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

16. května 2012 aktualizováno: 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).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

84

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Španělsko
      • Valencia, Španělsko, 46010
        • Gemma V Espí López

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Faktorové přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Jiný: 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.
Ostatní jména:
  • Tension-type Headache
Jiný: 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.
Ostatní jména:
  • Manipulace
  • Tension-type Headache
Experimentální: 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
Jiný: 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.
Ostatní jména:
  • Tension-type Headache
Jiný: 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.
Ostatní jména:
  • Manipulace
  • Tension-type Headache
Experimentální: Combined treatment
The group receiving combined treatment received the two previous techniques exactly with the same sequence.
Jiný: 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.
Ostatní jména:
  • Tension-type Headache
Jiný: 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.
Ostatní jména:
  • Manipulace
  • Tension-type Headache
Komparátor placeba: Control group
Control group not receive treatment and stayed in this position for 10 minutes
Jiný: 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.

Ostatní jména:
  • Tension-type Headache
  • Resting position

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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)
Časové okno: up to 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).
up to 4 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Multidimensional perception of pain, assessed by the McGill Pain Questionnaire
Časové okno: up to 8 weeks
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.
up to 8 weeks
Cervical ranges of motion, measured with the CROM-device
Časové okno: up to 8 weeks
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.
up to 8 weeks
Weekly register
Časové okno: up to 7 weeks
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
up to 7 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Valencia

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. ledna 2010

Primární dokončení (Aktuální)

1. prosince 2010

Dokončení studie (Aktuální)

1. prosince 2011

Termíny zápisu do studia

První předloženo

11. května 2012

První předloženo, které splnilo kritéria kontroly kvality

16. května 2012

První zveřejněno (Odhad)

17. května 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

17. května 2012

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. května 2012

Naposledy ověřeno

1. května 2012

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • UVT002

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

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