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

NCT01601015 | Completed DMC

• 1 other identifier: UVT002
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

Tension-type Headache

Keywords

Tension-type headache, Effectiveness, Manual therapy

Outcome Measures

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)

  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).

  up to 4 weeks

Secondary Outcomes (3)

• Multidimensional perception of pain, assessed by the McGill Pain Questionnaire

  up to 8 weeks

• Cervical ranges of motion, measured with the CROM-device

  up to 8 weeks

• Weekly register

  up to 7 weeks

Study Arms (4)

Manual therapy

EXPERIMENTAL

Manual therapy of Suboccipital soft tissue Inhibition treatment aims to release the suboccipital muscle spasm that maintains the occiput-atlas-axis joint dysfunction.

Other: Manual Therapy

Occiput-atlas-axis joint manipulation

EXPERIMENTAL

Is bilaterally administered. The aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction

Other: Manual Therapy

Combined treatment

EXPERIMENTAL

The group receiving combined treatment received the two previous techniques exactly with the same sequence.

Other: Manual Therapy

Control group

PLACEBO COMPARATOR

Control group not receive treatment and stayed in this position for 10 minutes

Other: placebo treatment

Interventions

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.

Also known as: Tension-type Headache

Manual therapy

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.

Also known as: Resting position, Tension-type Headache

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Gemma V Espí López

Valencia, Valencia, 46010, Spain

Location

Related Publications (1)

• Castien RF, van der Windt DA, Grooten A, Dekker J. Effectiveness of manual therapy for chronic tension-type headache: a pragmatic, randomised, clinical trial. Cephalalgia. 2011 Jan;31(2):133-43. doi: 10.1177/0333102410377362. Epub 2010 Jul 20.

  PMID: 20647241 RESULT

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gemma Victoria Espí López, PhD

  Physiotherapy Department. University of Valencia. Spain

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: May 17, 2012
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: May 17, 2012

Record last verified: 2012-05

Locations

ES (1)