Using cervical traction to reduce medication for neuropathic itch
Neck Traction to Reduce Gabaergic Medication Use for Neuropathic Itch- A Pilot Study
This study is testing whether cervical traction can help people with neuropathic itch reduce their need for medications like gabapentin or pregabalin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Scottsdale, Arizona) |
| Trial ID | NCT06751056 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of cervical traction as a treatment for reducing the use of GABAergic medications, specifically gabapentin or pregabalin, in patients experiencing neuropathic itch in the scalp, arms, and upper back. Participants will undergo cervical traction therapy while maintaining a stable dosage of their current medication for at least four weeks prior to the study. The goal is to determine if this non-invasive intervention can alleviate itch symptoms and decrease reliance on medication. The study will involve regular clinic visits and completion of questionnaires to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with neuropathic itch in the scalp, arms, or upper back who are currently on a stable dosage of gabapentin or pregabalin.
Not a fit: Patients with primary skin lesions causing their itch or those with contraindications to cervical traction will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological option for patients suffering from neuropathic itch, potentially reducing their need for medication.
How similar studies have performed: While the specific approach of using cervical traction for this purpose may be novel, similar studies exploring non-pharmacological treatments for neuropathic itch have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Scottsdale, Arizona
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: David Swanson — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.