PruritusNCT06751056
Cervical Traction to Reduce Gabaergic Medication Use for Neuropathic Itch
A study testing Cervical Traction Device in people with Pruritus, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pruritus
- What is being tested?
- Cervical Traction Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 10 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
David L Swanson, MD, 480 301 6169, swanson.david@mayo.edu
David L Swanson
About this study
Official title: Neck Traction to Reduce Gabaergic Medication Use for Neuropathic Itch- A Pilot 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.
- Conditions
- Pruritus
- Being tested
- Cervical Traction Device
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Traction DeviceDevice
Participants 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%.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Traction Group | Experimental | Patients who are on a stable dosage of gabapentin or pregabalin for scalp, arm or upper back pruritus without primary rash Receives: Device: Cervical Traction Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GABAergic medication usage
Reported as percentage of reduction in dosage of gabapentin or pregabalin after 12 weeks of home neck traction.
Measured: Baseline, 12 weeks
Secondary 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).
Measured: Baseline, 14 days, 28 days, 42 days, 56 days, and 72 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jun 2025
- Primary completion10 Jan 2027 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David L. Swanson, Mayo Clinic
- Investigators
- David Swanson, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751056
- Sponsor's protocol ID
- 24-003108
- Status last verified
- Sep 2026
- First submitted
- 20 Dec 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neck Traction to Reduce Gabaergic Medication Use for Neuropathic Itch- A Pilot Study
- ClinicalTrials.gov ID
- NCT06751056
- Acronym / sponsor ID
- 24-003108
- Conditions
- Pruritus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical Traction Group | Experimental | Device: Cervical Traction DevicePatients who are on a stable dosage of gabapentin or pregabalin for scalp, arm or upper back pruritus without primary rash |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical Traction 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%. | Device | Cervical Traction Group |
Primary outcome
Change in GABAergic medication usage
Time frame: Baseline, 12 weeks
Reported as percentage of reduction in dosage of gabapentin or pregabalin after 12 weeks of home neck traction.
1 secondary outcome
Pruritus Severity Score
Time frame: Baseline, 14 days, 28 days, 42 days, 56 days, and 72 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Swanson principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Traction Device in people with Pruritus, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GABAergic medication usage (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.