Clinical trial NCT02708953: Thoracic Spine Thrust Manipulation for Cervicogenic Headaches: A Randomized Clinical Trial
Official title: Thoracic Spine Thrust Manipulation for Cervicogenic Headaches: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache Disorders, Secondary
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Headache Disability Index
timeFrame: Baseline
measure: Headache Disability Index
timeFrame: 4 weeks
measure: Headache Disability Index
timeFrame: 8 weeks
measure: Headache Disability Index
timeFrame: 3 months
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Baseline
measure: Numeric Pain Rating Scale
timeFrame: 4 weeks
measure: Numeric Pain Rating Scale
timeFrame: 8 weeks
measure: Numeric Pain Rating Scale
timeFrame: 3 months
measure: Pain Self Efficacy Questionnaire (PSEQ)
timeFrame: Baseline
measure: Pain Self Efficacy Questionnaire (PSEQ)
timeFrame: 4 weeks
measure: Pain Self Efficacy Questionnaire (PSEQ)
timeFrame: 8 weeks
measure: Pain Self Efficacy Questionnaire (PSEQ)
timeFrame: 3 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Amy W McDevitt, DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.