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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06502951
Enrollment
120
Registered
2024-07-16
Start date
2024-07-20
Completion date
2026-05-01
Last updated
2025-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervicogenic Headache, Whiplash Injuries

Keywords

Headache, Whiplash

Brief summary

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.

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.

Interventions

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.

Non-thrust mobilization and exercise to upper cervical and upper thoracic regions. Up to 8 treatment sessions over 4 weeks.

Sponsors

Universidad Rey Juan Carlos
CollaboratorOTHER
Alabama Physical Therapy & Acupuncture
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change in Global Rating of Change Score for Neck Pain6 monthsRating score for self perceived change with range of -7 to +7. Higher scores indicate greater improvement.
Change in Medication Intake (Frequency of medication intake in last week)Baseline, 6 monthsOver the counter and prescription medication
Change in Headache Duration (Total hours of headaches in the last week)Baseline, 4 weeks, 3 months, 6 monthsTotal hours of headaches in the last week
Change in Global Rating of Change Score for Headaches6 monthsRating score for self perceived change with range of -7 to +7. Higher scores indicate greater improvement.
Change in Disability (Neck Disability Index, 0-50 points)Baseline, 4 weeks, 3 months, 6 months10 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.
Change in Neck Pain Intensity (Numeric Pain Rating Scale, 0-10 points)Baseline, 4 weeks, 3 months, 6 monthsRating score 0-10 points. Lower scores indicate lower pain intensity. Baseline score must exceed 2/10 to be included
Change in Pain Catastrophizing Scale (0-52 points)Baseline, 6 months13 questions each worth 0-4 points with maximum score of 52 points. Lower scores indicate less pain catastrophizing.
Change in Headache Frequency (Number of headaches in the last week)Baseline, 4 weeks, 3 months, 6 monthsNumber of headaches in the last week

Countries

United States

Contacts

Primary ContactJames Dunning, PhD, DPT
drjamesdunning@gmail.com801-707-9056
Backup ContactIan Young, DSc, PT
tybeewellness@gmail.com912-433-3531

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026