PainPhase 4NCT05046639
Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain
A Phase 4 study testing 10 mL 2% lidocaine and 10 mL preservative free saline in people with Pain and Amputation, run by Northwestern University at 1 site in United States.
Trial summary
Participants with chronic, refractory phantom limb pain (PLP) or residual limb pain (RLP) for more than 6 months will be enrolled in this clinical trial. Aim: Define the attributable pain relief and functional improvement in participants with PLP/RLP after contralateral limb sciatic nerve block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Amputation
- What is being tested?
- 10 mL 2% lidocaine and 10 mL preservative free saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 26 Jul 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 1. Age greater than 18 years of age at day of enrollment
- 2. Lower extremity amputation performed more than 12 months before study enrollment
- 3. PLP/RLP in affected amputated limb > 4 on numeric rating scale 26 (NRS26)
- 4. 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)
- 5. Willingness to undergo image guided diagnostic nerve block
Who cannot join
- 1. Refusal / inability to participate or provide consent
- 2. Contraindications to diagnostic nerve block
- 3. Non-neurogenic source of PLP/RLP
- 4. Current opioid use > 50 morphine milligram equivalents per day
- 5. Any interventional pain treatment in the residual limb within the last 30 days
- 6. Severe uncontrolled medical condition (i.e., hypertensive crisis, decompensated hypothyroidism)
- 7. Use of investigational pain drug within past 30 days or other concurrent clinical trial enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain; a Triple-Blind Randomized Crossover Controlled Trial
Participants with chronic, refractory phantom limb pain (PLP) or residual limb pain (RLP) for more than 6 months will be enrolled in this clinical trial. Aim: Define the attributable pain relief and functional improvement in participants with PLP/RLP after contralateral limb sciatic nerve block. Also, contribute to the basic science understanding of the crossed-withdraw reflex by demonstrating a known animal model phenomenon in human participants. Hypothesis: Contralateral limb sciatic nerve anesthetic block with 2% lidocaine provides immediate clinically meaningful pain reduction, defined as the proportion of patients with at least 50% improvement in numeric rating scale (NRS) pain score in PLP/RLP when compared to sham.
- Conditions
- Pain, Amputation
- Being tested
- 10 mL 2% lidocaine, 10 mL preservative free saline
- Keywords
- Pain, Amputation, Phantom Pain
- Medical subject headings
- Pain, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mL 2% lidocaineDrug
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine. Crossover treatment 5 days later using image guided sciatic nerve anesthetic block of the contralateral limb with 10 mL preservative-free saline.
10 mL preservative free salineDrug
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.
Crossover treatment 5 days later using Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 2% Lidocaine first, then Sham Preservative Free Saline | Experimental | Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
Crossover: Image guided sciatic nerve anesthetic block of the contralateral limb with 10 mL preservative-free saline.
Crossover treatment will occur 5 days after the first block. Receives: Drug: 10 mL 2% lidocaine |
| Sham Preservative Free Saline first, then Treatment Group 2% Lidocaine | Placebo comparator | Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.
Crossover: Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
Crossover treatment will occur 5 days after the first block. Receives: Drug: 10 mL preservative free saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting ≥ 50% Improvement in NRS Pain Score
Proportions of Participants Reporting ≥ 50% Improvement in NRS pain score on a scale of 0 (no pain) to 10 (worst pain imaginable) from baseline at 15 minutes in treatment and sham groups.
Measured: 15 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Sep 2021
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
Why it stopped: Principal investigator is leaving the university.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Crossover
- Model description
- Prospective Randomized Crossover Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Hogue, MD, Study director, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046639
- Sponsor's protocol ID
- STU00215101
- Status last verified
- Feb 2025
- First submitted
- 7 Sep 2021
- Last updated
- 3 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Richardson C, Glenn S, Horgan M, Nurmikko T. A prospective study of factors associated with the presence of phantom limb pain six months after major lower limb amputation in patients with peripheral vascular disease. J Pain. 2007 Oct;8(10):793-801. doi: 10.1016/j.jpain.2007.05.007. Epub 2007 Jul 12.
PubMed 17631056Cohen SP, Gilmore CA, Rauck RL, Lester DD, Trainer RJ, Phan T, Kapural L, North JM, Crosby ND, Boggs JW. Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Pain Following Amputation. Mil Med. 2019 Jul 1;184(7-8):e267-e274. doi: 10.1093/milmed/usz114.
PubMed 31111898Ephraim PL, Wegener ST, MacKenzie EJ, Dillingham TR, Pezzin LE. Phantom pain, residual limb pain, and back pain in amputees: results of a national survey. Arch Phys Med Rehabil. 2005 Oct;86(10):1910-9. doi: 10.1016/j.apmr.2005.03.031.
PubMed 16213230Hanley MA, Ehde DM, Jensen M, Czerniecki J, Smith DG, Robinson LR. Chronic pain associated with upper-limb loss. Am J Phys Med Rehabil. 2009 Sep;88(9):742-51; quiz 752, 779. doi: 10.1097/PHM.0b013e3181b306ec.
PubMed 19692791Kooijman CM, Dijkstra PU, Geertzen JHB, Elzinga A, van der Schans CP. Phantom pain and phantom sensations in upper limb amputees: an epidemiological study. Pain. 2000 Jul;87(1):33-41. doi: 10.1016/S0304-3959(00)00264-5.
PubMed 10863043Dijkstra PU, Geertzen JH, Stewart R, van der Schans CP. Phantom pain and risk factors: a multivariate analysis. J Pain Symptom Manage. 2002 Dec;24(6):578-85. doi: 10.1016/s0885-3924(02)00538-9.
PubMed 12551807Yin Y, Zhang L, Xiao H, Wen CB, Dai YE, Yang G, Zuo YX, Liu J. The pre-amputation pain and the postoperative deafferentation are the risk factors of phantom limb pain: a clinical survey in a sample of Chinese population. BMC Anesthesiol. 2017 May 26;17(1):69. doi: 10.1186/s12871-017-0359-6.
PubMed 28549447Desmond DM, Maclachlan M. Prevalence and characteristics of phantom limb pain and residual limb pain in the long term after upper limb amputation. Int J Rehabil Res. 2010 Sep;33(3):279-82. doi: 10.1097/MRR.0b013e328336388d.
PubMed 20101187Schley MT, Wilms P, Toepfner S, Schaller HP, Schmelz M, Konrad CJ, Birbaumer N. Painful and nonpainful phantom and stump sensations in acute traumatic amputees. J Trauma. 2008 Oct;65(4):858-64. doi: 10.1097/TA.0b013e31812eed9e.
PubMed 18849803Richardson C, Glenn S, Nurmikko T, Horgan M. Incidence of phantom phenomena including phantom limb pain 6 months after major lower limb amputation in patients with peripheral vascular disease. Clin J Pain. 2006 May;22(4):353-8. doi: 10.1097/01.ajp.0000177793.01415.bd.
PubMed 16691088
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. 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 Triple-Blind Randomized Crossover Controlled Trial
- ClinicalTrials.gov ID
- NCT05046639
- Acronym / sponsor ID
- STU00215101
- Conditions
- Pain, Amputation
- Keywords
- Pain, Amputation, Phantom Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator is leaving the university.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Posted 3 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants with chronic, refractory phantom limb pain (PLP) or residual limb pain (RLP) for more than 6 months will be enrolled in this clinical trial. Aim: Define the attributable pain relief and functional improvement in participants with PLP/RLP after contralateral limb sciatic nerve block. Also, contribute to the basic science understanding of the crossed-withdraw reflex by demonstrating a known animal model phenomenon in human participants. Hypothesis: Contralateral limb sciatic nerve anesthetic block with 2% lidocaine provides immediate clinically meaningful pain reduction, defined as the proportion of patients with at least 50% improvement in numeric rating scale (NRS) pain score in PLP/RLP when compared to sham.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective Randomized Crossover Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 2% Lidocaine first, then Sham Preservative Free Saline | Experimental | Drug: 10 mL 2% lidocaineImage guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine. Crossover: Image guided sciatic nerve anesthetic block of the contralateral limb with 10 mL preservative-free saline. Crossover treatment will occur 5 days after the first block. |
| Sham Preservative Free Saline first, then Treatment Group 2% Lidocaine | Placebo comparator | Drug: 10 mL preservative free salineImage guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline. Crossover: Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine. Crossover treatment will occur 5 days after the first block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Age greater than 18 years of age at day of enrollment
- 2. Lower extremity amputation performed more than 12 months before study enrollment
- 3. PLP/RLP in affected amputated limb > 4 on numeric rating scale 26 (NRS26)
- 4. 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)
- 5. Willingness to undergo image guided diagnostic nerve block
Key exclusion criteria (7 listed)
- 1. Refusal / inability to participate or provide consent
- 2. Contraindications to diagnostic nerve block
- 3. Non-neurogenic source of PLP/RLP
- 4. Current opioid use > 50 morphine milligram equivalents per day
- 5. 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 |
|---|---|---|
| 10 mL 2% lidocaineImage guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine. Crossover treatment 5 days later using image guided sciatic nerve anesthetic block of the contralateral limb with 10 mL preservative-free saline. | Drug | Treatment Group 2% Lidocaine first, then Sham Preservative Free Saline |
| 10 mL preservative free salineImage guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline. Crossover treatment 5 days later using Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine. | Drug | Sham Preservative Free Saline first, then Treatment Group 2% Lidocaine |
Primary outcome
Number of Participants Reporting ≥ 50% Improvement in NRS Pain Score
Time frame: 15 minutes after treatment
Proportions of Participants Reporting ≥ 50% Improvement in NRS pain score on a scale of 0 (no pain) to 10 (worst pain imaginable) from baseline at 15 minutes in treatment and sham groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17631056Richardson C, Glenn S, Horgan M, Nurmikko T. A prospective study of factors associated with the presence of phantom limb pain six months after major lower limb amputation in patients with peripheral vascular disease. J Pain. 2007 Oct;8(10):793-801. doi: 10.1016/j.jpain.2007.05.007. Epub 2007 Jul 12.
- Background: PubMed 31111898Cohen SP, Gilmore CA, Rauck RL, Lester DD, Trainer RJ, Phan T, Kapural L, North JM, Crosby ND, Boggs JW. Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Pain Following Amputation. Mil Med. 2019 Jul 1;184(7-8):e267-e274. doi: 10.1093/milmed/usz114.
- Background: PubMed 16213230Ephraim PL, Wegener ST, MacKenzie EJ, Dillingham TR, Pezzin LE. Phantom pain, residual limb pain, and back pain in amputees: results of a national survey. Arch Phys Med Rehabil. 2005 Oct;86(10):1910-9. doi: 10.1016/j.apmr.2005.03.031.
- Background: PubMed 19692791Hanley MA, Ehde DM, Jensen M, Czerniecki J, Smith DG, Robinson LR. Chronic pain associated with upper-limb loss. Am J Phys Med Rehabil. 2009 Sep;88(9):742-51; quiz 752, 779. doi: 10.1097/PHM.0b013e3181b306ec.
- Background: PubMed 10863043Kooijman CM, Dijkstra PU, Geertzen JHB, Elzinga A, van der Schans CP. Phantom pain and phantom sensations in upper limb amputees: an epidemiological study. Pain. 2000 Jul;87(1):33-41. doi: 10.1016/S0304-3959(00)00264-5.
- Background: PubMed 12551807Dijkstra PU, Geertzen JH, Stewart R, van der Schans CP. Phantom pain and risk factors: a multivariate analysis. J Pain Symptom Manage. 2002 Dec;24(6):578-85. doi: 10.1016/s0885-3924(02)00538-9.
- Background: PubMed 28549447Yin Y, Zhang L, Xiao H, Wen CB, Dai YE, Yang G, Zuo YX, Liu J. The pre-amputation pain and the postoperative deafferentation are the risk factors of phantom limb pain: a clinical survey in a sample of Chinese population. BMC Anesthesiol. 2017 May 26;17(1):69. doi: 10.1186/s12871-017-0359-6.
- Background: PubMed 20101187Desmond DM, Maclachlan M. Prevalence and characteristics of phantom limb pain and residual limb pain in the long term after upper limb amputation. Int J Rehabil Res. 2010 Sep;33(3):279-82. doi: 10.1097/MRR.0b013e328336388d.
- Background: PubMed 18849803Schley MT, Wilms P, Toepfner S, Schaller HP, Schmelz M, Konrad CJ, Birbaumer N. Painful and nonpainful phantom and stump sensations in acute traumatic amputees. J Trauma. 2008 Oct;65(4):858-64. doi: 10.1097/TA.0b013e31812eed9e.
- Results publication: PubMed 16691088Richardson C, Glenn S, Nurmikko T, Horgan M. Incidence of phantom phenomena including phantom limb pain 6 months after major lower limb amputation in patients with peripheral vascular disease. Clin J Pain. 2006 May;22(4):353-8. doi: 10.1097/01.ajp.0000177793.01415.bd.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruiting
Testing the Timing and Application of Virtual Reality Distraction During Knee Injections in a VA Pain Clinic
Pain Management, Injection Pain Prevention
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
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.
Charles Hogue, MD study director
Northwestern University
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 10 mL 2% lidocaine and 10 mL preservative free saline in people with Pain and Amputation, run by Northwestern University 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 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: stopped early, as of the sponsor's last update on 3 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Reporting ≥ 50% Improvement in NRS Pain Score (time frame: 15 minutes after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05046639, which also lists 10 linked publications.
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 3 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.