Limb Pain, PhantomPhase 4NCT06045936
A Study of Contralateral Limb Block
A Phase 4 study testing Lidocaine in people with Limb Pain, Phantom, run by Mayo Clinic at 1 site in United States.
Trial summary
This research is being done to determine if an anesthetic like Lidocaine, may be effective when injected around the sciatic nerve of the intact limb in patients with limb loss pain on the contralateral side. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limb Pain, Phantom
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2024to Dec 2026
- Phase
- Phase 4
- 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
- Lower extremity amputation performed more than 12 months before study enrollment
- PLP/RLP in affected amputated limb > 4 on NRS26
- Pain duration of more than 6 months despite a trial of conservative therapies for at least 2 months, including oral medications, topical medicines, physical therapy, and physical modalities (i.e., heat, cold, transcutaneous electrical nerve stimulation, phonophoresis)
- Willingness to undergo image guided diagnostic nerve block
Who cannot join
- Refusal / inability to participate or provide consent
- Contraindications to diagnostic nerve block
- Non-neurogenic source of PLP/RLP
- Current opioid use > 50 morphine milligram equivalents per day
- Any interventional pain treatment in the residual limb within the last 30 days
- Severe uncontrolled medical condition (i.e., hypertensive crisis, decompensated hypothyroidism)
- Use of investigational pain drug within past 30 days or other concurrent clinical trial enrollment
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 Health System - Mankato
Mankato, Minnesota, 56001
Cole Cheney, MD, 5156816338, cheney.cole@mayo.edu
About this study
Official title: Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain; a Double-Blind Randomized Controlled Trial
This research is being done to determine if an anesthetic like Lidocaine, may be effective when injected around the sciatic nerve of the intact limb in patients with limb loss pain on the contralateral side.
- Conditions
- Limb Pain, Phantom
- Being tested
- Lidocaine, Placebo
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
2 teaspoons of 2% lidocaine injection
PlaceboDrug
Saline injection
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Group | Experimental | Subjects will receive a lidocaine injection in the back of their residual limb. Receives: Drug: Lidocaine |
| Sham Group | Placebo comparator | Subjects will receive a placebo injection in the back of their residual limb. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain
Measured using self-reported Numerical Rating Scale (NRS) where 0=no pain and 10=worst pain.
Measured: Baseline, 60 minutes post injection
Change in Functional Improvement
Measured using self-reported 20-item Orthotic and Prosthetics User's Survey (OPUS) Lower Extremity Functional Status Measurement survey. Total scores range from 0-100 scale with higher scores indicating a better outcome.
Measured: Baseline, 5 days post-injection
Secondary outcomes (3)
Change in disability
Measured using self-reported 18-item The Groningen Activity Restriction Scale (GARS) that is a general disease independent instrument for measuring disability. Total scores range from 18-72. The higher the score the greater the disability.
Measured: Baseline, 5 days post-injection
Change in Pressure-Pain Algometry
Qualified study personnel will measure pain pressure threshold three times at each visit with an algometer on the participant's residual limb at the point of a maximal pain as indicated by the participant during pre-block physical examination, reported in kilopascal (kPa).
Measured: Baseline, 5 days post-injection
Step Count
Number of daily steps recorded by Modus StepWatch™ or Evolution EvoWalk™ fitted to the participant's prostheses
Measured: 5 days post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start18 Jun 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb Pain, PhantomStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cole W. Cheney, Mayo Clinic
- Investigators
- Cole Cheney, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045936
- Sponsor's protocol ID
- 22-010792
- Status last verified
- Jan 2026
- First submitted
- 5 Sep 2023
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain; a Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06045936
- Acronym / sponsor ID
- 22-010792
- Conditions
- Limb Pain, Phantom
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Sep 2023 (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.
This research is being done to determine if an anesthetic like Lidocaine, may be effective when injected around the sciatic nerve of the intact limb in patients with limb loss pain on the contralateral side.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Group | Experimental | Drug: LidocaineSubjects will receive a lidocaine injection in the back of their residual limb. |
| Sham Group | Placebo comparator | Drug: PlaceboSubjects will receive a placebo injection in the back of their residual limb. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Lower extremity amputation performed more than 12 months before study enrollment
- PLP/RLP in affected amputated limb > 4 on NRS26
- Pain duration of more than 6 months despite a trial of conservative therapies for at least 2 months, including oral medications, topical medicines, physical therapy, and physical modalities (i.e., heat, cold, transcutaneous electrical nerve stimulation, phonophoresis)
- Willingness to undergo image guided diagnostic nerve block
Key exclusion criteria (7 listed)
- Refusal / inability to participate or provide consent
- Contraindications to diagnostic nerve block
- Non-neurogenic source of PLP/RLP
- Current opioid use > 50 morphine milligram equivalents per day
- Any interventional pain treatment in the residual limb within the last 30 days
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 |
|---|---|---|
| Lidocaine2 teaspoons of 2% lidocaine injection | Drug | Lidocaine Group |
| PlaceboSaline injection | Drug | Sham Group |
Primary outcome
Change in pain
Time frame: Baseline, 60 minutes post injection
Measured using self-reported Numerical Rating Scale (NRS) where 0=no pain and 10=worst pain.
Change in Functional Improvement
Time frame: Baseline, 5 days post-injection
Measured using self-reported 20-item Orthotic and Prosthetics User's Survey (OPUS) Lower Extremity Functional Status Measurement survey. Total scores range from 0-100 scale with higher scores indicating a better outcome.
3 secondary outcomes
Change in disability
Time frame: Baseline, 5 days post-injection
Change in Pressure-Pain Algometry
Time frame: Baseline, 5 days post-injection
Step Count
Time frame: 5 days post-injection
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 6 Jan 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.
Cole Cheney, 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 Phase 4 study testing Lidocaine in people with Limb Pain, Phantom, 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 4 inclusion and 7 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 6 Jan 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 pain (time frame: Baseline, 60 minutes post injection). The study lists 2 primary outcomes in all. 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 6 Jan 2026.