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

16 maja 2012 zaktualizowane przez: 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).

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

84

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przypisanie czynnikowe
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: 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.
Inne nazwy:
  • Tension-type Headache
Inny: 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.
Inne nazwy:
  • Manipulacja
  • Tension-type Headache
Eksperymentalny: 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
Inny: 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.
Inne nazwy:
  • Tension-type Headache
Inny: 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.
Inne nazwy:
  • Manipulacja
  • Tension-type Headache
Eksperymentalny: Combined treatment
The group receiving combined treatment received the two previous techniques exactly with the same sequence.
Inny: 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.
Inne nazwy:
  • Tension-type Headache
Inny: 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.
Inne nazwy:
  • Manipulacja
  • Tension-type Headache
Komparator placebo: Control group
Control group not receive treatment and stayed in this position for 10 minutes
Inny: 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.

Inne nazwy:
  • Tension-type Headache
  • Resting position

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Multidimensional perception of pain, assessed by the McGill Pain Questionnaire
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Valencia

Publikacje i pomocne linki

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Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 stycznia 2010

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2010

Ukończenie studiów (Rzeczywisty)

1 grudnia 2011

Daty rejestracji na studia

Pierwszy przesłany

11 maja 2012

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 maja 2012

Pierwszy wysłany (Oszacować)

17 maja 2012

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

17 maja 2012

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 maja 2012

Ostatnia weryfikacja

1 maja 2012

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • UVT002

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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