Clinical trial NCT03583190: Cervical-Cranial Dry Needling vs. Orthopedic Manual Therapy for Cervicogenic Headache
Official title: Comparing the Use of Cervical-Cranial Dry Needling With Orthopedic Manual Therapy to the Cervical Spine for Cervicogenic Headache: A Multi-center RCT With 1-Year Follow Up
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervicogenic Headache
Keywords: Neck pain
Headache
Dry needling
manual therapy
Lead sponsor: Youngstown State University
Sponsor class: OTHER
Collaborators: name: Franklin Pierce University
First posted: 2018-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dry needling is a therapeutic modality used to treat a number of neuromusculoskeletal conditions. Practice trends suggest it is becoming widely used by Physical Therapists to help patients manage symptoms associated with CGH, however, there is limited scientific evidence demonstrating meaningful impact for dry needling for CGH. Manual therapy (thrust and non-thrust mobilizations) to the cervical spine are well researched and have an established treatment effect for managing symptoms related to CGH. The purpose of this study is to compare outcomes (1 week, 1 month, 3 months, 12 months) for patients with CGH treated with cervical-cranial dry needling or pragmatically applied orthopedic manual therapy to the cervical spine. In addition to either the cervical-cranial dry needling or manual therapy to the cervical spine, patients will also receive patient education, thoracic manipulation, and exercise.

Detailed description: The use of dry needling is becoming widely used by Physical Therapists in the United States for a number of neuromusculoskeletal conditions including cervicogenic headache (CGH). Dry needling is performed by taking a mono-filament needle and inserting it into symptomatic soft tissue. In this trial, the dry needling will be performed segmentally in the neck and along the patient's headache distribution pattern. Orthopedic manual therapy (OMT) may include both thrust and non-thrust techniques applied to a targeted spinal level and has a well-established treatment effect for patients with CGH. In this trial, the OMT will be applied pragmatically to the cervical spine at the most symptomatic level of the headache. Other interventions used in this trial will include patient education, thoracic manipulation and exercise.

Patients will be randomized to receive either dry needling or OMT 2x/week for 2 weeks and then 1-2x/week for 2 weeks totaling 6-8 visits over the course of 1 month. The 1 week and 1 month outcomes collected will be reported on separately from the 3 and 12 months.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Meets the IHS criteria for CGH
* Headache frequency of at least 1 per week over a period greater than 3 months.
* Demonstrates segmental dysfunction with passive mobility testing.

Exclusion Criteria:

Patients whose headache experience is primarily of migraine origin. Tension-type headache, headache pain \<2, contraindications to the interventions (malignancy, myelopathy, fracture, metabolic disease, rheumatoid arthritis, long-term corticosteroid use), headache presentation suggesting cervical arterial insufficiency, severe metal allergy, needle phobia, history of neck or thoracic spine surgery, Non-English speaking patients, therapist is unable to elicit the headache with passive accessory intervertebral movements (PAIVM), or pending litigation for neck pain and/or headache.

Primary outcomes:
measure: Change in NPRS headache intensity
timeFrame: Baseline, 1 week, 1 month, 3 months, 12 months.
Secondary outcomes:
measure: Change in disability using Neck Disability Index
timeFrame: Baseline 1 week, 1 month, 3 months, 12 months
measure: Change in disability using Headache Disability Index (HDI)
timeFrame: Baseline, 1 week, 1 month, 3 months, 12 months
measure: Leeds Assessment of Neuropathic Signs and Symptoms (LANSS)
timeFrame: Baseline
measure: Change in Medication intake
timeFrame: Baseline, 1 week, 1 month, 3 months, 12 months
measure: Patient Satisfaction
timeFrame: 1 month
measure: Health care utilization
timeFrame: 3 and 12 months
measure: SANE Percent Recovery
timeFrame: 1 month
measure: Change in current NPRS neck or headache intensity
timeFrame: Baseline and Immediately post intervention
Other outcomes:
Locations:
city: Youngstown
country: United States
facility: Youngstown State University
state: Ohio
Study officials:
affiliation: Associate Professor at Youngstown State University
name: David Griswold, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sedighi A, Nakhostin Ansari N, Naghdi S. Comparison of acute effects of superficial and deep dry needling into trigger points of suboccipital and upper trapezius muscles in patients with cervicogenic headache. J Bodyw Mov Ther. 2017 Oct;21(4):810-814. doi: 10.1016/j.jbmt.2017.01.002. Epub 2017 Jan 6.
citation: France S, Bown J, Nowosilskyj M, Mott M, Rand S, Walters J. Evidence for the use of dry needling and physiotherapy in the management of cervicogenic or tension-type headache: a systematic review. Cephalalgia. 2014 Oct;34(12):994-1003. doi: 10.1177/0333102414523847. Epub 2014 Mar 12.
citation: Bond BM, Kinslow C. Improvement in clinical outcomes after dry needling in a patient with occipital neuralgia. J Can Chiropr Assoc. 2015 Jun;59(2):101-10.