HeadacheNCT04305223
Dry Needling for Cervicogenic Headache
A study testing Dry Needling and Upper extremity stretching program in people with Headache and Cervicogenic Headache, run by Emory University at 1 site in United States.
Trial summary
This is a single-blinded randomized clinical trial. The primary aim of this study is to compare the effectiveness of dry needling of myofascial trigger points in the muscles of the head and cervical spine in addition to an upper extremity strengthening/stretching exercise program compared to a dry needling group alone… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache, Cervicogenic Headache
- What is being tested?
- Dry Needling and Upper extremity stretching program
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 1 Apr 2020
- 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
- Unilateral headache (HA) without side shift
- H/o pain triggered by neck movement
- Limitation in cervical range of motion
- Ispilateral neck, shoulder or arm pain
- Intermittent pain with episodes varying in duration
- Head and neck pain is non-throbbing in nature
Who cannot join
- Use of anti-coagulation medicine (except low dose aspirin)
- Pregnancy
- Acute or uncontrolled medical illness
- Opioid use within six months
- Fibromyalgia or diffuse painful syndromes in the UE or LE
- Substance abuse
- Presence of fever, vomiting or visual changes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Dry Needling Versus Upper Extremity Strengthening and Dry Needling for Individuals With Cervicogenic Headache
This is a single-blinded randomized clinical trial. The primary aim of this study is to compare the effectiveness of dry needling of myofascial trigger points in the muscles of the head and cervical spine in addition to an upper extremity strengthening/stretching exercise program compared to a dry needling group alone on pain scores, cervical range of motion, pain sensitivity and changes in severity and frequency of pain symptoms in individuals with cervicogenic headache.
Read the detailed description
This is a single-blinded randomized clinical trial. Eligible participants who agree to enroll in the study will be asked to attend four testing sessions. Participants in both groups will receive dry needling to the involved head and cervical muscles and the other group, in addition to receiving a dry needling intervention, will be instructed in a standard home exercise program consisting of strengthening and stretching exercises for the upper quarter. All dry needling (using standard clean technique) will be performed by licensed physical therapists board certified in orthopaedic physical therapy and having a minimum of 5 years of experience treating patient populations with dry needling.
The aim of this research study is to compare he effectiveness of dry needling alone with dry needling and a home exercise program on pain, pain sensitivity, cervical range of motion, and changes in the severity and frequency among individuals with headache symptoms.
- Conditions
- Headache, Cervicogenic Headache
- Being tested
- Dry Needling, Upper extremity stretching program
- Keywords
- Headache, Dry Needling
- Medical subject headings
- Headache, Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingProcedure or surgery
Also called Myofascial trigger point dry needling, Intramuscular stimulation
Dry Needling is a treatment technique whereby a sterile, single-use, fine filament needle is inserted into the muscle to assist with decreasing pain and improving function through the release of myofascial trigger points (knots in the muscle).
Upper extremity stretching programOther
A standard home exercise program consisting of strengthening and stretching exercises for the upper quarter
| Study group | Role | What they receive |
|---|---|---|
| Dry needling and upper extremity stretching program Arm | Experimental | Participants will receive a combination of dry needling and upper extremity stretching.
* Dry needling in regions of the head and cervical spine will be positioned supine, sidelying or prone with the relevant myofascial trigger points treated using a Seirin L- type 30 mm needle (Seirin America, Inc., Weymouth, MA). The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 5 minutes.
* A standard home exercise program consisting of strengthening and stretching exercises for the upper quarter. Receives: Procedure: Dry Needling; Other: Upper extremity stretching program |
| Dry Needling Arm | Active comparator | Dry needling in regions of the head and cervical spine will be positioned supine, sidelying or prone with the relevant myofascial trigger points treated using a Seirin L- type 30 mm needle (Seirin American, Inc., Weymouth, MA). The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 5 minutes. Receives: Procedure: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual analog score for pain level
Pain is reported using a Visual Analog Scale from 0-10 and evaluates the frequency, severity and duration of the pain. Higher score indicates worse outcome.
Measured: Baseline, Weeks 1 to 4 post intervention
Change in pain pressure threshold (PPT)
Pressure algometry is a method described to determine pressure pain threshold (PPT) by applying controlled pressure to a given body point. Measured with a pressure algometer: 0-50 KPa/s (kilopascal/second squared), minimum score representing increased pain to light touch/measuring allodynia.
Measured: Baseline, Weeks 1 to 4 post intervention
Change in cervical range of motion
Will measure C1-2 Active Range of Motion, min score, 0; max score 50 degrees, lower score more limited (worse outcome).
Measured: Baseline, Weeks 1 to 4 post intervention
Functional outcome measure: Change in neck disability index
Score ranges from 0-50 points: higher scores indicate higher levels of disability; Minimal detectable change (MDC), 5 points.
Measured: Baseline, Weeks 1 to 4 post intervention
Functional outcome measure: Change in headache disability index
Score ranges from 0-72: 0 is no disability, 72 is more severe disability. Minimally Clinically Important Difference (MCID) is 29 points.
Measured: Baseline, Weeks 1 to 4 post intervention
Change in Pain Frequency-Severity-Duration (PFDS) Scale
PFSD scale ranges from 1-140 with higher scores indicative of higher disability.
There is a composite score that ranges from 0-140. Higher score correlates with worse outcome.
Measured: Baseline, Weeks 1 to 4 post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start12 Feb 2020
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Model description
- single-blinded randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Geist, Emory University
- Investigators
- Kathleen Geist, PT, DPT, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305223
- Sponsor's protocol ID
- IRB00114985
- Status last verified
- May 2020
- First submitted
- 10 Mar 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dry Needling Versus Upper Extremity Strengthening and Dry Needling for Individuals With Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT04305223
- Acronym / sponsor ID
- IRB00114985
- Conditions
- Headache, Cervicogenic Headache
- Keywords
- Headache, Dry Needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 12 Mar 2020 (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.
This is a single-blinded randomized clinical trial. The primary aim of this study is to compare the effectiveness of dry needling of myofascial trigger points in the muscles of the head and cervical spine in addition to an upper extremity strengthening/stretching exercise program compared to a dry needling group alone on pain scores, cervical range of motion, pain sensitivity and changes in severity and frequency of pain symptoms in individuals with cervicogenic headache.
Detailed description
This is a single-blinded randomized clinical trial. Eligible participants who agree to enroll in the study will be asked to attend four testing sessions. Participants in both groups will receive dry needling to the involved head and cervical muscles and the other group, in addition to receiving a dry needling intervention, will be instructed in a standard home exercise program consisting of strengthening and stretching exercises for the upper quarter. All dry needling (using standard clean technique) will be performed by licensed physical therapists board certified in orthopaedic physical therapy and having a minimum of 5 years of experience treating patient populations with dry needling.
The aim of this research study is to compare he effectiveness of dry needling alone with dry needling and a home exercise program on pain, pain sensitivity, cervical range of motion, and changes in the severity and frequency among individuals with headache symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single-blinded randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Dry needling and upper extremity stretching program Arm | Experimental | Procedure: Dry Needling, Other: Upper extremity stretching programParticipants will receive a combination of dry needling and upper extremity stretching. * Dry needling in regions of the head and cervical spine will be positioned supine, sidelying or prone with the relevant myofascial trigger points treated using a Seirin L- type 30 mm needle (Seirin America, Inc., Weymouth, MA). The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 5 minutes. * A standard home exercise program consisting of strengthening and stretching exercises for the upper quarter. |
| Dry Needling Arm | Active comparator | Procedure: Dry NeedlingDry needling in regions of the head and cervical spine will be positioned supine, sidelying or prone with the relevant myofascial trigger points treated using a Seirin L- type 30 mm needle (Seirin American, Inc., Weymouth, MA). The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 5 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral headache (HA) without side shift
- H/o pain triggered by neck movement
- Limitation in cervical range of motion
- Ispilateral neck, shoulder or arm pain
- Intermittent pain with episodes varying in duration
Key exclusion criteria (7 listed)
- Use of anti-coagulation medicine (except low dose aspirin)
- Pregnancy
- Acute or uncontrolled medical illness
- Opioid use within six months
- Fibromyalgia or diffuse painful syndromes in the UE or LE
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 NeedlingAlso: Myofascial trigger point dry needling, Intramuscular stimulationDry Needling is a treatment technique whereby a sterile, single-use, fine filament needle is inserted into the muscle to assist with decreasing pain and improving function through the release of myofascial trigger points (knots in the muscle). | Procedure or surgery | Dry Needling Arm, Dry needling and upper extremity stretching program Arm |
| Upper extremity stretching programA standard home exercise program consisting of strengthening and stretching exercises for the upper quarter | Other | Dry needling and upper extremity stretching program Arm |
Primary outcome
Change in visual analog score for pain level
Time frame: Baseline, Weeks 1 to 4 post intervention
Pain is reported using a Visual Analog Scale from 0-10 and evaluates the frequency, severity and duration of the pain. Higher score indicates worse outcome.
Change in pain pressure threshold (PPT)
Time frame: Baseline, Weeks 1 to 4 post intervention
Pressure algometry is a method described to determine pressure pain threshold (PPT) by applying controlled pressure to a given body point. Measured with a pressure algometer: 0-50 KPa/s (kilopascal/second squared), minimum score representing increased pain to light touch/measuring allodynia.
Change in cervical range of motion
Time frame: Baseline, Weeks 1 to 4 post intervention
Will measure C1-2 Active Range of Motion, min score, 0; max score 50 degrees, lower score more limited (worse outcome).
Functional outcome measure: Change in neck disability index
Time frame: Baseline, Weeks 1 to 4 post intervention
Score ranges from 0-50 points: higher scores indicate higher levels of disability; Minimal detectable change (MDC), 5 points.
Functional outcome measure: Change in headache disability index
Time frame: Baseline, Weeks 1 to 4 post intervention
Score ranges from 0-72: 0 is no disability, 72 is more severe disability. Minimally Clinically Important Difference (MCID) is 29 points.
Change in Pain Frequency-Severity-Duration (PFDS) Scale
Time frame: Baseline, Weeks 1 to 4 post intervention
PFSD scale ranges from 1-140 with higher scores indicative of higher disability. There is a composite score that ranges from 0-140. Higher score correlates with worse outcome.
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 19 May 2020.
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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.
Kathleen Geist, PT, DPT principal investigator
Emory 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 Dry Needling and Upper extremity stretching program in people with Headache and Cervicogenic Headache, run by Emory 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 6 inclusion and 7 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 19 May 2020. 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 visual analog score for pain level (time frame: Baseline, Weeks 1 to 4 post intervention). The study lists 6 primary outcomes in all. 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 19 May 2020.