P-003 - (Poster #3) Patient Perspectives of Inadequately Managed Painful Diabetic Peripheral Neuropathy: A Qualitative Analysis

Pain associated with diabetic peripheral neuropathy is a common complication of diabetes, affecting an estimated 10-30% of people with diabetes in the United States (US). Several pharmacologic therapies are used to manage painful DPN, including antiseizure medications and antidepressants. Despite the availability of these therapies, many patients continue to experience inadequate management of painful DPN due to multiple factors, including variability in patient response to treatment, adverse effects, and uncertainty around long-term effectiveness of available therapies. Inadequately managed pain associated with DPN may lead to ongoing functional impairment, emotional burden, and dissatisfaction with care. As a chronic neuropathic condition primarily affecting the lower extremities, painful DPN can significantly impair patients’ quality of life by limiting mobility, disrupting sleep, and contributing to emotional distress (e.g., anxiety and depression). While prior research has described the symptoms and clinical burden of painful DPN, few studies have provided the patient perspective of challenges with inadequately managed pain. This study aimed to characterize how adults with painful DPN describe their symptoms, experiences with prescription neuropathic pain medications, and the impacts of inadequately managed pain associated with DPN on daily functioning and emotional well-being. 

Purpose/Objectives:

The objectives of this research were to: 1) characterize patient experiences with inadequately managed pain associated with DPN, including its impact on daily functioning and emotional well-being; and 2) identify unmet needs in the management of painful DPN from the patient perspective, including experiences with prescription pain medications, reasons for medication changes or discontinuation, and overall satisfaction with current painful DPN therapies among patients with inadequately managed pain.

Methods:

This cross-sectional study used qualitative research methods to collect and analyze patient descriptions of inadequately managed painful DPN (pDPN). The study sample included US-based adults (aged 18 to 80 years) who reported a diagnosis of type 1 or type 2 diabetes, pDPN in the bilateral lower extremities for ≥6 months prior to the time of screening, peak pain intensity ≥4 (0-10 scale) in the past 7 days, experience with ≥1 prescription pain medication in the past 6 months, and dissatisfaction with the pain relief provided by their current pDPN prescription medication(s). Purposive sampling was used to identify eligible participants. Patients with unrelated chronic pain conditions or a spinal cord stimulator were excluded.

The study was determined exempt by an independent institutional review board. Patients reviewed and provided informed consent prior to the start of the interview.

Individual, 60-minute semi-structured interviews were conducted using an interview guide aligned with study objectives. Patient interview transcripts were coded and analyzed using thematic analysis to identify key themes related to patients’ experiences with pDPN and its management.  Coding and analysis were conducted using ATLAS-ti 9.0 software, with independent coding of early transcripts to assess and confirm consistency and reliability of the analysis.

Results:

Twenty participants with pDPN participated in this study. Mean age was 55.6 years (range 22-77 years), half were retired (n=10, 50%), and most were male (n=11, 55.0%), White (n=13, 65%), and Medicare beneficiaries (n=11, 55%). The mean time since pDPN diagnosis was 6.2 years (range 1-20 years), and all participants reported either moderate (n=7, 35%; defined as 4-6 on the numeric rating scale, 0=no pain and 10=worst pain imaginable) or severe peak pain intensity (n=13, 65%; defined as ≥7).

Participants most commonly described pDPN symptoms as numbness (n=16), burning (n=10), tingling (n=6), electric sensations (n=6), pins and needles (n=6), and throbbing (n=6). Nearly all participants (n=18) reported experiencing symptoms daily, with pain that fluctuated in intensity throughout the day but never fully resolved, even with medication. Many (n=17) emphasized that their pain was emotionally burdensome, contributing to feelings such as frustration, helplessness and anxiety.

Participants reported pDPN-related impacts on physical functioning, including difficulties with standing/positioning (e.g., standing to sitting, kneeling) (n=18), walking (n=17), and maintaining balance (n=9). Nearly all participants experienced sleep disruptions due to pDPN (n=19), causing most (n=16) to experience fatigue. Many also reported emotional distress (n=17), such as fear, anxiety, or depression, and most (n=13) reported interference with their ability to work, leading to absenteeism, reduced productivity, and early retirement.

The majority (n=17) of participants were currently managing pain with oral prescription medications, including antiseizure medications (n=14), antidepressants (n=4), opioids (n=3), and non-steroidal anti-inflammatory drugs (n=3).  All participants indicated adherence challenges, including missing doses (n=12) or intentionally skipping doses due to side effects or fear of dependence (n=8).

Medication-related impacts were reported by the majority of participants, including negative impacts on energy (n=14) and sleep (n=12) that interfered with daily activities. Half (n=10) reported cognitive side effects from pDPN medications, such as brain fog and forgetfulness, which interfered with their ability to work or manage responsibilities. Participants reported these side effects limited self-care (n=14), household tasks (n=11), and driving (n=11).

Conclusions/Implications for future research and/or clinical care:

This qualitative research describes the perspectives of patients living with painful DPN and the limitations of pain management with prescription medications in real-world settings. Patients with painful DPN reported painful symptoms that negatively impact their daily functioning, including mobility, sleep, and ability to work; emotional impacts were also reported. While prescription medications were commonly used to manage painful DPN, patients reported limited effectiveness, challenges with tolerability, and side effects that interfered with activities of daily living and the ability to work. The combined patient-level impacts of both living with neuropathic pain and medication-related challenges, including side effects, underscore the need for improved pain management therapies that more effectively address patient-reported unmet needs in the management of pain associated with DPN.