NCT02708953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2019

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

3.4 years

First QC Date

March 10, 2016

Last Update Submit

February 3, 2021

Conditions

Headache Disorders, Secondary

Outcome Measures

Primary Outcomes (4)

  • Headache Disability Index

    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

    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

    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

    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 Outcomes (8)

  • Numeric Pain Rating Scale

    Baseline

  • Numeric Pain Rating Scale

    4 weeks

  • Numeric Pain Rating Scale

    8 weeks

  • Numeric Pain Rating Scale

    3 months

  • Pain Self Efficacy Questionnaire (PSEQ)

    Baseline

  • +3 more secondary outcomes

Study Arms (2)

Treatment (thoracic manipulation)

EXPERIMENTAL

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)

Wait-list (thoracic manipulation)

ACTIVE COMPARATOR

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)

Interventions

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.

Also known as: Manual therapy to thoracic spine
Treatment (thoracic manipulation)
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.

Also known as: Manual therapy to thoracic spine
Wait-list (thoracic manipulation)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • 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.

    PMID: 12221344BACKGROUND

MeSH Terms

Conditions

Headache Disorders, Secondary

Condition Hierarchy (Ancestors)

Headache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Amy W McDevitt, DPT

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 15, 2016

Study Start

May 1, 2016

Primary Completion

September 19, 2019

Study Completion

September 19, 2019

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

US(1)