What is cervical traction studying for neuropathic itch?

This trial is studying if using a neck traction device can reduce the need for GABAergic medications like gabapentin or pregabalin in people with neuropathic itch on the scalp, arms, or upper back. Sponsored by Mayo Clinic, it aims to explore new ways to manage itch by adjusting medication dose with device use. Participants will use the device daily while reporting their itch severity.

Who may be eligible for this pruritus clinical trial?

Adults 18 years or older with scalp, arm, or upper back neuropathic itch without a primary rash and who have been on a stable dose of gabapentin or pregabalin for at least four weeks may qualify. Eligible participants must be able to use the neck traction device and complete study questionnaires. Please review eligibility criteria for more details.

Is there any cost to participate in this pruritus clinical trial?

Study-related care, including the neck traction device and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should consider these potential costs when joining the trial.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06751056

Study of Neck Traction Device to Reduce Use of Gabapentin or Pregabalin for Itch on Scalp, Arm, and Upper Back

Led by Mayo Clinic · Updated on 2025-09-09

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether cervical traction can help reduce the use of GABAergic medications, such as gabapentin or pregabalin, in people experiencing neuropathic itch on the scalp, arm, or upper back without primary skin rash. This pilot study aims to understand if using a neck traction device can lower medication dosage while managing itch severity. The study is sponsored by Mayo Clinic and focuses on adults aged 18 and older who are on stable doses of these medications. Participants will use a cervical traction device at home daily for 12 weeks while continuing their current prescriptions for gabapentin or pregabalin. Every two weeks during the study, participants will complete electronic surveys to report their itch severity. Based on these survey results, the study team may adjust their medication dosage by up to 33% to find the optimal treatment balance. During the 12-week period, participants will be regularly monitored through surveys assessing itch severity at multiple time points. Researchers will measure changes in GABAergic medication use from the start to the end of the study and track itch severity scores throughout. The study involves ongoing communication with the team, medication adjustments, and adherence to device use and questionnaire completion to evaluate treatment effects and safety.

CONDITIONS

Brief Title

Cervical Traction to Reduce Gabaergic Medication Use for Neuropathic Itch

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

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 will not qualify if you...

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.
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 65 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.

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here