Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain

Overview

About this study

The purpose of this study is to 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- 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 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

Exclusion Criteria:

- 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/27/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Mankato, Minn.

Mayo Clinic principal investigator

Cole Cheney, M.D.

Open for enrollment

Contact information:

Cole Cheney M.D.

(507) 594-4227

Cheney.Cole@mayo.edu

More information

Publications

  • Chronic pain and reduced function are significant problems for Military Service members and Veterans following amputation. Peripheral nerve stimulation (PNS) is a promising therapy, but PNS systems have traditionally been limited by invasiveness and complications. Recently, a novel percutaneous PNS system was developed to reduce the risk of complications and enable delivery of stimulation without surgery. Read More on PubMed
  • To provide an overview of phantom limb pain (PLP) in China. This includes the prevalence of PLP and possible risk factors. Read More on PubMed
  • This study aims to describe the prevalence and characteristics of phantom limb pain and residual limb pain after upper limb amputation. One-hundred and forty-one participants (139 males; mean age 74.8 years; mean time since amputation 50.1 years) completed a self-report questionnaire assessing residual and phantom limb pain experience. Prevalence of phantom limb pain during the week preceding assessment was 42.6% (60 of 141). Prevalence of residual limb pain was 43.3% (61 of 141). More than one third of these had some pain constantly or most days. Phantom limb pain was commonly described as 'discomforting' (31 of 60) and associated with 'a little bit' of lifestyle interference (23 of 60). Residual limb pain was most often described as 'discomforting' (27 of 61) or 'distressing' (19 of 61) and was typically associated with low to moderate levels of lifestyle interference. Assessment of multiple dimensions of postamputation pain in the long term after upper limb amputation is warranted. Read More on PubMed
  • To describe the prevalence, intensity, and functional impact of the following types of pain associated with upper-limb loss: phantom limb, residual limb, back, neck, and nonamputated-limb pain. Read More on PubMed
  • The formation, prevalence, intensity, course, and predisposing factors of phantom limb pain were investigated to determine possible mechanisms of the origin of phantom limb pain in traumatic upper limb amputees. Read More on PubMed
  • Because of a lack of evidence to support any treatment for phantom limb pain (PLP), interest has turned to preventing it instead. However, like other areas of PLP research, there is little consensus regarding factors that may be associated with the development of PLP. This study was devised to identify physical and psychological factors associated with PLP development and maintenance. It was a prospective study of 59 patients listed for amputation of a lower limb due to peripheral vascular disease. Each was interviewed before amputation, and the survivors were reinterviewed 6 months afterward. Pain and coping style were the primary outcome measures. The use of high levels of passive coping strategies (P = .001), especially catastrophizing (P = .02) before amputation, were found to be associated with PLP development. Pain was only weakly associated with the presence of PLP 6 months after amputation. The ability to move the phantom (P = .01) and stump pain (P = .01) were postamputation factors associated with PLP. The complexity of the relationship between previous pain and coping style and the development of PLP is discussed alongside aspects of pain memory. Pre-emptive treatment of PLP will need to include psychological as well as physical interventions. Read More on PubMed
  • To describe the prevalence of amputation-related pain; to ascertain the intensity and affective quality of phantom pain, residual limb pain, back pain, and nonamputated limb pain; and to identify the role that demographics, amputation-related factors, and depressed mood may contribute to the experience of pain in the amputee. Read More on PubMed
  • Phantom pain has been given considerable attention in literature. Phantom pain reduces quality of life, and patients suffering from phantom pain make heavy use of the medical system. Many risk factors have been identified for phantom pain in univariate analyses, including phantom sensations, stump pain, pain prior to the amputation, cause of amputation, prosthesis use, and years elapsed since amputation. Multivariate analyses are lacking in the literature and, therefore, no estimation of an overall risk for phantom pain can be made. The aim of this study was to analyze risk factors in a multivariate analysis in 536 subjects (19% upper limb amputees and 81% lower limb amputees). These subjects filled out a questionnaire in which the following items were assessed; side, date, level, and reason of amputation, pre-amputation pain, presence or absence of phantom pain, phantom sensations and or stump pain, and prosthesis use. The prevalence of phantom pain was 72% (95% CI: 68 to 76%) for the total group, 41% (95% CI: 31 to 51%) in upper limb amputees and 80% (95% CI: 76 to 83%) in lower limb amputees. The most important risk factors for phantom pain were "bilateral amputation" and "lower limb amputation." The risk for phantom pain ranged from 0.33 for a 10-year-old patient with a distal upper limb amputation to 0.99 for a subject of 80 years with a bilateral lower limb amputation of which one side is an above knee amputation. Read More on PubMed
  • Phantom pain in subjects with an amputated limb is a well-known problem. However, estimates of the prevalence of phantom pain differ considerably in the literature. Various factors associated with phantom pain have been described including pain before the amputation, gender, dominance, and time elapsed since the amputation. The purposes of this study were to determine prevalence and factors associated with phantom pain and phantom sensations in upper limb amputees in The Netherlands. Additionally, the relationship between phantom pain, phantom sensations and prosthesis use in upper limb amputees was investigated. One hundred twenty-four upper limb amputees participated in this study. Subjects were asked to fill out a self-developed questionnaire scoring the following items: date, side, level, and reason of amputation, duration of experienced pain before amputation, frequencies with which phantom sensations, phantom pain, and stump pain are experienced, amount of trouble and suffering experienced, respectively, related to these sensations, type of phantom sensations, medical treatment received for phantom pain and/or stump pain, and the effects of the treatment, self medication, and prosthesis use. The response rate was 80%. The prevalence of phantom pain was 51%, of phantom sensations 76% and of stump pain 49%; 48% of the subjects experienced phantom pain a few times per day or more; 64% experienced moderate to very much suffering from the phantom pain. A significant association was found between phantom pain and phantom sensations (relative risk 11.3) and between phantom pain and stump pain (relative risk 1.9). No other factors associated with phantom pain or phantom sensations could be determined. Only four patients received medical treatment for their phantom pain. Phantom pain is a common problem in upper limb amputees that causes considerable suffering for the subjects involved. Only a minority of subjects are treated for phantom pain. Further research is needed to determine factors associated with phantom pain. Read More on PubMed