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

NCT01550276 | Completed DMC

• 1 other identifier: UVT001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Tension-type Headache

Keywords

Effectiveness; Tension-type headache; Manual therapy

Outcome Measures

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)

  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.

  up to 4 weeks

Secondary Outcomes (5)

• Impact of headache on daily life(HIT-6)

  up to 8 weeks

• Headache Disability Inventory (HDI)

  up to 8 weeks

• Headache pain intensity

  up to 8 weeks

• Ranges of motion of the craniocervical junction

  up to 8 weeks

• Headache diary

  up to 8 weeks

Study Arms (4)

Suboccipital soft tissue inhibition

EXPERIMENTAL

The SI treatment aims to release the suboccipital muscle spasm that maintains the occiput-atlas-axis joint dysfunction.

Other: Manual Therapy

Occiput-atlas-axis global manipulation

EXPERIMENTAL

The OAA manipulation was bilaterally administered and it attempts to restore the motion dysfunction of this complex

Other: Manual Therapy

The combination of both treatments

EXPERIMENTAL

Other: Manual Therapy

control group

PLACEBO COMPARATOR

Other: Placebo control

Interventions

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.

Suboccipital soft tissue inhibition

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.

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:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Gemma V Espí López

Valencia, Valencia, 46010, Spain

Location

Related Publications (2)

• 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 BACKGROUND

• 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.

  PMID: 25440210 DERIVED

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: February 15, 2012
• First Posted: March 9, 2012
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

ES (1)