Development of pain education in Nepali

The primary investigator (SS) developed the pain education resources in Nepali, based on the ‘Explain Pain’ pain education materials (NOIgroup Publishing, Adelaide, Australia).28 30 Figure 1 lists the development process, which included five steps.

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Figure 1

Steps in the development of pain education handbook. LBP, low back pain.

In the first step, SS developed a context and culture-specific pain education curriculum according to the process set out in Moseley and Butler.28 The curriculum was reviewed by the authors of that guide (including coauthor of this paper: GLM). Four key concepts (described below) were identified, with one additional optional concept if time permitted. The final curriculum, including the key concepts to deliver, details of contents and methods of delivery were published in our protocol paper31 and are also presented in online supplementary file 1 .

In the second step, a pain education handbook was created using contents from Explain Pain 28 30 and clinical practice guidelines on LBP.6–8 We used pain stories from Nepal to help explain the target concepts.31 We kept the Nepalese adaptations as simple as possible, so that patients with little to no formal education would understand them.

In the third step, the material was reviewed by four Nepalese with a medical (n=2) or non-medical (n=2) background and revised as a result. In the fourth step, we undertook initial pilot testing of the pain education handbook with six patients with chronic LBP. We focused here on its readability, the relevance of the stories and whether the new pictures created for the handbook delivered their intended meaning. The handbook text was revised, but no changes were made to the pictures. Finally, three native Nepali-speaking persons proof-read the handbook, and a final version was completed.

Research design

We conducted a two-arm, assessor-blinded, feasibility RCT. We registered the trial protocol at ClinicalTrials.gov. We used the Standard Protocol Items: Recommendations for Interventional Trials statement32 during the development of the protocol and followed the Consolidated Standards of Reporting Trials statement extension for a pilot and feasibility randomised trials33 for reporting. Feasibility was to be determined based on a priori criteria.31 For the detailed review of the research methods, we refer readers to the published protocol.31

Participants

We included adults (age 18 years or more) with non-specific LBP of any duration. We excluded patients with specific causes of LBP such as malignancy, fracture, infection or inflammatory arthritis identified from history or investigations. We also excluded pregnant women and patients presenting with the history of bladder and bowel incontinence or perineal anaesthesia.

We recruited participants from a rehabilitation hospital in Kathmandu, Nepal. We invited consecutive patients presenting at the centre to participate in the study. Additionally, we made advertisements on social media about the research to improve the recruitment, as almost 28% of Nepalese use Facebook (www.internetworldstats.com). We provided an appointment to interested candidates for screening at the centre. A research assistant (a trained physiotherapist) screened all potential participants for eligibility who expressed a willingness to participate in the current study. All participants signed the consent form prior to baseline assessment.

Interventions

We used the Template for Intervention Description and Replication (TIDieR) Checklist to plan and report the study interventions.34 35 There were two interventions in a two-arm RCT design. We provided pain education to the participants who were randomly allocated to the experimental group (pain education group [PEG]) and guideline-based physiotherapy treatment to the participants who were randomly allocated to the control group (CG). Treatment time for both groups was 1 hour.

The PEG group: delivery of pain education

The principal investigator (SS), who has received extensive training in Explain Pain via NOIgroup Professional Development and one-on-one mentoring with pain education experts, delivered the treatment. The pain education deliverer first asked two questions to the patients in the PEG: (1) ‘Is there anything in particular that you would like to learn about your low back pain, or pain in general?’ and (2) ‘Do you know what caused your low back pain? Can you please explain the cause of your low back pain from what you have understood, or what you have been told?’. Up to 15 min was allotted to addressing, with evidence-informed answers, any questions participants had and to clarify any misconceptions the patients had regarding their LBP. The rest of the session was used to deliver information regarding the target concepts.

Outcome measures

Demographic data were collected as per the recommendations of the National Institutes of Health (NIH) task force on research standards for chronic LBP.38

Sample size

Sample size estimation was performed to achieve the primary feasibility outcomes goals, as described in the protocol31 and registration documents, and not to detect differences in the secondary treatment effects outcomes.46 Based on guidance in the literature,47 the research team estimated that a sample size of 40 (20 in each treatment arm) would be sufficient to adequately evaluate the feasibility of undertaking a full clinical trial.31

Randomisation

The published research protocol31 was strictly followed. Allocation sequence was generated in random blocks of 4 and 6 using www.random.org by a researcher (JHA) who was not involved in recruitment. Allocation concealment was performed using sequentially numbered opaque, sealed envelopes, prepared by JHA, and maintained until the interventions were assigned to the study participants. The group allocation was revealed to the study participants and intervention providers only after completion of the baseline assessment.

Blinding

The assessor performing all the assessments was blinded to group allocation of the participants throughout the study. The data analyst (SS) was also blinded to group allocation. That is, after the assessor entered data in the Excel spreadsheet without knowledge of group allocation, the entered data were sent to JHA, who added codes for group allocation (red and blue) before the data analyses were performed. Unblinding of group allocation occurred after all planned analyses were complete.

Statistical methods

Baseline characteristics for demographic and clinical data of the participants were reported using descriptive statistics. The plans for analysis of primary outcome measures are presented in online supplementary file 2.

We planned the exploratory analysis of between-group differences in the secondary outcome measures using two-group t-tests, with the understanding that the current study was not powered to detect statistically significant between-group differences in the secondary outcomes. Rather, analyses of between group differences were computed primarily for descriptive purposes in order to inform decisions regarding the selection of measures for a possible future full clinical trial. The scores of the PROMIS measures were transferred into the template provided by www.assessmentcenter.net, which computed the total raw scores, T-scores and SEs. The assessment centre automatically handles missing items when performing the analysis. For other measures, missing items were imputed using the mean of the present items for that patient. The details of the measures with the psychometric properties are outlined in online supplementary file 3.

Patient and public involvement

Patients with LBP and non-clinician volunteers provided significant feedback in the development of the Nepalese pain education materials. We incorporated real but anonymous pain-related stories of Nepalese so that the intervention is relatable. Neither patients nor members of the public were involved in the design of the study.

Sample characteristics

The majority of participants in each group were men, married and Hindu. Baseline demographic characteristics were comparable between the groups. However, baseline scores on the secondary outcomes were somewhat higher in the PEG than the CG. Details of the baseline sample characteristics are presented in table 1.

Missing data

One item (item #10) in the baseline assessment of the PCS and one item in the follow-up assessment of CDRISC (item #8) were missing for one participant. Missing values were replaced by the mean score of the items responded to of each measure for that participant. One item in the baseline depression scale was missing for one participant, which was imputed by the PROMIS assessment centre during the analysis.

Primary (feasibility) outcomes

Results related to feasibility outcomes are presented in table 2, and summary results on feasibility criteria are presented in table 3.

Recruitment-related feasibility outcomes

Seventy candidates were invited to participate in the study. Twenty-eight participants (70%) were recruited from the data collection centre; 12 (30%) from community advertisements. Fifty-seven per cent of invited candidates participated. Of those who did not, 27 (90%) declined participation and 3 (10%) did not meet inclusion criteria. Forty out of 43 candidates (93%) screened were eligible to participate. All 40 participants (100%) who met the inclusion criteria provided written informed consent and were randomised to one of the study arms. One participant in each group was lost to follow-up. The reasons for all exclusions and losses to follow-up are outlined in the participant flow diagram (figure 2).

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Figure 2

Participant flow diagram.

Other findings

The standard LBP treatment protocol at the data collection centre typically included non-guideline-based care such as advice to rest, advice against physical activity, admission for bed rest and intensive passive therapies (mostly electrotherapy). Such a care pathway contrasts with the recommendations and treatments presented in both groups. We found it challenging to alter the physiotherapists’ usual practice.

Related to this, all of the physiotherapists who provided the CG treatment reported being dissatisfied with not being able to provide interventions they would normally provide, many of which were treatments that patients also wanted to receive, such as spine-specific exercises and manual therapies. Moreover, five of the physiotherapists who were initially trained in the guideline-based care prior to the initiation of the study left the treatment centre during the trial recruitment period. They were replaced by four physiotherapists who therefore had not been trained in guideline-based care as part of this study.

Primary feasibility outcomes

The recruitment rate exceeded our target of four participants enrolled every week. We used advertisements in social media, and we suspect that recruitment was aided by patient-to-patient word of mouth as the trial progressed. This, and the finding that our attrition rate (5%) was well below our a priori maximum rate of 20% (which is thought to lead to serious threats to validity48) was surprising, considering that most patients in both groups did not receive the care they expected to receive. This is encouraging because it suggests that a broader education strategy, to prepare potential patients for an alternative approach to their problem before including them in a trial, is probably not required.

Although screening and data collection procedures were generally acceptable to the assessor, the assessor provided important recommendations to improve overall screening and data collection. For example, extended assessment sessions might be avoided by upskilling the assessors in dealing with patients, who are often elderly and uneducated and who tend to tell stories about their pain rather than provide direct answers to the questions being asked. An important caveat here, however, is the potentially critical role that this extra time and attention—particularly insofar as it is dedicated to listening to patient stories—may have had in subsequent engagement and participation, particularly against the backdrop of unexpected care. The patients’ stories in fact provide a context and meaning of their health problems,49 which may be a therapeutic intervention in itself, and are important to establish a good doctor–patient relationship.50 Clearly, the cost–benefit relationship of time-limited assessment is likely to be individually specific and nuanced.

The advantages and disadvantages of interviewing patients without their friends or family members present are also worthy of consideration. There were instances when excluding an accompanying family member would have reduced the data collection time and possibly improved the accuracy of the answers. However, the relationships patients have with those around them play an important role in the experience of pain51 52 and what people do about it51; exclusion of important others at a critical time may also disengage the patient or instil other barriers to their participation in the project. A final pragmatic modification to improve assessment would be to organise pain-related and pain-unrelated questions into different sections of the data collection protocol, so as to avoid patients being confused regarding the domains being assessed.

Blinding appeared to be successful, and contamination appeared to be avoided. Most controlled trials do not adequately examine assessor blinding,53 even though it is widely considered a very important component of good study design.54 We were able to blind the assessor here because we could provide a separate office space that was isolated from the treatment area. We were also able to schedule appointments to avoid contact with assessors that would unblind them to group assignment. Our inclusion of participant-reported items to evaluate contamination is not routinely included in feasibility or full clinical trials; the common approach is to implement strategies to minimise the risk a priori but not investigate it post hoc. However, in settings such as that involved here, where the community is well connected and word of mouth appears to be a significant recruitment pathway, we considered it important to also examine potential contamination post hoc. Limiting the number of patient recruitments performed in a single day to two may also have helped avoid contamination, but to see no evidence of contamination was surprising.

Treatment credibility and satisfaction were high for both groups (even though the participants did not receive the treatment they expected). That most participants in the PEG found the material ‘easy’ or ‘very easy’ was surprising and contrary to an a priori feasibility criterion. Our protocol31 stipulated a response to this outcome requiring that the material presented be viewed as difficult before proceeding to full trial. Whether we should increase difficulty by increasing the number of concepts covered, or going more fully into the four concepts we chose, or both, will require some pilot testing. That secondary outcome data findings suggesting a beneficial effect in the PEG condition appears to support making such a change.

Secondary outcomes

Statistically significant improvements over time were observed for 7/8 outcomes in the PEG condition and 4/8 outcomes in the CG condition. Although assessment of the effectiveness of the interventions on the secondary outcomes was not a primary aim of this study, the significant between-group differences that were found were in favour of PEG, and the apparent effect was substantial on two key target outcomes: pain intensity and pain catastrophising (table 4). However, the consistently larger improvements in all of the other outcomes for the PEG condition, relative to the CG condition, suggests the possibility of wide benefits of pain education as compared with guideline care in Nepal. It should be remembered that these are secondary outcomes, not corrected for multiple analyses and therefore at risk of false positive results. However, these results add pertinence to the feasibility results; a full-scale clinical trial appears warranted.

Recommendations

Although the findings suggest that a clinical trial evaluating effectiveness of an adapted pain education intervention within Nepali primary and tertiary care is feasible, some improvements could be made. First, to improve the compliance of the physiotherapists with the CG treatment—guideline-based care—and adherence of patients to that care, the CG treatment condition may need to be modified. Ideally, this modification would be made so that the control treatment was consistent with the evidence-based practice paradigm as much as possible, for example, by giving participating patients and their therapists the ability to choose treatments that are mostly consistent with guideline recommendations for LBP treatment. For example, the guideline-based treatment could have two components: (1) mandatory first-line care recommended by the guidelines (education and reassurance, promotion of physical activity, early return to work and advice about positive prognosis for back pain), in addition to (2) a more pragmatic approach to LBP treatment. This second component may include any form of exercise (treadmill, static cycling or back-specific motor control or movement exercises), manual therapy (massage, mobilisation or manipulation, based on therapist’s preference) or electrotherapy treatment, according to therapist and patient preference (as per recommendations of evidence-based care55), as long as it is safe and does not extend treatment time to beyond 1 hour. We should also consider fidelity assessment of the interventions provided by the therapist to be certain that per-protocol treatment is being provided in each treatment arm.

A final modification would be the addition of economic analysis. Nepalese individuals are often poor, and the Nepalese public health system is resource poor. Not surprisingly, cost was a barrier to participation for 9% of potential participants. Pain education intervention appears to be a less resource-intensive alternative to current practice and could be delivered outside of the public health system, in community settings, although the costs and time of physiotherapist would be no different from guideline-based care as delivered in a physiotherapy department. Pain education might require more training of therapists, although training in guideline-based care may be necessary too. As such, a full trial would benefit from the addition of a full economic evaluation.

Strengths and limitations

The current study has a number of strengths: we used an active guideline-based care as the comparator group; we successfully blinded the assessor and analyst and assessed both blinding and contamination; outcomes were consistent with NIH recommendations on research standards for chronic LBP38 and core outcome sets for LBP research39; and we submitted our protocol prior to data collection and remained transparent in all reporting.56

To our knowledge, this is the first study to examine the feasibility of a clinical trial on LBP in Nepal. Conducting a feasibility study is an important step before conducting a full clinical trial,47 especially in a setting where a high-quality clinical trial has never been conducted, which lacks recommendations from previous experiences for such a study. For example, we had planned a full clinical trial in 201557 but were unable to recruit participants because the clinicians were too busy to collect data and provide interventions as per protocol, and we encountered difficulty ensuring access to an assessor blinded to group allocation because of multiple responsibilities of the clinicians. These are feasibility problems that would have been revealed in a preliminary feasibility study.47

The current study also has a number of important limitations. Our follow-up was shorter than we would use in a full clinical trial. The short follow-up duration was chosen because 1-week assessment was sufficient to answer the feasibility-related questions, but whether long-term follow-ups are feasible in this setting and population remains to be demonstrated. We did not assess treatment fidelity in the current study, because we did not have the resources to do so. That the current practice in the LBP management at the study site was very different from clinical practice guidelines made it harder for the physiotherapists to comply with the guideline-based care. Another limitation was that we did not include any measure of physical activity as a secondary outcome, despite improved physical activity being one aim of pain education. In a definitive trial, we may consider using a measure to assess physical activity such as International Physical Activity Questionnaire,58 or an objective measure of physical activity, such as Actigraphy.59 Finally, the experimental group treatment was provided by the primary author of the study who may have inadvertently communicated more enthusiasm for the experimental group treatment than the therapists providing the CG treatment; this may have influenced the study findings. A full clinical trial would ideally include a number of therapists who would be trained to deliver both treatments, as one way to control for the therapist effects. This could also improve the generalisability of the study findings.