Recruiting

Peri-neural Electrical Dry Needling

Sponsor:

Wheaton Franciscan Healthcare

Code:

NCT04252391

Conditions

Migraine Headache

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Perineural electrical dry needling

Standard Care

Study Details

Brief summary:

This study seeks to determine the effectiveness of a specific treatment protocol using dry needling with perineural electrical stimulation in comparison to standard treatment in physical therapy for patients with migraine headaches. This will be a randomized cross-over study in which participants will be in the first arm of the study, have a washout period, then cross over to the other arm of the study.

Conditions

Migraine Headache

Study ID

NCT04252391

Start date

Feb 18, 2020

Status verified date

May, 2022

Completion date

Apr, 2023

Anticipated

Primary completion date

Apr, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Men and women age 18 to 100 years old
  • Acute or chronic manifestation of migraine headaches or prior diagnosis of migraine headache.
  • Numeric pain rating of 3/10 (where 0= no pain and 10= worst pain)

Exclusion Criteria:

  • History of epilepsy
  • Needle-phobia
  • Unstable psychological status
  • Compromised immune system
  • Metallic allergy
  • Having not eaten within the past 3 hours
  • Inability to lie in prone, or side-lying
  • Pregnant or trying to become pregnant
  • Inability to consent or understand English.
  • Prisoners

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard care

Standard care will consist of standard physical therapy care which may include the following: cervical or thoracic manipulation or mobilization, muscle stretching, muscle strengthening, dry needling with or without electrical trigger point dry needling, soft tissue release and prescribed therapeutic exercises .

active comparator: standard care with perineural electrical dry needling.

This arm will consist of standard care with perineural electrical dry needling, using a high frequency stimulation placed near the nerve, differing from addressing muscular trigger points. For example, a dry needle placed in the semispinalis capitus muscle along the greater occipital nerve pathway, stimulated at 80 Hz.

Interventions

Perineural electrical dry needling

Standard care plus use of perineural electrical dry needling involving use of a monofilament needle of 15 or 30 mm length, 0.25 mm diameter will be placed utilizing the therapist's dominant hand following palpation of correct needle location. An electrical stimulation unit will be used to conduct an electrical impulse. The unit used will be an ES-130 by ITO (Japan) using a DC 9V battery producing an asymmetrical biphasic waveform. The unit has 6 available leads with alligator clamps, connecting to needle shafts. Parameters of PNED will include intensity set at a strong yet comfortable setting according to patient feedback. Treatment duration will be 15 minutes. Treatment frequency will be set to Medium at level 8 (80 Hz). Parameters will be set to elicit a sensory response.

Standard Care

cervical or thoracic manipulation or mobilization, muscle stretching, muscle strengthening, electrical trigger point dry needling , soft tissue release and prescribed therapeutic exercises .

Primary outcome measure

  • Change in numeric pain rating scale [ Time Frame: 1-6 days ]
  • Change in Neck disability index scale [ Time Frame: 1-6 days ]

Central Contacts and Locations

Central contacts

Jackie Kirchen, MS, CIP

414-465-3134jackie.kirchen@ascension.org

Locations

Ascension Rehabilitation Services

Recruiting

Milwaukee, Wisconsin, United States, 53221

Contacts

Joe Tepp, DPT

414-389-3023joseph.tepp@ascension.org

Principal Investigator:

Joe Tepp, DPT

More Information

Sponsor

Wheaton Franciscan Healthcare

Last update posted

May 9, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Wheaton Franciscan Healthcare on 2022-05-09.