Cervicogenic HeadacheNCT03583190
Cervical-Cranial Dry Needling vs. Orthopedic Manual Therapy for Cervicogenic Headache
A study testing Cervical-cranial dry needling, Orthopedic manual therapy and Thoracic Manipulation in people with Cervicogenic Headache, run by Youngstown State University at 1 site in United States.
Trial summary
Dry needling is a therapeutic modality used to treat a number of neuromusculoskeletal conditions. Practice trends suggest it is becoming widely used by Physical Therapists to help patients manage symptoms associated with CGH, however, there is limited scientific evidence demonstrating meaningful impact for dry… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Cervical-cranial dry needling, Orthopedic manual therapy and Thoracic Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2018to 10 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Meets the IHS criteria for CGH
- Headache frequency of at least 1 per week over a period greater than 3 months.
- Demonstrates segmental dysfunction with passive mobility testing.
Who cannot join
- Patients whose headache experience is primarily of migraine origin. Tension-type headache, headache pain <2, contraindications to the interventions (malignancy, myelopathy, fracture, metabolic disease, rheumatoid arthritis, long-term corticosteroid use), headache presentation suggesting cervical arterial insufficiency, severe metal allergy, needle phobia, history of neck or thoracic spine surgery, Non-English speaking patients, therapist is unable to elicit the headache with passive accessory intervertebral movements (PAIVM), or pending litigation for neck pain and/or headache.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Youngstown State University
Youngstown, Ohio, 44406
David W Griswold, PhD, DPT, 330-941-2419, dwgriswold@ysu.edu
About this study
Official title: Comparing the Use of Cervical-Cranial Dry Needling With Orthopedic Manual Therapy to the Cervical Spine for Cervicogenic Headache: A Multi-center RCT With 1-Year Follow Up
Dry needling is a therapeutic modality used to treat a number of neuromusculoskeletal conditions. Practice trends suggest it is becoming widely used by Physical Therapists to help patients manage symptoms associated with CGH, however, there is limited scientific evidence demonstrating meaningful impact for dry needling for CGH. Manual therapy (thrust and non-thrust mobilizations) to the cervical spine are well researched and have an established treatment effect for managing symptoms related to CGH. The purpose of this study is to compare outcomes (1 week, 1 month, 3 months, 12 months) for patients with CGH treated with cervical-cranial dry needling or pragmatically applied orthopedic manual therapy to the cervical spine. In addition to either the cervical-cranial dry needling or manual therapy to the cervical spine, patients will also receive patient education, thoracic manipulation, and exercise.
Read the detailed description
The use of dry needling is becoming widely used by Physical Therapists in the United States for a number of neuromusculoskeletal conditions including cervicogenic headache (CGH). Dry needling is performed by taking a mono-filament needle and inserting it into symptomatic soft tissue. In this trial, the dry needling will be performed segmentally in the neck and along the patient's headache distribution pattern. Orthopedic manual therapy (OMT) may include both thrust and non-thrust techniques applied to a targeted spinal level and has a well-established treatment effect for patients with CGH. In this trial, the OMT will be applied pragmatically to the cervical spine at the most symptomatic level of the headache. Other interventions used in this trial will include patient education, thoracic manipulation and exercise.
Patients will be randomized to receive either dry needling or OMT 2x/week for 2 weeks and then 1-2x/week for 2 weeks totaling 6-8 visits over the course of 1 month. The 1 week and 1 month outcomes collected will be reported on separately from the 3 and 12 months.
- Conditions
- Cervicogenic Headache
- Being tested
- Cervical-cranial dry needling, Orthopedic manual therapy, Thoracic Manipulation, Exercise, Patient Education
- Keywords
- Neck pain, Headache, Dry needling, manual therapy
- Medical subject headings
- Post-Traumatic Headache, Neck Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical-cranial dry needlingOther
Segmental needling of the neck and needling in the patient's headache distribution. Peripherally sensitized areas of the neck may also be dry needled based on the findings of the clinical evaluation.
Orthopedic manual therapyOther
Orthopedic Manual Therapy (OMT) that includes either mobilization or manipulation to the cervical spine applied pragmatically to the most symptomatic level.
Thoracic ManipulationOther
Thoracic Manipulation (applied pragmatically) to the levels determined to be provocative or hypomobile.
ExerciseOther
Clinicians select 1 active range of motion exercise for the cervical spine, deep cervical flexion endurance exercise, and 5 upper extremity exercises (from a set of 10). Additionally, patients will be assigned a headache management technique.
Patient EducationOther
Patients will receive education regarding their headache condition, proper performance of their symptom management technique, posture.
| Study group | Role | What they receive |
|---|---|---|
| Cervical-cranial dry needling | Experimental | Patients randomized to this arm will receive cervical-cranial dry needling, thoracic manipulation, and exercise. Receives: Other: Cervical-cranial dry needling; Other: Thoracic Manipulation; Other: Exercise; Other: Patient Education |
| Orthopedic Manual Therapy | Active comparator | Patients randomized to this arm will receive orthopedic manual therapy to cervical spine, thoracic manipulation, and exercise. Receives: Other: Orthopedic manual therapy; Other: Thoracic Manipulation; Other: Exercise; Other: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NPRS headache intensity
Average and most intense in the last week will be recorded using a 0 (no headache) to 10 (most intense)
Measured: Baseline, 1 week, 1 month, 3 months, 12 months.
Secondary outcomes (8)
Change in disability using Neck Disability Index
The NDI is a self-report measure of perceived disability comprised of ten questions using an ordinal scale from 0 to 5 for a maximum of 50 points.
Measured: Baseline 1 week, 1 month, 3 months, 12 months
Change in disability using Headache Disability Index (HDI)
The HDI assesses "the burden of chronic headaches," using 25 items that ask about the perceived impact of headaches on emotional functioning and daily activities. Items were designed specifically to assess the concerns of individuals with recurrent headache disorders.
Measured: Baseline, 1 week, 1 month, 3 months, 12 months
Leeds Assessment of Neuropathic Signs and Symptoms (LANSS)
Subjects identifying particular qualities about their pain (yes/no) that could suggest problems with how the nervous system is interpreting pain. There is a physical screening procedure involving a discriminate evaluation of different sensations (light touch, and sharp/dull) in an area of the subject's body (arm or leg) without pain compared to an area of their pain (neck or head). The questions and results from the physical testing are scored which can range from 0-24.
Measured: Baseline
Change in Medication intake
Patients will identify the medications + dosage they have consumed to treat their headache in the past week.
Measured: Baseline, 1 week, 1 month, 3 months, 12 months
Patient Satisfaction
Patient satisfaction will be assessed using the Patient Satisfaction Instrument (PSI) that measures several constructs related to clinical outcomes and patient care. The PSI consists of 12 questions rated using a scale, 1 (strongly disagree) to 5 (strongly agree).
Measured: 1 month
Health care utilization
Healthcare utilization will be reported by subjects identifying on a form any provider they have seen for care of their headaches, treatments they have received, and cost for their headaches.
Measured: 3 and 12 months
SANE Percent Recovery
Percent recovery will be measured using a global percentage of improvement is a measure of the patient's perception of the change in their condition.
Measured: 1 month
Change in current NPRS neck or headache intensity
Current level of headache or neck pain on a scale ranging from 0 (no headache) to 10 (most intense)
Measured: Baseline and Immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start5 Jul 2018
- Primary completion10 Oct 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Youngstown State University
- Sponsor type
- University, hospital or other
- Collaborators
- Franklin Pierce University
- Responsible party
- Sponsor
- Investigators
- David Griswold, PhD, Principal investigator, Associate Professor at Youngstown State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583190
- Sponsor's protocol ID
- 0177-08
- Status last verified
- Nov 2023
- First submitted
- 18 Jun 2018
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sedighi A, Nakhostin Ansari N, Naghdi S. Comparison of acute effects of superficial and deep dry needling into trigger points of suboccipital and upper trapezius muscles in patients with cervicogenic headache. J Bodyw Mov Ther. 2017 Oct;21(4):810-814. doi: 10.1016/j.jbmt.2017.01.002. Epub 2017 Jan 6.
PubMed 29037632France S, Bown J, Nowosilskyj M, Mott M, Rand S, Walters J. Evidence for the use of dry needling and physiotherapy in the management of cervicogenic or tension-type headache: a systematic review. Cephalalgia. 2014 Oct;34(12):994-1003. doi: 10.1177/0333102414523847. Epub 2014 Mar 12.
PubMed 24623124Bond BM, Kinslow C. Improvement in clinical outcomes after dry needling in a patient with occipital neuralgia. J Can Chiropr Assoc. 2015 Jun;59(2):101-10.
PubMed 26136602
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Use of Cervical-Cranial Dry Needling With Orthopedic Manual Therapy to the Cervical Spine for Cervicogenic Headache: A Multi-center RCT With 1-Year Follow Up
- ClinicalTrials.gov ID
- NCT03583190
- Acronym / sponsor ID
- 0177-08
- Conditions
- Cervicogenic Headache
- Keywords
- Neck pain, Headache, Dry needling, manual therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Youngstown State UniversityUniversity, hospital or other
- Collaborators
- Franklin Pierce University
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 11 Jul 2018 (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.
Dry needling is a therapeutic modality used to treat a number of neuromusculoskeletal conditions. Practice trends suggest it is becoming widely used by Physical Therapists to help patients manage symptoms associated with CGH, however, there is limited scientific evidence demonstrating meaningful impact for dry needling for CGH. Manual therapy (thrust and non-thrust mobilizations) to the cervical spine are well researched and have an established treatment effect for managing symptoms related to CGH. The purpose of this study is to compare outcomes (1 week, 1 month, 3 months, 12 months) for patients with CGH treated with cervical-cranial dry needling or pragmatically applied orthopedic manual therapy to the cervical spine. In addition to either the cervical-cranial dry needling or manual therapy to the cervical spine, patients will also receive patient education, thoracic manipulation, and exercise.
Detailed description
The use of dry needling is becoming widely used by Physical Therapists in the United States for a number of neuromusculoskeletal conditions including cervicogenic headache (CGH). Dry needling is performed by taking a mono-filament needle and inserting it into symptomatic soft tissue. In this trial, the dry needling will be performed segmentally in the neck and along the patient's headache distribution pattern. Orthopedic manual therapy (OMT) may include both thrust and non-thrust techniques applied to a targeted spinal level and has a well-established treatment effect for patients with CGH. In this trial, the OMT will be applied pragmatically to the cervical spine at the most symptomatic level of the headache. Other interventions used in this trial will include patient education, thoracic manipulation and exercise.
Patients will be randomized to receive either dry needling or OMT 2x/week for 2 weeks and then 1-2x/week for 2 weeks totaling 6-8 visits over the course of 1 month. The 1 week and 1 month outcomes collected will be reported on separately from the 3 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical-cranial dry needling | Experimental | Other: Cervical-cranial dry needling, Other: Thoracic Manipulation, Other: Exercise, Other: Patient EducationPatients randomized to this arm will receive cervical-cranial dry needling, thoracic manipulation, and exercise. |
| Orthopedic Manual Therapy | Active comparator | Other: Orthopedic manual therapy, Other: Thoracic Manipulation, Other: Exercise, Other: Patient EducationPatients randomized to this arm will receive orthopedic manual therapy to cervical spine, thoracic manipulation, and exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Meets the IHS criteria for CGH
- Headache frequency of at least 1 per week over a period greater than 3 months.
- Demonstrates segmental dysfunction with passive mobility testing.
Key exclusion criteria (1 listed)
- Patients whose headache experience is primarily of migraine origin. Tension-type headache, headache pain <2, contraindications to the interventions (malignancy, myelopathy, fracture, metabolic disease, rheumatoid arthritis, long-term corticosteroid use), headache presentation suggesting cervical arterial insufficiency, severe metal allergy, needle phobia, history of neck or thoracic spine surgery, Non-English speaking patients, therapist is unable to elicit the headache with passive accessory intervertebral movements (PAIVM), or pending litigation for neck pain and/or headache.
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 |
|---|---|---|
| Cervical-cranial dry needlingSegmental needling of the neck and needling in the patient's headache distribution. Peripherally sensitized areas of the neck may also be dry needled based on the findings of the clinical evaluation. | Other | Cervical-cranial dry needling |
| Orthopedic manual therapyOrthopedic Manual Therapy (OMT) that includes either mobilization or manipulation to the cervical spine applied pragmatically to the most symptomatic level. | Other | Orthopedic Manual Therapy |
| Thoracic ManipulationThoracic Manipulation (applied pragmatically) to the levels determined to be provocative or hypomobile. | Other | Cervical-cranial dry needling, Orthopedic Manual Therapy |
| ExerciseClinicians select 1 active range of motion exercise for the cervical spine, deep cervical flexion endurance exercise, and 5 upper extremity exercises (from a set of 10). Additionally, patients will be assigned a headache management technique. | Other | Cervical-cranial dry needling, Orthopedic Manual Therapy |
| Patient EducationPatients will receive education regarding their headache condition, proper performance of their symptom management technique, posture. | Other | Cervical-cranial dry needling, Orthopedic Manual Therapy |
Primary outcome
Change in NPRS headache intensity
Time frame: Baseline, 1 week, 1 month, 3 months, 12 months.
Average and most intense in the last week will be recorded using a 0 (no headache) to 10 (most intense)
8 secondary outcomes
Change in disability using Neck Disability Index
Time frame: Baseline 1 week, 1 month, 3 months, 12 months
Change in disability using Headache Disability Index (HDI)
Time frame: Baseline, 1 week, 1 month, 3 months, 12 months
Leeds Assessment of Neuropathic Signs and Symptoms (LANSS)
Time frame: Baseline
Change in Medication intake
Time frame: Baseline, 1 week, 1 month, 3 months, 12 months
Patient Satisfaction
Time frame: 1 month
Health care utilization
Time frame: 3 and 12 months
SANE Percent Recovery
Time frame: 1 month
Change in current NPRS neck or headache intensity
Time frame: Baseline and Immediately post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 29037632Sedighi A, Nakhostin Ansari N, Naghdi S. Comparison of acute effects of superficial and deep dry needling into trigger points of suboccipital and upper trapezius muscles in patients with cervicogenic headache. J Bodyw Mov Ther. 2017 Oct;21(4):810-814. doi: 10.1016/j.jbmt.2017.01.002. Epub 2017 Jan 6.
- Background: PubMed 24623124France S, Bown J, Nowosilskyj M, Mott M, Rand S, Walters J. Evidence for the use of dry needling and physiotherapy in the management of cervicogenic or tension-type headache: a systematic review. Cephalalgia. 2014 Oct;34(12):994-1003. doi: 10.1177/0333102414523847. Epub 2014 Mar 12.
- Background: PubMed 26136602Bond BM, Kinslow C. Improvement in clinical outcomes after dry needling in a patient with occipital neuralgia. J Can Chiropr Assoc. 2015 Jun;59(2):101-10.
- 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. This study is not recruiting at the moment.
David Griswold, PhD principal investigator
Associate Professor at Youngstown State 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 Cervical-cranial dry needling, Orthopedic manual therapy and Thoracic Manipulation in people with Cervicogenic Headache, run by Youngstown State University 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Griswold, PhD (330-941-2419, dwgriswold@ysu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NPRS headache intensity (time frame: Baseline, 1 week, 1 month, 3 months, 12 months.). 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 NCT03583190, which also lists 3 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 18 Nov 2023.