Cervical Traction to Reduce Gabaergic Medication Use for Neuropathic Itch
ConditionPruritus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Cervical Traction Device
DeviceParticipants will use their home neck traction devices daily for 12 weeks, while continuing their prescriptions for gabapentin or pregabalin. At study initiation and every 2 weeks thereafter for a total of 12 weeks, they will receive an electronic survey assessing their itch score. Based on survey results, they will receive a call from the study team to adjust their dosage of gabapentin or pregabalin by up to 33%.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Cervical Traction GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in GABAergic medication usage
Reported as percentage of reduction in dosage of gabapentin or pregabalin after 12 weeks of home neck traction.
Time frame
Baseline, 12 weeksSecondary outcomes
1
Pruritus Severity Score
A 12-item questionnaire assessing different aspects of pruritus. The items are grouped into five domains: pruritus intensity, pruritus extent, frequency and duration of pruritus, impact of pruritus on daily activities and mood, and assessment of scratching. Total scoring ranges from 3 (the lowest pruritus intensity) to 22 points (the highest pruritus intensity).
Time frame
Baseline, 14 days, 28 days, 42 days, 56 days, and 72 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov