Introduction
According to the International Diabetes Federation (IDF) 2021, 537 million people worldwide have diabetes at present, with considerable variation across estimates; the overall pooled prevalence of diabetic peripheral neuropathy (DPN) was 43.16% [1]. DPN is the most prevalent diabetic complication, with a lifetime frequency of about 50%. Due to gait abnormalities, fall-related injuries, foot ulceration, and amputation, DPN is a major cause of disability. About 20 to 30% of DPN patients experience neuropathic pain [2]. Damage to neurons, Schwann cells, and blood vessels within the nerve is the hallmark of peripheral neuropathy, the most frequent consequence of diabetes, which can affect up to 50% of people [3].
Type 1, type 2, and gestational diabetes are the three main types of diabetes mellitus. In type 1 diabetes, the autoimmune destruction of pancreatic beta cells leads to absolute insulin deficiency [4]. Type 2 diabetes, characterized by relative insulin insufficiency and insulin resistance, accounts for more than 90% of all diabetes cases [5]. Gestational diabetes during pregnancy increases the child’s risk of obesity and type 2 diabetes. Regular exercise raises insulin sensitivity, enhances blood glucose regulation, and promotes general well-being [6].
DPN, the second most common form of traumatic nerve injury, affects all peripheral nerves, including motor neurons, pain fibers, and the autonomic nervous system [7]. The presence of peripheral nerve dysfunction symptoms and signs in people with diabetes following the exclusion of other causes is known as diabetic neuropathy, which gradually advances proximally after beginning in the toes. It is a heterogeneous disorder characterized by progressive “glove and stocking” sensory loss with variable somatic, autonomic, proximal, distal, small and large-fiber involvement [8].
In diabetic polyneuropathy, early pathological changes include endoneurial microangiopathy, axonal loss, and predominant small-fiber degeneration, leading to impaired temperature perception, pain, and autonomic function, while large-fiber involvement occurs at later stages [9]. Asymptomatic peripheral neuropathy is possible. Symptoms may be either positive or negative when they occur. Loss of strength and sensation are negative indicators, whereas discomfort or pricking are positive indicators. Neuropathic pain and paresthesia are two of the most upsetting symptoms that people can experience [10]. A progressive loss of protective sensation in the skin and foot joints results from the first injury to the distal sensory and autonomic nerve fibers, followed by proximal progression. Preventive interventions (such as patient education, appropriate shoe usage, foot care, and yearly foot exams), glucose control, dietary changes, weight loss, and pain management are some of the strategies that make up DPN management [11]. The symptoms will differ based on whether the damaged fibers are large or small. Large fibers result in numbness, tingling, and impaired balance, while small fibers typically induce burning, electric shocks, stabbing, hyperalgesia, and allodynia. People with DPN are more likely to fall due to imbalances caused by altered proprioception. Compared to people with diabetes without peripheral neuropathy, those with DPN have a two to three times higher risk of falling [12].
Management of DPN focuses on glycemic control, foot care, and symptom relief, with pharmacologic therapy recommended for severe pain. Despite ongoing research, drug treatments provide limited benefit in slowing disease progression, prompting investigation of non-pharmacologic interventions such as exercise, infrared therapy, TENS, spinal cord stimulation, and biofeedback to improve neural circulation and mitigate axonal damage [13].
Intraneural facilitation (INF) is an emerging evidence-based intervention that enhances neurovascular circulation, improving oxygen and nutrient delivery to damaged nerves and potentially mitigating neuropathic symptoms. Foot massage (FM), by increasing peripheral blood flow, may similarly reduce discomfort, enhance skin sensation, and improve joint mobility in individuals with diabetic neuropathy. These approaches highlight the potential of circulation-targeted therapies in managing DPN [14, 15].
The Semmes-Weinstein Monofilament Examination (SWME) is commonly used and recommended for screening of peripheral neuropathy, as it is a quick, easy, and affordable assessment method and has a strong correlation with the risk of amputation, ulceration, and damage [16, 17]. The objective of this research was to assess the effect of INF and FM on sensory function in individuals with DPN.
Materials and Methods
Design and sample
This comparative study was conducted involving individuals diagnosed with DPN in 2024. A total of 66 participants with DPN were recruited from Saveetha College of Physiotherapy based on specific inclusion and exclusion criteria. A convenient sampling technique was used, and the OpenEpi software was used to calculate the sample size. A two-sided 95% confidence interval and a statistical power of 80% were employed to detect a mean difference of 4.8 between the groups, resulting in a total sample size of 66 participants (33 per group). Participants were randomly divided into two INF (n=33) and FM (n=33) groups using simple random sampling through the sealed envelope method. Inclusion criteria included individuals aged 40-60 years of either gender with a diagnosis of diabetes mellitus, the presence of positive neuropathic sensory symptoms, such as burning or aching pain primarily in the toes, feet, or legs, and a pre-test monofilament score between grades 2 and 5. Participants were excluded if they had a history of chemotherapy, radiation therapy, dialysis, foot ulcers, lower-extremity amputation or wounds, documented active alcohol or drug misuse, or proximal diabetic neuropathy.
Instrument
Semmes-Weinstein Monofilament Examination (SWME)
This tool uses 5.07/10g or 4.31/2g monofilaments to measure sensory impairment. On each foot, SWME was performed at three non-callused sites: the plantar aspect of the great toe and the plantar aspects of the first and fifth metatarsal heads. After being applied perpendicularly to the test location, the monofilament bent for approximately one second. If the patient feels the sensation, they respond “yes”. Pre-test and post-test assessments were performed using this monofilament test.
Procedure
The IF session commenced with the patient positioned in a relaxed supine posture to ensure comfort throughout the intervention. INF was initiated with the facilitation hold, wherein the contralateral joint was placed in its maximum loose-pack position, and a TheraBand was applied to guide the foot into inversion and upward movement. This position was sustained for 30 seconds and repeated for three sets, with a rest interval of 30 seconds between each set. Following this, the sub-hold was performed by maintaining the facilitation hold while the therapist gently lifted the affected limb, holding for 30 seconds, and repeating for three sets with 30-second pauses. Finally, both the facilitation hold and sub-hold were repeated on the affected side in the same manner. The overall intervention session was planned to take approximately 20-25 minutes, thereby ensuring adequate repetition and sufficient rest to optimize circulation and therapeutic outcomes in patients with DPN [18].
The FM session commenced with a brief warm-up to prepare the foot for massage and enhance circulation. The intervention began with effleurage (long stroke), in which the therapist used the palm to glide smoothly over the foot from the toes to the ankle and back down. This was performed for 2 minutes in continuous strokes. Following this, kneading was applied using the thumb to exert gentle circular pressure along the arch of the foot for 2 minutes. Next, thumb pressure was performed by applying gentle, sustained pressure with the thumb on specific points along the sole, particularly in the arch region, for 2 minutes. Subsequently, toe manipulation was carried out by gently pulling and twisting each toe, with light pressure applied at the base of each toe for approximately 1 minute per foot. This was followed by ankle rotation, in which the ankle was supported with one hand while the other hand guided circular rotations in both clockwise and counterclockwise directions for 1 minute in each direction. The session concluded with a cool-down effleurage stroke across the entire foot for 2 minutes, providing relaxation and closure to the intervention. The overall massage protocol was designed to last approximately 10-12 minutes per foot (20-25 minutes total), ensuring progressive stimulation, relaxation, and circulatory enhancement to mitigate complications of DPN.
Data analysis
The test of normality was checked using the Shapiro-Wilk test, which indicated a non-normal distribution. Therefore, nonparametric methods, the Mann-Whitney U test and the Wilcoxon signed-rank test, were used to examine differences between pre-test and post-test measures. The difference between the post-test values was assessed. Statistical analyses were conducted using SPSS version 22, with significance set at p<0.05.
Findings
A total of 66 subjects with DPN participated in the study. By gender, 41 participants were male (62.12%) and 25 were female (37.87%). By age group, participants aged 40-50 years numbered 23 (34.85%), and those aged 50–60 years numbered 43 (65.15%)
The pre-test and post-test assessments of INF and FM using the SWME were analyzed. For INF, the pre-test mean was 12.06±9.06 and the post-test mean was 7.06±4.19 (z=-2.26; p=0.023), indicating statistical significance. For FM, the pre-test mean was 12.24±8.21 and the post-test mean was 8.96±3.74 (z=-1.93; p=0.053). The post-test SWME scores were 7.06±4.19 for INF and 8.96±3.74 for FM
There was a statistically significant difference between the INF and FM groups on post-test SWME scores (INF: 7.06±4.19; FM: 8.96±3.74; z=-2.07, p=0.038).
Discussion
The aim of this research was to assess the effect of INF and FM on sensory function in individuals with DPN. This study provides novel comparative evidence showing that INF therapy yields greater improvements in sensory recovery and pain modulation than FM therapy among individuals with DPN. The findings underscore the therapeutic importance of targeting neurovascular mechanisms to restore small-fiber function and alleviate neuropathic symptoms, rather than focusing solely on superficial circulatory enhancement.
The significant improvements observed in the SWME within the INF group likely reflect enhanced endoneurial blood flow and oxygenation, thereby facilitating axonal repair, neural metabolism, and microvascular perfusion. These physiological adaptations are consistent with prior research demonstrating that INF increases intraneural blood flow and reduces ischemic neuropathic pain in individuals with type II diabetes [4, 13]. Recent findings further support these mechanisms, revealing measurable improvements in balance, protective sensation, and microcirculatory dynamics following INF intervention [18]. Collectively, this evidence indicates that INF not only mitigates pain but also promotes microvascular and neuroregenerative modulation in diabetic nerves.
In contrast, FM primarily exerts its therapeutic effects through cutaneous, muscular, and autonomic pathways, promoting vasodilation, peripheral perfusion, and sensory stimulation [19]. Although these mechanisms are beneficial, they appear less specific to small-fiber regeneration than those induced by INF. Nevertheless, several controlled trials have demonstrated that FM can significantly reduce neuropathic complaints and improve functional indices among patients with T2DM [15]. The gentle pressure and rhythmic stimulation applied to the lower limbs enhance local capillary flow, skin trophicity, and thermoregulation, while also relieving stress and promoting relaxation. Notably, a randomized controlled trial by Al-Fahham & Al-Jubouri reports a significant post-intervention reduction in Toronto Clinical Neuropathy Scores following a two-week FM regimen, supporting its role as an effective, non-pharmacological intervention for improving peripheral nerve function [20]. These findings reinforce FM’s value as a supportive adjunct in diabetic rehabilitation, complementing the neurovascular benefits achieved through INF.
Moreover, FM’s relaxation and comfort effects align with previous evidence emphasizing psychophysiological benefits, including reduced anxiety and enhanced quality of life [21]. Circulation-focused exercises, such as Buerger-Allen regimens have similarly demonstrated benefits in increasing limb perfusion and promoting wound healing in individuals with diabetes, underscoring the importance of integrating circulatory and neural interventions [22].
Despite these encouraging results, persistent balance impairments highlight the multifactorial pathophysiology of DPN, involving sensory, motor, and proprioceptive deficits. This underscores the need for multimodal rehabilitation strategies that combine INF with balance and proprioceptive training, resistance exercise, and patient-centered education [23]. Recent studies confirm that dynamic neuromuscular stabilization and balance-focused protocols enhance postural control and proprioception in DPN populations [24]. Furthermore, technology-assisted rehabilitation, including mobile feedback systems and adherence-tracking tools, has proven effective in improving patient engagement and sustaining behavioral change in chronic conditions [25]. Such integration may strengthen adherence to home-based INF and FM interventions and enhance long-term therapeutic outcomes.
Although limited by a modest sample size and short intervention period, this study’s findings are clinically meaningful, highlighting the distinct neurovascular advantages of INF. The consistency of sensory and pain improvements observed across recent INF research suggests its promise as a targeted, mechanism-based therapy for diabetic neuropathy. Future research should focus on large-scale randomized trials with extended follow-up to validate these findings and explore synergistic effects of combined multimodal models integrating INF, FM, circulatory exercises, and digital adherence technologies.
Conclusion
INF and FM are effective treatments for DPN, with INF showing a greater percentage of improvements in sensory function compared with FM.
Acknowledgments: The authors would like to thank the entire physiotherapy team members and patient administrators of the outpatient department of Saveetha College of Physiotherapy for their support in facilitating this research study.
Ethical Permissions: The research received the Institutional Scientific Review Board (ISRB) certificate from Saveetha College of Physiotherapy, SIMATS, under the approval number (19/032/2024/ISRB/SR/SCPT), in compliance with ethical research guidelines.
Conflicts of Interests: The authors declared no conflicts of interestd.
Authors' Contribution: Logeshwari VL (First Author), Introduction Writer/Methodologist/Main Researcher/Discussion Writer (20%); Subramanian SS (Second Author), Introduction Writer/Methodologist/Assistant Researcher/Discussion Writer (20%); Sahal M (Third Author), Introduction Writer/Methodologist/Assistant Researcher/Discussion Writer (15%); Bai P (Fourth Author), Methodologist/Assistant Researcher/Discussion Writer/Statistical Analyst (15%); Vianni DD (Fifth Author), Methodologist/Assistant Researcher/Statistical Analyst (10%); Singarayar EK (Sixth Author), Discussion Writer (10%); Alhalaiqa F (Seventh Author), Discussion Writer (10%)
Funding/Support: This study was self-funded with no external funding or financial support involved.