Cervicogenic HeadacheNCT01580280
Manual Therapy and Exercise in Patients With Cervicogenic Headache
A study testing Thrust Manipulation and Non-thrust Mobilization and Exercise in people with Cervicogenic Headache, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
Trial summary
Hypothesis: The group of cervicogenic headache patients receiving upper cervical and upper thoracic thrust manipulation will demonstrate significant and clinically important changes in outcomes when compared to the mobilization and exercise group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Thrust Manipulation and Non-thrust Mobilization and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Aug 2014
- 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
- Bilateral headaches
- 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.)
- History of whiplash injury within the last 6 weeks
- Diagnosis of cervical spinal stenosis
- Bilateral upper extremity symptoms
Show all 15Show fewer
- 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 upper extremity dermatome
- Prior surgery to the neck or thoracic spine.
- Involvement in litigation or worker's compensation regarding their neck pain and/or headaches.
- Physical therapy or chiropractic treatment for neck pain or headache in the 3 months before baseline examination.
- 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: Effect of Upper Cervical and Upper Thoracic Thrust Manipulation Versus Mobilization and Exercise in Patients With Cervicogenic Headache
Hypothesis: The group of cervicogenic headache patients receiving upper cervical and upper thoracic thrust manipulation will demonstrate significant and clinically important changes in outcomes when compared to the mobilization and exercise group.
Read the detailed description
Patients with cervicogenic headache will be randomized to receive 6-8 sessions over 2-4 weeks of either: (1) upper cervical and upper thoracic thrust manipulation, or (2) upper cervical and upper thoracic non-thrust mobilization and range of motion, strength and postural exercises.
- Conditions
- Cervicogenic Headache
- Being tested
- Thrust Manipulation, Non-thrust Mobilization and Exercise
- Keywords
- Cervicogenic, Headache, Neck Pain, Manipulation, Mobilization, Exercise
- Medical subject headings
- Post-Traumatic Headache, Headache, Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrust ManipulationOther
Also called High-velocity low-amplitude thrust manipulation of the spine
Upper cervical and upper thoracic thrust manipulation for 6-8 sessions over 2-4 weeks.
Non-thrust Mobilization and ExerciseOther
Also called Non-thrust mobilization to cervical and thoracic spines, Cervical range of motion, strength, and postural exercises
Upper cervical and upper thoracic non-thrust mobilization and exercise for 6-8 sessions over 2-4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Thrust manipulation | Experimental | Not described Receives: Other: Thrust Manipulation |
| Non-thrust mobilization and exercise | Active comparator | Not described Receives: Other: Non-thrust Mobilization and Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Frequency
The number of headache days in the past week (as registered in headache diary)
Measured: Baseline
Headache Frequency
The number of headache days in the past week (as registered in headache diary)
Measured: 1-week
Headache Frequency
The number of headache days in the past week (as registered in headache diary)
Measured: 4-weeks
Headache Frequency
The number of headache days in the past week (as registered in headache diary)
Measured: 3-months
Headache Intensity
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Measured: Baseline
Headache Intensity
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Measured: 1-week
Headache Intensity
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Measured: 4-weeks
Headache Intensity
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Measured: 3-months
Headache Duration
Average number of headache hours in the last week (as registered in the headache diary)
Measured: Baseline
Headache Duration
Average number of headache hours in the last week (as registered in the headache diary)
Measured: 1-week
Headache Duration
Average number of headache hours in the last week (as registered in the headache diary)
Measured: 4-weeks
Headache Duration
Average number of headache hours in the last week (as registered in the headache diary)
Measured: 3-months
Neck Disability Index (NDI)
Neck pain and disability
Measured: Baseline
Neck Disability Index (NDI)
Neck pain and disability
Measured: 1-week
Neck Disability Index (NDI)
Neck pain and disability
Measured: 4-weeks
Neck Disability Index (NDI)
Neck pain and disability
Measured: 3-months
Secondary outcomes (5)
Global Rating of Change (GROC)
Perceived improvement.
Measured: 1-week
Global Rating of Change (GROC)
Perceived improvement.
Measured: 4-weeks
Global Rating of Change (GROC)
Perceived improvement.
Measured: 3-months
Analgesic Use
Analgesic (medication intake) use per day (as registered in the headache diary).
Measured: Baseline
Analgesic Use
Analgesic (medication intake) use per day (as registered in the headache diary).
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alabama Physical Therapy & Acupuncture
- Sponsor type
- University, hospital or other
- Collaborators
- Long Island University
- Responsible party
- Sponsor
- Investigators
- Marshall Hagins, PT, PhD, Study chair, Long Island University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580280
- Sponsor's protocol ID
- 12/01-006
- Status last verified
- Nov 2014
- First submitted
- 16 Apr 2012
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dunning JR, Cleland JA, Waldrop MA, Arnot CF, Young IA, Turner M, Sigurdsson G. Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):5-18. doi: 10.2519/jospt.2012.3894. Epub 2011 Sep 30.
PubMed 21979312Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.
PubMed 26852024
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Upper Cervical and Upper Thoracic Thrust Manipulation Versus Mobilization and Exercise in Patients With Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT01580280
- Acronym / sponsor ID
- 12/01-006
- Conditions
- Cervicogenic Headache
- Keywords
- Cervicogenic, Headache, Neck Pain, Manipulation, Mobilization, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Alabama Physical Therapy & AcupunctureUniversity, hospital or other
- Collaborators
- Long Island University
- Study start
- Apr 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 19 Apr 2012 (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.
Hypothesis: The group of cervicogenic headache patients receiving upper cervical and upper thoracic thrust manipulation will demonstrate significant and clinically important changes in outcomes when compared to the mobilization and exercise group.
Detailed description
Patients with cervicogenic headache will be randomized to receive 6-8 sessions over 2-4 weeks of either: (1) upper cervical and upper thoracic thrust manipulation, or (2) upper cervical and upper thoracic non-thrust mobilization and range of motion, strength and postural exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrust manipulation | Experimental | Other: Thrust Manipulation |
| Non-thrust mobilization and exercise | Active comparator | Other: Non-thrust Mobilization and Exercise |
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 (15 listed)
- Bilateral headaches
- 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.)
- History of whiplash injury within the last 6 weeks
- Diagnosis of cervical spinal stenosis
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 |
|---|---|---|
| Thrust ManipulationAlso: High-velocity low-amplitude thrust manipulation of the spineUpper cervical and upper thoracic thrust manipulation for 6-8 sessions over 2-4 weeks. | Other | Thrust manipulation |
| Non-thrust Mobilization and ExerciseAlso: Non-thrust mobilization to cervical and thoracic spines, Cervical range of motion, strength, and postural exercisesUpper cervical and upper thoracic non-thrust mobilization and exercise for 6-8 sessions over 2-4 weeks. | Other | Non-thrust mobilization and exercise |
Primary outcome
Headache Frequency
Time frame: Baseline
The number of headache days in the past week (as registered in headache diary)
Headache Frequency
Time frame: 1-week
The number of headache days in the past week (as registered in headache diary)
Headache Frequency
Time frame: 4-weeks
The number of headache days in the past week (as registered in headache diary)
Headache Frequency
Time frame: 3-months
The number of headache days in the past week (as registered in headache diary)
Headache Intensity
Time frame: Baseline
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Headache Intensity
Time frame: 1-week
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Headache Intensity
Time frame: 4-weeks
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Headache Intensity
Time frame: 3-months
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Headache Duration
Time frame: Baseline
Average number of headache hours in the last week (as registered in the headache diary)
Headache Duration
Time frame: 1-week
Average number of headache hours in the last week (as registered in the headache diary)
Headache Duration
Time frame: 4-weeks
Average number of headache hours in the last week (as registered in the headache diary)
Headache Duration
Time frame: 3-months
Average number of headache hours in the last week (as registered in the headache diary)
Neck Disability Index (NDI)
Time frame: Baseline
Neck pain and disability
Neck Disability Index (NDI)
Time frame: 1-week
Neck pain and disability
Neck Disability Index (NDI)
Time frame: 4-weeks
Neck pain and disability
Neck Disability Index (NDI)
Time frame: 3-months
Neck pain and disability
5 secondary outcomes
Global Rating of Change (GROC)
Time frame: 1-week
Global Rating of Change (GROC)
Time frame: 4-weeks
Global Rating of Change (GROC)
Time frame: 3-months
Analgesic Use
Time frame: Baseline
Analgesic Use
Time frame: 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 14 Nov 2014.
- Background: PubMed 21979312Dunning JR, Cleland JA, Waldrop MA, Arnot CF, Young IA, Turner M, Sigurdsson G. Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):5-18. doi: 10.2519/jospt.2012.3894. Epub 2011 Sep 30.
- Derived from this study: PubMed 26852024Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.
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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.
Marshall Hagins, PT, PhD study chair
Long Island University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrust Manipulation and Non-thrust Mobilization and Exercise in people with Cervicogenic Headache, 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 15 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 14 Nov 2014. 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?
Headache Frequency (time frame: Baseline). The study lists 16 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 NCT01580280, which also lists 2 linked publications.
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 14 Nov 2014.