Recruiting

Cervical-Cranial Dry Needling vs. Orthopedic Manual Therapy

Sponsor:

Youngstown State University

Code:

NCT03583190

Conditions

Cervicogenic Headache

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cervical-cranial dry needling

Orthopedic manual therapy

Thoracic Manipulation

Exercise

Patient Education

Study Details

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.

Conditions

Cervicogenic Headache

Study ID

NCT03583190

Start date

Jul 5, 2018

Status verified date

Nov, 2023

Completion date

Dec 10, 2025

Anticipated

Primary completion date

Oct 10, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cervical-cranial dry needling

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

active comparator: Orthopedic Manual Therapy

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

Interventions

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.

Orthopedic manual therapy

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

Thoracic Manipulation

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

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.

Patient Education

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

Primary outcome measure

  • Change in NPRS headache intensity [ Time Frame: Baseline, 1 week, 1 month, 3 months, 12 months. ]

Central Contacts and Locations

Central contacts

David Griswold, PhD

330-941-2419dwgriswold@ysu.edu

Locations

Youngstown State University

Recruiting

Youngstown, Ohio, United States, 44406

Contacts

David W Griswold, PhD, DPT

330-941-2419dwgriswold@ysu.edu

More Information

Sponsor

Youngstown State University

Last update posted

Nov 18, 2023

Last verified

Nov, 2023

Keywords

  • Neck pain
  • Headache
  • Dry needling
  • manual therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Youngstown State University on 2023-11-18.