Clinical trial NCT01601015: Effectiveness of the Treatment of Tension-type Headache With Manual and Manipulative Therapy
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension-type Headache
Keywords: Tension-type headache, Effectiveness, Manual therapy
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Multidimensional perception of pain, assessed by the McGill Pain Questionnaire
timeFrame: up to 8 weeks
measure: Cervical ranges of motion, measured with the CROM-device
timeFrame: up to 8 weeks
measure: Weekly register
timeFrame: up to 7 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Gemma V Espí López
Study officials:
affiliation: Physiotherapy Department. University of Valencia. Spain
name: Gemma Victoria Espí López, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.