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

NCT03583190 | Unknown

• 1 other identifier: 0177-08
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Neck pain; Headache; Dry needling; manual therapy

Outcome Measures

Primary Outcomes (1)

• Change in NPRS headache intensity

  Average and most intense in the last week will be recorded using a 0 (no headache) to 10 (most intense)

  Baseline, 1 week, 1 month, 3 months, 12 months.

Secondary Outcomes (8)

• Change in disability using Neck Disability Index

  Baseline 1 week, 1 month, 3 months, 12 months

• Change in disability using Headache Disability Index (HDI)

  Baseline, 1 week, 1 month, 3 months, 12 months

• Leeds Assessment of Neuropathic Signs and Symptoms (LANSS)

  Baseline

• Change in Medication intake

  Baseline, 1 week, 1 month, 3 months, 12 months

• Patient Satisfaction

  1 month

Study Arms (2)

Cervical-cranial dry needling

EXPERIMENTAL

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

Other: Cervical-cranial dry needling; Other: Thoracic Manipulation; Other: Exercise; Other: Patient Education

Orthopedic Manual Therapy

ACTIVE COMPARATOR

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

Other: Orthopedic manual therapy; Other: Thoracic Manipulation; Other: Exercise; Other: Patient Education

Interventions

Cervical-cranial dry needling 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.

Cervical-cranial dry needling

Orthopedic manual therapy OTHER

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

Orthopedic Manual Therapy

Thoracic Manipulation OTHER

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

Cervical-cranial dry needling; Orthopedic Manual Therapy

Exercise 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.

Cervical-cranial dry needling; Orthopedic Manual Therapy

Patient Education OTHER

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

Cervical-cranial dry needling; Orthopedic Manual Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Youngstown State University: lead
• Franklin Pierce University: collaborator

Study Sites (1)

Youngstown State University

Youngstown, Ohio, 44406, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 29037632 BACKGROUND

• 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.

  PMID: 24623124 BACKGROUND

• 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.

  PMID: 26136602 BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache; Neck Pain; Headache

Interventions

Exercise; Patient Education as Topic

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• David Griswold, PhD

  Associate Professor at Youngstown State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Griswold, PhD

CONTACT

330-941-2419; dwgriswold@ysu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded the treatment group. The clinician providing treatment will be blinded to outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 11, 2018
• Study Start: July 5, 2018
• Primary Completion: October 10, 2025
• Study Completion: December 10, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)