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Completed

NCT Number: NCT01601015

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

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).

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Key information

Conditions

Tension-type Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gemma V Espí López

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual therapy

Other

Manual therapy of Suboccipital soft tissue Inhibition is performed with patient in supine position. The patient's head leans against the physiotherapist's hands, which palpate suboccipital muscles by sliding fingertips until contacting posterior arch of atlas. At this point, a deep and progressive gliding pressure is applied, for 10 minutes. The purpose of this technique is to release suboccipital muscle spasm, which can be responsible for the mobility dysfunction of the occiput-atlas-axis joint.

Other names: Tension-type Headache

Placebo treatment

Other

The physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups.

The control group received four sessions of placebo treatment, followed by ten minutes of resting position.

Other names: Resting position, Tension-type Headache

Primary outcomes

  1. 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)

    Time frame: 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 outcomes

  1. Multidimensional perception of pain, assessed by the McGill Pain Questionnaire

    Time frame: 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.

  2. Cervical ranges of motion, measured with the CROM-device

    Time frame: 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.

  3. Weekly register

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Effectiveness of the Treatment of Tension-type Headache With Manual and Manipulative Therapy in the Perception of Pain and Cervical Motion: a Double-blind, Randomized, Placebo-controlled Clinical Trial.

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
May 17, 2012
Registry last updated
May 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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