Neuropathic PainNCT05052645
Ear Acupuncture for Neuropathic Pain
A study testing Auricular acupuncture in people with Neuropathic Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to gather information on the effectiveness of auricular acupuncture (i.e., the placement of acupuncture needles in specific points on the ear) in reducing pain and improving quality of life among patients experiencing neuropathic pain in the acute inpatient rehabilitation setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Auricular acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2022to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients who have acute or chronic neuropathic pain of any etiology (traumatic, non-traumatic, central, peripheral, and mixed cases).
- Ability to provide informed consent.
- Ability to speak English and complete all aspects of this trial.
- At least 18 years of age.
- Patients will have stable neuropathic pain medication dosing for 3 days prior to enrollment to include gabapentin, pre-gabalin, TCAs, duloxetine, carbamazepine, oxcarbazepine, and venlafaxine).
Who cannot join
- Patients with platelet count <50,000 or known bleeding disorder.
- Patients in a severe immunocompromised state.
- Pregnant women. All patients who meet the criteria will have their medical records reviewed to ensure they are not pregnant.
- Allergy to gold.
- Use of non-FDA approved herbal supplements. Their effect on enhancing or blunting effect of acupuncture is not known. Patients using medical marijuana with an approved prescription from a state issuing such prescriptions will not be excluded.
- Current infection of the skin or cartilage of the ear.
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- Patients already using adjuvant modalities such as chiropractic, massage, yoga, tai chi, massage will not be excluded, but those who add in these modalities during the course of the intervention and observation period will be excluded.
- Patients not anticipated to stay for a minimum of 7 days after enrollment.
- Patient without mental capacity to participate in the consent process and the questionnaire responses.
- Fear of needles or no interest in acupuncture.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Auricular Acupuncture in the Treatment of Neuropathic Pain: A Randomized Controlled Trial
The purpose of this study is to gather information on the effectiveness of auricular acupuncture (i.e., the placement of acupuncture needles in specific points on the ear) in reducing pain and improving quality of life among patients experiencing neuropathic pain in the acute inpatient rehabilitation setting.
- Conditions
- Neuropathic Pain
- Being tested
- Auricular acupuncture
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupunctureProcedure or surgery
Placement of acupuncture needles in specific points on the ear in two consecutive treatments spaced 7 days apart.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Group | No intervention | Subjects will receive standard of care neuropathic pain treatment without acupuncture. |
| Acupuncture Treatment Group | Experimental | Subjects will receive acupuncture treatment in addition to to the standard of care neuropathic pain treatment. Receives: Procedure: Auricular acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported neuropathic pain scores
Measured on the numeric rating scale for pain (NRS Pain) for pain intensity using a scale of 0=no pain, 10=worst imaginable
Measured: Daily during inpatient stay, approximately 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study startSep 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: investigators have limited availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tony Y. Chon, Mayo Clinic
- Investigators
- Tony Chon, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052645
- Sponsor's protocol ID
- 20-010454
- Status last verified
- Dec 2022
- First submitted
- 13 Sep 2021
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture in the Treatment of Neuropathic Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05052645
- Acronym / sponsor ID
- 20-010454
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: investigators have limited availability
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 22 Sep 2021 (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 gather information on the effectiveness of auricular acupuncture (i.e., the placement of acupuncture needles in specific points on the ear) in reducing pain and improving quality of life among patients experiencing neuropathic pain in the acute inpatient rehabilitation setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Group | No intervention | –Subjects will receive standard of care neuropathic pain treatment without acupuncture. |
| Acupuncture Treatment Group | Experimental | Procedure: Auricular acupunctureSubjects will receive acupuncture treatment in addition to to the standard of care neuropathic pain treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have acute or chronic neuropathic pain of any etiology (traumatic, non-traumatic, central, peripheral, and mixed cases).
- Ability to provide informed consent.
- Ability to speak English and complete all aspects of this trial.
- At least 18 years of age.
- Patients will have stable neuropathic pain medication dosing for 3 days prior to enrollment to include gabapentin, pre-gabalin, TCAs, duloxetine, carbamazepine, oxcarbazepine, and venlafaxine).
Key exclusion criteria (10 listed)
- Patients with platelet count <50,000 or known bleeding disorder.
- Patients in a severe immunocompromised state.
- Pregnant women. All patients who meet the criteria will have their medical records reviewed to ensure they are not pregnant.
- Allergy to gold.
- Use of non-FDA approved herbal supplements. Their effect on enhancing or blunting effect of acupuncture is not known. Patients using medical marijuana with an approved prescription from a state issuing such prescriptions will not be excluded.
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 |
|---|---|---|
| Auricular acupuncturePlacement of acupuncture needles in specific points on the ear in two consecutive treatments spaced 7 days apart. | Procedure or surgery | Acupuncture Treatment Group |
Primary outcome
Change in self-reported neuropathic pain scores
Time frame: Daily during inpatient stay, approximately 7-10 days
Measured on the numeric rating scale for pain (NRS Pain) for pain intensity using a scale of 0=no pain, 10=worst imaginable
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Tony Chon, MD 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 Auricular acupuncture in people with Neuropathic Pain, 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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 8 Dec 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported neuropathic pain scores (time frame: Daily during inpatient stay, approximately 7-10 days). 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 8 Dec 2022.