Effectiveness of the Treatment of Tension-type Headache With Manual and Manipulative Therapy

NCT ID: NCT01601015

Last Updated: 2012-05-17

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. Tension-type headache (TTH) is the most common form of primary headache and it is a real problem for the subjects suffering from it. Until now, physiotherapy treatments have included different techniques combined together, without establishing which of them is more effective.

Objective. The purpose of this study is to know the effectiveness of manipulative and manual therapy treatments, with regard to pain perception and neck mobility in patients with tension-type headache.

Methods: A double-blind, randomized clinical trial was conducted, with 84 patients diagnosed with tension-type headache, divided into three treatment groups -manual therapy, manipulative therapy, and a combination of both techniques-, and a placebo control group. Four treatment sessions were administered during four weeks, with post-treatment assessment, and follow-up at one month. Cervical ranges of motion were assessed (CROM device), as well as pain perception (McGill Pain Questionnaire), and frequency and intensity of headaches (weekly register).

Conditions

Tension-type Headache

Study Design

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

Study Groups

Manual therapy

Manual therapy of Suboccipital soft tissue Inhibition treatment aims to release the suboccipital muscle spasm that maintains the occiput-atlas-axis joint dysfunction.

Group Type: EXPERIMENTAL

Manual Therapy

Intervention Type: OTHER

Manual therapy of Suboccipital soft tissue Inhibition is performed with patient in supine position. The patient's head leans against the physiotherapist's hands, which palpate suboccipital muscles by sliding fingertips until contacting posterior arch of atlas. At this point, a deep and progressive gliding pressure is applied, for 10 minutes. The purpose of this technique is to release suboccipital muscle spasm, which can be responsible for the mobility dysfunction of the occiput-atlas-axis joint.

Occiput-atlas-axis joint manipulation

Is bilaterally administered. The aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction

Group Type: EXPERIMENTAL

Manual Therapy

Intervention Type: OTHER

Occiput-atlas-axis joint manipulation is performed in the same position as the previous technique. It is bilaterally administered and it consists of 2 phases: firstly, rotation with gentle head decompression with no flexo-extension and slight lateral flexion is performed, followed by small circumductions aimed at increasing arterial viscoelasticity and searching for adequate joint barrier through selective tension; secondly, a high speed thrust manipulation in pure rotation towards the side to be manipulated is performed, with a head helicoidal movement, with the aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction.

Combined treatment

The group receiving combined treatment received the two previous techniques exactly with the same sequence.

Group Type: EXPERIMENTAL

Manual Therapy

Intervention Type: OTHER

Occiput-atlas-axis joint manipulation is performed in the same position as the previous technique. It is bilaterally administered and it consists of 2 phases: firstly, rotation with gentle head decompression with no flexo-extension and slight lateral flexion is performed, followed by small circumductions aimed at increasing arterial viscoelasticity and searching for adequate joint barrier through selective tension; secondly, a high speed thrust manipulation in pure rotation towards the side to be manipulated is performed, with a head helicoidal movement, with the aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction.

Control group

Control group not receive treatment and stayed in this position for 10 minutes

Group Type: PLACEBO_COMPARATOR

placebo treatment

Intervention Type: OTHER

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

Manual therapy of Suboccipital soft tissue Inhibition is performed with patient in supine position. The patient's head leans against the physiotherapist's hands, which palpate suboccipital muscles by sliding fingertips until contacting posterior arch of atlas. At this point, a deep and progressive gliding pressure is applied, for 10 minutes. The purpose of this technique is to release suboccipital muscle spasm, which can be responsible for the mobility dysfunction of the occiput-atlas-axis joint.

Intervention Type: OTHER

Manual Therapy

Occiput-atlas-axis joint manipulation is performed in the same position as the previous technique. It is bilaterally administered and it consists of 2 phases: firstly, rotation with gentle head decompression with no flexo-extension and slight lateral flexion is performed, followed by small circumductions aimed at increasing arterial viscoelasticity and searching for adequate joint barrier through selective tension; secondly, a high speed thrust manipulation in pure rotation towards the side to be manipulated is performed, with a head helicoidal movement, with the aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction.

Intervention Type: OTHER

Manual Therapy

Occiput-atlas-axis joint manipulation is performed in the same position as the previous technique. It is bilaterally administered and it consists of 2 phases: firstly, rotation with gentle head decompression with no flexo-extension and slight lateral flexion is performed, followed by small circumductions aimed at increasing arterial viscoelasticity and searching for adequate joint barrier through selective tension; secondly, a high speed thrust manipulation in pure rotation towards the side to be manipulated is performed, with a head helicoidal movement, with the aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction.

Intervention Type: OTHER

placebo treatment

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

Other Intervention Names

Tension-type Headache; Tension-type Headache; manipulation; Tension-type Headache; Manipulation; Resting position; Tension-type Headache

Eligibility Criteria

Inclusion Criteria

• Subjects aged between 18 and 65 years
• Diagnosis of frequent ETTH and CTTH
• Having headache episodes on more than 1 day per month
• Headache episodes lasting from 30 minutes to 7 days
• Headaches having at least 2 of the following characteristics:

• Bilateral location of pain
• Pressing non pulsating quality
• Mild or moderate intensity
• Not aggravated by physical activity
• Sufferers may present photophobia, phonophobia, nausea or vomiting
• Headache may be associated with pericranial tenderness
• Suffering from TTH for over 3 months
• Subjects being under pharmacological control

Exclusion Criteria

• Patients with infrequent ETTH, and patients with probable TTH in its frequent and infrequent forms.

• Headache that is aggravated by head movements.
• Metabolic or musculoskeletal disorders with symptoms similar to headache
• Previous neck trauma
• Vertigo, dizziness, arterial hypertension.
• Joint stiffness, arteriosclerosis or advanced degenerative osteoarthritis
• Patients with heart devices
• Patients in process of pharmacological adaptation
• Excessive emotional tension
• Neurological disorders
• Laxity of neck soft tissues
• Radiological alterations
• General hypermobility or hyperlaxity
• Joint instability
• Pregnancy

• 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: RESULT

PMID: 20647241 (View on PubMed)

Other Identifiers

UVT002

Identifier Type: -

Identifier Source: org_study_id