The Effectiveness of Thermal Neuromodulation Using Precise Heat in the Treatment of Chronic Low Back Pain Over 60 Days: An In-Home User Trial.

PURPOSE: Two previous independent double-blind randomized studies demonstrated that thermal neuromodulation using high temperature pulsed heat reduced pain in subjects with chronic low back pain. The present study examined the effects of high temperature pulsed heat via an experimental device in a real-world In-Home Use Trial (IHUT) over a sixty-day period. MATERIALS AND METHODS: This in-home study recruited 34 subjects with chronic low back pain, provided them with an experimental device that delivered treatment session of high temperature pulsed heat up to 45°C, and followed them for eight weeks. Subjects were allowed to use the device as needed. Primary outcome was pain rating as measured by the 11-point Numeric Pain Scale at baseline, four and eight weeks of treatment. The secondary outcome measures were the interference with daily living components of the Brief Pain Inventory at baseline versus eight weeks of treatment. RESULTS: Thirty-two subjects completed the study. Pain levels were 5.81 at baseline, 2.79 at four weeks and 2.25 at eight weeks. All changes in pain levels between baseline and four weeks, baseline, and eight weeks and between four and eight weeks were statistically significant (p < 0.05). At eight weeks, the seven components of pain interference with activities of daily living and pain interference with walking were statistically reduced (P < 0.05). About 72% of subjects reported a single 30-minute treatment session produced over 3 hours of pain relief. CONCLUSION: An eight-week in-home trial of high-temperature thermal modulation devices produced significant reductions in pain and pain interference with activities of daily living, an important measure of function. Efforts were made to control and reduce study contamination. This study provides important initial data for long-term outcome studies of thermal neuromodulation using high temperature pulsed heat to treat low back pain and to improve subject function and demonstrated that individuals with chronic pain can effectively self-manage pain.

Properties of Thermal Analgesia in a Human Chronic Low Back Pain Model.

PURPOSE: For years, heat has been used for comfort and analgesia is recommended as a first-line therapy in many clinical guidelines. Yet, there are questions that remain about the actual effectiveness of heat for a condition as common as chronic low back pain, and factors such as time of onset, optimal temperature, and duration of effect. MATERIALS AND METHODS: A randomized double-blinded controlled trial was designed to compare the analgesic response to heat delivered via pulses at 45°C (experimental group, N=49) to steady heat at 37°C (control group, N=51) in subjects with longstanding low back pain. Treatment lasted 30 minutes with follow-up out to four hours. The hypothesis was that the experimental group would experience a higher degree of analgesia compared to the control group. Time of onset and duration of effect were also measured. RESULTS: Both groups were similar in average duration of pain (10.3 years). The primary outcome measure was pain reduction at 30 minutes after the end of treatment, using a 10-points numeric pain scale. Reduction in pain was greater for the experimental group than the control group (difference in mean reduction = 0.72, 95% CI 0.15-1.29, p = 0.014). Statistically significant differences in pain levels were observed from the first measure at 5 minutes of treatment through 120 minutes after completion of treatment. Reduction in pain associated movement was greater in the active heat group than the placebo group (p = 0.04). CONCLUSION: High-level pulsed heat (45°C) produced significantly more analgesia as compared to steady heat at 37°C at the primary end point and for an additional 2 hours after treatment. The onset of analgesia was rapid, <5 minutes of treatment. The results of this trial provide insight into the mechanisms and properties of thermal analgesia that are not well understood in a chronic low back pain model.

Educating generalist physicians about chronic pain: live experts and online education can provide durable benefits.

OBJECTIVE: Determine whether lectures by national experts and a publicly available online program with similar educational objectives can improve knowledge, attitudes, and beliefs (KAB) important to chronic pain management. DESIGN: A pretest-posttest randomized design with two active educational interventions in two different physician groups and a third physician group that received live education on a different topic to control for outside influences, including retesting effects, on our evaluation. PARTICIPANTS: A total of 136 community-based primary care physicians met eligibility criteria. All physicians attended the educational program to which they were assigned. Ninety-five physicians (70%) provided complete data for evaluation. MEASUREMENTS: Physician responses to a standardized 50-item pain management KAB survey before, immediately after, and 3 months following the interventions. RESULTS: The study groups and the 41 physicians not providing outcomes information were similar with respect to age, sex, race, percent engaged in primary care, and number of patients seen per week. Physician survey scores improved immediately following both pain education programs (live: 138.0-->150.6, P < 0.001; online: 143.6-->150.4, P = 0.007), but did not change appreciably in the control group (139.2-->142.5, P > 0.05). Findings persisted at 3 months. Satisfaction measures were high (4.00-4.72 on 1-5 scale) and not significantly different (P = 0.072-0.893) between groups. CONCLUSIONS: When used under similar conditions, national speakers and a publicly available online CME program were associated with improved pain management KAB in physicians. The benefits lasted for 3 months. These findings support the continued use of these pain education strategies.

KnowPain-50: a tool for assessing physician pain management education.

BACKGROUND: Despite a need for better physician pain management education, there are no widely accepted assessment or outcome measures to support this work. OBJECTIVE: Create a self-assessment tool to measure physician educational needs and the effectiveness of chronic pain educational programs. DESIGN: We used expert consensus to draft a 142-item survey that covered essential areas of chronic pain management. We tested the survey in 106 physicians, including 22 pain management experts and used predefined psychometric criteria to eliminate 70 items. We then eliminated 22 remaining items that did not correlate with the management of a standardized chronic pain patient by 27 academic physicians. We evaluated internal consistency using Cronbach's alpha. RESULTS: The final 50-item survey assessed physician knowledge, attitudes, and beliefs in: 1) initial pain assessment; 2) defining goals and expectations; 3) development of a treatment plan; 4) implementation of a treatment plan; 5) reassessment and management of longitudinal care; and 6) management of environmental issues. The survey demonstrated good internal consistency in all physician populations studied (alpha = 0.77-0.85). Average scores in 84 "pilot" physician users of a CME Website (135.8-138.5) were significantly lower (P < 0.01) than scores in 27 academic physicians (150.0), or 22 pain experts (177.5). CONCLUSIONS: This survey, the KnowPain-50, has good psychometric properties, correlates with clinical behaviors, and appears to distinguish between physicians with different levels of pain management expertise. It may be a useful measure of the effectiveness of physician pain management education programs.

Safety and acceptability of the research lumbar puncture.

Three hundred forty-two subjects underwent 428 research lumbar punctures for studies of cerebrospinal fluid (CSF) biomarkers. Subjects were 67 Alzheimer disease or mild cognitive impairment (AD/MCI) patients and 275 cognitively normal adults aged 21 to 88. Lumbar puncture was performed in the lateral decubitus or sitting position using the Sprotte 24 g atraumatic spinal needle. Up to 34 ml of cerebrospinal fluid were collected. Anxiety and pain experienced during lumbar puncture were rated on a visual analog scale. The frequency of any adverse event (11.7%), clinically significant adverse events (3.97%), and typical post-lumbar puncture headache (PLPHA) (0.93%) was low. Risk of post-lumbar puncture headache was unrelated to age, gender, position during lumbar puncture, ml of cerebrospinal fluid collected, or minutes of recumbent rest following lumbar puncture. The frequency of post-lumbar puncture headache was lower in AD/MCI (P = 0.03) than any other subject group. Anxiety and pain ratings were low. Younger subjects reported more anxiety than old (P = 0.001) and AD/MCI subjects (P = 0.008) and more pain than older normal subjects (P = 0.013). Pain ratings for women were higher than those for men (P = 0.006). Using the Sprotte 24 g spinal needle, research lumbar puncture can be performed with a very low rate of clinically significant adverse events and with good acceptability in cognitively impaired persons and cognitively normal adults of all ages.

A clinical trial of distraction techniques for pain and anxiety control during cataract surgery.

This research study evaluates the effectiveness of distraction interventions on subject perceptions of discomfort or pain and anxiety during the ocular anesthetic injection prior to cataract surgery. Eighty subjects received either usual care, usual care with massage, usual care with verbal coaching and slow breathing, or usual care with massage and verbal coaching and slow breathing combined as different types of distraction interventions. After the ocular anesthetic injection(s), the subjects rated their level of experienced discomfort or pain and anxiety on a Likert scale of 0 to 10. The statistical analyses revealed a significant reduction of discomfort or pain and anxiety when the distraction interventions were implemented during the ocular anesthetic injections. Because the different distraction interventions are effective, inexpensive, and easy to implement, routine use during ocular anesthetic injections, prior to cataract surgery, is recommended.

Developing a computerized data collection and decision support system for cancer pain management.

Contemporary nursing practice needs reengineering to deliver its service effectively and efficiently. Using computer technology to support clinicians' decision making may be a parsimonious way to provide high-quality, patient-centered, efficient care. The process of developing the PAINReportIt and PAINConsultN system is described, and the results of two pilot studies in which the system was tested are summarized. The feasibility of using the system to assess pain and provide decision support for clinicians is demonstrated. The findings show PAINReportIt to be promising as an effective, efficient way for patients to report their pain. Whether PAINConsultN is an effective answer to cancer pain management barriers warrants further evaluation with larger samples. The advantages of using the system, as compared with use of the traditional pain management process, are discussed.

Teaching Brief Interventions for Smoking Cessation via an Interactive Computer-based Tutorial.

Many current smokers do not plan on quitting any time soon. For these smokers, the immediate treatment goal is not a quit attempt, but an increase in readiness to stop smoking. In the present study we developed an interactive multimedia simulation and tutoring environment that teaches healthcare professionals to provide brief motivational interviewing-based smoking cessation interventions tailored to the patient's current readiness to change. This tutorial utilizes a cognitive science-derived learning approach that provides tailored feedback and lessons based on learners' pre-existing knowledge, is highly interactive and allows learners to practice skills in simulated clinical situations. Results from two pilot studies indicate that healthcare professionals and students found the software easy and enjoyable to use and successfully learned MI-based strategies for smoking cessation.

An interactive computer tutorial to teach pain assessment.

Under-treated pain is a significant problem. Health care institutions are under increasing pressure from patients and accreditation bodies to improve staff training in pain management. Pain assessment, a necessary pre-cursor to good pain management, is a complex multi-step process requiring sophisticated understanding and superior communication skills. This article describes the development and usability testing of an interactive, Internet-deliverable, multimedia tutorial to teach best practice pain assessment. The software platform allowed non-programmers to create multimedia tutorials and included the capability to simulate role-plays. The tutorial was designed to actively engage and respond to the learner and to include skills practice. Twenty-five nurses took the tutorial and rated it positively on a usability questionnaire in terms of ease-of-use and learning method.

Pain response to perineuromal injection of normal saline, epinephrine, and lidocaine in humans.

In animal neuroma models the application of alpha-adrenergic agonists causes a burst of spontaneous afferent activity. The increased activity has been hypothesized to generate nociceptive input. Corroborative work in humans, however, has not been done. Nine subjects with chronic nerve end neuromas received perineuromal injections of normal saline, epinephrine (5 micrograms), and lidocaine in a blinded manner. Qualitative and quantitative pain assessments were performed with each injection. Epinephrine, but not saline, caused an intense increase in reported pain with subjects often commenting that the appendage was "on fire". Lidocaine significantly reduced but did not completely abolish the reported pain. The chemosensitivity of the neuroma to epinephrine may explain some of the clinical responses noted after sympathetic system manipulation. It is likely that alpha-adrenergic sensitivity is only one of many components sustaining or exacerbating pain after nerve injury.

Intrathecal methadone: a dose-response study and comparison with intrathecal morphine 0.5 mg.

The analgesic and adverse effects of intrathecal methadone 5 mg, 10 mg and 20 mg were assessed and compared with intrathecal morphine 0.5 mg. The study was conducted on 38 patients who underwent total knee or hip replacement surgery. The intrathecal opioid was administered at the end of surgery and assessments began 1 h thereafter and continued for 24 h. Pain measurements, supplementary analgesia requirements, and adverse effects were recorded. Intrathecal morphine 0.5 mg provided effective and prolonged analgesia. Intrathecal methadone 5 mg, 10 mg, and 20 mg produced good analgesia of 4 h duration. Thereafter the median pain scores with intrathecal methadone were consistently higher (worse) than those with intrathecal morphine (P less than 0.05). The time to the onset of discomfort severe enough to require supplemental morphine was longer after intrathecal morphine than following methadone (15 h with morphine 0.5 mg; 6.25 h, 6.5 h and 6 h with methadone 5 mg, 10 mg, and 20 mg respectively: P less than 0.05). Central nervous system depression manifesting as respiratory depression, hypotension, and excessive drowsiness occurred in 3 of 8 patients injected with methadone 20 mg intrathecally. Generalized pruritus, nausea, vomiting, and urinary retention were common and equally distributed among the treatment groups. We conclude that both intrathecal morphine 0.5 mg and methadone 5, 10, and 20 mg provide excellent analgesia but that morphine has a more prolonged effect. Methadone 20 mg produced unacceptable side effects. Clinical evidence for rostral spread of methadone within the CSF, as indicated by facial itching and excessive drowsiness, was less apparent with 5 mg than with 10 and 20 mg. Various explanations for the observed differences between the drugs are discussed.

A comparison of the effects of intrathecal fentanyl and lidocaine on established postamputation stump pain.

Eight patients with established lower limb postamputation stump pain were given lumbar intrathecal fentanyl 25 micrograms and lidocaine 70 mg 2 weeks apart in an attempt to better understand the role of peripheral and central mechanisms in this condition. Baseline pain was recorded and then analgetic and side effects and their duration were assessed. Three self-administered questionnaires with appropriate psychometric proprieties were given to the patients. Intrathecal fentanyl always abolished the pain. Its onset was rapid being heralded within 1-2.5 min by a pleasant sensation of warmth involving the lower trunk and legs. Analgesia was complete by 5-10 min and had a median duration of 8 h. The patients had a sense of well being and were unable to elicit discomfort by pain aggravating maneuvers. Normal motor and sensory functions were retained. Pruritus was the only adverse effect unique to intrathecal fentanyl. Intrathecal lidocaine usually relieved the discomfort but was unable to abolish it in 3 of 8 patients despite adequate neural blockade. Its onset of action was slower and duration of effect shorter than fentanyl. Intrathecal fentanyl provided profound analgesia associated with normalization of stump sensations and euphoria, probably due to a segmental spinal action. The effects of lidocaine were inferior to fentanyl due to the associated motor and sensory paralyses as well as the absence of euphoria. This study suggests that, while peripheral mechanisms played a role, central mechanisms involving the spinal cord were more important in the modulation of established stump pain in the 8 subjects evaluated.

The effect of intravenous lidocaine, tocainide, and mexiletine on spontaneously active fibers originating in rat sciatic neuromas.

The effects of intravenously administered subanesthetic concentrations of lidocaine, tocainide, and mexiletine on spontaneously active fibers (SAFs) originating in 7-day-old rat sciatic neuromas were studied. Control injections of normal saline caused no decrease in SAF or discharge rate. Lidocaine and tocainide given in incremental doses of 5, 10, 15, 20 and up to 25 mg/kg caused nearly all observed SAFs to stop firing. Mexiletine given in doses of 3, 5, 7, 10 and up to 15 mg/kg showed similar results at lower doses. All agents decreased the sensitivity of SAF to mechanical stimulation. No conduction blockade occurred at these doses of intravenously administered local anesthetics. The demonstrated reduction in firing rate of SAF may explain the pain relief observed in clinical trials of these orally available agents.

Relief of persistent postamputation stump and phantom limb pain with intrathecal fentanyl.

Two patients with postamputation stump and phantom limb pain respectively responded favorably to intrathecal fentanyl which temporarily abolished the pain, normalized sensations and produced euphoria without supraspinal effects. One of the patients subsequently received intrathecal, extradural and intravenous fentanyl as well as intrathecal lidocaine. The neuraxial (intrathecal and epidural) fentanyl temporarily abolished the pain. Intravenous fentanyl and intrathecal lidocine were unable to reproduce this effect. Neuraxial fentanyl apparently produced its effects by a segmental spinal action. Spinal modulation of postamputation pain was important in these patients.

Pain responses to perineuromal injection of normal saline, gallamine, and lidocaine in humans.

Rat neurons have shown an increase of spontaneously active fibers to systemically administered potassium channel blocking agents such as tetraethylammonium chloride (TEA) and gallamine. Neuroma formation and spontaneous activity have been associated with autotomy in rats and pain in humans. To evaluate the chemosensitivity of human neurons to potassium channel blocking agents, 9 subjects with neuroma pain underwent perineuromal injection in a single-blinded fashion of normal saline, gallamine, and lidocaine. Sodium had no effect on control pain levels, while gallamine significantly increased and lidocaine significantly decreased pain from control levels. Three of 4 patients with accompanying phantom limb pain noted an increase in pain after the injection of gallamine. The data suggest that peripheral input plays a modulating but not solitary role in both neuroma and phantom limb pain. Agents which increase potassium channel permeability or decrease sodium influx would be predicted to decreased perceived pain.