Cervicogenic HeadachesNCT02373605
Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache
A study testing Dry Needling,Thrust Manipulation and Exercise,Non-thrust Mobilization in people with Cervicogenic Headaches, 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: non-thrust mobilization and exercise versus thrust manipulation and dry needling. Physical therapists commonly use all of these techniques to treat cervicogenic headaches. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervicogenic Headaches
- 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
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 15 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria
- Headache frequency of at least one per week for a minimum of 3 months
- Minimum pain score (NPRS) of 2/10 and minimum disability score (NDI) of 10/50
Who cannot join
- 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. tumors, fracture, metabolic diseases, RA, osteoporosis, history of prolonged steroid use, etc.
- History of whiplash injury within the last 6 weeks
- Diagnosis of cervical stenosis
- Bilateral upper extremity symptoms
- Evidence of CNS 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, presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes).
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- Two or more positive neurologic signs consistent with nerve root compression, including any 2 of the following:
- Muscle weakness involving a major muscle group of the upper extremity.
- Diminished UE deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
- Diminished or absent sensation to pinprick in any UE dermatome.
- Prior surgery to neck of thoracic spine
- Involvement in litigation or worker's compensation regarding their neck pain and/or headaches
- PT or chiropractic care treatment for neck pain or headaches in the 3 months prior to baseline exam.
- Any condition that might contraindicate spinal manipulative therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alabama Physical Therapy & Acupuncture
Montgomery, Alabama, 36117
About this study
Official title: Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache: a Multi-center Randomized Clinical Trial
The purpose of this research is to compare two different approaches for treating patients with cervicogenic headaches: 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 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 HVLA thrust manipulation group, or the (2) Exercise and non-thrust mobilization group
- Conditions
- Cervicogenic Headaches
- Being tested
- Dry Needling,Thrust Manipulation, Exercise,Non-thrust Mobilization
- Medical subject headings
- Post-Traumatic 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 | Not described Receives: Other: Dry Needling,Thrust Manipulation |
| Exercise,Non-thrust Mobilization | Active comparator | Not described 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 (NPRS) (Rating Score)
Rating Score. Baseline score must exceed 2/10 to be included in the study.
Measured: Baseline, 1 week, 4 weeks, 3 months
Change in Headache Frequency (Number of headaches in the last week)
Number of headaches in the last week
Measured: Baseline, 1 week, 4 weeks, 3 months
Change in Disability (NDI 0-50 points)
10 Questions each worth 0-5 points with maximum score of 50 points possible. Baseline score must exceed 10/50 to be included in study.
Measured: Baseline, 1 week, 4 weeks, 3 months
Secondary outcomes (3)
Change in Global Rating of Change Score
Measured: 1 week, 4 weeks, 3 months
Change in Medication Intake (Frequency of medication intake in last week)
Measured: Baseline, 3 months
Change in Headache Duration (Total hours of headaches in the last week)
Total hours of headaches in the last week
Measured: Baseline, 1 week, 4 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completion15 May 2018
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadachesStudies 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
- 142 participants (actual)
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, DPT PhD, Principal investigator, American Academy of Manipulative Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373605
- Sponsor's protocol ID
- AAMT0001
- Status last verified
- Jun 2018
- First submitted
- 10 Feb 2015
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Dunning J, Butts R, Zacharko N, Fandry K, Young I, Wheeler K, Day J, Fernandez-de-Las-Penas C. Spinal manipulation and perineural electrical dry needling in patients with cervicogenic headache: a multicenter randomized clinical trial. Spine J. 2021 Feb;21(2):284-295. doi: 10.1016/j.spinee.2020.10.008. Epub 2020 Oct 13.
PubMed 33065273
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache: a Multi-center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02373605
- Acronym / sponsor ID
- AAMT0001
- Conditions
- Cervicogenic Headaches
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Alabama Physical Therapy & AcupunctureUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- Feb 2015
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 27 Feb 2015 (estimated)
- 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: 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 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 HVLA thrust manipulation group, or the (2) Exercise and non-thrust mobilization group
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 Manipulation |
| Exercise,Non-thrust Mobilization | Active comparator | Other: Exercise,Non-thrust Mobilization |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria
- Headache frequency of at least one per week for a minimum of 3 months
- Minimum pain score (NPRS) of 2/10 and minimum disability score (NDI) of 10/50
Key exclusion criteria (14 listed)
- 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. tumors, fracture, metabolic diseases, RA, osteoporosis, history of prolonged steroid use, etc.
- History of whiplash injury within the last 6 weeks
- Diagnosis of cervical stenosis
- Bilateral upper extremity symptoms
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 (NPRS) (Rating Score)
Time frame: Baseline, 1 week, 4 weeks, 3 months
Rating Score. Baseline score must exceed 2/10 to be included in the study.
Change in Headache Frequency (Number of headaches in the last week)
Time frame: Baseline, 1 week, 4 weeks, 3 months
Number of headaches in the last week
Change in Disability (NDI 0-50 points)
Time frame: Baseline, 1 week, 4 weeks, 3 months
10 Questions each worth 0-5 points with maximum score of 50 points possible. Baseline score must exceed 10/50 to be included in study.
3 secondary outcomes
Change in Global Rating of Change Score
Time frame: 1 week, 4 weeks, 3 months
Change in Medication Intake (Frequency of medication intake in last week)
Time frame: Baseline, 3 months
Change in Headache Duration (Total hours of headaches in the last week)
Time frame: Baseline, 1 week, 4 weeks, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Derived from this study: PubMed 33065273Dunning J, Butts R, Zacharko N, Fandry K, Young I, Wheeler K, Day J, Fernandez-de-Las-Penas C. Spinal manipulation and perineural electrical dry needling in patients with cervicogenic headache: a multicenter randomized clinical trial. Spine J. 2021 Feb;21(2):284-295. doi: 10.1016/j.spinee.2020.10.008. Epub 2020 Oct 13.
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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. This study is not recruiting at the moment.
James Dunning, DPT PhD 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 Headaches, 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 6 Jun 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Headache Intensity (NPRS) (Rating Score) (time frame: Baseline, 1 week, 4 weeks, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02373605, which also lists 1 linked publication.
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 6 Jun 2018.