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NCT Number: NCT01550276

Treatment of Tension-type Headache With Articulatory and Suboccipital Soft Tissue Therapy

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.

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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

  • 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

Treatment and study plan

Manual therapy

Other

All patients were assessed in the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). Four treatment sessions (one session per week). Prior to each treatment session, 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 SI treatment aims to release the suboccipital muscle spasm10 that maintains the occiput-atlas-axis joint dysfunction. This technique, which was administered for 10 minutes, uses a deep and progressive gliding pressure applied with the fingertips towards the posterior arch of atlas.

Placebo control

Other

All patients were assessed in the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). Four treatment sessions (one session per week). Prior to each treatment session, 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.

Primary outcomes

  1. 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)

    Time frame: up to 4 weeks

    This interview gathers information about age, sex, intensity and frequency of headache (with a Visual Analog Scale from 0 to 10), severity of pain (low, moderate, high), qualities of pain (Bilateral location of pain, Pulsating pressure, Not aggravated by physical activity, Photofobia/Phonofobia, Nausea/Vomiting, Pericranial tenderness), cranial location of pain, family history of headache, triggers, aggravating and pain-relieving factors, as well as any previous physiotherapy treatment for headache relief.

Secondary outcomes

  1. Impact of headache on daily life(HIT-6)

    Time frame: up to 8 weeks

    It consists of 6 items each with 4 response options ranging from "never" (6 points) to "always" (13 points), and has shown high reliability in previous studies (alpha 0.87).

  2. Headache Disability Inventory (HDI)

    Time frame: up to 8 weeks

    Two first items concerning the frequency and intensity of headaches and a questionnaire of 25 items assessing emotional and functional aspects with 4 possible response options, with an alpha reliability of 0.76-0.83

  3. Headache pain intensity

    Time frame: up to 8 weeks

    rated daily by the patient on the 0-10 Visual Analogue Scale (VAS) (0 = no pain, 10 = most severe pain).

  4. Ranges of motion of the craniocervical junction

    Time frame: up to 8 weeks

    measured with the CROM-device. This instrument has demonstrated a good intra-tester reliability for the movements of cervical flexion, extension, lateral flexion and rotation (ICC > 0.80) (ICC>0.80). However, not having found any previous studies about its reliability for the craniocervical junction (upper cervical joint), we performed -before using this device in our study- an inter-tester reliability analysis with our two examiners and 10 patients not participating in this study, which showed a Pearson's correlation of 0.98

  5. Headache diary

    Time frame: up to 8 weeks

    During the four-week treatment period and in the follow-up phase, patients recorded on a daily basis the characteristics of headache with data regarding headache frequency and intensity, associated headache symptoms of photophobia or phonophobia, nausea or vomiting, and pericranial tenderness, completing a total of 7 weekly records.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Treatment of Tension-type Headache With Articulatory and Suboccipital Soft Tissue Therapy: a Double-blind, Randomized, Placebo-controlled Clinical Trial

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Mar 9, 2012
Registry last updated
Mar 9, 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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