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NCT Number: NCT06502951

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

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Physical therapy or chiropractic treatment for neck pain and/or headache in the past 3 months.
  • Any condition that might contraindicate spinal manipulative therapy or dry needling.

Treatment and study plan

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.

Other names: Spinal Manipulation, Dry Needling

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.

Other names: Exercise, Non-thrust Mobilization

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change in Global Rating of Change Score for Headaches

    Time frame: 6 months

    Rating score for self perceived change with range of -7 to +7. Higher scores indicate greater improvement.

  2. Change in Global Rating of Change Score for Neck Pain

    Time frame: 6 months

    Rating score for self perceived change with range of -7 to +7. Higher scores indicate greater improvement.

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

    Time frame: Baseline, 6 months

    Over the counter and prescription medication

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

    Time frame: Baseline, 4 weeks, 3 months, 6 months

    Total hours of headaches in the last week

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

    Time frame: Baseline, 4 weeks, 3 months, 6 months

    Number of headaches in the last week

  6. Change in Disability (Neck Disability Index, 0-50 points)

    Time frame: 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.

  7. Change in Neck Pain Intensity (Numeric Pain Rating Scale, 0-10 points)

    Time frame: 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

  8. Change in Pain Catastrophizing Scale (0-52 points)

    Time frame: Baseline, 6 months

    13 questions each worth 0-4 points with maximum score of 52 points. Lower scores indicate less pain catastrophizing.

Study contacts

Contact information is provided by the study sponsor or research team.

Ian Young, DSc, PT

CONTACT

[email protected]

912-433-3531

James Dunning, PhD, DPT

CONTACT

[email protected]

801-707-9056

Sponsors and collaborators

Lead sponsor

Alabama Physical Therapy & Acupuncture

Other

Collaborators

  • Universidad Rey Juan Carlos

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2024
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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