Cervicogenic HeadacheNCT03730896
Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches
A study testing Dry needling in people with Cervicogenic Headache, run by Florida Gulf Coast University at 1 site in United States.
Trial summary
Evaluating the benefit of dry needling of the sternocleidomastoid muscle in subjects with cervicogenic headaches. 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?
- Dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Mar 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
- Age between 18-65 years old
- Primary complaint of cervicogenic headache
- Restricted cervical Range of motion
- Neck Disability Index > 20 points
Who cannot join
- Red flags identified during the patients physical therapy initial evaluation (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, symptoms of vertebrobasilary insufficiency, pregnancy, cervical spinal stenosis, bilateral upper extremity symptoms etc.
- Use of blood thinners
- History of whiplash injury within the past six weeks
- 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), etc.
- 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
Show all 13Show fewer
- Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps)
- Diminished or absent sensation to pinprick in any upper extremity dermatome
- Prior surgery to the neck or thoracic spine
- Chiropractic, Physical Therapy, or Acupuncture treatment for their neck pain in the last 6-months
- Workers compensation or pending legal action regarding their headaches
- Insufficient English language skills to complete all questionnaires
- Inability to comply with treatment and follow-up schedule
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrated therapy Practice PC
Hobart, Indiana, 46342
About this study
Official title: Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches - A Randomized Clinical Trial
Evaluating the benefit of dry needling of the sternocleidomastoid muscle in subjects with cervicogenic headaches.
Read the detailed description
The purpose of this study is to determine whether individuals with cervicogenic headache respond favorably to a program of manual therapy in combination with dry needling of the major muscle between chest bone and the head (sternocleidomastoid muscle) compared to manual therapy directed to the upper body quadrant alone.
The researchers will conduct a randomized clinical trial to assess the effectiveness of a manual therapy and dry needling approach (group 1) vs. manual therapy only. (group 2)
- Conditions
- Cervicogenic Headache
- Being tested
- Dry needling
- Keywords
- Dry needling, Cervicogenic headache, Manual therapy
- 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 needlingProcedure or surgery
Dryneedling of the sternocleidomastoid muscles within a standard treatment approach of physical therapy
| Study group | Role | What they receive |
|---|---|---|
| standard care group | No intervention | Normal manual therapy interventions Clinician will decide normal course of treatment |
| Dry needling | Experimental | Dryneedling group Clinician will decide normal course of treatment and dry needling of the Sternocleidomastoid muscle (SCM) muscle will be added to that treatment Receives: Procedure: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Headache Disability Index (HDI) score
Questionnaire for self report, this will be on a 0-100 score
Measured: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Secondary outcomes (3)
Change in cervical range of motion using an inclinometer/ change in high cervical range of motion using the Flexion-Rotation Test (FRT)
range of motion assessment, this will be measured in degrees with standardized goniometer measure
Measured: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Change in the neck disability Index score
Self report neck pain questionnaire, This is a 0-100 score
Measured: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Change in visual analogue scale score
Pain intensity scale,on a 10 cm line patient is asked to mark pain with one vertical mark
Measured: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Oct 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Why it stopped: Not enough viable subjects
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Gulf Coast University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rob Sillevis, PhD, Principal investigator, FGCU Assistent Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730896
- Sponsor's protocol ID
- FGCU IRB 2018-49
- Status last verified
- Jul 2020
- First submitted
- 29 Oct 2018
- Last updated
- 23 Jul 2020
- 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 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03730896
- Acronym / sponsor ID
- FGCU IRB 2018-49
- Conditions
- Cervicogenic Headache
- Keywords
- Dry needling, Cervicogenic headache, Manual therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough viable subjects
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Florida Gulf Coast UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 5 Nov 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.
Evaluating the benefit of dry needling of the sternocleidomastoid muscle in subjects with cervicogenic headaches.
Detailed description
The purpose of this study is to determine whether individuals with cervicogenic headache respond favorably to a program of manual therapy in combination with dry needling of the major muscle between chest bone and the head (sternocleidomastoid muscle) compared to manual therapy directed to the upper body quadrant alone.
The researchers will conduct a randomized clinical trial to assess the effectiveness of a manual therapy and dry needling approach (group 1) vs. manual therapy only. (group 2)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care group | No intervention | –Normal manual therapy interventions Clinician will decide normal course of treatment |
| Dry needling | Experimental | Procedure: Dry needlingDryneedling group Clinician will decide normal course of treatment and dry needling of the Sternocleidomastoid muscle (SCM) muscle will be added to that treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18-65 years old
- Primary complaint of cervicogenic headache
- Restricted cervical Range of motion
- Neck Disability Index > 20 points
Key exclusion criteria (13 listed)
- Red flags identified during the patients physical therapy initial evaluation (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, symptoms of vertebrobasilary insufficiency, pregnancy, cervical spinal stenosis, bilateral upper extremity symptoms etc.
- Use of blood thinners
- History of whiplash injury within the past six weeks
- 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), etc.
- Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
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 needlingDryneedling of the sternocleidomastoid muscles within a standard treatment approach of physical therapy | Procedure or surgery | Dry needling |
Primary outcome
Change in Headache Disability Index (HDI) score
Time frame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Questionnaire for self report, this will be on a 0-100 score
3 secondary outcomes
Change in cervical range of motion using an inclinometer/ change in high cervical range of motion using the Flexion-Rotation Test (FRT)
Time frame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Change in the neck disability Index score
Time frame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Change in visual analogue scale score
Time frame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Results and safety
The study was stopped early (reason given: Not enough viable subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- 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.
Rob Sillevis, PhD principal investigator
FGCU Assistent Professor
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 in people with Cervicogenic Headache, run by Florida Gulf Coast 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 13 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: stopped early, as of the sponsor's last update on 23 Jul 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 was stopped early (reason given: Not enough viable subjects). Results are not available in the source record.
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 Disability Index (HDI) score (time frame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)). 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 23 Jul 2020.