Manipulation and Dry Needling in Patients With Cervicogenic Headache and WAD II

Upper Cervical Spine Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache and Type II Whiplash Associated Disorder: a Multi-center Randomized Clinical Trial

The purpose of this research is to compare two different approaches for treating patients with cervicogenic headaches associated with type II whiplash associated disorder: non-thrust mobilization and exercise versus thrust manipulation and dry needling. Physical therapists commonly use all of these techniques to treat cervicogenic headaches. This study is attempting to find out if one treatment strategy is more effective than the other.

Study Overview

• Status: Recruiting
• Conditions: Whiplash Injuries; Cervicogenic Headache
• Intervention / Treatment: Other: Dry Needling,Thrust Manipulation; Other: Exercise,Non-thrust Mobilization

Detailed Description

Patients with cervicogenic headaches and type II whiplash associated disorder will be randomized to receive 1-2 treatment sessions per week for 4 weeks (up to 8 sessions total) of either: (1) dry needling and upper cervical high-velocity low-amplitude thrust manipulation, or (2) exercise and non-thrust mobilization.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ian Young, DSc, PT; Phone Number: 912-433-3531; Email: tybeewellness@gmail.com
• Study Contact Backup: Name: James Dunning, PhD, DPT; Phone Number: 801-707-9056; Email: drjamesdunning@gmail.com

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36117
      • Recruiting
      • Alabama Physical Therapy & Acupuncture
      • Contact: James Dunning, PhD, DPT; Phone Number: 801-707-9056; Email: jamesdunning@hotmail.com
      • Contact: Ian Young, DSc PT; Phone Number: 912-433-3531; Email: tybeewellness@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subacute (> 4 weeks) or chronic type II whiplash associated disorder. Neck pain and headache following motor vehicle accident with reduced range of motion & point tenderness.
2. Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria.
3. Headache frequency of at least one per week since the whiplash injury.
4. Headache intensity of greater than 2/10 on the NPRS.
5. Neck pain intensity of greater than 2/10 on the NPRS.
6. Neck Disability Index score of greater than 10/50 on the NDI.

Exclusion Criteria:

1. WAD I (neck pain, but no physical signs), WAD III (neck pain and neurological signs), WAD IV (neck pain + fracture/dislocation).
2. Positive screen for cervical radiography (Canadian C-Spine Rules).
3. Bilateral headaches (typical of tension type headaches).
4. Diagnosis / signs & symptoms of concussion (confusion, disorientation, or impaired consciousness; loss of memory for events immediately before or after the MVA; and one or more of the following: nausea, vomiting, visual disturbances, vertigo, gait and/or postural imbalance, and impaired memory and/or concentration).
5. Diagnosis of fibromyalgia.
6. Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia, or hyperlipidemia.
7. Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e., tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.).
8. Diagnosis of cervical spinal stenosis.
9. Bilateral upper extremity symptoms.
10. Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes).

11. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

    1. Muscle weakness involving a major muscle group of the upper extremity.
    2. Diminished upper extremity deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
    3. Diminished or absent sensation to pinprick in any UE dermatome.
12. Prior surgery to the head, neck, or thoracic spine.
13. Physical therapy or chiropractic treatment for neck pain and/or headache in the past 3 months.
14. Any condition that might contraindicate spinal manipulative therapy or dry needling.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry Needling,Thrust Manipulation; Dry needling to the craniofacial, upper cervical, and cervicothoracic regions. High-velocity thrust manipulation to the upper cervical spine, mid/lower cervical spine, and cervicothoracic spinal regions.	Other: Dry Needling,Thrust Manipulation; HVLA thrust manipulation to upper cervical and upper thoracic regions. Dry needling to cervicothoracic and craniofacial regions. Up to 8 treatment sessions over 4 weeks.; Other Names: Spinal Manipulation; Dry Needling
Active Comparator: Exercise,Non-thrust Mobilization; Nonthrust joint mobilization to the upper cervical spine, mid/lower cervical spine, and cervicothoracic spinal regions. Cranio-cervical flexion exercises, peri-scapular progressive resistance exercises, and electrothermal modalities	Other: Exercise,Non-thrust Mobilization; Non-thrust mobilization and exercise to upper cervical and upper thoracic regions. Up to 8 treatment sessions over 4 weeks.; Other Names: Exercise; Non-thrust Mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Headache Intensity (Numeric Pain Rating Scale, 0-10) (Rating Score)	Rating Score on 0-10 scale. Baseline score must exceed 2/10 to be included. Lower scores indicate less pain intensity. the study.	Baseline, 4 weeks, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Global Rating of Change Score for Headaches	Rating score for self perceived change with range of -7 to +7. Higher scores indicate greater improvement.	6 months
Change in Global Rating of Change Score for Neck Pain	Rating score for self perceived change with range of -7 to +7. Higher scores indicate greater improvement.	6 months
Change in Medication Intake (Frequency of medication intake in last week)	Over the counter and prescription medication	Baseline, 6 months
Change in Headache Duration (Total hours of headaches in the last week)	Total hours of headaches in the last week	Baseline, 4 weeks, 3 months, 6 months
Change in Headache Frequency (Number of headaches in the last week)	Number of headaches in the last week	Baseline, 4 weeks, 3 months, 6 months
Change in Disability (Neck Disability Index, 0-50 points)	10 Questions each worth 0-5 points with maximum score of 50 points possible. Lower scores indicate lower disability levels. Baseline score must exceed 10/50 to be included in study.	Baseline, 4 weeks, 3 months, 6 months
Change in Neck Pain Intensity (Numeric Pain Rating Scale, 0-10 points)	Rating score 0-10 points. Lower scores indicate lower pain intensity. Baseline score must exceed 2/10 to be included	Baseline, 4 weeks, 3 months, 6 months
Change in Pain Catastrophizing Scale (0-52 points)	13 questions each worth 0-4 points with maximum score of 52 points. Lower scores indicate less pain catastrophizing.	Baseline, 6 months

Collaborators and Investigators

• Sponsor: Alabama Physical Therapy & Acupuncture
• Collaborators: Universidad Rey Juan Carlos
• Investigators: Principal Investigator: James Dunning, PhD, DPT, American Academy of Manipulative Therapy

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Headache; Whiplash
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Headache Disorders; Headache Disorders, Secondary; Neck Injuries; Headache; Post-Traumatic Headache; Whiplash Injuries
• Other Study ID Numbers: AAMT0018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No