A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered by transforaminal injection for lumbosacral radicular pain.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03372161.

Efficacy and Safety of Cryoneurolysis for Treatment of Chronic Head Pain Secondary to Occipital Neuralgia: A Pilot Study.

PURPOSE: Treatment of chronic pain associated with occipital neuralgia (ON) is complex, and no consensus statement or guidelines have been published for ON management. This pilot study evaluated the efficacy and safety of cryoneurolysis for management of ON-associated chronic pain. PATIENTS AND METHODS: The study was a prospective, multicenter, nonrandomized cohort study assessing the degree and duration of clinical effect of cryoneurolysis therapy for reducing pain in patients diagnosed with unilateral or bilateral ON. The primary outcome measure was improvement in pain due to ON from baseline to day 7, measured on an 11-point numeric rating scale for pain. Secondary outcome measures included duration of treatment effects and safety events, including anticipated observations and adverse events. Treatment effect was assessed at days 7, 30, and 56 by asking the patient if they were continuing to experience a treatment effect, with potential responses of "effect," "no effect," or "no longer effective." A posttreatment questionnaire evaluated patient satisfaction. RESULTS: Twenty-six patients (9 men, 17 women) with a mean age of 49.1 years enrolled and completed the study. A total of 64% (16/25) of participants reported a clinically important improvement of ≥2 points in numeric rating scale pain scores at day 7; similar results persisted to day 30. Treatment effects were reported by 50% (13/26) of participants at day 30, with a continued effect reported by 35% (9/26) of participants at day 56. Overall, ~70% of participants were satisfied with treatment at 7, 30, and 56 days. No serious anticipated observations, adverse events, or unanticipated adverse device effects were reported. CONCLUSION: Cryoneurolysis provided significant relief from pain associated with ON ≤30 days after treatment and had an acceptable safety profile.

Repeat Epidural Injections of SP-102 (Dexamethasone Sodium Phosphate Injectable Gel) in Subjects with Lumbosacral Radiculopathy.

PURPOSE: SP-102 is a novel epidural steroid injection (ESI) formulation of 10 mg dexamethasone sodium phosphate in a viscous gel solution. Repeat dosing of ESIs is possible if required for pain relief, but with consideration of hypothalamic-pituitary-adrenal (HPA) axis suppression from prolonged systemic exposure. This phase I/II study investigated the effect of initial and repeat SP-102 injections on HPA suppression and analgesia. METHODS: Subjects with lumbosacral radiculopathy received an initial epidural SP-102 injection (T1) on day 1, followed by a repeat injection (T2) on ≥28 days later. To determine HPA suppression, area under the effect curve over 28 days and maximum change from baseline were calculated for cortisol, glucose levels, and white blood cell (WBC) count. Equivalent effect on HPA suppression of T1 relative to T2 was determined if the 90% CIs for ratios of these measures were within 80%-125%. The effect of repeat injections on leg and back pain was also assessed. RESULTS: Based on the responder analysis, all subjects had achieved a cortisol response by day 3 after initial injection and by day 2 after repeat injection. The repeat injection had similar effects on glucose levels and WBC count to the initial injection. Pain scores decreased after each injection and remained low for the 28-day follow-up, with some evidence of improved analgesic effect of the second dose compared with the first. There were no serious adverse events or discontinuations due to adverse events. CONCLUSION: The lack of cumulative effect and rapid resolution of HPA suppression following repeated SP-102 dosing suggests that consideration of HPA pharmacodynamics is not clinically relevant when making decisions regarding repeat dosing. SP-102 ESIs provided prolonged pain relief, with preliminary evidence of greater efficacy after repeat injection. A phase III trial is ongoing. CLINICAL TRIAL IDENTIFIER: ClinicalTrials.gov: NCT03613662.

Predicting Response to Subacromial Injections and Lidocaine/Tetracaine Patch from Pretreatment Pain Quality in Patients with Shoulder Impingement Syndrome.

OBJECTIVES: No existing pain treatment is effective for all pain problems, and response to pain treatment is highly variable. Knowledge regarding the patient factors that predict response to different treatments could benefit patients by providing an empirical foundation for patient-treatment matching. This study sought to test the hypothesis that improvements following two treatments thought to operate via similar mechanisms would be predicted by similar baseline pain qualities. DESIGN: Prospective prediction analysis using data from a previously published open label trial comparing a heated lidocaine/tetracaine patch versus subacromial corticosteroid injection for the treatment of pain in individuals with shoulder impingement syndrome. RESULTS: Consistent with the study hypothesis, the response to the two treatments were predicted by similar baseline pain qualities; specifically, higher baseline levels of unpleasant, electric, and sensitive pain predicted subsequent improvements in sleep interference, work/activity interference, and patient global ratings of improvement, respectively. CONCLUSIONS: The findings are consistent with the combined ideas that (1) those who have the most to gain (i.e., those reporting the highest levels of various pain qualities) can expect the best response to effective treatments and (2) different pain qualities may be associated with different types of outcomes. The findings support further research to examine how pain quality measures may be used to improve patient-treatment matching, and therefore, ultimately improve the efficiency, efficacy, and overall benefit-risk of pain treatment.

The pain quality response profile of a corticosteroid injections and heated lidocaine/tetracaine patch in the treatment of shoulder impingement syndrome.

OBJECTIVES: To describe the effects of 2 pain treatments for shoulder impingement syndrome (SIS), and illustrate how investigators can use pain quality information to understand treatment response differences. MATERIALS AND METHODS: This study presents pain quality data from a randomized open-label study comparing the effects of an injection of triamcinolone and up to twice daily application of a heated lidocaine/tetracaine (Trilexis) patch in individuals with SIS. Study participants completed a measure of pain quality at baseline and again on study days 14, 28, and 42 following initiation of 2 treatments for SIS. Baseline and posttreatment pain quality scores were graphed to provide a visual representation of treatment-associated changes. Analyses of variance were used to examine the differences between treatment conditions in changes in pain quality with treatment. RESULTS: Both treatments resulted in substantial (and similar) pretreatment to posttreatment improvements in many pain qualities. However, differences in the time course of treatment effects were observed for itchy and heavy qualities. DISCUSSION: Although 2 different pain treatments appear to have the same effects when only pretreatment to posttreatment changes are examined, treatment differences emerged when the time course of treatment is examined. The findings support the importance of assessing both pain qualities and time course of treatment as outcome domains. The results illustrate how investigators can use data from clinical trials to provide a more fine-tuned description of treatment effects, providing knowledge that could be helpful in selecting treatment options at the individual patient level. SUMMARY: Examination of the effects of pain treatments on pain qualities over time will help researchers and clinicians understand if certain pain quality domains respond faster to one treatment versus another, and may identify differences between treatments that would not be observed by measures of global pain intensity alone.

A randomized clinical study of the heated lidocaine/tetracaine patch versus subacromial corticosteroid injection for the treatment of pain associated with shoulder impingement syndrome.

BACKGROUND: Treatment for pain due to shoulder impingement syndrome (SIS) typically begins conservatively with nonsteroidal anti-inflammatory drugs and physical therapy and can include subacromial injection of corticosteroids, particularly in patients unresponsive to conservative measures. The heated lidocaine/tetracaine (HLT) patch has been reported to reduce SIS pain in a small case series. METHODS: This was a prospective, randomized, open-label clinical trial in which adult patients with SIS pain lasting at least 14 days, with an average intensity of ≥4 on a 0-10 scale (0= no pain, 10= worst pain) were randomized to treatment with the HLT patch or a single subacromial injection of triamcinolone acetonide (10 mg). Patients in the HLT patch group applied a single HLT patch to the shoulder for 4 hours twice daily, with a 12-hour interval between treatments during the first 14 days, and could continue to use the patch on an as-needed basis (up to twice daily) during the second 14-day period. No treatment was allowed in the final 14-day period. At baseline and at days 14, 28, and 42, patients rated their pain and pain interference with specific activities (0-10 scale). RESULTS: Sixty patients enrolled in the study (average age =51 years, range 18-75, n=21 female). Average pain scores declined from 6.0±1.6 at baseline to 3.5±2.4 at day 42 in the HLT patch group (n=29, P<0.001) and from 5.6±1.2 to 3.2±2.6 in the injection group (n=31, P<0.001). Similar improvements were seen in each group for worst pain; pain interference with general activity, work, or sleep; and range of motion. No significant between-group differences were seen for any pain or pain interference scores at any time point. CONCLUSION: These results suggest that short-term, noninvasive treatment with the HLT patch has similar efficacy to subacromial corticosteroid injections for the treatment of pain associated with SIS.

Acute pain: effective management requires comprehensive assessment.

Pain is among the most common reasons that patients seek medical care, and inadequate assessment may result in suboptimal management. Acute pain in response to trauma or surgery can be complex, variable, and dynamic, but its assessment is often simplistic and brief. One-dimensional rating scale measures of pain severity facilitate rapid evaluation and often form the basis of treatment algorithms. However, additional features of pain should inform the selection of a treatment regimen, and can include pain qualities, duration, impact on functional capabilities, and underlying cause. Patient age, sex, psychosocial features, and comorbid conditions are also important features to consider. Use of a multidimensional tool is recommended for assessing many of these features if time permits. Additionally, clinicians often fail to recognize or consider the potentially detrimental long-term effects of acute pain. As the United States continues to experience a prescription drug crisis, a "universal precautions" approach including abuse risk assessment and abuse deterrence strategies should be implemented for patients receiving opioids. Increased efforts and research are necessary to enhance the utility of available acute pain assessment tools. Developing more comprehensive tools for patient assessment is the first step in achieving the ultimate goal of effective acute pain management. The objectives of this review are to summarize issues regarding the complexity of acute pain and to provide suggestions for its evaluation.

Utility of the heated lidocaine/tetracaine patch in the treatment of pain associated with shoulder impingement syndrome: a pilot study.

INTRODUCTION: Pain control is an important first step in the treatment of shoulder impingement syndrome (SIS) because fear of pain must be removed as an obstacle to participation in an appropriate physical therapy program. METHODS: Adult patients with SIS-associated pain of at least 2 weeks' duration and who had an average pain score of ≥4 on the zero- to ten-point Numeric Pain Rating Scale were eligible to enroll in this 2-week pilot study. Patients were treated with the heated lidocaine/tetracaine (70 mg/70 mg) patch (HLT patch) placed over the site of shoulder tenderness each morning and evening for a period of 2 to 4 hours. Average and worst pain during the previous 24 hours and shoulder range of motion were assessed at baseline and on Day 14. Results were expressed as change and percent change from baseline to Day 14. This pilot study was not powered for rigorous statistical analysis. RESULTS: Twenty patients (seven male, 13 female; average age 51.2 ± 10.8 years [mean ± standard deviation]) enrolled in this study, and 18 patients completed the protocol. The mean average pain score at baseline was 5.5 ± 1.1 (range 4 to 8). In the per-protocol population, average and worst pain scores declined by 2.4 ± 2.0 and 3.7 ± 2.7 points, respectively. Two-thirds of the patients demonstrated a clinically meaningful ≥30% decline in average pain score, and half of the patients demonstrated a ≥50% decline in average pain score. Shoulder internal rotation increased by 29.7° ± 21.8° and abduction increased by 40.0° ± 44.2°. Application-site erythema was reported by ten patients at some time during the study. CONCLUSION: Patients treated with the HLT patch for 14 days demonstrated clinically meaningful improvement in pain intensity and range of motion. Further controlled research is necessary to characterize the efficacy and tolerability of the HLT patch in the treatment of SIS.

Heated lidocaine-tetracaine patch for management of shoulder impingement syndrome.

Shoulder impingement syndrome (SIS), a chronic shoulder pain condition, often stems from repetitive overhead activities. In the current report, the author presents 2 cases of SIS. In the first, a woman with a history of SIS found that physical therapy and subacromial steroid injections, while effective, were problematic for long-term use. Previous use in the author's practice demonstrated convenient shoulder pain relief using the heated lidocaine 70 mg-tetracaine 70 mg topical patch. She initially used the heated lidocaine-tetracaine patch twice daily and tapered over 4 weeks to as-needed use for successful pain control. In the other case, a female adolescent athlete with a history of SIS tried, on the recommendation of the author, using the heated transdermal patch instead of steroid injections. Her pain was successfully controlled during activity and at rest with 12 hours-on/12 hours-off patch application. The heated lidocaine-tetracaine topical patch may be an early conservative treatment for patients with acute pain from SIS and warrants examination in controlled studies.