Clinical trial NCT01550276: Treatment of Tension-type Headache With Articulatory and Suboccipital Soft Tissue Therapy
Official title: Treatment of Tension-type Headache With Articulatory and Suboccipital Soft Tissue Therapy: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension-type Headache
Keywords: Effectiveness
Tension-type headache
Manual therapy
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2012-03-09
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. Headache is one of the most common causes of consultation in primary health care and neurology in Europe. Cervical muscle tension can maintain a restriction of joint motion at the suboccipital level, facilitating the referred head pain.

Objective. To evaluate the effectiveness of two manual therapy treatments for tension-type headache.

Methods. A randomized double-blind clinical trial was conducted, for a period of 4 weeks and a follow-up at one month post-treatment. Eighty-four patients with tension-type headache were assigned to 4 groups (3 treatment groups and 1 control group). Treatments included manual therapy of suboccipital soft tissue inhibition, occiput-atlas-axis global manipulation, and a combination of both techniques. Outcome measures were: impact of headache, disability caused by headache, ranges of motion of the craniocervical junction, frequency and intensity of headache, and associated headache symptoms.

Results. After 8 weeks, there were significant improvements in impact of headache (p=0.01), disability (p=0.001), and craniocervical flexion (p=0.03) for the suboccipital soft tissue inhibition group; in headache impact and disability (p=0.000), pain intensity (p=0.02) and craniocervical flexion (p=0.004) and extension (p=0.04) for the occiput-atlas-axis group; and in impact (p=0.002), functional disability (p=0.000), headache frequency (p=0.002) and intensity (p=0.001), craniocervical flexion (p=0.008) and extension (p=0.003) and associated headache symptoms (p=0.01) for the combined therapy group, with effect sizes from medium to large.

Conclusions. Occiput-atlas-axis and combined therapy group treatments are more effective than suboccipital soft tissue inhibition for tension-type headache. The treatment with suboccipital soft tissue inhibition, despite producing less significant results, also has positive effects on different aspects of headache.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years, episodes of headaches lasting from 30 minutes to 7 days, headache having at least two of the following characteristics: \*bilateral location

  * pressing non-pulsating quality
  * mild or moderate intensity
  * not aggravated by routine physical activity.
* Participants may present photophobia or phonophobia, nausea or vomiting, pericranial tenderness, with evolution of more than three months, and they must be under pharmacological control.

Exclusion Criteria:

* Patients with other types of headache
* Headache that is aggravated by head movements
* Metabolic disorders or musculoskeletal complaints previous neck trauma
* Vertigo
* Dizziness
* Arterial hypertension
* Advanced degenerative osteoarthritis
* Neck joint stiffness
* Signs of malignancy
* Pregnancy
* Patients with cardiac devices
* Patients in process of pharmacological adaptation, and excessive emotional tension

Primary outcomes:
measure: Firstly, 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: Impact of headache on daily life(HIT-6)
timeFrame: up to 8 weeks
measure: Headache Disability Inventory (HDI)
timeFrame: up to 8 weeks
measure: Headache pain intensity
timeFrame: up to 8 weeks
measure: Ranges of motion of the craniocervical junction
timeFrame: up to 8 weeks
measure: Headache diary
timeFrame: up to 8 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.
citation: Espi-Lopez GV, Gomez-Conesa A, Gomez AA, Martinez JB, Pascual-Vaca AO, Blanco CR. Treatment of tension-type headache with articulatory and suboccipital soft tissue therapy: A double-blind, randomized, placebo-controlled clinical trial. J Bodyw Mov Ther. 2014 Oct;18(4):576-85. doi: 10.1016/j.jbmt.2014.01.001. Epub 2014 Jan 10.