ClinicalTrials.gg
RecruitingNCT06751056Updated Sep 9, 2026

Cervical Traction to Reduce Gabaergic Medication Use for Neuropathic Itch

An interventional study of Cervical Traction Device in Pruritus, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pruritus

Browse trials for

03

In context

Pruritus

490 studies on the registry are indexed under Pruritus; 93 are open to participants now.

This study's planned enrollment of 12 is below the median of 60 across 422 interventional studies indexed under Pruritus.

Browse Pruritus studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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, disease to the spine, spinal cord compression, active infections of the head and neck) that would make neck traction .
  • 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 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 , persons with uncontrolled diabetes ( ≥ 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 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Cervical Traction Group

    Patients who are on a stable dosage of gabapentin or pregabalin for scalp, arm or upper back pruritus without primary rash

    Device: Cervical Traction Device

Interventions

  • DeviceCervical Traction Device

    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%.

06

What researchers measure

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 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).

    Time frame: Baseline, 14 days, 28 days, 42 days, 56 days, and 72 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2025 (actual). Primary completion is estimated for Jan 2027, 19 months after the start.

Of 85 non-industry interventional studies with no phase under Pruritus, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's planned 19 months is above that.

Counting every sponsor, half of 101 studies reached it within 7 months; a quarter within 3 and three quarters within 13.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2024
First posted
Dec 27, 2024
StartActual
Jun 1, 2025
Primary completionEst.
Jan 10, 2027
CompletionEst.
Jan 10, 2027
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06751056
Lead sponsor
Mayo Clinic
Responsible party
David L. Swanson (Professor of Dermatology, Mayo Clinic) — Principal investigator
First posted
Dec 27, 2024
Start date
Jun 1, 2025
Primary completion
Jan 10, 2027 (estimated)
Completion
Jan 10, 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

David Swanson
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion