Clinical trial NCT06502951: Manipulation and Dry Needling in Patients With Cervicogenic Headache and WAD II
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervicogenic Headache
Whiplash Injuries
Keywords: Headache
Whiplash
Lead sponsor: Alabama Physical Therapy & Acupuncture
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2024-07-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in Headache Intensity (Numeric Pain Rating Scale, 0-10) (Rating Score)
timeFrame: Baseline, 4 weeks, 3 months, 6 months
Secondary outcomes:
measure: Change in Global Rating of Change Score for Headaches
timeFrame: 6 months
measure: Change in Global Rating of Change Score for Neck Pain
timeFrame: 6 months
measure: Change in Medication Intake (Frequency of medication intake in last week)
timeFrame: Baseline, 6 months
measure: Change in Headache Duration (Total hours of headaches in the last week)
timeFrame: Baseline, 4 weeks, 3 months, 6 months
measure: Change in Headache Frequency (Number of headaches in the last week)
timeFrame: Baseline, 4 weeks, 3 months, 6 months
measure: Change in Disability (Neck Disability Index, 0-50 points)
timeFrame: Baseline, 4 weeks, 3 months, 6 months
measure: Change in Neck Pain Intensity (Numeric Pain Rating Scale, 0-10 points)
timeFrame: Baseline, 4 weeks, 3 months, 6 months
measure: Change in Pain Catastrophizing Scale (0-52 points)
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Alabama Physical Therapy & Acupuncture
state: Alabama
Study officials:
affiliation: American Academy of Manipulative Therapy
name: James Dunning, PhD, DPT
role: PRINCIPAL_INVESTIGATOR
References: