search
Back to results

Mobilization Versus Manipulation for the Treatment of Cervicogenic Headaches

Primary Purpose

Cervicogenic Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thrust Mobilization
Non-Thrust Mobilizations
Sponsored by
Franklin Pierce University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient must be English-speaking and have appropriate medical literacy to participate in the study
  2. The physical examination must yield a reproducible familiar/concordant neck, head, jaw symptom or dysfunction
  3. Pain reports of at least 2/10 for a headache or neck pain intensity
  4. Neck Disability reports of at least a 20% or greater impact
  5. Patients that report having at least two headaches within one month

Exclusion Criteria:

  1. The presence of any know red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
  2. Patients who exhibit any red flag symptoms: positive upper or lower motor neuron testing. Signs or symptoms consistent cervical myelopathy or radiculopathy with nerve root compression (muscle weakness involving a major muscle group of the upper extremity, diminished upper extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any upper extremity dermatome
  3. Patients who exhibit any red flag symptoms of cervical instability tests, or have a positive VBI or CAD testing, showing signs of the 5 D's (dizziness, drop attacks, dysarthria, dysphagia, diplopia) or patient who have signs of 3 N's (Nystagmus, nausea, other neurological symptoms).
  4. Prior surgery to the cervical spine or head (including cerebral shunts)
  5. Women who are pregnant in their third trimester

Sites / Locations

  • Pain Relief and Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cervical Thrust Mobilizations

Cervical Non-Thrust Mobilizations

Arm Description

Once therapist has assessed subject and has found the patients most comparable sign they will be performing a high velocity thrust at the end of the patients available range, as described by Maitland's Approach. The thrust will be performed only once. The therapist will perform either a localized cervical rotation thrust which primary movement is rotation or a longitudinal cephalad C1 and C2 thrust, both targeting the upper cervical spine.

Therapists will perform unilateral posterior to anterior mobilization (UPA) or central posterior to anterior (CPA) mobilizations grades I-IV as described above by Maitland concepts at levels C0-C3 which reproduce the patient's most comparable sign. Therapists will be instructed to perform 3x 30 second bouts of mobilizations at that level.

Outcomes

Primary Outcome Measures

Neck Disability Index
The Neck Disability Index contains 10 items, seven related to activities of daily living, two related to pain, and one item related to concentration. Each item is scored from 0-5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.

Secondary Outcome Measures

Numeric Pain Rating scale
Patients will be asked to indicate the intensity of their pain using an 11-point scale ranging from 0 ("no pain") to 10 ("worst pain imaginable").
Headache Impact Test
The Headache Impact Test is a 6 item self-report, questionnaire and the responses on all questions are summed to produce a total score ranging from 36 to 78, with higher scores indicating a greater impact of headache on daily life.
Global Rating of Change Scale
Patients will be asked to rate their overall perception of improvement since beginning treatment on a scale ranging from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better).
Patient Acceptable Symptom State
The Patient Acceptable Symptom State (PASS) is used to define the level of symptoms beyond which patients consider themselves well. The PASS question: "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?" with response options "yes" or "no".
Active cervical range of motion
The active cervical range of motion (ACROM) assessment of the cervical spine will include flexion and extension in the sagittal plane, lateral flexion in the frontal plane and rotation in the transverse plane. A single inclinometer and Cervical Range of Motion Device will be used to collect ACROM.

Full Information

First Posted
April 12, 2019
Last Updated
April 26, 2020
Sponsor
Franklin Pierce University
search

1. Study Identification

Unique Protocol Identification Number
NCT03919630
Brief Title
Mobilization Versus Manipulation for the Treatment of Cervicogenic Headaches
Official Title
Non-Thrust Versus Thrust Mobilizations to the Upper Segments of Cervical Spine Plus Exercise for Treatment of Cervicogenic Headaches
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
April 14, 2020 (Actual)
Study Completion Date
April 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Franklin Pierce University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
There is currently a gap within the literature as to the effects of a thrust versus non-thrust mobilizations techniques specifically to the upper cervical spine C0-C3 along with home exercise program to help reduce frequency and intensity of cervicogenic headaches. Therefore, the purpose of this study is to examine the effectiveness of in treating headaches using non-thrust or thrust mobilizations in addition to postural corrective exercises on patient outcomes measures.
Detailed Description
Cervicogenic headaches are classified as secondary headaches and typically rise from a musculoskeletal, cervical spine, disc, or soft tissue elements and are accompanied by neck pain. Dominant features of cervicogenic headache include unilateral head pain, external pressure over the ipsilateral upper neck, limited cervical range of motion, and trigger attacks by various neck motions. Cervicogenic headaches typically originate from the atlanto-occipital and upper 3 segments of the cervical spine and can radiate to the head or face region. Physical therapist have for some time been treating cervicogenic headaches with a variety of different treatment techniques ranging from conservative therapy, passive and active range of motion, stretching for cervical, strengthening exercises for the upper extremity, and manual therapy. However, little is known about the effects of thrust and non-thrust manipulative physical therapy treatments along with exercises to help reduce cervicogenic headaches. The purpose of this study is to assess the effectiveness of physical therapy in treating headaches using non-thrust to the upper 3 segments of the cervical spine or thrust mobilizations to the upper 3 segments, plus the addition of postural corrective exercises in treating cervicogenic headaches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cervical Thrust Mobilizations
Arm Type
Experimental
Arm Description
Once therapist has assessed subject and has found the patients most comparable sign they will be performing a high velocity thrust at the end of the patients available range, as described by Maitland's Approach. The thrust will be performed only once. The therapist will perform either a localized cervical rotation thrust which primary movement is rotation or a longitudinal cephalad C1 and C2 thrust, both targeting the upper cervical spine.
Arm Title
Cervical Non-Thrust Mobilizations
Arm Type
Active Comparator
Arm Description
Therapists will perform unilateral posterior to anterior mobilization (UPA) or central posterior to anterior (CPA) mobilizations grades I-IV as described above by Maitland concepts at levels C0-C3 which reproduce the patient's most comparable sign. Therapists will be instructed to perform 3x 30 second bouts of mobilizations at that level.
Intervention Type
Other
Intervention Name(s)
Thrust Mobilization
Intervention Description
Once therapist has assessed subject and has found the patients most comparable sign they will be performing a high velocity thrust at the end of the patients available range, as described by Maitland's Approach. The thrust will be performed only once. The therapist will perform either a localized cervical rotation thrust which primary movement is rotation or a longitudinal cephalad C1 and C2 thrust, both targeting the upper cervical spine
Intervention Type
Other
Intervention Name(s)
Non-Thrust Mobilizations
Intervention Description
Therapists will perform unilateral posterior to anterior mobilization (UPA) or central posterior to anterior (CPA) mobilizations grades I-IV as described above by Maitland concepts at levels C0-C3 which reproduce the patient's most comparable sign. Therapists will be instructed to perform 3x 30 second bouts of mobilizations at that level.
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
The Neck Disability Index contains 10 items, seven related to activities of daily living, two related to pain, and one item related to concentration. Each item is scored from 0-5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.
Time Frame
Baseline, 4-weeks and 1-month follow-up
Secondary Outcome Measure Information:
Title
Numeric Pain Rating scale
Description
Patients will be asked to indicate the intensity of their pain using an 11-point scale ranging from 0 ("no pain") to 10 ("worst pain imaginable").
Time Frame
Baseline, 1 hour, 48 hours, 4-weeks and 1-month follow-up
Title
Headache Impact Test
Description
The Headache Impact Test is a 6 item self-report, questionnaire and the responses on all questions are summed to produce a total score ranging from 36 to 78, with higher scores indicating a greater impact of headache on daily life.
Time Frame
Baseline, 4-weeks and 1-month follow-up
Title
Global Rating of Change Scale
Description
Patients will be asked to rate their overall perception of improvement since beginning treatment on a scale ranging from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better).
Time Frame
48 hours, 4-weeks and 1-month follow-up
Title
Patient Acceptable Symptom State
Description
The Patient Acceptable Symptom State (PASS) is used to define the level of symptoms beyond which patients consider themselves well. The PASS question: "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?" with response options "yes" or "no".
Time Frame
4-weeks and 1-month follow-up
Title
Active cervical range of motion
Description
The active cervical range of motion (ACROM) assessment of the cervical spine will include flexion and extension in the sagittal plane, lateral flexion in the frontal plane and rotation in the transverse plane. A single inclinometer and Cervical Range of Motion Device will be used to collect ACROM.
Time Frame
Baseline, 1 hour, 48 hours, 4-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must be English-speaking and have appropriate medical literacy to participate in the study The physical examination must yield a reproducible familiar/concordant neck, head, jaw symptom or dysfunction Pain reports of at least 2/10 for a headache or neck pain intensity Neck Disability reports of at least a 20% or greater impact Patients that report having at least two headaches within one month Exclusion Criteria: The presence of any know red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.) Patients who exhibit any red flag symptoms: positive upper or lower motor neuron testing. Signs or symptoms consistent cervical myelopathy or radiculopathy with nerve root compression (muscle weakness involving a major muscle group of the upper extremity, diminished upper extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any upper extremity dermatome Patients who exhibit any red flag symptoms of cervical instability tests, or have a positive VBI or CAD testing, showing signs of the 5 D's (dizziness, drop attacks, dysarthria, dysphagia, diplopia) or patient who have signs of 3 N's (Nystagmus, nausea, other neurological symptoms). Prior surgery to the cervical spine or head (including cerebral shunts) Women who are pregnant in their third trimester
Facility Information:
Facility Name
Pain Relief and Physical Therapy
City
Havertown
State/Province
Pennsylvania
ZIP/Postal Code
19083
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33148134
Citation
Lerner-Lentz A, O'Halloran B, Donaldson M, Cleland JA. Pragmatic application of manipulation versus mobilization to the upper segments of the cervical spine plus exercise for treatment of cervicogenic headache: a randomized clinical trial. J Man Manip Ther. 2021 Oct;29(5):267-275. doi: 10.1080/10669817.2020.1834322. Epub 2020 Nov 5.
Results Reference
derived

Learn more about this trial

Mobilization Versus Manipulation for the Treatment of Cervicogenic Headaches

We'll reach out to this number within 24 hrs