About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

Mobilization Versus Manipulation for the Treatment of Cervicogenic Headaches

Clinicaltrials.gov identifier NCT03919630

Recruitment Status Completed

First Posted April 18, 2019

Last update posted April 28, 2020

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.

  • Condition or Disease:Cervicogenic Headache
  • Intervention/Treatment: Other: Thrust Mobilization
    Other: Non-Thrust Mobilizations
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 48 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Official Title: Non-Thrust Versus Thrust Mobilizations to the Upper Segments of Cervical Spine Plus Exercise for Treatment of Cervicogenic Headaches
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: April 2020
  • Actual Study Completion Date: April 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Cervical Thrust Mobilizations
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.
Other: Thrust Mobilization
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
Active Comparator: Cervical Non-Thrust Mobilizations
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.
Other: Non-Thrust Mobilizations
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.
Outcome Measures
  • Primary Outcome Measures: 1. Neck Disability Index [ Time Frame: Baseline, 4-weeks and 1-month follow-up ]
    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: 1. Numeric Pain Rating scale [ Time Frame: Baseline, 1 hour, 48 hours, 4-weeks and 1-month follow-up ]
    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").
  • 2. Headache Impact Test [ Time Frame: Baseline, 4-weeks and 1-month follow-up ]
    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.
  • 3. Global Rating of Change Scale [ Time Frame: 48 hours, 4-weeks and 1-month follow-up ]
    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).
  • 4. Patient Acceptable Symptom State [ Time Frame: 4-weeks and 1-month follow-up ]
    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".
  • 5. Active cervical range of motion [ Time Frame: Baseline, 1 hour, 48 hours, 4-weeks ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts
Locations

United States, Pennsylvania
Pain Relief and Physical Therapy
Havertown

Sponsors and Collaborators

Franklin Pierce University

More Information
  • Responsible Party: Franklin Pierce University
  • ClinicalTrials.gov Identifier: NCT03919630 History of Changes
  • Other Study ID Numbers: JC432019
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: April 28, 2020
  • Last Verified: April 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Post-Traumatic Headache Headache