Effect of Palpatory Neuromodulation of the Trigeminal Nerve for Tenderness in the Posterior Neck Musculature

NCT04936659 | Completed

• 1 other identifier: 1444471
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the extent to which a non-invasive, palpatory neuromodulatory protocol on the trigeminal nerve endings on the face can affect tenderness felt on the posterior neck musculature, using the Isotouch pressure sensor system. Specific Aim 1: Subjects will see a decrease in tenderness in the posterior neck musculature. Specific Aim 2: Subjects will show a decrease in tenderness on the trigeminal tender points found on the face.

Conditions

Neuromodulation; Neck Pain

Keywords

trigeminal nerve

Outcome Measures

Primary Outcomes (1)

• Cervical muscle tenderness

  Palpatory assessment of muscle tenderness measured on a visual analog scale of 0-10

  Change from pre to immediately post intervention

Study Arms (1)

Treatment group

EXPERIMENTAL

Other: neuromodulation

Interventions

neuromodulation OTHER

Palpatory neuromodulation of the V1 and V2 branches of the trigeminal nerve where they exit onto the face.

Treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65 2. Has posterior neck muscle discomfort 3. Has none of the following within the past 12 months:
• traumatic brain injury
• concussion
• whiplash
• dental work (cavity filling, root canal, tooth extraction, tooth implantation)
• facial trauma
• facial reconstruction surgery
• diagnosis of migraine headaches with daily or weekly medication use
• diagnosis of cluster type headaches with daily or weekly medication use 4. No neurological diagnoses, such as:
• trigeminal neuralgia
• facial numbness
• paralysis of the face 5. No cervical spine issues such as:
• Bulging disc
• Vertebral fusion surgery
• Vertebral disc removal surgery 6. No skin disorder of the face, neck or scalp such as:

You may not qualify if:

• \. Below the age of 18 or over the age of 65 2. Any of the following within the past 12 months:
• traumatic brain injury
• concussion
• whiplash
• dental work (cavity filling, root canal, tooth extraction, tooth implantation)
• facial trauma
• facial reconstruction surgery.
• Diagnosis of migraine headaches with daily or weekly medication use
• Diagnosis of cluster headaches with daily or weekly medication use 3. Any of the following neurologic diagnoses:
• trigeminal neuralgia
• facial numbness
• paralysis of the face
• Cervical spine issues (bulging disc, vertebral fusion, or vertebral disc removal)
• Skin disorders of the face, neck, or scalp such as Shingles or Herpes Zoster
• Pregnancy

Sponsors & Collaborators

• University of North Texas Health Science Center: lead
• American Osteopathic Association: collaborator

Study Sites (1)

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Kendi Hensel, DO, PhD

  University of North Texas Health Science Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: June 23, 2021
• Study Start: October 13, 2017
• Primary Completion: May 30, 2019
• Study Completion: May 1, 2020
• Last Updated: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)