Pain Education for Patients With Low Back Pain in Nepal: A Feasibility Study

All the consecutive participants presenting at the physiotherapy department will be explained about the study and invited to participate in the study. The number of participants not willing to participate will be recorded with the reason for not wanting to participate. Total number of patients not willing to participate will be recorded with the reasons not to participate.

The total number of participants screened, found eligible, and recruited will be recorded during the screening and recruitment process. The reasons why the participants were ineligible for inclusion in the study will be recorded for every participant who did not meet the eligibility criteria. If the participants refused to participate in the study, the reasons for refusal will be recorded. Finally, the consent rates will be recorded. The number of participants screened, who were eligible, who consented to participate, who refused to participate, reasons for exclusion and refusal will be reported as frequencies.

By asking the assessor two questions at the end of the follow-up assessment: (1) Did you receive any information that indicated which group the participant belonged to? and (2) How did you receive information about which group the patients belonged to? Assessor's guess if the participants belonged to experimental or control group will be recorded. The responses will be coded as 'correct guess' or 'incorrect guess.' The frequency of "yes" and "no" as the answer to the first question will be counted. The frequency of the correct and incorrect guesses will also be counted. Finally, reasons for guesses will qualitatively analyzed.

The lead researcher will interview the physiotherapist(s) screening the patients for eligibility by asking the following open-ended question at the end of every week, "Were there any difficulties or challenges in screening and recruiting the participants the past week?" The responses will be recorded as 'Yes' or 'No'.

The assessor will ask all the participants during recruitment if randomly allocating one of the two treatments is acceptable to them.

Contamination between the groups will be assessed by asking all the participant of the study the following questions at the follow-up assessment: (1) "Have you talked to other participants in this study about the intervention they are receiving?"; If yes, further ask, "Was your attitude towards the intervention, or intervention changed after talking to one of the participants in the other group?"; (2) "Are you aware of the intervention that any participants in the other group are receiving in the study?"; and (3) Are any of the participants in the other group aware of the type of intervention you are receiving in this study?" Participants in the usual care group will be asked the following question: "Did you read the pain education booklet or watch the video which is one of the components of the intervention group?"

It will be assessed using five questions. Responses for each of the five questions will be recorded on a Likert Scale where, 0= "Not at all", 1= "A little bit", 2= "Somewhat", 3= "Quite a bit", 4= "Very much."

Adherence to home treatment will be assessed by asking the participants in both groups to maintain a log of home treatment, in which the participants will tick mark a box for every day for a total of five days. Total number of responses will be computed by adding the number of days. Adherence will be computed by summing total number of home interventions in each group, represented by a discrete number. Reasons for non-adherence will be listed and analyzed qualitatively.

All the participants in both the groups will be assessed using Patient Global Assessment of Treatment Satisfaction (PGATS) scale.64 65 The question asked will be, ''How satisfied are you overall with the study treatment?'' on a 5-point categorical scale (0 = ''Very dissatisfied''; 1 = ''Dissatisfied''; 2 = ''Neutral or no preference''; 3 = ''Satisfied''; 4 = ''Very satisfied'') at the follow-up assessment point. Mean scores of satisfaction of treatment between the groups will be compared using a t-test.

All the participants in both the groups will be asked about the difficulty in understanding the information provided by the physiotherapist. The question asked will be, "How difficult was it for you to understand the information provided by the physiotherapist?" using a on a 5-point Likert Scale, where 1= "Very easy", 2= "Easy", 3= "Neither easy nor difficult", 4= "Difficult", 5= "Very difficult."

All the participants in both the groups will be asked about any adverse events after the treatment. The adverse events will be recorded as a written down verbatim. The type of adverse events will be recorded. The frequency of adverse events in each group will be compared and reported.

5 point, Ordinal scale; It asks respondents to rate how much pain interfered with their daily life (e.g., enjoyment of life, ability to concentrate, day-to-day activities) in past 7 days on 5-point Likert scales (1 = "Not at all," 2 = "A little bit," 3 = "Somewhat," 4 = "Quite a bit," 5 = "Very much"). Total scores can range between 6 to 30. Higher scores indicate more pain interference and worse physical function.

5-point, Ordinal scale; It asks the respondents to rate their current pain, worst and average pain intensity in past 7 days on 5-point Likert Scales (1 = "Had no Pain," 2 = "Mild," 3 = "Moderate," 4 = "Severe," and 5 = "Very severe"). Worst pain, average pain, and current pain intensity in the past 7 days are scored on a Likert scale ranging from 1-5. Total score ranges from 3-15, with greater scores indicating more intense pain.

5-point, Ordinal scale; General quality of life health in the past one week will be assessed on a scale ranging from 0 to 4, by asking the question, "in general, how would you rate your overall quality of life during the past week?" The responses will be recorded on a Likert Scale from 1 = "Poor", 2= "Fair", 3= "Good", 4= "Very good", and 5= "Excellent".2 Greater score indicate better quality of life.

A 13 item 5-point, Ordinal scale. Respondents are asked to indicate the degree or frequency with which they have each catastrophizing response listed when they "… are experiencing pain" on a 5-point Likert scale (0 = "Not at all," 1 = "To a slight degree," 2 = "To a moderate degree," 3 = "To a great degree," and 4 = "All the time"). The total PCS score can range from 0 to 52 with higher scores representing higher pain catastrophizing.

Single item Score ranges from 1-7, Ordinal scale. Assesses overall improvement since the first assessment. Score ranges from 1 to 7. GROC score =4, indicate no change. Scores greater than 4 indicate greater improvement and scores lower than 4 means greater worsening in health condition.

5-point, Ordinal scale. It asks respondents to rate sleep related questions on a 5-point Likert scale. Every item is scored on a scale from 1-5. Total scores range from 7 to 35. Greater scores indicate more sleep disturbance.

5-point, Ordinal scale. The Depression items asks respondents to indicate the frequency that they have experienced feelings such as worthlessness, helplessness, sadness, hopelessness over the past 7 days on a 5-point verbal rating scale (1 = "Never," 2 = "Rarely," 3 = "Sometimes," 4 = "Often," and 5 = "Always").

Has 10 items, 4-point, Ordinal scale. Each item is rated by respondents on a 5-point Likert scale: 0 = "Not true at all", 1 = "Rarely true," 2 = "Sometimes true," 3 = "Often true," and 4 = "True nearly all the time". The total score can range from 0 to 40, with higher scores indicating higher resilience.

Names, and dosage of pain medication intake will be recorded. E.g., name of the medicine Dosage in mg Total number of medications taken since the baseline assessment. Other treatments if the patients have undertaken will be recorded.