Condition or disease | Intervention/treatment | Phase |
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Cervicogenic Headache | Other: Thrust Mobilization Other: Non-Thrust Mobilizations | Not Applicable |
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 |
Arm | Intervention/treatment |
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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.
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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
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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.
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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.
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Pain Relief and Physical Therapy | |
Havertown, Pennsylvania, United States, 19083 |
Tracking Information | |||||
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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 |
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.
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Original Primary Outcome Measures ICMJE |
Neck Disability Index [ Time Frame: Baseline, 4-weeks and 1-month follow-up ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE | Cervicogenic Headache | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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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 |