Introduction
Clinical trials in physiotherapy (CTP) are significant in advancing evidence-based practices (EBP) and improving patient outcomes [Citation1]. Physiotherapy, as a branch of healthcare, involves the use of physical modalities, exercises, and manual therapy techniques to promote pain relief, improve mobility, enhance function, and hence the overall quality of life of patients [Citation2]. In India, as the field continues to grow, clinical trials are gaining momentum with the passage of time [Citation3,Citation4]. However, this emerging landscape faces several challenges that need to be addressed for the effective conduct of trials and the overall progress of physiotherapy. This article explores the current challenges faced by physiotherapy clinical trials in India and discusses potential future trends that can shape the landscape for the better. CTP serves as an essential component of evidence-based practice, providing valuable insights through the effects of different physiotherapy interventions for various conditions and outcomes such as pain reduction, functional improvement, disability reduction, quality of life enhancement, and patient satisfaction. These trials typically follow a rigorous scientific methodology, including randomisation, blinding, control groups, and predefined outcome measures, to ensure the validity and reliability of the findings [Citation5]. Recently, India has witnessed significant advancements in physiotherapy research and clinical settings through an increased number of clinical trials. These trials explore a range of interventions, including exercise therapy, manual therapy, electrotherapy, and various specialised techniques targeting specific conditions. They involve diverse patient populations, encompassing individuals with musculoskeletal disorders, neurological conditions, cardiopulmonary impairments, and other health issues [Citation6]. Findings retrieved from clinical trials in physiotherapy contribute to the development of evidence-based guidelines and protocols, aiding physiotherapists in delivering effective tailored interventions to their patients [Citation1,Citation7,Citation8]. Furthermore, these trials foster collaborations among researchers, clinicians, and other healthcare professionals, promoting the exchange of knowledge and best practices within the field [Citation9,Citation10].
Current trend and challenges
Lack of awareness and knowledge
One of the primary challenges in CTP in India is the lack of awareness and knowledge among physiotherapy students and professionals. High percentages are unaware of the importance of clinical trials or hold active misconceptions about them. This lack of awareness leads to low patient recruitment and active participation, hindering the progress of trials and limiting their generalisability.
Retarded irregular funding
Financial constraints pose one of the most significant challenges for conducting CTP in India. Limited funding opportunities from government bodies, private organisations, and pharmaceutical companies impede the initiation and continuation of trials. With constrained financial support, researchers face difficulties in recruiting participants, procuring necessary equipment, and analysing the data, thereby hindering the advancement of EBP in physiotherapy.
Regulatory complexities
Navigating the regulatory landscape is another hurdle faced by CTP in India. Researchers must adhere to the guidelines set by regulatory authorities, such as the Drugs Controller General of India (DCGI), Indian Council of Medical Research (ICMR), and ethics committees, even if not directly applicable. Thus, complex and time-consuming regulatory processes delay trial initiation and completion, increasing administrative burden and costs for researchers.
Absence of collaboration and networking
Lack of collaboration and networking among researchers, clinicians, and institutions is another significant challenge in the CTP ecosystem. Collaboration is essential for sharing resources, expertise, and best practices, which greatly enhance trial design, implementation, and interpretation of results. Strengthening collaborations at both national and international levels can foster innovation and improve the quality of clinical trials in physiotherapy.
Recruitment and retention
Recruiting an adequate number of participants and ensuring their retention throughout the trial duration is also a persistent challenge. India’s diverse population and cultural variations can influence recruitment and retention rates. Additionally, strict eligibility criteria and logistical barriers further limit patient enrolments. Thus, it is crucial to develop effective strategies aimed at enhancing participant recruitment and retention through community engagement, patient education, and addressing logistical domain.
Appropriate and efficient intervention
The implementation of relevant and effective interventions for the target population is a crucial factor in the success of clinical trials involving physiotherapy. The continued use of interventions that might not be in line with the most recent research or international best practices, however, is a significant barrier to the advancement of these trials, especially in India. The investigation of posture-modifying interventions for patients with chronic low back pain (CLBP) as a means of reducing pain is one well-known example. There are still a high number of trials looking into posture modification as a primary intervention for CLBP, despite numerous studies showing alternative and more effective interventions, such as targeted exercise programs and cognitive-behavioral therapy. This disparity prompts questions about the appropriateness and applicability of interventions in clinical trials for physiotherapy in India. Clinical research may continue to use antiquated interventions for a variety of reasons. Lack of access to current research publications and updates, especially for researchers working in resource-constrained environments, is one reason why this could be the case.
Future recommendations
Enhancement in awareness
Improving public awareness about the importance and benefits of participating in physiotherapy clinical trials is crucial. Initiatives like public health campaigns, community engagement programs, and media outreach should be prioritised to play a pivotal role in dispelling misconceptions, fostering trust, and encouraging participation. Collaboration within and outside the respective geographical distribution between researchers, healthcare professionals, and patient advocacy groups can greatly facilitate and impact the dissemination of accurate information about clinical trials to the public.
Fostering funding
All efforts to expand funding opportunities for CTP in India should be prioritised. Government bodies, research organisations, and philanthropic foundations should consider allocating more resources to support research in the field of physiotherapy. Collaboration with private sectors, including pharmaceutical companies, has the potential to provide additional financial support for trials. Thus, supporting researchers through optimal and regularised funding would enable them to conduct trials with a larger sample size and robust methodologies, enhancing the quality and impact of their findings.
Streamlining regulatory processes
Simplifying and streamlining procedures by government bodies can expedite the initiation and completion of physiotherapy clinical trials, ideally before or at least on time. Designated authorities should work towards creating an efficient and transparent system, reducing administrative burden, and promoting timely approvals.
Conclusion
CTP in India can significantly contribute to augmenting treatment in clinical settings. They provide valuable insights into the effects and safety of various treatment approaches, helping physiotherapists make informed decisions in patient care. By promoting EBP, these trials contribute to improving patient outcomes and advancements in the field of physiotherapy.
Recommendations
Mandatory educational programs
Physiotherapy institutes should implement mandatory educational programs to raise awareness about the significance of clinical trials among undergraduate and postgraduate students, PhD scholars, healthcare professionals, and the general population. Emphasis should be placed on highlighting the benefits and ethical considerations of clinical trials.
Increment in fund allocation
Government bodies, research organisations, and private sectors should allocate more resources for CTPs. Collaboration between stakeholders can further enhance funding opportunities and support innovative research endeavours.
Simplify regulatory processes
Regulatory authorities should work towards simplifying and streamlining the approval processes for clinical trials, ensuring transparent and timely setups. This will reduce administrative burden and expedite trial initiation and completion.
Promote inter and intra-collaboration and networking
Encourage collaboration and networking among researchers, clinicians, and institutions through conferences, workshops, and research forums. This will facilitate knowledge sharing and resource utilisation, fostering a collaborative research environment.
Develop culturally sensitive recruitment strategies
Implement tailor-made recruitment strategies that address cultural diversity and the specific needs of the Indian population. This may include community engagement, patient education, and addressing logistical barriers, ultimately enhancing both the quality and quantity of research participation.
Encourage international collaborations
Foster collaborations between researchers from India and international counterparts to leverage global expertise, enhance trial design, and promote cross-cultural learning. International collaborations can bring valuable perspectives and resources to Indian physiotherapy research endeavours.
Long-term follow-up studies
Conducting long-term follow-up studies with the aim of evaluating and assessing the effectiveness and sustainability of physiotherapy interventions will vastly contribute to EBP. Such studies will facilitate the development of a continuous movement towards advancement in clinical practice, providing valuable insights into the long-term outcomes and impacts of physiotherapy interventions.
Author contributions
MS conceptualised the idea, while AC and JS were responsible for writing and final revision.
Ethical statement
The Departmental Research committee of the Galgotias University decided that this study did not need ethics approval.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Additional information
Funding
References
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