Clinical trial NCT06751056: Cervical Traction to Reduce Gabaergic Medication Use for Neuropathic Itch
Official title: Neck Traction to Reduce Gabaergic Medication Use for Neuropathic Itch- A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pruritus
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in GABAergic medication usage
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Pruritus Severity Score
timeFrame: Baseline, 14 days, 28 days, 42 days, 56 days, and 72 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: David Swanson
role: PRINCIPAL_INVESTIGATOR
References: