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出境医 / 临床实验 / Mobilization Versus Manipulation for the Treatment of Cervicogenic Headaches

Mobilization Versus Manipulation for the Treatment of Cervicogenic Headaches

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 Intervention/treatment Phase
Cervicogenic Headache Other: Thrust Mobilization Other: Non-Thrust Mobilizations Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 1, 2019
Actual Primary Completion Date : April 14, 2020
Actual Study Completion Date : April 14, 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
Layout table for eligibility information
Ages Eligible for Study:   18 Years 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

Locations
Layout table for location information
United States, Pennsylvania
Pain Relief and Physical Therapy
Havertown, Pennsylvania, United States, 19083
Sponsors and Collaborators
Franklin Pierce University
Tracking Information
First Submitted Date  ICMJE April 12, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date April 28, 2020
Actual Study Start Date  ICMJE May 1, 2019
Actual Primary Completion Date April 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
Neck Disability Index [ Time Frame: Baseline, 4-weeks and 1-month follow-up ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • 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").
  • 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.
  • 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).
  • 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".
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • Numeric Pain Rating scale [ Time Frame: Baseline, 1 hour, 48 hours, 4-weeks and 1-month follow-up ]
  • Head Impact Test [ Time Frame: Baseline, 4-weeks and 1-month follow-up ]
  • Global Rating of Change Scale [ Time Frame: 48 hours, 4-weeks and 1-month follow-up ]
  • Patient Acceptable Symptom Rate [ Time Frame: 4-weeks and 1-month follow-up ]
  • Active cervical range of motion [ Time Frame: Baseline, 1 hour, 48 hours, 4-weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mobilization Versus Manipulation for the Treatment of Cervicogenic Headaches
Official Title  ICMJE Non-Thrust Versus Thrust Mobilizations to the Upper Segments of Cervical Spine Plus Exercise for Treatment of Cervicogenic Headaches
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Cervicogenic Headache
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Thrust Mobilization
  • 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.
    Intervention: Other: Non-Thrust Mobilizations
Publications * 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. 2020 Nov 5:1-9. doi: 10.1080/10669817.2020.1834322. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2019)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 14, 2020
Actual Primary Completion Date April 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03919630
Other Study ID Numbers  ICMJE JC432019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Joshua Cleland, DPT, OCS, Franklin Pierce University
Study Sponsor  ICMJE Franklin Pierce University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Franklin Pierce University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP