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Chronic MigraineNCT05893914

Intramuscular Electrical Stimulation for the Treatment of Trigger Points in Patients With Migraine

A study testing Dry Needling and intramuscular electrical stimulation to trigger points in people with Chronic Migraine, run by Thomas W. Perreault, PT at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this single-case experimental study is to investigate the effects of intramuscular electrical stimulation for the treatment of trigger points on reducing the frequency of headaches in a small sample of patients with chronic migraine. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Migraine
What is being tested?
Dry Needling and intramuscular electrical stimulation to trigger points
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
4 Aug 2023to 7 Oct 2024
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

  • At least a 6-month history of headaches consistent with a diagnosis of chronic migraine headache according to International Headache Society (IHS) criteria
  • Presence of trigger points in at least 2 of the following posterior cervical muscles, ipsilateral to the side of headache, and reproducing headache symptoms upon stimulation within the distribution of headache
  • splenius capitis
  • splenius cervicis
  • semispinalis capitis/cervicis
  • cervical multifidi
  • obliquus capitis inferior

Who cannot join

  • Presence of other primary or secondary headache diagnoses, including medication overuse headache
  • cervical radiculopathy
  • cervical spondylosis or stenosis
  • previous surgery in the cervical spine region
  • history of whiplash
  • pregnancy
Show all 15Show fewer
  • fibromyalgia
  • Having received any of the following within the past 12 months
  • trigger point injection
  • anesthetic blocks
  • radiofrequency lesioning
  • botulinum toxin injections
  • acupuncture
  • dry needling
  • physical therapy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Wentworth Douglass Hospital

    Dover, New Hampshire, 03820

Other trials in United States

About this study

Official title: Intramuscular Electrical Stimulation for the Treatment of Trigger Points in Patients With Migraine: A Single Case Experimental Design

The goal of this single-case experimental study is to investigate the effects of intramuscular electrical stimulation for the treatment of trigger points on reducing the frequency of headaches in a small sample of patients with chronic migraine. Additionally, this study seeks to investigate the effects of intramuscular electrical stimulation to trigger points on reducing the overall headache intensity, impact and disability using research validated questionnaires.Intramuscular electrical stimulation is a treatment that uses needles to deliver electrical current into muscles, or trigger points, for reducing pain and improving function. Trigger points are painful spots within taut bands of muscle that produce pain when pressure is applied or spontaneously. Participants will be included if they have at least a 6-month history of chronic migraine headache. Due to the nature of the single case experimental design study, participants will each serve as their own controls and be randomized to various baseline measures where they will record headaches and symptoms using an electronic headache diary. During the intervention phase, participants will receive dry needling treatment with intramuscular electrical stimulation, and will continue recording in the electronic headache diary and complete all self reported outcome measures at the final treatment session.

Read the detailed description

This study will recruit four participants with chronic migraine, in a non-concurrent manner. A non-concurrent multiple baseline line, A-B design will be implemented. Patients being referred for rehabilitation services to Wentworth Douglass Hospital Outpatient Physical Therapy Department with a diagnosis of migraine or headache will be screened for eligibility. Initial consultation for study eligibility will be by phone using a brief screening tool. Participants who preliminarily meet the eligibility criteria and are willing to participate in the study will be scheduled for the initial evaluation. In this study participants will be involved in two separate phases, a baseline phase and intervention phase. Before the clinical measurements or objective examination procedures are carried out, participants who are eligible based on pre-screening criteria, must sign the informed consent for study participation if willing to participate. Once signed, clinical examination tests will be carried out to determine full eligibility. All participants will undergo the following objective measures;

  1. Manual examination for trigger points assessed by palpation
  2. Pressure pain threshold will be assessed in the location of the trigger points using an analogue algometer (Force Dial FDK 20, Wagner Instruments, Greenwich. Connecticut)
  3. Cervical spine active range of motion will be measured using a standard universal goniometer for cervical rotation, and a standard inclinometer for all other motions
  4. A neurological examination will be performed consisting of screening of cranial nerves, deep tendon reflex testing; dermatome sensation testing; and myotome testing, except for the C1-C4 levels which are difficult to assess clinically via manual muscle testing
  5. Segmental mobility will be tested using a lateral gliding and segmental side- bending maneuvers
  6. Flexion rotation test will be performed bilaterally to assess for pain provocation, mobility of the upper cervical spine and to further rule out secondary causes of headache
  7. Ligamentous safety tests to assess the alar and transverse ligaments will be assessed including the side-bending stress test and anterior shear test.
  8. Craniocervical flexion test will be used to assess function of the deep neck flexors

Fully eligible participants will then be randomized to one of four baseline tiers using an online randomization tool. The first tier will include 4 weeks (28 days) of baseline measures (phase A), followed by 5 weeks of treatment and symptom monitoring (phase B); the second tier will include 5 weeks (35 days) of baseline measures, followed by 5 weeks of treatment and symptom monitoring (phase B); the third tier will include 6 weeks (42 days) of baseline measure, followed by 5 weeks for treatment and symptom monitoring; and the fourth tier will include 7 weeks (49 days) of baseline measure, followed by 5 weeks for treatment and symptom monitoring.

During the intervention phase, participants will receive five sessions of dry needling treatment with intramuscular electrical stimulation, one session per week for 5 weeks total. Sterilized disposable stainless-steel needles will be used and will include one standard size, .30 mm x 50 mm APS needle (Agupunt, Spain). Dry needling will be applied to trigger points in at least two of the following posterior cervical muscles; splenius capitis, splenius cervicis, semispinalis capitis/cervicis, cervical multifidi and obliquus capitis inferior. Trigger points will be treated on the side of headache or bilaterally if trigger points are present and coincide with headache. Following elicitation of a local twitch response, needles will be left in place and connected to a charge generating device, ITO ES-160 electro-acupuncture unit (manufactured by ITO Co, Ltd, Tokyo, Japan). Parameters for electrical stimulation will be as follows; alternating frequencies of 6 hertz and 20 hertz using a symmetrical biphasic waveform will be used in place of fixed frequencies. An intensity will be chosen that will elicit a "strong but not painful" response, typically within the range of 0.5 to 6 milliamps, and pulse durations of 300 microseconds will be used. A treatment duration of fifteen minutes will be selected for electrical stimulation to trigger points.

Being tested
Dry Needling and intramuscular electrical stimulation to trigger points

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry Needling and intramuscular electrical stimulation to trigger pointsProcedure or surgery

    Dry needling will be applied to trigger points in at least two of the following posterior cervical muscles; splenius capitis, splenius cervicis, semispinalis capitis/cervicis, cervical multifidi (from C2-4) and obliquus capitis inferior. Following elicitation of a local twitch response, needles will be left in place and connected to a charge generating device for intramuscular electrical stimulation.

Study groups in NCT05893914
Study groupRoleWhat they receive
4 week baselineOtherRandomization to the first tier will include 4 weeks (28 days) of baseline measures (phase A), followed by 5 weeks of treatment and symptom monitoring (phase B)
Receives: Procedure: Dry Needling and intramuscular electrical stimulation to trigger points
5 week baselineOtherRandomization to the second tier will include 5 weeks (35 days) of baseline measures (phase A), followed by 5 weeks of treatment and symptom monitoring (phase B)
Receives: Procedure: Dry Needling and intramuscular electrical stimulation to trigger points
6 week baselineOtherRandomization to the third tier will include 6 weeks (42 days) of baseline measures, followed by 5 weeks of treatment and symptom monitoring (phase B)
Receives: Procedure: Dry Needling and intramuscular electrical stimulation to trigger points
7 week baselineOtherRandomization to the fourth tier will include 7 weeks (49 days) of baseline measure, followed by 5 weeks of treatment and symptom monitoring
Receives: Procedure: Dry Needling and intramuscular electrical stimulation to trigger points

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Headache Frequency

    For this study the reduction in headache frequency, which is reduction in the number of headache days over a 1-month period, will be the primary outcome measure. More specifically, the change in headache days over a 4-week period in the intervention phase compared to baseline. Headache diary reports will be kept by patients through each phase of the study using an electronic headache diary called the Migraine Buddy application. Headache characteristics, triggers and medication use will also be recorded in the headache diary, with a time stamp feature for data collection in real time.

    A migraine day will be defined as a day with a headache that lasts at least 4 hours; meets ICHD-III criteria C and D for migraine without aura (1.1), B and C for migraine with aura (1.2), or ICHD-III criteria for probable migraine (1.6); or a day with a headache that is successfully treated with migraine-specific acute medication.

    Measured: 4 weeks

Secondary outcomes (2)
  1. Headache Impact Test-6 (HIT-6)

    The Headache Impact Test (HIT-6) is six-item questionnaire that provides a global measure of adverse headache impact. The HIT-6 items measure the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning and psychological distress. In addition, it also measures the severity of headache pain.

    The final HIT-6 score is calculated from the sum of the six items and ranges between 36 and 78. Higher scores indicate greater impact. The four headache impact severity categories are little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78).

    Measured: 4 weeks

  2. Migraine Disability Assessment Test (MIDAS)

    The Migraine Disability Assessment Test questionnaire measures headache related disability based on five disability questions. The MIDAS score is derived as the sum of lost days due to headache recorded from the five questions. In addition, two questions (A and B) gather information on headache frequency along with the intensity of headache pain. A recall interval of 3 months was chosen for all MIDAS questions.

    The following is the 4-point grading system for the MIDAS questionnaire: grade 1 (scores ranging from 0 to 5) implies little or no disability, grade 2 (scores ranging from 6 to 10) implies mild disability, grade 3 (scores ranging from 11 to 20) implies moderate disability, grade 4 (21 or greater) implies severe disability.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2023
  2. Study start4 Aug 2023
  3. Primary completion7 Oct 2024
  4. Study completion7 Oct 2024

Resources

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
Factorial
Model description
Single-case non-concurrent multiple baseline experimental design.
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05893914
Sponsor's protocol ID
2023P000931
Status last verified
May 2025
First submitted
30 May 2023
Last updated
8 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tate RL, Perdices M, Rosenkoetter U, Shadish W, Vohra S, Barlow DH, Horner R, Kazdin A, Kratochwill T, McDonald S, Sampson M, Shamseer L, Togher L, Albin R, Backman C, Douglas J, Evans JJ, Gast D, Manolov R, Mitchell G, Nickels L, Nikles J, Ownsworth T, Rose M, Schmid CH, Wilson B. The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement. Phys Ther. 2016 Jul;96(7):e1-e10. doi: 10.2522/ptj.2016.96.7.e1.

    PubMed 27371692
  • Tassorelli C, Diener HC, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults. Cephalalgia. 2018 Apr;38(5):815-832. doi: 10.1177/0333102418758283. Epub 2018 Mar 4.

    PubMed 29504482
  • Perreault T, Arendt-Nielson L, Fernandez-de-Las-Penas C, Dommerholt J, Herrero P, Hubbard R. Intramuscular Electrical Stimulation for the Treatment of Trigger Points in Patients with Chronic Migraine: A Protocol for a Pilot Study Using a Single-Case Experimental Design. Medicina (Kaunas). 2023 Jul 28;59(8):1380. doi: 10.3390/medicina59081380.

    PubMed 37629671

Questions about this trial

What is this clinical trial studying?

A study testing Dry Needling and intramuscular electrical stimulation to trigger points in people with Chronic Migraine, run by Thomas W. Perreault, PT 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 7 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 8 May 2025. 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: 4 weeks). 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 NCT05893914, 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 8 May 2025.

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