Clinical trial NCT01580280: Manual Therapy and Exercise in Patients With Cervicogenic Headache
Official title: Effect of Upper Cervical and Upper Thoracic Thrust Manipulation Versus Mobilization and Exercise in Patients With Cervicogenic Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervicogenic Headache
Keywords: Cervicogenic
Headache
Neck Pain
Manipulation
Mobilization
Exercise
Lead sponsor: Alabama Physical Therapy & Acupuncture
Sponsor class: OTHER
Collaborators: name: Long Island University
First posted: 2012-04-19
Enrollment: 112
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: Hypothesis: The group of cervicogenic headache patients receiving upper cervical and upper thoracic thrust manipulation will demonstrate significant and clinically important changes in outcomes when compared to the mobilization and exercise group.

Detailed description: Patients with cervicogenic headache will be randomized to receive 6-8 sessions over 2-4 weeks of either: (1) upper cervical and upper thoracic thrust manipulation, or (2) upper cervical and upper thoracic non-thrust mobilization and range of motion, strength and postural exercises.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria
* Headache frequency of at least one per week for a minimum of 3 months
* Minimum pain score (NPRS) of 2/10 and minimum disability score (NDI) of 10/50

Exclusion Criteria:

* Bilateral headaches
* Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia
* Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
* History of whiplash injury within the last 6 weeks
* Diagnosis of cervical spinal stenosis
* Bilateral upper extremity symptoms
* Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes)
* Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

  * Muscle weakness involving a major muscle group of the upper extremity.
  * Diminished upper extremity deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
  * Diminished or absent sensation to pinprick in any upper extremity dermatome
* Prior surgery to the neck or thoracic spine.
* Involvement in litigation or worker's compensation regarding their neck pain and/or headaches.
* Physical therapy or chiropractic treatment for neck pain or headache in the 3 months before baseline examination.
* Any condition that might contraindicate spinal manipulative therapy

Primary outcomes:
measure: Headache Frequency
timeFrame: Baseline
measure: Headache Frequency
timeFrame: 1-week
measure: Headache Frequency
timeFrame: 4-weeks
measure: Headache Frequency
timeFrame: 3-months
measure: Headache Intensity
timeFrame: Baseline
measure: Headache Intensity
timeFrame: 1-week
measure: Headache Intensity
timeFrame: 4-weeks
measure: Headache Intensity
timeFrame: 3-months
measure: Headache Duration
timeFrame: Baseline
measure: Headache Duration
timeFrame: 1-week
measure: Headache Duration
timeFrame: 4-weeks
measure: Headache Duration
timeFrame: 3-months
measure: Neck Disability Index (NDI)
timeFrame: Baseline
measure: Neck Disability Index (NDI)
timeFrame: 1-week
measure: Neck Disability Index (NDI)
timeFrame: 4-weeks
measure: Neck Disability Index (NDI)
timeFrame: 3-months
Secondary outcomes:
measure: Global Rating of Change (GROC)
timeFrame: 1-week
measure: Global Rating of Change (GROC)
timeFrame: 4-weeks
measure: Global Rating of Change (GROC)
timeFrame: 3-months
measure: Analgesic Use
timeFrame: Baseline
measure: Analgesic Use
timeFrame: 3-months
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Alabama Physical Therapy & Acupuncture
state: Alabama
Study officials:
affiliation: Long Island University
name: Marshall Hagins, PT, PhD
role: STUDY_CHAIR
References:
citation: Dunning JR, Cleland JA, Waldrop MA, Arnot CF, Young IA, Turner M, Sigurdsson G. Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):5-18. doi: 10.2519/jospt.2012.3894. Epub 2011 Sep 30.
citation: Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.