Table 1

Schedule of enrolment, assessment and interventions

TimepointStudy period
EnrolmentAllocationPost allocationFinal Assessment
−T1 T0 T1 T2 T3
Enrolment
 Eligibility screeningX
 Explain study procedure/provide participant information sheetsX
 Informed consentX
 Random treatment allocationX
Intervention
 Experimental intervention (PEG)X
 Control group (CG)X
Assessment
 Baseline descriptive variables
  Sociodemographic information (age, sex, address, occupation, religion and ethnicity)X
 History
  Pain history (site of pain, duration of pain, continuous or intermittent pain, aggravating and relieving factors)X
  ComorbiditiesX
 Feasibility
 Willingness to participate in a randomised controlled trialX
  Acceptability of random allocation to one of the two groupsX
  Acceptability of intervention session (one session in a week with home treatment programme throughout the week)X
  Feasibility of blinding the assessor*X
  Eligibility and recruitment ratesX
  Acceptability of screening procedures*W
  Understanding possible contamination between the groupsX
  Evaluating the credibility of the interventionXX
  Adherence to interventionX
  Treatment satisfactionX
  Difficulty in understanding the treatmentsX
 Secondary outcomes
  PROMIS Pain interferenceXX
  PROMIS Pain intensityXX
  Quality of lifeXX
  PROMIS Sleep disturbanceXX
  PROMIS DepressionXX
  GROCX
  PCSXX
  CD-RISC-10XX
  • *Assessed by the therapist providing intervention; all other outcomes are assessed by the blinded outcome assessor.

  • CD-RISC-10, 10-item Connor-Davidson Resilience Scale; GROC, Global Rating of Change; PCS, Pain Catastrophizing Scale; PROMIS , Patient-Reported Outcome Measurement Information System; T1 , enrolment time; T0 , allocation time; T1 , baseline assessment (before treatment); T2 , during treatment; T3 , 1 week post-treatment; W, assessment at the end of every week on Fridays.