Cervical-Cranial Dry Needling vs. Orthopedic Manual Therapy for Cervicogenic Headache

Youngstown State University

Status: Enrolling

Conditions: Cervicogenic Headache

Treatments: Other: Thoracic Manipulation; Other: Orthopedic manual therapy; Other: Cervical-cranial dry needling; Other: Patient Education; Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03583190

0177-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Cervical-cranial dry needling

Experimental group

Description:

Patients randomized to this arm will receive cervical-cranial dry needling, thoracic manipulation, and exercise.

Treatment:

Other: Patient Education

Other: Exercise

Other: Cervical-cranial dry needling

Other: Thoracic Manipulation

Orthopedic Manual Therapy

Active Comparator group

Description:

Patients randomized to this arm will receive orthopedic manual therapy to cervical spine, thoracic manipulation, and exercise.

Treatment:

Other: Patient Education

Other: Orthopedic manual therapy

Other: Exercise

Other: Thoracic Manipulation