Comparing treatments for cervicogenic headaches and whiplash injuries
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
This study is testing whether dry needling with thrust manipulation or exercise with non-thrust mobilization works better for people with cervicogenic headaches from whiplash injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Alabama Physical Therapy & Acupuncture Academic / other |
| Locations | 1 site (Montgomery, Alabama) |
| Trial ID | NCT06502951 on ClinicalTrials.gov |
What this trial studies
This research compares two treatment approaches for patients suffering from cervicogenic headaches associated with type II whiplash injuries. Participants will be randomly assigned to receive either dry needling combined with thrust manipulation or exercise with non-thrust mobilization. The treatment will consist of 1-2 sessions per week over a period of four weeks, totaling up to eight sessions. The goal is to determine which method is more effective in alleviating symptoms.
Who should consider this trial
Good fit: Ideal candidates are individuals with subacute or chronic type II whiplash associated disorder and cervicogenic headaches following a motor vehicle accident.
Not a fit: Patients with WAD I, III, or IV, or those with bilateral headaches or signs of concussion may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with more effective treatment options for managing cervicogenic headaches and whiplash injuries.
How similar studies have performed: Other studies have explored similar treatment methods, but the specific comparison of these two approaches in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Montgomery, Alabama
- Alabama Physical Therapy & Acupuncture — Montgomery, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: James Dunning, PhD, DPT — American Academy of Manipulative Therapy
- Study coordinator: James Dunning, PhD, DPT
- Email: drjamesdunning@gmail.com
- Phone: 801-707-9056
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.