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

NCT ID: NCT01550276

Last Updated: 2012-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Suboccipital soft tissue inhibition

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

Group Type: EXPERIMENTAL

Manual Therapy

Intervention Type: 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.

Occiput-atlas-axis global manipulation

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

Group Type: EXPERIMENTAL

Manual Therapy

Intervention Type: 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 OAA manipulation was bilaterally administered and it attempts to restore the motion dysfunction of this complex. It is a structural technique performed on a vertical line along the odontoid process of axis; neither flexion nor extension is used, and lateroflexion is minimal.

The combination of both treatments

Group Type: EXPERIMENTAL

Manual Therapy

Intervention Type: 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 combination of both treatments aims to determine whether this combination has greater effects than the separate application of each treatment. After receiving the treatment, the subjects in the experimental groups stayed for five minutes in the supine resting position, in neutral ranges of cervical flexion, extension, lateral flexion and rotation.

control group

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: 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.

Interventions

Manual Therapy

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.

Intervention Type: OTHER

Manual Therapy

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 OAA manipulation was bilaterally administered and it attempts to restore the motion dysfunction of this complex. It is a structural technique performed on a vertical line along the odontoid process of axis; neither flexion nor extension is used, and lateroflexion is minimal.

Intervention Type: OTHER

Manual Therapy

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 combination of both treatments aims to determine whether this combination has greater effects than the separate application of each treatment. After receiving the treatment, the subjects in the experimental groups stayed for five minutes in the supine resting position, in neutral ranges of cervical flexion, extension, lateral flexion and rotation.

Intervention Type: OTHER

Placebo control

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

GEMMA V ESPÍ LÓPEZ, PhD

PhD, PT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gemma Victoria Espí López, PhD

Role: PRINCIPAL_INVESTIGATOR

Physiotherapy Department. University of Valencia. Spain

Locations

Gemma V Espí López

Valencia, Valencia, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 20647241 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25440210 (View on PubMed)

Other Identifiers

UVT001

Identifier Type: -

Identifier Source: org_study_id