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

February 3, 2021 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Manual therapy to thoracic spine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
4 weeks
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.
8 weeks
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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
4 weeks
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.
8 weeks
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.
3 months
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.
Baseline
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.
4 weeks
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 weeks
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amy W McDevitt, DPT, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-0983

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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