Table 2

How will each primary feasibility objective be assessed?

Serial NumberObjectivesMeasures to assess specific objectivesStatistical analysis
1Willingness to participate in a randomised controlled trialAll the consecutive participants presenting at the physiotherapy department will be approached and invited to participate. The number and rate of participants willing versus not willing to participate will be recorded, as well the reasons for not wanting to participate.Total number of patients not willing to participate will be summed and reasons for non-participation collated.
2Feasibility of blinding the assessorFeasibility of blinding will be assessed by asking the assessor two questions at the end of the follow-up assessment:
1. Did you receive any information that indicated to you which group the participant was assigned to?
2. How did you receive information about group assignment?
Assessor’s guess regarding group assignment group will be recorded for each participant. The responses will be coded as correct or incorrect guess.
The frequency and relative rates of ‘Yes’ and ‘No’ as the answer to the first question will be computed, as will the frequency and relative rates of correct and incorrect guesses. Finally, reasons for guesses will be recorded as verbatim and reported.
3Eligibility and recruitment ratesThe 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 study inclusion will be recorded for every participant who did not meet eligibility criteria. Reasons for declining participation will be recorded for every eligible individual who declined participation. Consent rates will also be recorded.The number of participants screened, who were eligible, who consented to participate, who refused to participate will be computed. The reasons for exclusion and refusal will also be collated.
4Acceptability of screening proceduresThe lead researcher will interview the physiotherapist(s) screening the potential participants 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’. If the answer to this question is ‘Yes’, the lead researcher will ask the following open-ended question, ‘What were the difficulties and challenges?’. Responses will be written down verbatim. Additionally, the outcome assessor will complete a form every time he or she encounters a difficulty or a challenge during screening. Outcome assessors will also be asked about their recommendations for overcoming any challenges that they identify.
Time taken to complete the questionnaires will be recorded.
The frequency of difficulties or challenges will be counted.
The difficulties and challenges will be noted, categorised if possible, and reported. Results will be used to improve the screening procedure in the full trial in future, and therapists’ recommendations will be considered.
5Acceptability of random allocation to a treatment groupOutcome assessor will ask the participants if random allocation to one of the two treatment groups is acceptable to the participants. Responses will be recorded as ‘Acceptable’, ‘Not acceptable’ or ‘No preference’.The frequencies of each response will be computed separately for each treatment condition.
6Understanding possible contamination between the groupsContamination between the groups will be assessed by asking all the study participants the following questions at 1 week following treatment:
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?’;
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 control 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?’
These questions are adapted from a cotwin controlled feasibility trial.62
The frequencies of the participants who responded affirmatively to each question will be computed separately for each treatment condition.
7Credibility and acceptability of the interventionsTreatment credibility will be assessed using five questions adapted from Borkovec and Nau.63 The questions will be modified to fit ‘Pain education’ and ‘Control group’ as a treatment for patients with LBP and will be administered to all the participants in both conditions. One, important cultural adaptation for the scoring will be made by changing the numerical scale proposed by Borkovec and Nau to a Verbal Rating Scale, because Numerical Rating Scales have been shown to be unsuitable in Nepalese with musculoskeletal pain, especially in those who are older and have low educational attainment.64 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’. The questions are:
1. How logical does the treatment provided seem to you for the management of low back pain?
2. How confident would you be that this treatment would be successful in reducing pain?
3. How confident would you be in recommending this treatment to a friend or family who also has LBP?
4. If you were having low back pain again, would you be willing to undergo such treatment?
5. How successful do you feel this treatment would be in reducing pain in other parts of the body, for example, knee pain?
All the questions will be asked at baseline and at 1 week following treatment.
Mean of the total scores on the credibility scale will be computed separately for each condition. Between-condition differences in creditability will be evaluated using a t-test.
8Adherence to the interventionAdherence to treatment will be assessed by asking the participants in both conditions to maintain a record of daily home treatment that was followed by every participant. The participants will tick mark a box for every day for a total of 5 days between the two assessment time-points to indicate their adherence to prescribed home exercise programme. Additionally, participants will be requested to record any deviation of prescribed home treatment programme (eg, additional visit to the clinic and use of other interventions). Finally, question regarding non-adherence will be asked.The total number of treatment adherence days will be summed for each treatment condition separately.
Deviation from the treatment protocol will be recorded.
Finally, the reasons for non-adherence will also be listed.
9Satisfaction of treatmentAll the participants in both the conditions will be asked to respond to the Patient Global Assessment of Treatment Satisfaction scale at 1 week following treatment.65 66 The question asked will be, ‘How satisfied are you overall with the study treatment?’ Responses to this question are made on a five-point categorical scale (0=‘Very dissatisfied’; 1=‘Dissatisfied’; 2=‘Neutral or no preference’; 3= ‘Satisfied’; 4=‘Very satisfied’).Mean treatment satisfaction scores will be computed for each treatment condition separately. Between-condition differences will be evaluated using a t-test.
10Difficulty in understanding the information provided by the physiotherapist.All the participants 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?’ Responses will be provided on a 5-point Likert scale, where 1=‘Very easy’, 2=‘Easy’, 3=‘Neither easy nor difficult’, 4=‘Difficult’, 5=‘Very difficult’.The differences in the difficulty in understanding the information provided will be compared between the two groups.
11Difficulty in understanding the instructions for what to do.All participants will be asked about the difficulty in understanding the instructions provided by the physiotherapist for what to do at home. The question asked will be, ‘How difficult was it for you to understand the instructions provided by the physiotherapist for what to do at home?’ using a on a 5-point Likert scale, where 1=‘Very easy’, 2=‘Easy’, 3=‘Neither easy nor difficult’, 4=‘Difficult’, 5=‘Very difficult’.Frequencies and rates of each response category will be computed for each group separately.
12Adverse eventsAll participants will be asked about any adverse events after treatment. All responses will be recorded verbatim.The number of adverse events listed will be computed for each treatment condition separately. The responses will be analysed qualitatively (see text).
  • LBP, low back pain.