includes the following aspects: a) sensory, description of pain in time-space terms; b) affective, description of pain in terms of stress, fear and neurovegetative aspects; and c) evaluative, pain described in terms of general assessment. The McGill Pain Questionnaire is validated in Spanish population \[13, 14\] and it consists of 66 word descriptors divided into 20 groups, including in each group between 2 and 6 adjectives describing pain. Moreover, it includes a section in which patients register the intensity of pain.
Cervical ranges of motion, measured with the CROM-device	up to 8 weeks	The CROM-device combines a system of inclinometers and magnets set on a head mainframe with a nose-piece (positions like eyeglasses) and it measures angles of flexion, extension, lateral flexion and rotation. As it includes a system of magnets, the CROM must not be used in subjects with heart devices.
Weekly register	up to 7 weeks	Frequency and intensity of headache, assessed with a seven register weekly. Patients recorded headache frequency as well as intensity of pain measured by the VAS Scale

Trial Locations

Locations (1)

Gemma V Espí López; 🇪🇸 Valencia, Spain