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

NCT05893914 | Completed

• 1 other identifier: 2023P000931
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (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.

  4 weeks

Secondary Outcomes (2)

• Headache Impact Test-6 (HIT-6)

  4 weeks

• Migraine Disability Assessment Test (MIDAS)

  3 months

Other Outcomes (2)

• Pressure pain threshold

  5 weeks

• Numeric Pain Rating Scale

  4 weeks

Study Arms (4)

4 week baseline

OTHER

Randomization 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)

Procedure: Dry Needling and intramuscular electrical stimulation to trigger points

5 week baseline

OTHER

Randomization 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)

Procedure: Dry Needling and intramuscular electrical stimulation to trigger points

6 week baseline

OTHER

Randomization to the third tier will include 6 weeks (42 days) of baseline measures, followed by 5 weeks of treatment and symptom monitoring (phase B)

Procedure: Dry Needling and intramuscular electrical stimulation to trigger points

7 week baseline

OTHER

Randomization to the fourth tier will include 7 weeks (49 days) of baseline measure, followed by 5 weeks of treatment and symptom monitoring

Procedure: Dry Needling and intramuscular electrical stimulation to trigger points

Interventions

Dry Needling and intramuscular electrical stimulation to trigger points PROCEDURE

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.

4 week baseline; 5 week baseline; 6 week baseline; 7 week baseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Thomas W. Perreault, PT: lead

Study Sites (1)

Wentworth Douglass Hospital

Dover, New Hampshire, 03820, United States

Location

Related Publications (3)

• 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.

  PMID: 27371692 BACKGROUND

• 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.

  PMID: 29504482 BACKGROUND

• 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.

  PMID: 37629671 DERIVED

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Thomas Perreault, DPT

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Specialist

Model Details: Single-case non-concurrent multiple baseline experimental design.

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: August 4, 2023
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)