Painful neuropathy is a widespread and disabling consequence of peripheral nerve injury, marked by persistent sensory disturbances such as burning sensations, tingling paresthesias, sharp shooting pains, numbness, and motor impairments including weakness and gait instability.¹ These symptoms—often worsening at night and intensified by normally non-painful stimuli (allodynia)—significantly impair sleep quality, physical performance, psychological well-being, and overall productivity, thereby imposing a considerable burden on affected individuals and healthcare systems globally.² Among the various causes, diabetic peripheral neuropathy (DPN) is the most prevalent, affecting approximately 10–50% of individuals with diabetes mellitus. Its occurrence increases with advancing age, longer duration of diabetes, poor glycemic control, and the presence of associated comorbid conditions.³ In India, epidemiological studies from different regions prevalence of peripheral neuropathy, ranging from 5 to 2400 per 10,000 population. Its burden is rising due to increasing diabetes prevalence, lifestyle changes.⁴

Other etiologies contributing to painful neuropathy include post-herpetic neuralgia, alcohol-induced neuropathy, chemotherapy-induced peripheral neuropathy, vitamin deficiencies, and idiopathic causes. Regardless of etiology, neuropathic pain mechanisms involve peripheral sensitization, central sensitization, ectopic discharges, and inflammatory mediators, leading to chronic and refractory symptoms.⁵

​ Current management strategies focus on symptomatic relief rather than disease modification. International guidelines recommend first-line pharmacotherapies such as pregabalin, gabapentin, duloxetine, and tricyclic antidepressants, with opioids and topical agents reserved for refractory cases.⁶ However, treatment patterns vary widely across regions due to differences in healthcare access, prescribing practices, cost considerations, and patient-related factors. In real-world settings, polypharmacy and suboptimal dosing are common, potentially affecting therapeutic outcomes and adherence.

​ Despite the high burden of painful neuropathy in India, there is limited contemporary real-world data describing its clinical characteristics, severity patterns, comorbidities, and current treatment practices. Understanding these factors is crucial for identifying gaps in care and optimizing evidence-based management strategies tailored to the Indian population.

Therefore, this cross-sectional study aims to explore the clinical characteristics and treatment patterns of painful neuropathy among Indian patients in routine clinical practice, providing insights into disease presentation and therapeutic approaches in a real-world setting.

MATERIALS AND METHODS

Study Design

This was a cross-sectional, observational, post-marketing study conducted to evaluate the clinical characteristics and treatment patterns of patients diagnosed with painful neuropathy in routine clinical practice.

Study Population

Inclusion Criteria:

Adults (≥18 years) attending outpatient clinics with a clinical diagnosis of painful neuropathy, including diabetic peripheral neuropathy, postherpetic neuralgia, or other neuropathic pain syndromes.

Exclusion Criteria:

Patients with non-neuropathic pain conditions (e.g., musculoskeletal or inflammatory arthritis), severe cognitive or communication impairment, or a history of substance abuse or addiction.

Study Period and Duration

The total study duration was 12 months, conducted from April 2024 to May 2025.

Study Setting

The study was carried out across 295 centers in India, reflecting a broad, multicenter representation of real-world clinical practice.

Data Collection

In this multicenter, cross-sectional study (ALKPN1 protocol v1.0; dated 25 March 2024), anonymized electronic medical records of adult patients (≥18 years) with a confirmed diagnosis of painful neuropathy were retrospectively reviewed and analyzed over a 12-month period. Data were extracted from routinely maintained clinical records without direct patient interaction, ensuring confidentiality and anonymity of patient information.

Ethical Approval

The study protocol was reviewed and approved by Institutional Ethics Committees prior to initiation. The study was conducted in accordance with applicable ethical guidelines and regulatory requirements.

Statistical Analysis

Descriptive statistics were used to summarize data with continuous variables expressed as mean ± SD or median (IQR) and categorical variables as frequencies and percentages.

RESULTS

The study included 4,418 patients with neuropathy, most of whom had peripheral neuropathy. The majority were males (73.83%, n=3,262), and the mean age of the participants was 49.31 ± 11.26 years, with ages ranging from 18 to 79 years (Table 1).

Table 1: Summary of Demographic and Baseline Characteristics​

Peripheral neuropathy predominated (98.46%; n=4,350), followed by mixed/combination (1.20%; n=53) and central neuropathy (0.34%; n=15) [Table 2].

Table 2: Distribution of Neuropathy Diagnoses​

Comorbid diabetes mellitus affected 15.07% (n=666), hypertension 3.89% (n=172), and musculoskeletal conditions 8.71% (n=385) [Table 3][Figure 1].

Table 3: Overview of Associated Medical Conditions​

Figure 1: Overview of Associated Medical Conditions​

Sensory symptoms included numbness (49.39%; n=2,182) and paresthesia (42.08%; n=1,859); motor symptoms featured weakness (60.10%; n=2,655) and muscle atrophy (27.00%; n=1,193) [Table 4].

Table 4: Distribution of Sensory and Motor Symptoms among Neuropathy Patients​

Neuropathic pharmacotherapy relied heavily on pregabalin + methylcobalamin (48.53%; n=2,144), pregabalin monotherapy (10.80%; n=477), and combination regimens (e.g., methylcobalamin + nortriptyline + pregabalin: 3.62%; n=160) [Table 5].

Table 5: Overview of Neuropathic Medications​

Pain severity per Visual Analogue Scale (VAS) revealed moderate pain in 42.67% (n=1,885), mild in 41.10% (n=1,816), and severe in 16.23% (n=717) [Figure 2].

Figure 2: Pain Severity Profile in Patients with Neuropathy

DISCUSSION

This large, multicenter cross-sectional study provides real-world insights into the clinical spectrum and treatment practices of painful neuropathy in Indian patients. The overwhelming predominance of peripheral neuropathy (98.46%) highlights its clinical dominance compared with mixed and central neuropathic conditions. This finding is consistent with existing literature indicating that peripheral etiologies—particularly metabolic, toxic, and compressive causes—account for the majority of neuropathic pain presentations in routine practice.⁷

Diabetes mellitus emerged as the most common comorbidity (15.07%), reinforcing its well-established association with peripheral nerve damage and painful neuropathic syndromes. Although the proportion of patients with documented diabetes in this cohort appears lower than that reported in some epidemiological studies, this may reflect under-documentation, inclusion of non-diabetic neuropathies, or variability in referral patterns. Hypertension and musculoskeletal disorders were less frequent but clinically relevant, as vascular and structural factors may contribute to symptom amplification and functional limitation. Nonetheless, diabetes remains a major driver of neuropathic morbidity globally, particularly in countries such as India with a high diabetes burden.⁸

The symptom profile in this cohort underscores the heterogeneous yet predominantly sensorimotor nature of neuropathy. Nearly half of the patients reported numbness (49.39%) and paresthesia (42.08%), classical sensory manifestations of nerve dysfunction. Notably, motor involvement was also prominent, with weakness observed in 60.10% and muscle atrophy in 27.00% of patients. The high prevalence of motor deficits suggests either advanced disease at presentation or delayed healthcare seeking, which may have implications for long-term disability and rehabilitation needs.⁹

Pain severity assessment revealed that the majority of patients experienced mild to moderate pain (approximately 84%), while 16.23% reported severe pain. This distribution suggests a substantial symptomatic burden, even though extreme pain was less common. Given that moderate pain can significantly impair sleep, mood, and productivity, these findings emphasize the importance of timely and optimized pain management strategies.¹⁰

Treatment patterns demonstrated a clear preference for pregabalin-based regimens, particularly the combination of pregabalin with methylcobalamin (48.53%). This reflects prevailing prescribing trends in India, where neuropathic pain agents are frequently co-administered with neurotropic vitamins, possibly to address underlying nutritional deficiencies or to enhance nerve repair. Pregabalin monotherapy (10.80%) was less common, and alternative agents such as gabapentin (0.43%) and duloxetine-containing combinations were prescribed in a minority of patients. The limited use of duloxetine and gabapentin may be influenced by physician familiarity, tolerability considerations, cost factors, or perceived effectiveness. International guidelines recommend pregabalin, duloxetine, gabapentin, and tricyclic antidepressants as first-line agents for neuropathic pain. International guidelines recommend combination therapy for neuropathic pain only when optimized monotherapy provides inadequate relief.^10,11,12

The relatively modest use of tricyclic antidepressant combinations and multinutrient formulations (3.15%) further reflects selective prescribing patterns. While international guidelines recommend several first-line options—including pregabalin, duloxetine, gabapentin, and tricyclic antidepressants—the observed dominance of pregabalin suggests regional practice preferences and potential gaps in therapeutic diversification.^11,12

Overall, this study highlights that peripheral neuropathy constitutes the major burden of neuropathic pain in Indian clinical settings, with diabetes as a key associated comorbidity and pregabalin-based combinations as the cornerstone of pharmacotherapy. The findings underscore the need for standardized treatment algorithms, early diagnosis, and individualized management strategies to optimize outcomes and reduce long-term disability in patients with painful neuropathy.

As a cross-sectional, retrospective analysis, the study is limited by its observational design, potential documentation bias, lack of longitudinal follow-up, and inability to establish causal relationships between clinical characteristics and treatment outcomes.

CONCLUSION

This large multicenter cross-sectional study demonstrates that peripheral neuropathy is the predominant form of painful neuropathy in Indian clinical practice, with diabetes being the most common comorbidity. Most patients presented with sensory symptoms accompanied by significant motor involvement and experienced mild-to-moderate pain severity. Pregabalin-based combinations, particularly with methylcobalamin, were the most frequently prescribed therapies, highlighting prevailing real-world treatment preferences. These findings underscore the need for early diagnosis alignment with evidence-based guidelines to improve patient outcomes.

Conflict of Interest

All the authors (Dr. Nishikant Madkholkar, Dr. Kushal Sarda, and Dr. Akhilesh Sharma) are full-time employees of Alkem Laboratories.

Author Contributions

All authors contributed substantially to the study conception, data analysis, manuscript drafting, and final approval of the submitted version.

REFERENCE

1. Tesfaye, S., & Selvarajah, D. (2012). Advances in the epidemiology, pathogenesis and management of diabetic peripheral neuropathy. Diabetes/Metabolism Research and Reviews, 28(Suppl 1), 8–14. https://doi.org/10.1002/dmrr.2239
2. Ziegler, D., Papanas, N., Vinik, A. I., & Shaw, J. E. (2014). Epidemiology of polyneuropathy in diabetes and prediabetes. Handbook of Clinical Neurology, 126, 3–22. https://doi.org/10.1016/B978-0-444-53480-4.00001-1
3. Callaghan, B. C., Cheng, H. T., Stables, C. L., Smith, A. L., & Feldman, E. L. (2012). Diabetic neuropathy: Clinical manifestations and current treatments. The Lancet Neurology, 11(6), 521–534. https://doi.org/10.1016/S1474-4422(12)70065-0
4. Trivedi S, Pandit A, Ganguly G, Das SK. Epidemiology of peripheral neuropathy: An Indian perspective. Annals of Indian academy of neurology. 2017 Jul 1;20(3):173-84.
5. Baron R. Mechanisms of disease: neuropathic pain—a clinical perspective. Nature clinical practice Neurology. 2006 Feb;2(2):95-106.
6. Bates D, Schultheis BC, Hanes MC, Jolly SM, Chakravarthy KV, Deer TR, Levy RM, Hunter CW. A comprehensive algorithm for management of neuropathic pain. Pain Medicine. 2019 Jun 1;20(Supplement_1):S2-12.
7. Torrance N, Smith BH, Bennett MI, Lee AJ. The epidemiology of chronic pain of predominantly neuropathic origin. Results from a general population survey. The Journal of Pain. 2006 Apr 1;7(4):281-9.
8. Nicholson B, Verma S. Comorbidities in chronic neuropathic pain. Pain medicine. 2004 Mar 1;5(suppl_1):S9-27.
9. Ziegler D, Tesfaye S, Spallone V, Gurieva I, Al Kaabi J, Mankovsky B, Martinka E, Radulian G, Nguyen KT, Stirban AO, Tankova T. Screening, diagnosis and management of diabetic sensorimotor polyneuropathy in clinical practice: International expert consensus recommendations. Diabetes research and clinical practice. 2022 Apr 1;186:109063.
10. Kaye AD, Armistead G, Amedio LS, Manthei ME, Ahmadzadeh S, Bernhardt B, Shekoohi S. Evolving treatment strategies for neuropathic pain: a narrative review. Medicina. 2025 Jun 10;61(6):1063.
11. Dworkin RH, O'Connor AB, Audette J, Baron R, Gourlay GK, Haanpää ML, Kent JL, Krane EJ, LeBel AA, Levy RM, Mackey SC. Recommendations for the pharmacological management of neuropathic pain: an overview and literature update. InMayo Clinic Proceedings 2010 Mar 1 (Vol. 85, No. 3, pp. S3-S14). Elsevier.
12. International Association for the Study of Pain (IASP). Pharmacological treatment recommendations for neuropathic pain. Pain. 2011;152(10):2204–2205.