Clinical trial NCT03919630: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cervicogenic Headache
Lead sponsor: Franklin Pierce University
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Neck Disability Index
timeFrame: Baseline, 4-weeks and 1-month follow-up
Secondary outcomes:
measure: Numeric Pain Rating scale
timeFrame: Baseline, 1 hour, 48 hours, 4-weeks and 1-month follow-up
measure: Headache Impact Test
timeFrame: Baseline, 4-weeks and 1-month follow-up
measure: Global Rating of Change Scale
timeFrame: 48 hours, 4-weeks and 1-month follow-up
measure: Patient Acceptable Symptom State
timeFrame: 4-weeks and 1-month follow-up
measure: Active cervical range of motion
timeFrame: Baseline, 1 hour, 48 hours, 4-weeks
Other outcomes:
Locations:
city: Havertown
country: United States
facility: Pain Relief and Physical Therapy
state: Pennsylvania
Study officials:
References:
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.