Thoracic Spine Thrust Manipulation for Cervicogenic Headaches: A Randomized Clinical Trial
3. Februar 2021 aktualisiert von: University of Colorado, Denver
Headaches have been listed as 1 of the 10 most disabling conditions worldwide.
(Stovner et al., 2007) and cervicogenic headaches (CeHs) comprise 15% of the individuals with these complaints.
(Nillsson, 1995); (Fernandez de-las-penas et al., 2005) The current best approach to the conservative care of this condition has yet to be determined.
The primary aim of this study is to determine whether individuals with CeHs will respond to a program of thoracic spine thrust manipulation in isolation.
This may further the current body of evidence by offering an alternative, potentially safer approach to the conservative care of individuals with this condition.
Additionally, results of this study may serve to drive a larger scale Randomized Clinical Trial (RCT) by offering information regarding feasibility of recruitment of individuals with chronic CeHs as well as timing and dosing of the intervention.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Headaches have been listed as 1 of the 10 most disabling conditions worldwide.
(Stovner et al., 2007) and cervicogenic headaches (CeHs) comprise 15% of the individuals with these complaints.
(Nillsson, 1995); (Fernandez de-las-penas et al., 2005) The current best approach to the conservative care of this condition has yet to be determined.
Evidence suggests that manipulative therapy aimed at the cervical spine in combination with exercise is helpful in alleviating these symptoms.
(Jull et al., 2002) The risk of injury from cervical spine manipulative techniques has been documented to be remote (Haldeman et al., 2002; DiFabio 1999), however the potential consequences can be severe.
Therefore with inherently lower risks, thoracic spine manipulations may be a suitable alternative as the evidence is accumulating for its influence on the cervical spine.
(Mintken et al., 2010; Boyles et al., 2009; Cleland et al., 2005 & 2007 A & B, 2010; Flynn et al., 2001; Fernandez-de-las-penas et al., 2004; Piva et al., 2000; Browder et al., 2004) The primary aim of this study is to determine whether individuals with CeHs will respond to a program of thoracic spine thrust manipulation in isolation.
This may further the current body of evidence by offering an alternative, potentially safer approach to the conservative care of individuals with this condition.
Additionally, results of this study may serve to drive a larger scale RCT by offering information regarding feasibility of recruitment of individuals with chronic CeHs as well as timing and dosing of the intervention.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
48
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80045
- University of Colorado Anschutz Medical Campus
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 60 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Between 18 and 60 years old Sjaastad et al for CeH, which included
- unilateral or unilateral dominant side-consistent headache associated with neck pain and aggravated by neck postures or movement (Sjaastad et al., 1998)
- joint tenderness in at least one of the three upper cervical joints (C0-C3) as assessed by manual palpation
- headache frequency of at least one per week over the past 2 months
Exclusion Criteria:
- red flags noted in the patient's Neck Medical Screening Questionnaire (e.g. tumor, fracture)
- metabolic diseases RA, osteoporosis, prolonged history of steroid use, symptoms of vertebrobasilary insufficiency, pregnancy, cervical spinal stenosis, bilateral upper extremity symptoms etc.)
- history of whiplash injury within the past six weeks
- evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes
- two or more positive neurologic signs consistent with nerve root compression, including any two of the following: muscle weakness involving a major muscle group of the upper extremity, diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps reflex), diminished or absent sensation to pinprick in any upper extremity dermatome
- prior surgery to the neck or thoracic spine
- chiropractic or physical therapy treatment for their headaches over the past 6-months
- bilateral headache description
- migraine headaches with or without aura
- workers compensation or pending legal action regarding their headaches
- inability to comply with treatment and follow-up schedule
- we will not recruit individuals whom the researcher is in a position to punish or reward, whether through grades, evaluations, or promotions
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Treatment (thoracic manipulation)
Patients in the initial manipulation group will attend physical therapy two sessions per week for 3 weeks for a total of 6 sessions.
Each treatment session will last for a total of 15 minutes.
After the initial manipulation group receives 3 weeks of treatment they will wait for 1-week, be retested, and then crossover into the other group.
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Manipulation techniques will include: CT junction manipulation seated and supine, upper thoracic manipulation, middle thoracic spine manipulation in seated and supine, middle thoracic spine manipulation in prone, thoracic active range of motion exercise and instruction to maintain usual activity level within the limits of pain.
Andere Namen:
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Aktiver Komparator: Wait-list (thoracic manipulation)
When individuals are assigned to the wait-list control group they will serve as the control for 3 weeks while the initial manipulation group receives treatment.
After serving as the wait-list control condition for 3 weeks, this group will then return for testing and will receive the manipulation package as described below at 4 weeks.
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Manipulation techniques will include: CT junction manipulation seated and supine, upper thoracic manipulation, middle thoracic spine manipulation in seated and supine, middle thoracic spine manipulation in prone, thoracic active range of motion exercise and instruction to maintain usual activity level within the limits of pain.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Headache Disability Index
Zeitfenster: Baseline
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Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life.
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Baseline
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Headache Disability Index
Zeitfenster: 4 weeks
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Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life.
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4 weeks
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Headache Disability Index
Zeitfenster: 8 weeks
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Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life.
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8 weeks
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Headache Disability Index
Zeitfenster: 3 months
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Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life.
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3 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Numeric Pain Rating Scale
Zeitfenster: Baseline
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An 11-point NPRS will be used to measure pain intensity.
Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours.
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Baseline
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Numeric Pain Rating Scale
Zeitfenster: 4 weeks
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An 11-point NPRS will be used to measure pain intensity.
Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours.
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4 weeks
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Numeric Pain Rating Scale
Zeitfenster: 8 weeks
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An 11-point NPRS will be used to measure pain intensity.
Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours.
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8 weeks
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Numeric Pain Rating Scale
Zeitfenster: 3 months
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An 11-point NPRS will be used to measure pain intensity.
Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours.
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3 months
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Pain Self Efficacy Questionnaire (PSEQ)
Zeitfenster: Baseline
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The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain.
Items are listed on a 0 to 6 scale, with a maximum score of 60 points.
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Baseline
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Pain Self Efficacy Questionnaire (PSEQ)
Zeitfenster: 4 weeks
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The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain.
Items are listed on a 0 to 6 scale, with a maximum score of 60 points.
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4 weeks
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Pain Self Efficacy Questionnaire (PSEQ)
Zeitfenster: 8 weeks
|
The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain.
Items are listed on a 0 to 6 scale, with a maximum score of 60 points.
|
8 weeks
|
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Pain Self Efficacy Questionnaire (PSEQ)
Zeitfenster: 3 months
|
The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain.
Items are listed on a 0 to 6 scale, with a maximum score of 60 points.
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3 months
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Amy W McDevitt, DPT, University of Colorado, Denver
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Mai 2016
Primärer Abschluss (Tatsächlich)
19. September 2019
Studienabschluss (Tatsächlich)
19. September 2019
Studienanmeldedaten
Zuerst eingereicht
10. März 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. März 2016
Zuerst gepostet (Schätzen)
15. März 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. Februar 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. Februar 2021
Zuletzt verifiziert
1. Februar 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 15-0983
Plan für individuelle Teilnehmerdaten (IPD)
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UNENTSCHIEDEN
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