Background
Methods/Design
Trial design
Participants
Procedure
Randomisation and allocation concealment
Interventions
Education control condition
PCST + Ex condition
Module number | Coping skill | Content |
---|---|---|
1
|
Progressive relaxation
| Teach Gate Control Theory (how thoughts, feelings, and actions affect and are affected by pain). Introduce and demonstrate progressive relaxation with animation; walk user through use of the technique and active practice; help user identify/address circumstances that might impede relaxation and chose strategies to overcome obstacles; plan regular practice times; set practice goal. |
2
|
Mini-practices
| Review prior session content and practices; Introduce and demonstrate “mini-practices” (brief relaxation) with animation; walk user through use of the technique and active practice, gather/evaluate pre- and post- activity pain; help user identify/address circumstances that might impede relaxation and chose strategies to overcome obstacles; discuss benefits and reminders for practicing; plan regular practice times; set and review practice goals. |
3
|
Activity/rest cycling
| Review prior session content and practices; Introduce concept of activity/rest cycling; identify activities user tends to overdo; vicarious learning exercise demonstrate how to change overdone activities; create personal plan to fit daily routine and personal goals; review how other skills help with use of this one; plan regular practice times; set and review practice goals. |
4
|
Pleasant activity scheduling and identify negative automatic thoughts
| Review prior session content and practices; Introduce concept of pleasant activity scheduling; lead user through exercise for adding pleasant activities to their lives; mini-practice of 10-minute pleasant activity to be done immediately (gather/ evaluate pre- and post- activity pain); schedule 3 pleasant activities for week; problem-solve barriers with interactive vicarious learning exercise; Introduce concept of negative automatic thoughts; describe connections between thoughts, emotions, behaviors, and pain; walk user through a thoughts exercise; plan regular practices; set and review practice goals. |
5
|
Identify/change negative automatic thoughts and coping thoughts
| Review prior session content and practices; Continue and advance prior session’s activities related to automatic thoughts and introduce coping thoughts. Practice identifying negative thoughts and accompanying emotional and physical reactions of virtual patients, then self; exercise to teach generation of alternative thoughts, then practice and record accompanying sensations. Focus on teaching generation of alternative thoughts, practice generating calming self-statements; practice skills and get feedback; identify and address circumstances that impede use of these skills and strategies to overcome obstacles; “mini-practices” for specific circumstances; plan regular practices; set and review practice goals. |
6
|
Pleasant imagery and distraction techniques
| Review prior session content and practices; Introduce pleasant imagery and auditory and focal point distraction techniques; complete exercises with audio instructions; plan regular practices; set and review practice goals. |
7
|
Problem Solving
| Review prior session content and practices;; Introduce concept of problem solving and describe steps; demonstrate problem solving with character stories; generate list of challenging situations; exercise to help users select skills for each situation, with personalized plan for overcoming barriers; plan regular practices; set and review practice goals. |
8
|
Monitoring for maintenance
| Review all session content; evaluate skill frequency, helpfulness and comparison to other users; exercises to develop plan for maintenance of skills; motivate further practice and skill development; remind how skills facilitate personal goals; review practice goals. |
Booster sessions
| Review module 8 as well as revisit any useful/meaningful sessions. |
Maximum of 6 exercises (with progression as appropriate) | |||
---|---|---|---|
2 knee extensor strengthening exercises | |||
1 hip abductor strengthening exercise | |||
1 hamstring strengthening exercise | |||
1 calf strengthening exercise | |||
1 other exercise chosen based on assessment findings | |||
1. Quads strengthening (each program must include 2 exercises)
| |||
Knee extension
| Non weight-bearing | A. Seated knee extension (with resistance) with 5 second hold |
Indications: suggested as an initial exercise |
Progression: Increase cuff weight or theraband resistance – red through to black | |||
Simplification: eliminate weight or see 1B | |||
Non weight-bearing | B. Inner range quads over roll (with resistance) with 5 second hold |
Indications: Usually only required when any flair ups with seated knee extension (1A) | |
Progression: Use appropriate level of ankle cuff weight | |||
Simplification: eliminate weight if flare up | |||
Sit-to-stand
| Weight-bearing | C. Sit to stand without using hands |
Indications: suggested as an initial exercise |
Progression: lower chair height, hover above the seat without touching down, more weight on affected leg, slit leg position (affected leg closer to seat) | |||
Simplification: use hands | |||
Steps
| Weight-bearing | D. Step-ups |
Indications: suitable progression from sit to stand (1C) |
Progression: Increase step height, hold extra weight (in hands or backpack) | |||
Simplification: sit to stand (1C) | |||
Weight-bearing | E. Forward touchdowns from a step |
Indications: suitable progression from step-ups (1D) | |
Progression: Increase step height, hold extra weight (in hands or backpack), don’t touch down | |||
Simplification: step-ups (1D) | |||
Partial squats
| Weight-bearing | F. Partial wall squats |
Indications: suitable progression from sit to stand (1C) |
Progression: Increase to 5 sec hold, more weight on study side) | |||
Simplification: if find flare/problematic step back to sit to stand (1C) | |||
2. Hip abductor strengthening (1 exercise)
| |||
Standing hip abduction
| Non weight-bearing | A. Side leg raises in standing |
Indications: suggested as an initial exercise |
Progression: Increase cuff weight or theraband resistance – red through to black | |||
Simplification: eliminate weight | |||
Side stepping
| Weight-bearing | B. Crab walk with resistance band |
Indications: good progression from standing leg side raises (2A) |
Progression: Increase theraband resistance – red through to black | |||
Simplification: side leg raises in standing (2A) | |||
Standing hip abduction
| Weight bearing | C. Wall push standing on study leg |
Indications: good progression from crab walking (2B) and for variety at final session |
Progression: Increase step height. Hold extra weight (in hands or backpack) | |||
Simplification: If unable to tolerate static standing on joint then avoid and use 2B or 2A. Precaution in those with increased varus. | |||
3. Hamstring strengthening (1 exercise)
| |||
Standing knee flexion
| Non weight-bearing | Standing over bench knee curls with weight |
Progression: Increase cuff weight or theraband resistance – red through to black |
Simplification: eliminate weight | |||
4. Calf strengthening (1 exercise)
| |||
Standing plantar-flexion
| Weight-bearing | Double heel raises |
Progression: single heel raises, raises from the edge of a step |
5. Others (1 exercise if appropriate)
| |||
Knee ROM
| Weight bearing | A. Deep squats holding onto a bench/chair |
Progression: increase squat depth |
Hip ROM
| Weight bearing | B. Deep lunges holding onto back of chair/bench |
Progression: increase lunge depth |
Hip extensors
| Weight-bearing | C. Bridging |
Progression: split leg bridge, single bridge with a hold, bridging one leg |
Treatment fidelity
Descriptive data
Outcome measures
Primary outcome measures | Data collection instrument | Collection points |
---|---|---|
Average walking pain in past week | 11-point numeric rating scale | 0, 3¥, and 9 months |
Physical function in past 48 hours | WOMAC osteoarthritis Index physical function subscale | 0, 3¥, and 9 months |
Secondary outcome measures
| ||
Pain in past 48 hours | WOMAC osteoarthritis Index pain subscale | 0, 3 and 9 months |
Perceived change overall | 7-point ordinal scale | 3 and 9 months |
Perceived change in pain | 7-point ordinal scale | 3 and 9 months |
Perceived change in function | 7-point ordinal scale | 3 and 9 months |
Health-related quality of life | Assessment of Quality of Life questionnaire (AQoL2) | 0, 3 and 9 months |
Self-reported psychological measures | Arthritis self-efficacy scale | 0, 3 and 9 months |
Coping Strategies questionnaire (CSQ) | 0, 3 and 9 months | |
Pain Catastrophizing Scale (PCS) | 0, 3 and 9 months | |
Other measures
| ||
Adherence to intervention | Number of physiotherapy sessions attended | During intervention |
Weekly home exercise log books | During intervention | |
PainCOACH module completion | During intervention | |
PainCOACH practice via COACHTrack/ log books | During intervention | |
Home exercises - 11-point numeric rating scale | 3, 6 and 9 months | |
Frequency of home exercise sessions previous 2 weeks | 3, 6 and 9 months | |
Frequency of pain coping skills in previous 2 weeks | 3, 6 and 9 months | |
Educational material accessed in previous 3 months | 3, 6 and 9 months | |
Adverse events and harms | Questionnaire | 3, 6 and 9 months |
Health cost data | Questionnaire | 9 months |
Descriptive information | Questionnaire | 0 months |
Medications and co-interventions | Questionnaire | 0, 3, 9 months |
Treatment benefit expectations | 5-point ordinal scale | 0 months |
Process measures
| ||
Treatment satisfaction | Questionnaire | 3 months |
Appropriateness of the intervention | Program (System) usability scale | 3 months |