Recruiting

Cervical Traction

Sponsor:

Mayo Clinic

Code:

NCT06751056

Conditions

Pruritus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cervical Traction Device

Study Details

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

Study ID

NCT06751056

Start date

Jun 1, 2025

Status verified date

Sep, 2025

Completion date

Jan 10, 2027

Anticipated

Primary completion date

Jan 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cervical Traction Group

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

Interventions

Cervical Traction 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%.

Primary outcome measure

  • Change in GABAergic medication usage [ Time Frame: Baseline, 12 weeks ]

Central Contacts and Locations

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Principal Investigator:

David L Swanson

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-09-09.