Chronic Pain Self-management Support With Pain Education and Exercise
Chronic Pain Self-management Support With Pain Education and Exercise
The purpose of this study is to determine whether the combination of self-management support,
 pain science education, and individualized, goal-oriented exercises helps people with chronic
 pain to increase their function.
Primary objective: This study will test the hypothesis that participants with chronic pain
 experience greater change in function with ChrOnic pain self-ManageMent support with pain
 science EducatioN and exerCisE (COMMENCE) in comparison to a wait-list control.

 Secondary objective #1: This study will test the hypotheses that people with chronic pain
 experience greater change in pain intensity, pain interference, self-efficacy, catastrophic
 thinking, fear of movement/re-injury, pain neurophysiology knowledge, how much participants
 are bothered by difficulty with functional activities, fatigue, depressive symptoms, health
 care utilization and work status with COMMENCE in comparison to a wait-list control.

 Secondary objective #2: This study will identify demographic, psychological, or
 psychophysical variables that are predictive of treatment response.

 Design: This study will be a randomized trial with parallel groups, a wait-list control and
 balanced randomization. A cross-over will take place after a 12-week follow-up assessment
 (ie. the group initially receiving treatment will receive no treatment and the group
 initially on the wait-list will receive treatment for 6 weeks). The between group comparison
 will be performed using only the data up to the 12-week follow-up due to anticipated
 carry-over effects with self-management support. Data collected after the cross-over will be
 used to help identify factors that predict response to the intervention.

 Blinding: Due to the nature of the treatment and comparison, participants and the treating
 physiotherapist will not be blinded. The assessor who is completing the two objective
 measures will be blind to the treatment allocation. Data analysis will be performed by
 someone who is not blinded to the group allocation.

 Setting: 110 participants with chronic pain will be recruited at Woodstock and Area Community
 Health Centre (WACHC) in Woodstock, Ontario, Canada. WACHC has an interdisciplinary team of
 health care providers that provide care to priority populations in Oxford County, Ontario,
 Canada. The priority populations include people with the following barriers to accessing
 health care: addictions concerns, mental health challenges, low incomes, lack of health
 insurance, and isolated seniors. The investigators expect this sample to represent a
 marginalized population of people with chronic often excluded from chronic pain treatment and
 research by barriers to accessing health care.

 Sample Size: The sample size necessary for a randomized controlled trial with three repeated
 measures at 0, 7 and 18 weeks was calculated using online sample size software (GLIMMPSE
 2.0). The calculation was performed using a significance level of 0.05, a power of 0.8, a
 minimum detectable mean difference between groups of 10 points on the Short Musculoskeletal
 Function Assessment Dysfunction Index (SMFA-DI) at both 7 weeks and 18 weeks, and a standard
 deviation of 23 points on the SMFA-DI based on clinical data at WACHC. The needed sample size
 calculated was 88 participants. To account for a potential 20% drop-out rate, 110
 participants will be recruited

 Allocation: The allocation sequence will be generated by a study investigator who is not
 involved in the enrolment of participants or assigning interventions. A computer-generated
 blocked random number schedule will be used to determine allocation sequence. The block size
 will be unknown to the other study investigators. The allocation sequence will be concealed
 through the use of sequentially numbered, opaque envelopes, opened after the initial
 assessment.

 Co-intervention: Participants will be free to continue with other treatments. Other
 treatments will be recorded through self-report at each assessment time-point and analyzed
 for between group differences.

 Withdrawing Participants from this Study: Participants may withdraw from the treatment at any
 time. Participants who choose to withdraw will be documented and data will be analyzed as a
 member of the group to which they were randomly assigned (intention-to-treat)

 Potential prognostic indicators or predictors of response: Potential predictors of response
 for secondary objective #2 will include baseline measures for each of the outcome measures
 listed under outcomes as well as post-traumatic stress measured by the Post-traumatic Stress
 Disorder Checklist, sense of perceived injustice measured by the Injustice Experience
 Questionnaire, number of medications, comorbidities measured by disease count, and
 expectations for recovery. Expectations for recovery will be assessed with two questions: i)
 Do you think your pain will improve? ii) Do you think your functional abilities will improve?

 Demographic information: The following information will be collected at the initial
 assessment and analyzed as potential covariates and predictors of response: age, sex, work
 status prior to symptom onset, length of time since symptom onset in months, diagnosis
 provided by a medical professional as reported by the patient, medication use, previous
 treatment received, and expectations for recovery.

 Treatment fidelity: Treatment fidelity will be assessed through a combination of attendance
 (categorized as <25%, 25-49%, 50-74%, ≥75% of visits) and adherence to self-management
 strategies. This will be measured by clinician report when the clinician reviews the workbook
 at each individual treatment session.

 Data monitoring and auditing: This trial will not include a data monitoring committee and
 will not be audited outside of the study investigators

 Analysis: Statistical analysis will be conducted using Stata software, version 13 (StataCorp,
 College Station, Texas, USA). Baseline characteristics for treatment and wait-list groups
 will be compared using a Student's t-test for continuous data and Chi squared or Fisher's
 exact test for categorical variables. Analysis for the primary objective and secondary
 objective #1 will be performed using linear mixed-effects modelling with data from three
 repeated measures (baseline, 7 weeks, 18 weeks). A p value of less than 0.05 will be
 considered indicative of statistical significance. The primary analysis will use intention to
 treat principles, but a secondary analysis to investigate efficacy for those that complete
 75% of visits will be performed as well (per protocol analysis). Predictors of response
 (change in SMFA-DI) will be determined using a series of multiple regression models.
Inclusion Criteria:

 -  participants will all be adults who have been experiencing non-cancer related pain for
 at least 12 weeks

 Exclusion Criteria:

 -  cancer related pain

 -  medical "red flags" suggestive of a non-neuromusculoskeletal etiology of symptoms

 -  casted fracture within the last 12 weeks

 -  related surgery within the last 26 weeks

 -  evidence of upper motor neuron lesion