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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-05

Study Completion Date

2025-12-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cervicogenic Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

The outcome assessor will be blinded the treatment group. The clinician providing treatment will be blinded to outcomes.

Study Groups

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Cervical-cranial dry needling

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

Group Type EXPERIMENTAL

Cervical-cranial dry needling

Intervention Type OTHER

Segmental needling of the neck and needling in the patient's headache distribution. Peripherally sensitized areas of the neck may also be dry needled based on the findings of the clinical evaluation.

Thoracic Manipulation

Intervention Type OTHER

Thoracic Manipulation (applied pragmatically) to the levels determined to be provocative or hypomobile.

Exercise

Intervention Type OTHER

Clinicians select 1 active range of motion exercise for the cervical spine, deep cervical flexion endurance exercise, and 5 upper extremity exercises (from a set of 10). Additionally, patients will be assigned a headache management technique.

Patient Education

Intervention Type OTHER

Patients will receive education regarding their headache condition, proper performance of their symptom management technique, posture.

Orthopedic Manual Therapy

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

Group Type ACTIVE_COMPARATOR

Orthopedic manual therapy

Intervention Type OTHER

Orthopedic Manual Therapy (OMT) that includes either mobilization or manipulation to the cervical spine applied pragmatically to the most symptomatic level.

Thoracic Manipulation

Intervention Type OTHER

Thoracic Manipulation (applied pragmatically) to the levels determined to be provocative or hypomobile.

Exercise

Intervention Type OTHER

Clinicians select 1 active range of motion exercise for the cervical spine, deep cervical flexion endurance exercise, and 5 upper extremity exercises (from a set of 10). Additionally, patients will be assigned a headache management technique.

Patient Education

Intervention Type OTHER

Patients will receive education regarding their headache condition, proper performance of their symptom management technique, posture.

Interventions

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Cervical-cranial dry needling

Segmental needling of the neck and needling in the patient's headache distribution. Peripherally sensitized areas of the neck may also be dry needled based on the findings of the clinical evaluation.

Intervention Type OTHER

Orthopedic manual therapy

Orthopedic Manual Therapy (OMT) that includes either mobilization or manipulation to the cervical spine applied pragmatically to the most symptomatic level.

Intervention Type OTHER

Thoracic Manipulation

Thoracic Manipulation (applied pragmatically) to the levels determined to be provocative or hypomobile.

Intervention Type OTHER

Exercise

Clinicians select 1 active range of motion exercise for the cervical spine, deep cervical flexion endurance exercise, and 5 upper extremity exercises (from a set of 10). Additionally, patients will be assigned a headache management technique.

Intervention Type OTHER

Patient Education

Patients will receive education regarding their headache condition, proper performance of their symptom management technique, posture.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No