Treatment of Tension-type Headache With Articulatory and Suboccipital Soft Tissue Therapy
- Conditions
- Tension-type Headache
- Interventions
- Other: Manual TherapyOther: Placebo control
- Registration Number
- NCT01550276
- Lead Sponsor
- University of Valencia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Suboccipital soft tissue inhibition Manual Therapy The SI treatment aims to release the suboccipital muscle spasm that maintains the occiput-atlas-axis joint dysfunction. Occiput-atlas-axis global manipulation Manual Therapy The OAA manipulation was bilaterally administered and it attempts to restore the motion dysfunction of this complex The combination of both treatments Manual Therapy - control group Placebo control -
- Primary Outcome Measures
Name Time Method 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) 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 Outcome Measures
Name Time Method Impact of headache on daily life(HIT-6) 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).
Headache Disability Inventory (HDI) 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
Headache pain intensity up to 8 weeks rated daily by the patient on the 0-10 Visual Analogue Scale (VAS) (0 = no pain, 10 = most severe pain).
Ranges of motion of the craniocervical junction 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
Headache diary 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.
Trial Locations
- Locations (1)
Gemma V Espí López
🇪🇸Valencia, Spain