Cervicogenic HeadacheNCT06502951
Manipulation and Dry Needling in Patients With Cervicogenic Headache and WAD II
A study testing Dry Needling,Thrust Manipulation and Exercise,Non-thrust Mobilization in people with Cervicogenic Headache and Whiplash Injuries, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervicogenic Headache, Whiplash Injuries
- What is being tested?
- Dry Needling,Thrust Manipulation and Exercise,Non-thrust Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Alabama Physical Therapy & Acupuncture
Montgomery, Alabama, 36117
James Dunning, PhD, DPT, 801-707-9056, jamesdunning@hotmail.com
Ian Young, DSc PT, 912-433-3531, tybeewellness@gmail.com
About this study
Official 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
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.
- Conditions
- Cervicogenic Headache, Whiplash Injuries
- Being tested
- Dry Needling,Thrust Manipulation, Exercise,Non-thrust Mobilization
- Keywords
- Headache, Whiplash
- Medical subject headings
- Post-Traumatic Headache, Whiplash Injuries, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Needling,Thrust ManipulationOther
Also called Spinal Manipulation, Dry Needling
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 MobilizationOther
Also called Exercise, Non-thrust Mobilization
Non-thrust mobilization and exercise to upper cervical and upper thoracic regions. Up to 8 treatment sessions over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Exercise,Non-thrust Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, 3 months, 6 months
Secondary outcomes (8)
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.
Measured: 6 months
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.
Measured: 6 months
Change in Medication Intake (Frequency of medication intake in last week)
Over the counter and prescription medication
Measured: Baseline, 6 months
Change in Headache Duration (Total hours of headaches in the last week)
Total hours of headaches in the last week
Measured: Baseline, 4 weeks, 3 months, 6 months
Change in Headache Frequency (Number of headaches in the last week)
Number of headaches in the last week
Measured: Baseline, 4 weeks, 3 months, 6 months
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.
Measured: Baseline, 4 weeks, 3 months, 6 months
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
Measured: Baseline, 4 weeks, 3 months, 6 months
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.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start20 Jul 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alabama Physical Therapy & Acupuncture
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture
- Investigators
- James Dunning, PhD, DPT, Principal investigator, American Academy of Manipulative Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502951
- Sponsor's protocol ID
- AAMT0018
- Status last verified
- May 2025
- First submitted
- 9 Jul 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06502951
- Acronym / sponsor ID
- AAMT0018
- Conditions
- Cervicogenic Headache, Whiplash Injuries
- Keywords
- Headache, Whiplash
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alabama Physical Therapy & AcupunctureUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling,Thrust Manipulation | Experimental | Other: Dry Needling,Thrust ManipulationDry 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. |
| Exercise,Non-thrust Mobilization | Active comparator | Other: Exercise,Non-thrust MobilizationNonthrust 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry Needling,Thrust ManipulationAlso: Spinal Manipulation, Dry NeedlingHVLA 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 | Dry Needling,Thrust Manipulation |
| Exercise,Non-thrust MobilizationAlso: Exercise, Non-thrust MobilizationNon-thrust mobilization and exercise to upper cervical and upper thoracic regions. Up to 8 treatment sessions over 4 weeks. | Other | Exercise,Non-thrust Mobilization |
Primary outcome
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.
8 secondary outcomes
Change in Global Rating of Change Score for Headaches
Time frame: 6 months
Change in Global Rating of Change Score for Neck Pain
Time frame: 6 months
Change in Medication Intake (Frequency of medication intake in last week)
Time frame: Baseline, 6 months
Change in Headache Duration (Total hours of headaches in the last week)
Time frame: Baseline, 4 weeks, 3 months, 6 months
Change in Headache Frequency (Number of headaches in the last week)
Time frame: Baseline, 4 weeks, 3 months, 6 months
Change in Disability (Neck Disability Index, 0-50 points)
Time frame: Baseline, 4 weeks, 3 months, 6 months
Change in Neck Pain Intensity (Numeric Pain Rating Scale, 0-10 points)
Time frame: Baseline, 4 weeks, 3 months, 6 months
Change in Pain Catastrophizing Scale (0-52 points)
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Dunning, PhD, DPT principal investigator
American Academy of Manipulative Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling,Thrust Manipulation and Exercise,Non-thrust Mobilization in people with Cervicogenic Headache and Whiplash Injuries, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Dunning, PhD, DPT (801-707-9056, drjamesdunning@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Headache Intensity (Numeric Pain Rating Scale, 0-10) (Rating Score) (time frame: Baseline, 4 weeks, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.