Leprosy, also known as Hansen’s disease, is a chronic infectious disease caused by Mycobacterium leprae. It primarily involves the skin, mucosa of the upper respiratory tract, peripheral nerves, and eyes. Despite global efforts to control and eradicate the disease, leprosy remains an important public health concern in developing countries such as India, Brazil, and Indonesia [1]. The disease is well known to cause significant potential disabilities and deformities if not diagnosed or treated early. Multidrug therapy (MDT) was first introduced by the World Health Organization (WHO) in the early 1980s and played an important role in the management of leprosy and in lowering the global burden of leprosy. MDT involves the combination of drugs including rifampicin, dapsone, and clofazimine administered over 6 months for paucibacillary (PB) and 12 months for multibacillary (MB) cases [2]. This regimen is bactericidal and also stops disease transmission and prevents further nerve damage. However, in many cases, the disabilities sometimes progress despite the completion of MDT due to irreversible nerve injuries that occurred before the initiation of treatment [3]. 

The World Health Organization (WHO) grading system for leprosy-related disabilities is a standardized tool for the assessment of functional impairments resulting from the disease. It has five grades starting from Grade 0 no impairment), Grade 1 (loss of sensation without visible deformity), and Grade 2 (visible deformities or damage) for eyes, hands, and feet [4]. This system is now widely used in clinical and public health assessments to monitor the impact of leprosy on patients and to evaluate the effectiveness of interventions including MDT. As per WHO early diagnosis and prompt initiation of MDT is crucial for preventing disability in leprosy cases. However, studies have indicated that a significant number of cases with Grade 1 or Grade 2 disabilities at the time of diagnosis show delay in health-seeking behavior, diagnosis, or referral [5]. While MDT is very effective in controlling the disease and preventing further nerve damage, it cannot reverse existing disabilities. The assessing changes in WHO disabilities pretreatment and post-treatment with MDT provides valuable insight into the functional outcomes of treatment and the need for additional rehabilitation requirements. India is a country that contributes to about 50% of the total global newly detected leprosy cases annually and also continues to face challenges in early detection and disability prevention [6]. Despite the availability of free MDT, many patients here show permanent nerve damage and deformities which significantly impact their quality of life. Assessing WHO disability grades before and after MDT helps us know the disease's progress and also shows where improvements in managing and preventing disabilities are needed. Based on this background we in the current study aimed to assess the pattern and severity of WHO disabilities among leprosy patients at diagnosis and after completion of MDT. The results of this study will provide an evaluation of the effectiveness of current treatment protocols and the need for integrated approaches which include physiotherapy, occupational therapy, and community-based rehabilitation to improve patient outcomes.

The prospective observational study was done in the Department of Dermatology, Venerology and Leprosy, Osmania Medical College and General Hospital, Hyderabad, Telangana. Institutional Ethical approval was obtained for the study. Written consent was obtained from all the participants of the study after explaining the nature of the study in vernacular language.

Inclusion criteria:

1. All newly diagnosed leprosy patients, attending DVL OP, in Osmania General Hospital during the period of study.
2. Age > 14 yrs.
3. Males and Females
4. Willing to participate in the study voluntarily

Exclusion criteria

1. Age < 14yrs
2. Patients already diagnosed and in treatment
3. Treatment Defaulters
4. Pregnant and lactating women.
5. Patients with HIV.
6. Patients who are non-compliant and not willing to give consent.

Method of Data Collection: A total of n=50 cases were detected and included during the duration of the study. Patients were counseled regarding the disease and informed consent was taken before including the study. In every case, a detailed history and thorough cutaneous and systemic examination were done and a Slit Skin Smear examination was done for all the patients to confirm the diagnosis. A biopsy was done wherever the Slit Skin Smear was Negative. The cutaneous examination was done as described below:

1. Examination of skin lesions included a number of lesions, distribution, shape, size, and morphology of the lesions. Morphology included color, surface, border and presence/absence/sparseness of hair, lesional tenderness.
2. Sensory examination included examination of lesional sensation for temperature (hot/cold water in test tubes), touch (wisp of cotton wool), and for pain (pin prick).
3. Peripheral nerve examination.
4. Disabilities and deformities were recorded.

Examination for temperature sensation: Testing thermal sensation is important as in early lesions it may be the only sensation impaired. It is traditionally carried out by applying test tubes containing cold tap water(50c-100c) and warm water (400c-500c). On a hot day, one may need to add ice to tap water or water kept in a refrigerator to test for cold sensation. The patient was allowed to feel the test tubes containing cold and hot water at random and once appreciation was established, the patches were tested and compared with normal skin. Inability or a delay in appreciation was indicative of absent or impaired sensations.

Examination for touch sensation: The patient was explained about the testing and allowed to appreciate the normal sensations of touch on normal skin and then compare them with affected skin. For objective testing, the patient was asked to close their eyes. Sensations were tested especially over the lesions and peripheral parts. On the face, looked for impaired sensations rather than anesthesia because of the rich and overlapping nerve supply. In the regions with thicker skin (palm and soles) touch sensation was tested with the tip of a ball-point pen gently, without producing an indentation deeper than 2mm.

Examination for pain sensation: Paper pins cleaned with spirit or alcohol were used for testing for pain. The absence of pain was recorded as anesthesia. A paper pin was pressed sufficiently to produce pain but not to draw blood and was discarded after a single use.

Examination of Peripheral nerves: was done for nerve enlargement, tenderness, nodularity, and abscess formation and for symmetry of involvement.

Examination of Face: The face was examined for any skin lesions involving the periocular area, loss of eyebrows, eye lashes, frequency of blinking, blink interval and blink completeness, ear lobe infiltration, sagging of ear lobules, collapse of the bridge of nose.

Examination of Motor

 Function: Voluntary muscle testing (VMT) was done and was graded as follows.

Grade 5 – Normal power,

Grade 4 – Muscle contraction against slight resistance but power subnormal.

Grade 3 – Movement possible without resistance.

Grade 2 – Active movement when gravity is eliminated.

Grade 1 – Flicker of movement.

Grade 0 – No movement.

Slit Skin Smear Examination: SSS was done for all patients and was classified in the Ridley Jopling spectrum based on calculated BI and MI.

Skin Biopsy: Skin Biopsy was done and sent for HPE wherever SSS was negative to confirm and classify the disease.

Routine Investigations: CBP, CUE, ESR, RBS, RFT, LFT, G6PD, Chest X-ray, ECG, HIV, and HbsAg were done before initiating MDT. Disabilities and deformities present before starting MDT were recorded. Patients were asked for a follow-up every 2 weeks to assess any reactions during MDT, and were assessed for disabilities and deformities every 3 months. After completion of MDT patients were tested for BI and MI before relieving them from MDT and disabilities and deformities any were recorded.

Statistical Methods: The data was entered in Microsoft Excel 2021 version. Data was analyzed using Microsoft Excel and Epi Info 7.2.1.0. Descriptive and inferential statistical analyses were used in the present study. Results on continuous measurements were presented on Mean +/- SD(Min-Max) and results on categorical measurements were presented in numbers (%). Significance was assessed at a 5% level of significance. Chi-square test was used to assess the significance.

A total of n=53 cases attending the Dermatology Venerology and Leprology Outpatient Department were included in the study based on the inclusion and exclusion criteria. N=3 cases were lost to follow-up. So, they were excluded from the data analysis, and data from 50 cases was analyzed. The demographic profile of the cases is depicted in Table 1. A critical analysis of the table shows that the majority of patients were males (70%) and the most frequently reported age group was between 20–39 years, with the 20–29-year age group having the highest percentage.  The analysis of the socioeconomic status revealed that a significant proportion (70%) belonged to the upper-lower socioeconomic class. These demographic patterns show that leprosy predominantly affects individuals in their productive years and from lower socioeconomic backgrounds, which may contribute to delayed health-seeking behavior and influence disease progression.

Table 2 shows the occupational background and family history of leprosy among patients. The patients with leprosy diagnosis were frequent drivers and daily wage laborers (20%) each. This was followed by housewives (16%) and small-scale vendors. The results show that individuals engaged in manual labor or informal sectors are more commonly affected. Assessment of family history of leprosy revealed that 4% of the patients had a positive family history of leprosy. This shows a limited intra-familial transmission, possibly due to increased awareness and early isolation. Occupational exposure and low socioeconomic status appear to be significant risk factors for disease acquisition and delay in diagnosis.

Table 3 describes the diagnostic profile, including duration before presentation, comorbidity with diabetes, skin smear status, and whether a skin biopsy was performed. The results showed that nearly fifty percent of the patients presented to the hospital after more than a year of symptom onset, indicating delayed healthcare access. There were 4% of cases who had diabetes, showing minimal association. Skin smear was positive for 64% of cases. The skin biopsy was performed in 36%. The diagnostic delay and underutilization of skin biopsy suggest a need for better diagnostic outreach and awareness to enhance early detection and appropriate classification of leprosy.

Table 4 presents the clinical classification of leprosy cases based on the WHO criteria along with nerve involvement in the cases. The results showed that a vast majority (88%) were multibacillary cases, with borderline tuberculoid (42%) being the most frequent Ridley-Jopling subtype. Nerve involvement was highly prevalent (90%) of cases of the study. Most patients show multiple nerve thickening. This distribution of cases in the study showed that most of the cases were in advanced stages at the time of diagnosis. This highlights the importance of thorough clinical examination for nerve involvement because plays an important role in determining disability and treatment outcomes. The predominance of multibacillary and nerve-involved cases indicates a more contagious and progressive disease burden.

Table 5 shows the results of the frequency of leprosy reactions. Erythema Nodosum Leprosum (ENL) and Reversal Reaction (RR) at diagnosis and during multidrug therapy (MDT). ENL was found in 18% at diagnosis and 20% during MDT.  Reversal reaction was observed in 4% and 6% of cases respectively. The majority of cases 74% experienced no reaction. ENL was the more prevalent reaction, showing a high number of multibacillary cases. These reactions are significant contributors to nerve damage and disability. Therefore, early detection and management of reactions during MDT are essential to prevent the worsening of disease and long-term complications in affected patients.

Table 6 reveals the disability profile before and after MDT in the cases of the study. A critical analysis of the cases was done at the presentation and their grading before and after MDT. Anesthesia was the most frequently found disability (52%) of cases, followed by ulcers and claw hands in 14% of cases. Grade 2 disability was seen in 48% of patients at presentation. Post-MDT, Grade 0 disability improved to 50%, although 30% still had Grade 2 disability. While MDT reduced the disability burden a significant number of patients continued to exhibit lasting impairments. This shows the importance of early diagnosis and rehabilitation efforts to reduce irreversible nerve damage and functional loss in leprosy.

This study was done in 53 newly diagnosed cases of Hansen's disease out of which 3 were lost in follow-up and were excluded from the study. Our study provided important aspects of the disability burden associated with a diagnosis of leprosy after multi-drug therapy (MDT). We were able to identify clinical and socioeconomic risk factors linked to deformity development and progression in our cohort. Leprosy-related disability is a multi-stage process that includes impairment, disability (activity limitation), and handicap (participation restriction) [7]. Impairments both primary and secondary arise from nerve damage skin changes, and sensory and motor loss. Disabilities occur when these impairments interfere with daily activities and persistent disability may cause social and occupational exclusion termed handicap [7]. Deformities visible or invisible represent structural and functional consequences of this damage, such as madarosis, foot drop, or trophic ulcers [8]. If a person has MB leprosy, multiple nerve problems, leprosy reactions, or a delay in treatment, the risk of deformity development increases [9]. Epidemiological studies have shown that men, adults, and those who perform manual work are affected more often [8]. The deformity is caused by eight factors: anesthetic medications, lack of moisture, muscle paralysis, improper use of the limb, wounds, scar tissue, infectious agents, and bacteria in the tissue. Many countries around the world deal with leprosy as a public health problem, as approximately two lakh cases are registered every year [10]. Thus, the focus of leprosy programs has shifted from merely administering MDT to preventing disability. Our study aligns with this perspective, showing a significant disability burden at diagnosis and new-onset disabilities during the MDT.

The results of this study showed that 94% of cases were aged 20–59 years. These findings are in agreement with other similar studies done in the past where they found adult age group is more frequently affected. An analysis of the association between age and disability grade was (p=0.2989), showing no significance. The results are in concordance with other studies however the results from these show variable responses [5, 11, 12, 13]. The sex distribution in this study revealed male predominance which is consistent with other studies [5, 11]. The association of socioeconomic factors such as occupation and stigma prevents males from seeking early treatment, we also found manual laborers were at increased risk of nerve damage or deformity [12]. 70% of our cases belonged to lower socioeconomic groups similar observations have been made by Raghavendra et al. [11] and Kumar et al, [14]. Poverty, overcrowding, and limited access to healthcare are the contributors to delayed diagnosis and disability [15]. The clinical spectrum analysis in our cases showed that 88% were MB cases, with borderline tuberculoid (BT) being the most common subtype (42%). Similar findings have been reported by international studies where the majority of cases are MB type [13, 14]. The results of this study showed that nerve involvement correlated significantly with disability grade (p=0.0447). Patients with greater than or equal to 3 nerves involved have higher odds of Grade 2 disability.  These observations are similar to the other several studies done previously in this field thus, emphasizing the prognostic value of nerve involvement in leprosy cases [5, 12, 16]. Therefore, it is necessary for thorough nerve assessment in every new leprosy case. We found that delay in treatment had a strong association with 2 disabilities (OR=4.35, p=0.006). Kumar et al. [5] in a similar study have underlined the importance of reducing diagnostic and therapeutic delays. The results of this study showed that Lepra reactions were present in 22% of cases and they were significantly associated with higher grades of disability (p=0.03). Other studies have found similar trends although no statistical significance has been attributed [5, 17]. Few other studies have confirmed this association, especially with ENL reaction and MB Leprosy [16]. In the end, our study highlights multiple modifiable risk factors that are important in leprosy cases.  Important among them are delayed diagnosis, multiple nerve involvement, and the presence of lepra reactions that are associated with disability in leprosy. These findings underscore the importance of early detection, prompt MDT initiation, and vigilant monitoring to prevent irreversible deformities in affected individuals.

In conclusion, our study highlights several important risk factors contributing to leprosy, including the number of peripheral nerves involved. The existence of lepra reactions at diagnosis or during treatment or delay in diagnosis and therapy initiation are major risk factors. Although, multidrug therapy (MDT) is very effective for the treatment of physical disabilities often persists post-treatment, therefore, there is a need to formulate new strategies to minimize the burden of disability. Some of these strategies include systematic post-treatment follow-up and implementation of evidence-based interventions. Delayed treatment significantly increases the likelihood of irreversible complications. Leprosy continues to affect predominantly the lower socio-economic groups, likely due to poor awareness and limited access to healthcare. As the renowned leprologist Latapi aptly stated, leprosy is “the thermometer of civilization.” Its eradication depends not only on medical intervention but also on addressing the underlying socio-economic and cultural determinants of health.

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