Cervical Traction to Reduce Gabaergic Medication Use for Neuropathic Itch
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 24-003108
NCT ID: NCT06751056
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Persons with scalp, arm, and upper back pruritis 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 dysesthesia.
- A history of spinal surgery or other conditions that would make cervical traction contraindicated.
- 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 ≥ 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.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 3/21/2024. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator David Swanson, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available