ClinicalTrials.gg
RecruitingNCT06502951Updated May 11, 2025

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

An interventional study of Dry Needling,Thrust Manipulation and Exercise,Non-thrust Mobilization in Cervicogenic Headache and Whiplash Injuries, sponsored by Alabama Physical Therapy & Acupuncture. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-11.

Sponsored by Alabama Physical Therapy & Acupuncture · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cervicogenic Headache
  • Whiplash Injuries

Keywords

  • Headache
  • Whiplash
03

In context

Post-Traumatic Headache

192 studies on the registry are indexed under Post-Traumatic Headache; 54 are open to participants now.

This study's planned enrollment of 120 is above the median of 44 across 169 interventional studies indexed under Post-Traumatic Headache.

Browse Post-Traumatic Headache studies →

Lead sponsor

Alabama Physical Therapy & Acupuncture is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, , 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Dry Needling,Thrust Manipulation

  • Active comparator
    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

    Other: Exercise,Non-thrust Mobilization

Interventions

  • OtherDry 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.

    Also known as: Spinal Manipulation, Dry Needling

  • OtherExercise,Non-thrust Mobilization

    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

06

What researchers measure

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.

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

Secondary outcomes

  1. Change in Global Rating of Change Score for Headaches

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

    Over the counter and prescription medication

    Time frame: Baseline, 6 months

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

    Total hours of headaches in the last week

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

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

    Number of headaches in the last week

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

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

    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.

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

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

    Rating score 0-10 points. Lower scores indicate lower pain intensity. Baseline score must exceed 2/10 to be included

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

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

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

    Time frame: Baseline, 6 months

07

Study locations

1 of 1 sites recruiting
  • Alabama Physical Therapy & Acupuncture
    Montgomery, Alabama 36117, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for May 2026, 21 months after the start.

Of 89 non-industry interventional studies with no phase under Post-Traumatic Headache, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 21 months is above that.

Counting every sponsor, half of 90 studies reached it within 12 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2024
First posted
Jul 16, 2024
StartActual
Jul 20, 2024
Primary completionEst.
May 1, 2026
CompletionEst.
May 1, 2026
Last update
May 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06502951
Lead sponsor
Alabama Physical Therapy & Acupuncture
Responsible party
James Dunning, DPT, MSc, FAAOMPT (PhD, DPT, FAAOMPT, Alabama Physical Therapy & Acupuncture) — Principal investigator
First posted
Jul 16, 2024
Start date
Jul 20, 2024
Primary completion
May 1, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
May 11, 2025

Study contacts

James Dunning, PhD, DPT
Contact
drjamesdunning@gmail.com
801-707-9056
Ian Young, DSc, PT
Contact
tybeewellness@gmail.com
912-433-3531
James Dunning, PhD, DPT
principal investigator · American Academy of Manipulative Therapy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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