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

Not Applicable

Recruiting

• Conditions: Whiplash Injuries; Cervicogenic Headache
• Interventions: Other: Exercise,Non-thrust Mobilization; Other: Dry Needling,Thrust Manipulation

• Registration Number: NCT06502951
• Lead Sponsor: Alabama Physical Therapy & Acupuncture

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.

Study Timeline

• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-16
• Study Start: 2024-07-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise,Non-thrust Mobilization	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
Dry Needling,Thrust Manipulation	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Global Rating of Change Score for Neck Pain	6 months	Rating 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 months	Over the counter and prescription medication
Change in Headache Duration (Total hours of headaches in the last week)	Baseline, 4 weeks, 3 months, 6 months	Total hours of headaches in the last week
Change in Headache Frequency (Number of headaches in the last week)	Baseline, 4 weeks, 3 months, 6 months	Number of headaches in the last week
Change in Disability (Neck Disability Index, 0-50 points)	Baseline, 4 weeks, 3 months, 6 months	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.
Change in Global Rating of Change Score for Headaches	6 months	Rating score for self perceived change with range of -7 to +7. Higher scores indicate greater improvement.
Change in Neck Pain Intensity (Numeric Pain Rating Scale, 0-10 points)	Baseline, 4 weeks, 3 months, 6 months	Rating 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 months	13 questions each worth 0-4 points with maximum score of 52 points. Lower scores indicate less pain catastrophizing.

Trial Locations

Locations (1)

Alabama Physical Therapy & Acupuncture; 🇺🇸 Montgomery, Alabama, United States