NCT06751056RecruitingNot Applicable
Neck Traction to Reduce Gabaergic Medication Use for Neuropathic Itch- A Pilot Study
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in GABAergic medication usage
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: Cervical Traction Device (Device)
Outcomes
Primary Outcomes
Change in GABAergic medication usage
Time Frame: Baseline, 12 weeks
Reported as percentage of reduction in dosage of gabapentin or pregabalin after 12 weeks of home neck traction.
Secondary Outcomes
- Pruritus Severity Score(Baseline, 14 days, 28 days, 42 days, 56 days, and 72 days)
Investigators
David L. Swanson
Professor of Dermatology
Mayo Clinic
Study Sites (1)
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