Cervical Traction to Reduce Gabaergic Medication Use for Neuropathic Itch

NCT06751056 | Recruiting FDA Device

• 1 other identifier: 24-003108
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if cervical traction is an effective treatment to reduce GABAergic medication use for scalp, arm, and upper back neuropathic itch.

Conditions

Pruritus

Outcome Measures

Primary Outcomes (1)

• Change in GABAergic medication usage

  Reported as percentage of reduction in dosage of gabapentin or pregabalin after 12 weeks of home neck traction.

  Baseline, 12 weeks

Secondary Outcomes (1)

• Pruritus Severity Score

  Baseline, 14 days, 28 days, 42 days, 56 days, and 72 days

Study Arms (1)

Cervical Traction Group

EXPERIMENTAL

Patients who are on a stable dosage of gabapentin or pregabalin for scalp, arm or upper back pruritus without primary rash

Device: Cervical Traction Device

Interventions

Cervical Traction Device DEVICE

Participants will use their home neck traction devices daily for 12 weeks, while continuing their prescriptions for gabapentin or pregabalin. At study initiation and every 2 weeks thereafter for a total of 12 weeks, they will receive an electronic survey assessing their itch score. Based on survey results, they will receive a call from the study team to adjust their dosage of gabapentin or pregabalin by up to 33%.

Cervical Traction Group

Eligibility Criteria

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

You may qualify if:

• Persons with scalp, arm, and upper back pruritus without primary skin lesions.
• Persons 18 or older.
• Person on a stable dosage of gabapentin or pregabalin over the preceding 4 week period.
• Persons willing and able to comply with clinic visits and study-related procedures.
• Persons willing and able to understand and complete study-related questionnaires.
• Persons willing and able to provide voluntary signed informed consent.

You may not qualify if:

• Primary skin lesions driving scalp, arm, or upper back pruritus.
• A history of spinal surgery or other conditions (acute or traumatic spinal injury, spinal instability, spinal fracture, rheumatoid arthritis, metastatic disease to the spine, spinal cord compression, active infections of the head and neck) that would make neck traction contraindicated.
• Unable to comfortably lay down on the floor and get back up without assistance.
• Medical conditions in which gabapentin and/or pregabalin is contraindicated.
• Current enrollment in physical therapy with exercises addressing the cervical spine.
• Planned or anticipated use of any prohibited medications or procedures during study treatment.
• Presence of skin comorbidities that may interfere with study assessments.
• Currently pregnant or breastfeeding or plans to become pregnant or breastfeed during the participation in the study. Persons of childbearing age who are not on reliable contraception will be considered on a case-by-case basis.
• o Participants of childbearing age who are not on reliable contraception (hormonal contraceptive pills, patch, or ring, intrauterine device, subdermal hormonal implant, tubal ligation, depot medroxyprogesterone injections) will be required to complete monthly urine pregnancy tests.
• Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study. Examples include, but are not limited to, a short life expectancy, persons with uncontrolled diabetes (HbA1c ≥ 9%), cardiovascular conditions (e.g. stage III or IV cardiac failure), severe renal conditions (e.g. patients on dialysis), debilitating neurological conditions (e.g. demyelinating diseases), active major autoimmune diseases (e.g. lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), or other severe endocrinological, gastrointestinal, hepatobiliary, metabolic, pulmonary, or lymphatic diseases. The specific justification for persons excluded under this criterion will be noted in study documents.
• Any other medical or psychological condition (including relevant laboratory abnormalities at screening) that, in the opinion of the investigator, may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient as a result of his/her participation in this clinical trial, may make participation unreliable, or may interfere with study assessments. The specific justification for persons excluded under this criterion will be noted in study documents.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Swanson

  Mayo Clinic

  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 of Dermatology

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): January 10, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)