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Thoracic Spine Thrust Manipulation for Cervicogenic Headaches: A Randomized Clinical Trial

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02708953
First received: March 10, 2016
Last updated: November 16, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention
Headache Disorders, Secondary Procedure: Thoracic manipulation (Manipulation Group) Procedure: Thoracic Manipulation (Control wait-list)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thoracic Spine Thrust Manipulation for Cervicogenic Headaches: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Headache Disability Index [ Time Frame: Baseline ]
    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.

  • Headache Disability Index [ Time Frame: 4 weeks ]
    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.

  • Headache Disability Index [ Time Frame: 8 weeks ]
    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.

  • Headache Disability Index [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures:
  • Numeric Pain Rating Scale [ Time Frame: Baseline ]
    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.

  • Numeric Pain Rating Scale [ Time Frame: 4 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.

  • Numeric Pain Rating Scale [ Time Frame: 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.

  • Numeric Pain Rating Scale [ Time Frame: 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.

  • Pain Self Efficacy Questionnaire (PSEQ) [ Time Frame: Baseline ]
    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.

  • Pain Self Efficacy Questionnaire (PSEQ) [ Time Frame: 4 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.

  • Pain Self Efficacy Questionnaire (PSEQ) [ Time Frame: 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.

  • Pain Self Efficacy Questionnaire (PSEQ) [ Time Frame: 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.


Estimated Enrollment: 48
Study Start Date: May 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Thoracic manipulation (Manipulation Group)
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.
Other Name: Manual therapy to thoracic spine
Active Comparator: 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.
Procedure: Thoracic Manipulation (Control wait-list)
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.
Other Name: Manual therapy to thoracic spine

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

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02708953

Contacts
Contact: Amy w McDevitt, DPT 303-724-1906 amy.mcdevitt@ucdenver.edu
Contact: Paul E Mintken, DPT 303-724-9545 paul.mintken@ucdenver.edu

Locations
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Amy Mcdevitt, DPT    303-724-1906    AMY.MCDEVITT@UCDENVER.EDU   
Contact: Paul Mintken, DPT    3037249545    paul.mintken@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Amy W McDevitt, DPT University of Colorado, Denver
  More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02708953     History of Changes
Other Study ID Numbers: 15-0983
Study First Received: March 10, 2016
Last Updated: November 16, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Headache
Headache Disorders
Post-Traumatic Headache
Headache Disorders, Secondary
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 19, 2017