Effectiveness of the Treatment of Tension-type Headache With Manual and Manipulative Therapy
2012年5月16日 更新者：GEMMA V ESPÍ LÓPEZ, PhD、University of Valencia
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.
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).
調査の概要
研究の種類
介入
入学 (実際)
84
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Valencia、スペイン、46010
- Gemma V Espí López
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
他の名前：
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.
他の名前：
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実験的：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
|
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.
他の名前：
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.
他の名前：
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実験的：Combined treatment
The group receiving combined treatment received the two previous techniques exactly with the same sequence.
|
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.
他の名前：
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.
他の名前：
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プラセボコンパレーター：Control group
Control group not receive treatment and stayed in this position for 10 minutes
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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)
時間枠：up to 4 weeks
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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).
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up to 4 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Multidimensional perception of pain, assessed by the McGill Pain Questionnaire
時間枠：up to 8 weeks
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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.
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up to 8 weeks
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Cervical ranges of motion, measured with the CROM-device
時間枠：up to 8 weeks
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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.
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up to 8 weeks
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Weekly register
時間枠：up to 7 weeks
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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
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up to 7 weeks
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年1月1日
一次修了 (実際)
2010年12月1日
研究の完了 (実際)
2011年12月1日
試験登録日
最初に提出
2012年5月11日
QC基準を満たした最初の提出物
2012年5月16日
最初の投稿 (見積もり)
2012年5月17日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年5月17日
QC基準を満たした最後の更新が送信されました
2012年5月16日
最終確認日
2012年5月1日
詳しくは
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