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

NCT ID: NCT06502951

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-20

Study Completion Date

2026-05-01

Brief Summary

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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

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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.

Conditions

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Cervicogenic Headache Whiplash Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Dry Needling,Thrust Manipulation

Intervention Type OTHER

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.

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

Group Type ACTIVE_COMPARATOR

Exercise,Non-thrust Mobilization

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Spinal Manipulation Dry Needling Exercise Non-thrust Mobilization

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Rey Juan Carlos

OTHER

Sponsor Role collaborator

Alabama Physical Therapy & Acupuncture

OTHER

Sponsor Role lead

Responsible Party

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James Dunning, DPT, MSc, FAAOMPT

PhD, DPT, FAAOMPT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Dunning, PhD, DPT

Role: PRINCIPAL_INVESTIGATOR

American Academy of Manipulative Therapy

Locations

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Alabama Physical Therapy & Acupuncture

Montgomery, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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James Dunning, PhD, DPT

Role: CONTACT

801-707-9056

Ian Young, DSc, PT

Role: CONTACT

912-433-3531

Facility Contacts

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James Dunning, PhD, DPT

Role: primary

801-707-9056

Ian Young, DSc PT

Role: backup

912-433-3531

Other Identifiers

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AAMT0018

Identifier Type: -

Identifier Source: org_study_id

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