37 Additionally, exploration of feasibility of pain education in those with no schooling or low educational attainment is important in order to inform clinical practice. We will include uneducated patients who cannot sign an informed consent in order to increase the inclusion of uneducated or low education group, given that 31% people in Nepal who are 5 years old or more cannot read and write. For those who cannot sign the consent, a witness will sign on their behalf, or the study participant will provide a thumb print on the form for those who cannot write or sign the form as per the ethical guidelines provided by Nepal Health Research Council (NHRC). If the participants are found eligible, informed consent will be obtained. If the potential participants are interested in participating, they will be screened for eligibility by a research assistant who is a physiotherapist.
A study information sheet will be provided to all potential participants. This will include information about the benefits and potential harms of the intervention, the time required for the completion of the study, follow-up duration, voluntariness of participation, cost of participation and the rights to withdraw from the study at any point.
The study purpose and procedures will be described to potential participants.
The results of the full trial will have significant clinical implications for the management of LBP in Nepal and similar cultures, providing empirical evidence if pain education is a viable treatment for the management of LBP, and if it is effective in reducing pain, disability and emotional distress.Ĭonsecutive participants with non-specific LBP will be invited to participate in this study. The findings from the proposed feasibility study will inform the planning and design of a full trial, if the results indicate that a full trial is warranted. We propose a feasibility trial because: (1) the intervention (ie, pain education) will need significant cultural adaptation, although it has been evaluated for efficacy previously in other languages and western cultures (2) the adapted intervention has never been investigated for its efficacy or effectiveness before (3) the population in question (individuals with extremely low socioeconomic status and educational attainment in Nepal) is unique and (4) a high-quality clinical trial in individuals with LBP has not been conducted in Nepal to our knowledge, and we therefore do not know if a full trial is feasible. Thus, before testing the adapted pain education in a full clinical trial, a feasibility study is needed in order to determine if a full clinical trial based on the adapted intervention is warranted, or if additional modifications may be needed prior to performing the full trial. However, it is possible that the adaptations made could potentially reduce its effectiveness. Therefore, in order to evaluate the effectiveness of pain education in individuals with non-specific LBP from Nepal, culturally appropriate pain education materials should first be developed for Nepal, specifically.
Therefore, when developing pain education materials in a newer language or culture, (significant) cultural adaptations of the education materials may be required to make it suitable for the target population, as culturally inappropriate education may not produce desirable results. 30 However, the pain education materials that have been developed in western cultures are not necessarily valid and equally effective in reducing pain and disability in non-western cultures. It has been previously hypothesised that this type of education programme using metaphors and stories may be an effective intervention in Nepalese with chronic pain. 29 This intervention has a list of target key concepts to be delivered and includes the curriculum contents to deliver the key concepts using up-to-date pain science knowledge, stories and metaphors. 27 28 Pain education is structured education programme with specific aims and objectives. 26 However, the second type of education-pain biology education (hereafter called as ‘pain education’)-has been shown to have positive effects on both pain and disability. 26 The first refers to educating patients about vertebral anatomy and pathoanatomy of the spine, which has been shown to be ineffective and may even have negative effects on LBP outcomes. Patient education for LBP that has been investigated in randomised controlled trials is basically of two types: biomedical education and pain biology education.