Clinical trial NCT02373605: Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache
Official title: Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache: a Multi-center Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervicogenic Headaches
Lead sponsor: Alabama Physical Therapy & Acupuncture
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2015-02-27
Enrollment: 142
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: The purpose of this research is to compare two different approaches for treating patients with cervicogenic headaches: non-thrust mobilization and exercise versus thrust manipulation and dry needling. Physical therapists commonly use all of these techniques to treat cervicogenic headaches. This study is attempting to find out if one treatment strategy is more effective than the other.

Detailed description: Patients with cervicogenic headaches will be randomized to receive 1-2 treatment sessions per week for 4 weeks (up to 8 sessions total) of either: (1) Dry Needling and HVLA thrust manipulation group, or the (2) Exercise and non-thrust mobilization group

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia
2. Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumors, fracture, metabolic diseases, RA, osteoporosis, history of prolonged steroid use, etc.
3. History of whiplash injury within the last 6 weeks
4. Diagnosis of cervical stenosis
5. Bilateral upper extremity symptoms
6. Evidence of CNS 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, presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes).
7. Two or more positive neurologic signs consistent with nerve root compression, including any 2 of the following:

   1. Muscle weakness involving a major muscle group of the upper extremity.
   2. Diminished UE deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
   3. Diminished or absent sensation to pinprick in any UE dermatome.
8. Prior surgery to neck of thoracic spine
9. Involvement in litigation or worker's compensation regarding their neck pain and/or headaches
10. PT or chiropractic care treatment for neck pain or headaches in the 3 months prior to baseline exam.
11. Any condition that might contraindicate spinal manipulative therapy.

Primary outcomes:
measure: Change in Headache Intensity (NPRS) (Rating Score)
timeFrame: Baseline, 1 week, 4 weeks, 3 months
measure: Change in Headache Frequency (Number of headaches in the last week)
timeFrame: Baseline, 1 week, 4 weeks, 3 months
measure: Change in Disability (NDI 0-50 points)
timeFrame: Baseline, 1 week, 4 weeks, 3 months
Secondary outcomes:
measure: Change in Global Rating of Change Score
timeFrame: 1 week, 4 weeks, 3 months
measure: Change in Medication Intake (Frequency of medication intake in last week)
timeFrame: Baseline, 3 months
measure: Change in Headache Duration (Total hours of headaches in the last week)
timeFrame: Baseline, 1 week, 4 weeks, 3 months
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Alabama Physical Therapy & Acupuncture
state: Alabama
Study officials:
affiliation: American Academy of Manipulative Therapy
name: James Dunning, DPT PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dunning J, Butts R, Zacharko N, Fandry K, Young I, Wheeler K, Day J, Fernandez-de-Las-Penas C. Spinal manipulation and perineural electrical dry needling in patients with cervicogenic headache: a multicenter randomized clinical trial. Spine J. 2021 Feb;21(2):284-295. doi: 10.1016/j.spinee.2020.10.008. Epub 2020 Oct 13.