Thoracic Spine Thrust Manipulation for Cervicogenic Headaches: A Randomized Clinical Trial
3. februar 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
48
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Colorado
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Aurora, Colorado, Forente stater, 80045
- University of Colorado Anschutz Medical Campus
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
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Aktiv 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Headache Disability Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Numeric Pain Rating Scale
Tidsramme: 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
Tidsramme: 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.
|
4 weeks
|
|
Numeric Pain Rating Scale
Tidsramme: 8 weeks
|
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.
|
8 weeks
|
|
Numeric Pain Rating Scale
Tidsramme: 3 months
|
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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
|
Pain Self Efficacy Questionnaire (PSEQ)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Amy W McDevitt, DPT, University of Colorado, Denver
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2016
Primær fullføring (Faktiske)
19. september 2019
Studiet fullført (Faktiske)
19. september 2019
Datoer for studieregistrering
Først innsendt
10. mars 2016
Først innsendt som oppfylte QC-kriteriene
10. mars 2016
Først lagt ut (Anslag)
15. mars 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. februar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. februar 2021
Sist bekreftet
1. februar 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 15-0983
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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