Effectiveness of the Treatment of Tension-type Headache With Manual and Manipulative Therapy
This study has been completed.
Sponsor:
University of Valencia
Information provided by (Responsible Party):
GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
ClinicalTrials.gov Identifier:
NCT01601015
First received: May 11, 2012
Last updated: May 16, 2012
Last verified: May 2012
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Tension-type Headache |
Other: Manual Therapy Other: placebo treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effectiveness of the Treatment of Tension-type Headache With Manual and Manipulative Therapy in the Perception of Pain and Cervical Motion: a Double-blind, Randomized, Placebo-controlled Clinical Trial. |
Resource links provided by NLM:
Further study details as provided by University of Valencia:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Firstly, socio-demographic data and characteristics of headache were collected during the four weeks prior to the treatment through individual clinical interview carried out by a physiotherapist who did not participate in the outcome assessment nor in the administration of treatments. It included age and sex, location of pain, side dominance of pain, type of pressure, connection with physical activity, frequency, severity of pain, associated symptoms and pain intensity, rated by the patient on the 0-10 Visual Analogue Scale (VAS) (0 = no pain, 10 = most severe pain).
Secondary Outcome Measures:
- Multidimensional perception of pain, assessed by the McGill Pain Questionnaire [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]includes the following aspects: a) sensory, description of pain in time-space terms; b) affective, description of pain in terms of stress, fear and neurovegetative aspects; and c) evaluative, pain described in terms of general assessment. The McGill Pain Questionnaire is validated in Spanish population [13, 14] and it consists of 66 word descriptors divided into 20 groups, including in each group between 2 and 6 adjectives describing pain. Moreover, it includes a section in which patients register the intensity of pain.
- Cervical ranges of motion, measured with the CROM-device [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]The CROM-device combines a system of inclinometers and magnets set on a head mainframe with a nose-piece (positions like eyeglasses) and it measures angles of flexion, extension, lateral flexion and rotation. As it includes a system of magnets, the CROM must not be used in subjects with heart devices.
- Weekly register [ Time Frame: up to 7 weeks ] [ Designated as safety issue: No ]Frequency and intensity of headache, assessed with a seven register weekly. Patients recorded headache frequency as well as intensity of pain measured by the VAS Scale
| Enrollment: | 84 |
| Study Start Date: | January 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Other: 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.
Other Names:
|
|
Experimental: 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
|
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.
Other Names:
|
|
Experimental: Combined treatment
The group receiving combined treatment received the two previous techniques exactly with the same sequence.
|
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.
Other Names:
|
|
Placebo Comparator: Control group
Control group not receive treatment and stayed in this position for 10 minutes
|
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. Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601015
Locations
| Spain | |
| Gemma V Espí López | |
| Valencia, Spain, 46010 | |
Sponsors and Collaborators
University of Valencia
Investigators
| Principal Investigator: | Gemma Victoria Espí López, PhD | Physiotherapy Department. University of Valencia. Spain |
More Information
Publications:
| Responsible Party: | GEMMA V ESPÍ LÓPEZ, PhD, PhD, PT, University of Valencia |
| ClinicalTrials.gov Identifier: | NCT01601015 History of Changes |
| Other Study ID Numbers: | UVT002 |
| Study First Received: | May 11, 2012 |
| Last Updated: | May 16, 2012 |
| Health Authority: | Spain: Ethics Committee Spain:University of Murcia |
Keywords provided by University of Valencia:
|
Tension-type headache, Effectiveness, Manual therapy |
Additional relevant MeSH terms:
|
Headache Tension-Type Headache Pain Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013