Spine-care needs and perceived barriers to accessing and implementing a model of spine-care for mechanical spine pain in rural community of Raigad district, Maharashtra: A mixed-method study.

This mixed-methods study using a participatory research approach will be conducted in the rural community of two of the five randomly selected villages in the Raigad district of Maharashtra (adopted by MGM Institute of Health Science under the Unnat Bharat Abhiyan). The study will assess the implementation of a context-specific and culturally-adapted treatment model of care for mechanical spine pain. It will involve both qualitative and quantitative study designs and will be conducted amongst 1000 residents in the selected villages and will include all the stakeholders namely the community leaders, residents, and patients with spine pain, along with the local physicians and frontline health (ASHA and Anganwadi) workers. The study will help to assess the existing spine care in the rural community and the needs, along with understanding the facilitators and barriers to adopting an evidence-based treatment model. The treatment will include educating the community and frontline health workers about recognizing serious pathology related to spine pain and managing non-serious mechanical spine pain with self-care and low-intensity exercises. A pilot of the supervised intervention will be done using a randomized clinical trial on patients with mechanical neck or back pain. All the exercises will be evidence-based and culturally adapted to the rural community. The primary and secondary outcome measures will be collected at baseline and the mentioned timelines during and after the intervention. The primary outcome measures are as follows: a) For determining the extent of mechanical spine pain and the existing care in the rural community using a retrospective chart review and community survey, b) For assessing the intent to adopt the treatment model amongst all stakeholders using semi-structured interviews and focus groups and using three implementation outcome measures namely the Acceptability of Intervention Measures (AIM), the Intervention Appropriateness Measure (IAM), and the Feasibility of Intervention Measures (FIM), and c) To study the efficacy of the Intervention using validated and standardized Marathi versions of clinical outcome measures namely- Visual Analogue Scale and Wong-Baker Faces for assessing pain; Patient Specific Functional Scale for function; the World Health Organization Disability Assessment 2.0 (WHODAS 2.0) to measure ability; EURO QoL 5D 5L (EQ 5DL) for measuring health-related quality of life; Neck Disability Index (NDI) and Oswestry Disability Index (ODI) for measuring disability and function related to spine pain; the MGM Ground Level Activity Exposure Questionnaire ( MGMGLAEQ)- Brief and the Rural Indian Activity Limitation Questionnaire (RIALQ) for assessing their activity limitations with respect to ground level activities and rural lifestyle respectively. The secondary outcomes will include administrative data (Implementation Status Report) to keep a log of the activities and communication and the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) to document the modifications to Implementation strategies throughout the project.