Effects of Adding an Internet-Based Pain Coping Skills Training Protocol to a Standardized Education and Exercise Program for People With Persistent Hip Pain (HOPE Trial): Randomized Controlled Trial Protocol

Control—standardized education and exercise therapy (common to both groups).

Participants in this group will receive a URL link, username, and password to access educational material about hip OA during the first 8 weeks of intervention. The educational material comprises 8 short information sheets produced and provided by Arthritis Australia for the general public via the organization's website (http://www.arthritisaustralia.com.au). Participants will be instructed to access one fact sheet per week over 8 weeks. These sheets cover information on: arthritis, OA, managing pain, physical activity, saving energy, healthy eating, emotions, and tips for hip OA. Participants will have the option to read the sheets online or print out the sheets.

Participants also will undertake a physical therapist–instructed, home-based exercise program between weeks 8 and 24 of the study. They will attend five 30-minute face-to-face physical therapist–instructed exercise sessions (approximately one session every 3 weeks) focused on developing an individualized home exercise program designed to strengthen lower limb muscles and increase hip joint range of motion.^20,21 Programs will contain 3 mandatory exercises, one each of quadriceps muscle strengthening, hip abductor strengthening, and hip stretch/flexibility exercises, and 2 or 3 other exercises chosen at the physical therapists' discretion based on their assessment of the patient (Tab. 2).

Exercise type and intensity will be individualized and relevant to participants' nominated short- and long-term goals. Participants will aim to complete their exercises 3 times per week. For strengthening exercises, the minimum dosage will be 3 sets of 10 repetitions aiming for a self-rated level of effort of at least 5 out of 10 (hard) on a modified Borg Rating of Perceived Exertion. The dosage for stretching/flexibility exercises will be 2 minutes total for each stretch, comprising repetitions of 20- to 60-second holds. For functional/balance exercises, the dosage will be 4 minutes' duration. To minimize burden of exercise, treatment and evaluation will focus on the study hip.

The physical therapist will progress exercises by varying the number of repetitions, load, or degree of difficulty based on the participant's symptom response, any adverse effects, quality of performance, and rating of perceived exertion. If a specific exercise aggravates the participant's pain, the physical therapist will either modify the exercise until the pain flare-up settles or change the exercise if it remains pain-provoking. Participants will be encouraged to continue exercising after the intervention period and, therefore, will be taught how to modify their program, including changing exercises for variety.

Participants will be encouraged to use the study interventions as their sole treatment during the study period. Information in regard to other treatments used will be collected and compared between groups. Regular monitoring of participant attendance and adherence also will be made and necessary reminders sent throughout the study.

PCST—Internet-based PCST protocol combined with standardized education and exercise therapy.

Participants in this group will receive an Internet-based PCST protocol during weeks 1 through 8, in addition to the control group interventions described above. The Internet-based PCST protocol will be provided using the PainCOACH program, which translates key therapeutic components of face-to-face PCST²³ for delivery in 8 highly interactive, automated training sessions. A variety of built-in program features help enhance engagement and adherence.¹² Additionally, theoretically based methods drawn from social cognitive theory,^24,25 adult learning theory,^26,27 and principles of multimedia instruction²⁸ are used to reinforce skill learning and mastery. The program's eight 35- to 45-minute modules, designed to be completed weekly, each provide interactive training in a cognitive or behavioral pain coping skill. Module 1 provides an overview, including a therapeutic rationale of PCST, followed by training in progressive muscle relaxation. Modules 2 through 7 teach brief relaxation skills, activity-rest cycling, pleasant activity scheduling, cognitive restructuring, pleasant imagery, and problem solving. Module 8 consolidates learning and teaches strategies for long-term skill use.

PainCOACH also includes a number of supplementary features to support use of new skills. These features include: (1) COACHtrack, which promotes self-monitoring and provides summaries of progress over time; (2) COACHchat, which allows participants to read about others' experiences and to submit descriptions of their own experiences, similar to observational learning that people would receive in face-to-face PCST groups; and (3) MyCOACH, which provides information about the program, the study, and actions to take in a medical or mental health emergency. A companion workbook provides instructions for using PainCOACH, an overview of its modules and features, and worksheets and practice logs.

Participants will receive monthly booster sessions following the intervention period; they will be encouraged to revisit the final module and any modules they found useful in managing their hip symptoms. A summary of the content and flow of PainCOACH modules is provided in Table 3. Consistent with a face-to-face PCST protocol, participants will be asked to practice and actively use each new skill they learn, and skills practice will be reviewed in subsequent sessions. The recommended home practice schedule for each module is outlined in Table 3.

Hip pain on walking measured with an 11-point NRS.

Average hip pain on walking over the previous week will be self-reported using an 11-point NRS (0=“no pain” to 10=“worst pain possible”). This measure is reliable and valid in OA populations.³⁰

Physical function measured with the function subscale of the WOMAC.

Physical function will be measured by the WOMAC (Likert version 3.1).³¹ This is a disease-specific self-report questionnaire with extensive evidence of validity, reliability, and responsiveness in OA populations.³² The physical function subscale contains 17 questions (each answered on a Likert scale, where 0=no dysfunction and 4=extreme dysfunction), with a total score ranging from 0 (no dysfunction) to 68 (maximum dysfunction).

Secondary outcome measures are: (1) participant-perceived response to treatment measured on a 7-point scale; (2) hip pain measured with the WOMAC pain subscale; (3) health-related quality of life measured with the Assessment of Quality of Life (AQoL); (4) use of coping skills to manage pain using the coping attempts scale of the Coping Strategies Questionnaire (CSQ); (5) self-efficacy for pain and function measured with the Arthritis Self-Efficacy Scale; (6) pain catastrophizing using the Pain Catastrophizing Scale; and (7) emotional states of depression, anxiety, and stress using the 21-item version of the Depression Anxiety Stress Scales (DASS-21) questionnaire.

Participant-perceived response to treatment measured on a 7-point scale.

Participants will rate their perceived change in (1) pain, (2) physical function, and (3) overall condition on a 7-point ordinal scale (1=much worse to 7=much better). It has been shown to be a reliable and clinically relevant method of identifying improvements that are truly meaningful to participants.³³ Participants who report that they are moderately better and above will be classified as “improved.”

Hip pain measured with the WOMAC pain subscale.

Hip pain also will be captured using the WOMAC pain subscale, which contains 5 questions, each answered on a Likert scale, where 0=no pain and 4=extreme pain. Its total score ranges from 0 (no pain) to 20 (maximum pain).³¹

Health-related quality of life measured with the AQoL.

The AQoL questionnaire (version AQoL-II) contains 20 questions covering 6 dimensions of health-related quality of life: independent living, social relationships, physical senses, coping, pain, and psychological well-being. Responses are provided on a 5-point scale. Scores range from −0.04 (worst possible health-related quality of life) to 1.00 (full health-related quality of life). The AQoL-II has strong evidence of validity and responsiveness.^34,35 A clinically important difference has been defined as a change of 0.04 AQoL units.³⁶

Use of coping skills to manage pain measured with the coping attempts scale of the CSQ.

The CSQ³⁷ assesses how often a patient uses 6 cognitive and behavioral pain coping strategies to manage pain: diverting attention, reinterpreting pain sensations, coping self-statements, ignoring pain sensations, praying and hoping, and increasing activity level. Items are measured on a 7-point Likert scale (0=never uses coping skills and 6=always uses coping skills). Based on prior factor analyses of this instrument,³⁸ participants' responses will be converted to scores on the Coping Attempts factor of the CSQ, ranging from 0 to 163. The CSQ has demonstrated sensitivity to change from treatment in people with chronic pain as well as good internal consistency and construct validity.³⁸

Self-efficacy for pain and function measured with the Arthritis Self-Efficacy Scale.

The Arthritis Self-Efficacy Scale³⁹ assesses confidence for managing pain (5 questions) and physical function (9 questions) on a 10-point NRS (1=very uncertain to 10=very certain). Scores will be calculated as an average of reported values. This scale is reliable and valid in OA populations.³⁹

Pain catastrophizing measured with the Pain Catastrophizing Scale.

The Pain Catastrophizing Scale⁴⁰ measures the tendency to ruminate about pain, magnify pain, and feel helpless about pain. All 13 items are measured on a 5-point Likert scale (0=low levels of catastrophizing to 4=high levels of catastrophizing). The highest possible total score of 52 indicates the greatest level of catastrophizing. It has high internal consistency and is associated with heightened pain, psychological distress, and physical disability.⁴⁰

Emotional states of depression, anxiety and stress measured with the DASS-21.

The DASS-21⁴¹ measures 3 related negative emotional states of depression, anxiety, and stress. The 21-item short form, with 7 questions for each emotion, will be used instead of the full version to reduce participant burden. Responses range from 0 (did not apply to me) to 3 (applied to me very much or most of the time). Scores from each subscale are summed and multiplied by 2 to give a total score ranging from 0 to 42. Higher scores indicate greater distress. It has high internal consistency and construct validity.^41,42

Other measures will include: (1) treatment adherence, (2) physical activity levels, (3) adverse events and use of health services and cointerventions, (4) expectations of treatment effect, and (5) process measures.

Treatment adherence.

The number of physical therapy sessions attended will be recorded by physical therapists. Adherence to home exercises during weeks 8 through 24 will be self-reported in weekly logbooks. Participants also will provide 2 “snapshots” of their exercise adherence by self-reporting the number of exercise sessions completed in the previous 2 weeks at 2 time points (24 and 52 weeks). Participants will rate their adherence to their home exercise program over the previous 4 months using an online 11-point NRS (from “not at all” to “completely as instructed”) at 24 weeks and over the previous 6 months at 52 weeks. The physical therapist will rate the participants' level of adherence to the exercise program at the final physical therapy session on an 11-point NRS.

The number of PainCOACH sessions completed will be automatically recorded by the program and monitored regularly by the researchers. Pain coping skills practice will be recorded using COACHtrack or by completing weekly logs that will be returned to the researchers. Participants will rate their adherence to practicing PainCOACH skills using an online 11-point NRS (from “not at all” to “completely as instructed”) at week 8. They also will report the number of days they practiced their PainCOACH skills and the particular skills practiced (in the previous 2 weeks) at 24 and 52 weeks.

Participants in both groups will record the number of Internet-based education information sheets they accessed in the previous 8 weeks at week 8 and which information sheets were accessed in the last 4 months at week 24 and in the last 6 months at week 52.

Physical activity levels.

Habitual physical activity will be measured at 8, 24, and 52 weeks using the Physical Activity Scale for the Elderly (PASE), which measures the type and level of habitual physical activity in the previous week. It is a valid measure in older adults with chronic pain,⁴³ and scores correlate with average daily readings from an accelerometer.⁴⁴

Adverse events and use of health services and cointerventions.

Adverse events will be defined as any health problems that participants believed to be caused by the treatment and that (1) required them to see a health professional or take medications or (2) interfered with function for 2 or more days. Information on adverse events will be collected for both groups via logbooks and at weeks 8, 24, and 52 using online surveys. Data on use of health services and cointerventions will be collected via an online survey at 0, 24, and 52 weeks. Data on direct health care costs and direct non–health care resources for the previous 6 months will be collected at 24 and 52 weeks via an online survey.

Expectations of treatment effect.

At baseline, participants will be asked about their expectation of the effect they think the study treatments will have on their hip pain using a 5-point ordinal scale ranging from “no effect” to “complete recovery.”

Process measures.

Additional process measures about the acceptability of the educational information and about PainCOACH will be collected using custom-designed questionnaires. At week 8, these measures will include: (1) satisfaction with the Internet-based educational information and PainCOACH and (2) acceptability of PainCOACH. At weeks 24 and 52, data on usefulness of the PainCOACH skills using a series of 11-point NRSs (from 0=not at all to 10=extremely useful) will be collected.

Sample size calculation.

The primary endpoints of the trial are between-group differences in change in hip pain on walking (NRS) and change in physical function (WOMAC) at 24 weeks. The minimum clinically important difference to be detected in OA trials is a change in pain of 1.8 units (out of 10)^45,46 and change in function of 6 nonnormalized points (out of 68).⁴⁷ Based on our previous randomized controlled trial of a physical therapy intervention for hip OA, we assumed a between-participant standard deviation of 1.2 for pain and 8.8 units for physical function and a baseline to week 24 follow-up correlation of 0.45 for pain and 0.35 for physical function. The required sample size for analysis of covariance of change controlling for the baseline value with power set at 90% and a significance level at .05 is 59 participants per group for physical function and 11 participants per group for pain. To be adequately powered for both primary outcomes and allowing for an approximate 20% dropout rate, we will recruit 71 participants per group.

Data analysis.

Main analyses comparing the groups will be performed by our statistician in a blinded fashion using an intention-to-treat analysis including all available data. Demographic characteristics, as well as baseline scores on primary and secondary outcome measures, will be inspected to assess baseline comparability of treatment groups. These variables also will be examined for participants who withdraw from the study and those who remain. Descriptive statistics will be presented for each group as the mean change (standard deviation, 95% confidence interval) in the outcomes from baseline to each time point. For continuous outcomes, differences in change will be compared between groups using linear regression random-effects modeling adjusted for baseline values of the outcome and sex, including random effects for the treating physical therapist to account for clustering of outcomes by therapist. Model assumptions will be checked using standard diagnostic plots. Improvement between groups (based on perceived ratings of change and attainment of the minimum clinically important difference for pain and function) will be compared using logistic regression models adjusted for sex and with random effects for therapist. Missing data will be accounted for using multiple imputation methodology.⁴⁸ To estimate treatment effects under full adherence, we will use a 2-stage least squares approach and report these findings as a secondary analysis.

Cost-effectiveness analysis.

The economic evaluation will assess the incremental cost-effectiveness of the Internet-based PCST protocol compared with the control protocol. We will test the hypothesis that adding Internet-delivered PCST leads to a positive social benefit of lower net costs. The marginal cost of Internet-based PCST is close to zero once the system is set up, but the cost of other health care may change as a consequence of its efficacy. The incremental cost will be compared with the incremental benefits of treatment in terms of a clinically significant reduction in hip pain, a clinically significant improvement in self-reported physical function, and the difference in quality-adjusted life years (QALYs). The incremental QALYs will be measured by the between-group difference in mean AQoL scores over 12 months. A social perspective on costs will be taken and will include resource use incurred both by health services and by the participant, regardless of payment source.

Health care costs will be calculated from the utilization data and average unit costs for each item. We will not include the setup costs of PCST in the primary analysis. The inclusion of time and productivity gains is controversial, and the cost-effectiveness ratios will be calculated with and without these “indirect costs” in the primary analysis, but a secondary analysis will include the money value of time gains from increased hours of work. We will calculate net benefits for a range of hypothetical money values of outcomes based on individual cost and outcome differences between groups over the 12 months estimated using linear regression random-effects modeling adjusted for baseline values of the outcome and sex, including random effects for the treating physical therapist,⁴⁹ and test if net benefits are greater than zero. Missing data in the regression analysis will be accounted for using multiple imputation methodology. Sensitivity to potential overdispersion in cost data will be tested using nonparametric bootstrapping of cost differences and generalized linear modeling.