Implementing Community-based Non-pharmacological Interventions for Chronic Low Back Pain: A Realist Perspective on Challenges,Lessons and Sustainability from a Randomised Controlled Trial

Introduction

Chronic low back pain (CLBP) remains a leading contributor to global disability. ¹ In the Indian context, both rural and urban populations experience a significant burden, with rural communities disproportionately affected due to infrastructural limitations, socioeconomic disparities and cultural determinants. ² Evidence-based, multidisciplinary, non-pharmacologic interventions, such as yoga, structured physical exercise, cognitive-behavioural strategies and many more, are advocated by international guidelines. ³ However, translating these into scalable, community-level interventions under publicly funded health programmes presents considerable operational and contextual challenges.

Drawing upon a community-based randomised controlled trial (RCT), this commentary adopts a realist evaluation lens to explore implementation barriers, challenges faced, adaptive strategies employed and lessons learnt during the execution of a multi-site research project on CLBP in low-resource settings.

Brief About the Project

This publicly funded (by the Department of Science and Technology–Science and Technology of Yoga and Meditation, under the Ministry of Science and Technology) project evaluates the long-term effects of the Integrated Approach of Yoga Therapy (IAYT) on physical and mental health, quality of life and biomarkers in adults with CLBP. In this ongoing research project, a total of 264 CLBP participants (aged 18–65) are being randomised into three groups: IAYT, physical therapy or usual care. The IAYT and physical therapy groups receive 15 days of supervised sessions (90 minutes/day, 6 days/week), followed by weekly sessions for 2 weeks and then monthly sessions for 6 months, alongside home practice (45 minutes, 4 days/week) in this ongoing project. The interventions are being delivered through a community-based Drive-In Drive-Out (DIDO) model in addition to treatment as usual, with the control group receiving standard treatment. This study aims to generate real-world evidence on the comparative effectiveness of yoga and physical therapy in managing CLBP. Conducted in rural and semi-urban regions in and around Chandigarh, India, the trial adopts a realist approach to better understand the practical realities of implementing non-pharmacological interventions. To date, a total of 134 patients have been recruited. Patients were followed up at 15 days, 1 month, 3 months, 6 months and 1 year. Multiple pain-reported outcomes assessed are pain intensity, disability, pain catastrophising, fear-avoidance, quality of life, depression and anxiety in addition to biomarkers.

The following sections outline the key implementation barriers, adaptive strategies employed and lessons learnt.

Implementation Barriers and Strategic Responses

Structural Health System Limitations

Community Awareness and Education

Barrier: The health literacy was notably limited in the rural and semi-urban regions where the study is being conducted. A lack of understanding about musculoskeletal conditions and the importance of early intervention contributed to delays in seeking appropriate care. Many individuals were unaware of the benefits of preventive strategies or non-pharmacological treatments such as physical therapy or yoga. These gaps in knowledge significantly hindered both initial participation and long-term adherence to the intervention.

Strategic Response: Targeted outreach through health camps played a key role in identifying individuals with potential care needs. Community engagement and awareness initiatives in local languages (Hindi and Punjabi), including posters, self-management physical demonstrations and culturally resonant street plays (nukkad natak), effectively communicated concepts such as emphasis on self-management, posture correction, proper ergonomics, physical activity and non-pharmacological approaches. Educational materials such as back care booklets and exercise/yoga pamphlets further helped normalise care-seeking behaviour and dispel prevalent myths, thereby reducing stigma, raising awareness and encouraging participation.

Financial Constraints

Barrier: Widespread poverty and economic hardship were prevalent across the study sites, which posed significant barriers to healthcare access. For many individuals, even basic healthcare expenses, such as transportation to the health centre, diagnostic tests or medications, were difficult to afford. Although the intervention services were offered free of cost and at the site of the community by trained staff (DIDO model), indirect costs (e.g., time away from work and travel expenses) impacted participation and follow-up. These financial constraints limited individuals’ consistent access to complementary care, affecting treatment continuity and effectiveness.

Strategic Response: To mitigate the financial burden, the intervention incorporated free health screenings (e.g., blood pressure and glucose monitoring) and distribution of essential pain medications free of cost, reducing direct out-of-pocket expenses. To address indirect costs, sessions were scheduled in a community place accessible to almost all participants at convenient times to avoid income loss, particularly for daily wage earners. Holding activities at accessible community sites reduced travel needs, improving participation and follow-up among economically constrained individuals.

Lack of Prioritisation of Chronic Pain

Barrier: Chronic pain, particularly LBP, is not widely recognised as a priority condition, both at the individual level and within public health policy frameworks in India. This systemic neglect has resulted in a lack of structured services, trained personnel and dedicated resources for chronic pain management at the primary care level. Furthermore, cultural reliance on traditional or home-based remedies often takes precedence over evidence-based interventions, leading to underutilisation of available services.

Strategic Response: To address this barrier, the intervention focused on engaging primary health centres (PHCs) and frontline health workers (e.g., Accredited Social Health Activists, Auxiliary Nurse Midwives, multipurpose workers) to build local ownership and embed pain care into existing service delivery structures. This collaboration not only supported implementation logistics but also helped sensitise healthcare providers to the seriousness of CLBP as a public health issue. Health workers were also trained for early recognition and referral to hospitals with dedicated pain clinics when needed. Additionally, culturally adapted awareness initiatives and multilingual educational materials were used to counter the prevailing reliance on non-evidence-based home/local remedies (massages, prolonged rest, over-the-counter analgesics, some potentially harmful approaches such as hard material presses and cuts at the site of pain, etc.) and promote evidence-based treatment options such as yoga and physical therapy.

Recruitment Constraints

Barrier: Recruitment was significantly constrained by low awareness of the programme and limited footfall of CLBP patients at the health centre, where initial recruitment efforts were concentrated. Due to insufficient enrolment, a door-to-door survey was conducted at the first site, followed by multiple health camps to improve outreach. Contributing factors included sociocultural perceptions that deprioritised musculoskeletal pain unless associated with trauma or visible disability, limited understanding of first-line-high-value non-pharmacological interventions and widespread acceptance of chronic pain as a normal consequence of ageing or occupational stress.

Strategic Response

To improve awareness and turnout, community health workers initially led door-to-door outreach and mobilisation. However, recruitment later shifted to time-efficient, centralised camp-based enrolment at accessible locations, enhancing reach and resource use. Simplified informational outreach on CLBP and its management was carried out through posters, back care booklets and group education sessions conducted in local languages. Involvement of local health personnel helped overcome sociocultural hesitancy and enhanced credibility.

Retention Constraints

Barrier: Participant retention was adversely affected by several contextual and logistical factors. Work obligations and inflexible daily routines made consistent attendance difficult, particularly for daily wage earners, manual labourers and women burdened with household responsibilities. For many, the commitment to physically demanding jobs or household chores left little time or energy to attend daily sessions. In the first location, the temple, as the only available intervention venue, was perceived as religiously affiliated, which discouraged participation in the exercise/yoga sessions. Furthermore, scepticism about the programme’s sustainability, especially in underserved or marginalised communities, contributed to early dropouts. As a result, early attrition rates reached up to 50%.

Strategic Response

To address work-related barriers, flexible scheduling was introduced through staggered daily sessions and multiple batch options. Incentives such as healthy refreshments and yoga mats were provided to participants who met attendance benchmarks, serving as positive reinforcement to encourage continued engagement. Recognising the deterrent effect of religious associations at the first site, intervention venues were shifted to neutral community spaces such as community halls and centres to ensure inclusivity and improve comfort for all participants. Continuous engagement and local health worker support helped reduce attrition to around 20% in later batches.

Logistical and Operational Bottlenecks

Barrier

Implementation faced both human resource and infrastructure inadequacies. Only two of the four proposed staff positions were sanctioned, reflecting a common manpower budget constraint in many low and middle income countries (LMICs). Limited internet access necessitated manual documentation, increasing operational burden.

Strategic Response

To address staff shortages, the project engaged local health workers and local site volunteers for community outreach and task-sharing. Interdisciplinary coordination ensured integrated care delivery. The help of local NGOs was sought for a few sites. Communication used calls and family messaging groups to overcome digital gaps. These adaptations, supported by role clarity and capacity-building, strengthened delivery and sustainability in low-resource settings.

Sociocultural and Psychological Barriers

Barrier

Misconceptions framing yoga as religious rather than therapeutic hindered enrolment. Cultural and social norms, gender roles and domestic responsibilities, particularly for women, further restricted participation. Receptivity was diminished by patients’ fear-avoidance beliefs, lack of trust in programme sustainability, a preference for pharmacological over behavioural interventions and evidence-based strategies such as exercise/yoga. Limited health literacy compounded these challenges.

Strategic Response

To counter misconceptions of yoga as religious, the programme used neutral, inclusive language and involved local frontline workers to build community trust. Gender-sensitive strategies, such as women-only groups, addressed cultural norms and domestic duties. Behavioural counselling and motivational interviewing reduced fear-avoidance and boosted confidence in movement therapies. Simple, evidence-based explanations highlighted the benefits of non-drug therapy to address the preference for medication. Ongoing engagement with repeated follow-ups reinforced trust and participation, especially in communities new to structured health programmes. These tailored adaptations enhanced receptivity, engagement and sustained adherence.

Blood Sampling Challenges

Barrier

While blood sampling for biomarkers was an essential component of this RCT protocol and required at baseline, 3, 6 and 12 months, many participants dropped out of the study due to reluctance to provide follow-up blood samples. This occurred despite their initial consent at the baseline visit.

Strategic Response

While this posed a persistent challenge, the team emphasised repeated counselling and adjusted expectations to retain participants. However, no fully effective workaround was identified, highlighting a broader, pragmatic issue in field-based research globally.

Challenges in Monitoring and Follow-up

Barrier

Accurate follow-up was hindered by a few transient or incorrect addresses, requiring resource-intensive door-to-door outreach. Additionally, a few untraceable or incorrect mobile numbers limited the effectiveness of phone-based reminders, further necessitating in-person visits. Moreover, seasonal migration of the labour class, especially in semi-urban regions, further hampered the timely follow-ups in a few.

Strategic Response

To address challenges posed by transient or inaccurate contact information and seasonal migration, follow-up efforts shifted from labour-intensive door-to-door visits to a more streamlined approach. This included leveraging PHC-based follow-up visits as structured checkpoints to monitor patient progress. Family-based communication supported engagement and retention, especially in semiurban and mobile populations, improving continuity despite contact and migration challenges.

Key Learnings

• Community Ownership is Crucial: Participatory planning, early engagement and the identification of local champions improved both credibility and compliance.

• Awareness Must Precede Adherence: Awareness and trust-building are crucial before expecting compliance. Investment in community sensitisation and patient education is essential before expecting behavioural change.

• Role Clarity Promotes Sustainability: Clearly defined provider roles and sustained interdisciplinary collaboration must be structured from inception to avoid redundancy and optimise care delivery and long-term viability.

• Contextual Adaptation Requires Local Leadership: Effective implementation depends on actively involving local healthcare providers and local field volunteers; aligning programme design with locally identified needs, constraints and resources.

• Sustainability Demands Policy Integration: Programmes should be embedded within existing public health frameworks to ensure continuity, scalability and funding support. Linking with national health missions can enhance reach.

Conclusion

This realist evaluation underscores the contextual complexity inherent in deploying a community-based intervention research project for CLBP in resource-constrained settings. Despite evidence supporting high-value first-line management such as patient education, self-management, physical exercise and yoga for CLBP, their successful implementation hinges on community engagement, trust-building, contextual tailoring and integration with existing health systems. Sustainable and scalable care models in LMICs such as India must be anchored in patient-centred, community-owned paradigms. Addressing the multifactorial barriers across individual, sociocultural, logistical and systemic domains is pivotal to achieving long-term impact and improving functional outcomes for underserved populations.