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

NCT06502951 | Recruiting

• 1 other identifier: AAMT0018
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervicogenic Headache; Whiplash Injuries

Keywords

Headache; Whiplash

Outcome Measures

Primary Outcomes (1)

• Change in Headache Intensity (Numeric Pain Rating Scale, 0-10) (Rating Score)

  Rating Score on 0-10 scale. Baseline score must exceed 2/10 to be included. Lower scores indicate less pain intensity. the study.

  Baseline, 4 weeks, 3 months, 6 months

Secondary Outcomes (8)

• Change in Global Rating of Change Score for Headaches

  6 months

• Change in Global Rating of Change Score for Neck Pain

  6 months

• Change in Medication Intake (Frequency of medication intake in last week)

  Baseline, 6 months

• Change in Headache Duration (Total hours of headaches in the last week)

  Baseline, 4 weeks, 3 months, 6 months

• Change in Headache Frequency (Number of headaches in the last week)

  Baseline, 4 weeks, 3 months, 6 months

Study Arms (2)

Dry Needling,Thrust Manipulation

EXPERIMENTAL

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.

Other: Dry Needling,Thrust Manipulation

Exercise,Non-thrust Mobilization

ACTIVE COMPARATOR

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

Other: Exercise,Non-thrust Mobilization

Interventions

Dry Needling,Thrust Manipulation 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.

Also known as: Spinal Manipulation, Dry Needling

Dry Needling,Thrust Manipulation

Exercise,Non-thrust Mobilization OTHER

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

Also known as: Exercise, Non-thrust Mobilization

Exercise,Non-thrust Mobilization

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria.
• Headache frequency of at least one per week since the whiplash injury.
• Headache intensity of greater than 2/10 on the NPRS.
• Neck pain intensity of greater than 2/10 on the NPRS.
• Neck Disability Index score of greater than 10/50 on the NDI.

You may not qualify if:

• WAD I (neck pain, but no physical signs), WAD III (neck pain and neurological signs), WAD IV (neck pain + fracture/dislocation).
• Positive screen for cervical radiography (Canadian C-Spine Rules).
• Bilateral headaches (typical of tension type headaches).
• 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).
• Diagnosis of fibromyalgia.
• Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia, or hyperlipidemia.
• 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.).
• Diagnosis of cervical spinal stenosis.
• Bilateral upper extremity symptoms.
• 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).
• Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
• Muscle weakness involving a major muscle group of the upper extremity.
• Diminished upper extremity deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
• Diminished or absent sensation to pinprick in any UE dermatome.
• Prior surgery to the head, neck, or thoracic spine.

Sponsors & Collaborators

• Alabama Physical Therapy & Acupuncture: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Alabama Physical Therapy & Acupuncture

Montgomery, Alabama, 36117, United States

RECRUITING

MeSH Terms

Conditions

Post-Traumatic Headache; Whiplash Injuries; Headache

Interventions

Dry Needling; Manipulation, Spinal; Exercise

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neck Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Musculoskeletal Manipulations; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• James Dunning, PhD, DPT

  American Academy of Manipulative Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Dunning, PhD, DPT

CONTACT

801-707-9056; drjamesdunning@gmail.com

Ian Young, DSc, PT

CONTACT

912-433-3531; tybeewellness@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, DPT, FAAOMPT

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: July 20, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)