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Completed

NCT Number: NCT02708953

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thoracic manipulation (Manipulation Group)

Procedure

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 names: Manual therapy to thoracic spine

Thoracic Manipulation (Control wait-list)

Procedure

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 names: Manual therapy to thoracic spine

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 15, 2016
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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