Back to resultsEffectiveness of the Treatment of Tension-type Headache With Manual and Manipulative Therapy
Primary Purpose
Tension-type Headache
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy
Manual Therapy
Manual Therapy
placebo treatment
Sponsored by
About this trial
This is an interventional treatment trial for Tension-type Headache focused on measuring Tension-type headache, Effectiveness, Manual therapy
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
Sites / Locations
- Gemma V Espí López
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Manual therapy
Occiput-atlas-axis joint manipulation
Combined treatment
Control group
Arm Description
Manual therapy of Suboccipital soft tissue Inhibition treatment aims to release the suboccipital muscle spasm that maintains the occiput-atlas-axis joint dysfunction.
Is bilaterally administered. The aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction
The group receiving combined treatment received the two previous techniques exactly with the same sequence.
Control group not receive treatment and stayed in this position for 10 minutes
Outcomes
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)
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01601015
Brief Title
Effectiveness of the Treatment of Tension-type Headache With Manual and Manipulative Therapy
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-type Headache
Keywords
Tension-type headache, Effectiveness, Manual therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual therapy
Arm Type
Experimental
Arm Description
Manual therapy of Suboccipital soft tissue Inhibition treatment aims to release the suboccipital muscle spasm that maintains the occiput-atlas-axis joint dysfunction.
Arm Title
Occiput-atlas-axis joint manipulation
Arm Type
Experimental
Arm Description
Is bilaterally administered. The aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction
Arm Title
Combined treatment
Arm Type
Experimental
Arm Description
The group receiving combined treatment received the two previous techniques exactly with the same sequence.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group not receive treatment and stayed in this position for 10 minutes
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Other Intervention Name(s)
Tension-type Headache
Intervention Description
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
Intervention Name(s)
Manual Therapy
Other Intervention Name(s)
Tension-type Headache, manipulation
Intervention Description
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
Intervention Name(s)
Manual Therapy
Other Intervention Name(s)
Tension-type Headache, Manipulation
Intervention Description
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
Intervention Name(s)
placebo treatment
Other Intervention Name(s)
Resting position, Tension-type Headache
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Multidimensional perception of pain, assessed by the McGill Pain Questionnaire
Description
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.
Time Frame
up to 8 weeks
Title
Cervical ranges of motion, measured with the CROM-device
Description
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.
Time Frame
up to 8 weeks
Title
Weekly register
Description
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
Time Frame
up to 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gemma Victoria Espí López, PhD
Organizational Affiliation
Physiotherapy Department. University of Valencia. Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gemma V Espí López
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
20647241
Citation
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.
Results Reference
result
Learn more about this trial
Effectiveness of the Treatment of Tension-type Headache With Manual and Manipulative Therapy
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