Clinical Trials

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.