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Chronic pain is associated with poor physical and emotional functioning. Nonpharmacological interventions can help, but improvements are small and not sustained. Previous clinical trials do not follow recommendations to comprehensively target objectively measured and performance-based physical function in addition to self-reported physical function.
This study aimed to establish feasibility benchmarks and explore improvements in physical (self-reported, performance based, and objectively measured) and emotional function, pain outcomes, and coping through a pilot randomized controlled trial of a mind-body physical activity program (
Patients with chronic pain were randomized to the
Feasibility benchmarks (eg, recruitment, acceptability, credibility, therapist adherence, adherence to practice at home, ActiGraph wear, and client satisfaction) were good to excellent and similar in both programs. Within each program, we observed improvement in the 6-min walk test (mean increase=+41 m, SD 41.15;
These preliminary findings support a fully powered efficacy trial of the two programs against an education control group. We present a model for successfully using the Initiative on the Methods, Measurement, and Pain Assessment in Clinical Trials criteria for a comprehensive assessment of physical function and following evidence-based models to maximize feasibility before formal efficacy testing.
ClinicalTrial.gov NCT03412916; https://clinicaltrials.gov/ct2/show/NCT03412916
Chronic musculoskeletal pain is costly [
Using the International Classification of Functioning, Disability and Health (ICF) guidelines [
Our long-term goal is to conduct a fully powered RCT comparing 2 identical mind-body physical activity programs, one with a Fitbit device (
We used a sequential approach to the development and initial testing of our mind-body physical activity program focused on multiple iterations to optimize it, meet a-priori set markers of feasibility, and establish a signal of improvement in outcomes (
Here, we report on feasibility markers and within-group improvements in outcomes after a pilot RCT of the refined
We recruited patients with heterogeneous musculoskeletal chronic pain via direct referrals from the Massachusetts General Hospital Pain Clinic as well as flyers and hospital-wide email lists advertising our study. Recruitment occurred between July 2018 and September 2019. The study was funded by the NCCIH and approved by Massachusetts General Hospital’s institutional review board (IRB). The inclusion criteria were as follows: (1) ≥18 years old, (2) self-reported nonmalignant chronic pain for >3 months, (3) ability to walk unassisted for at least 6 min, (4) access to a mobile device with Bluetooth version 4.0, (5) no change in psychotropic or pain medications for the past 3 months, and (6) cleared for participation by a physician. The exclusion criteria were as follows: (1) medical illness expected to worsen in the next 6 months, (2) serious and untreated psychiatric illness or active suicidality, (3) current untreated substance use disorder, (4) practicing meditation/yoga or relaxation response skills for >45 min a week in the past 6 months, (5) using a Fitbit device in the past 6 months, and (6) engaged in regular physical exercise for >30 min daily by self-report.
We screened all referrals via a phone call using a standard, IRB-approved scripted checklist. All participants were informed that the goal of the program was to increase physical activity rather than decrease pain. We documented all reasons for ineligibility (
Development of the original 8-week programs, details on program skills, and exit interviews to inform the current program versions have been previously reported [
The
Details can be found in the study by Greenberg et al [
In the last group session, participants were handed the ActiGraph and were instructed to complete the activity log again for 1 week. They were asked to return the following week as a group to complete the postintervention assessment. Participants were again compensated with US $30 for the assessment session.
Feasibility markers were determined to be consistent with guidelines for intervention development [
We assessed objectively measured, performance-based, and self-reported physical function per the IMMPACT criteria [
We measured the actual number of steps taken daily by each participant using the
We measured performance-based physical function via the 6-min walk test [
We used 3 self-report measures recommended by IMMPACT [
We measured anxiety using the PROMIS anxiety scale [
We assessed pain intensity at rest and with activity using the
We assessed pain-related coping using the
We assessed adaptive coping skills using the
We used the
We first assessed the sample characteristics using descriptive statistics. We then analyzed feasibility markers based on the proportion of participants who achieved each benchmark, as detailed earlier in the
In line with recommendations for pilot RCTs [
A total of 265 participants were referred and assessed for eligibility, and 82 participants were randomized (41 in each group;
Demographic characteristics of participants.
Demographic characteristics | GetActive (n=41) | GetActive-Fitbit (n=41) | |||
Age (years), mean (SD) | 54.46 (14.5) | 49.07 (14.2) | |||
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Male | 18 (43.9) | 10 (24.4) | ||
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Female | 23 (56.1) | 31 (75.6) | ||
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Hispanic or Latino/Latina | 4 (9.8) | 4 (9.8) | ||
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Not Hispanic or Latino/Latina | 35 (85.4) | 37 (90.2) | ||
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Missing | 2 (4.9) | N/Aa | ||
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American Indian/Alaskan Native | 2 (4.9) | 0 (0.0) | ||
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Asian | 1 (2.4) | 2 (4.9) | ||
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Black/African American | 5 (12.2) | 2 (4.9) | ||
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Native Hawaiian/Pacific Islander | 0 (0.0) | 0 (0.0) | ||
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White | 32 (78.0) | 34 (82.9) | ||
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More than one race | 1 (2.4) | 3 (7.3) | ||
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Single, never married | 13 (31.7) | 15 (36.6) | ||
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Living with significant other | 5 (12.2) | 6 (14.6) | ||
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Married | 15 (36.6) | 8 (19.5) | ||
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Separated/divorced | 5 (12.2) | 11 (26.8) | ||
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Widowed | 3 (7.3) | 1 (2.4) | ||
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High school (12 years) | 5 (12.2) | 6 (14.6) | ||
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Some college/associate degree (<16 years) | 15 (36.6) | 11 (26.8) | ||
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Completed college (16 years) | 9 (22.0) | 8 (19.5) | ||
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Graduate/professional degree (>16 years) | 12 (29.3) | 16 (39.0) |
aN/A: data not applicable.
Program acceptability, feasibility of quantitative measures, therapist adherence, patient adherence to activity and home practice, adherence to wearing the ActiGraph (as well as Fitbit for the
Feasibility and acceptability of the programs.
Outcomesa | GetActive | GetActive-Fitbit |
Program acceptability | 31 out of 41 participants (76%) attended ≥7 out of 10 group or make-up sessions: good | 34 out of 41 participants (83%) attended ≥7 out of 10 group or make-up sessions: excellent |
Credibility and expectancy | 27 out of 41 participants (66%) scored above the scale midpoint for expectancy: acceptable; 37 out of 41 participants (90%) scored above the scale midpoint for credibility: excellent | 38 out of 41 participants (93%) scored above the scale midpoint for credibility: excellent; 22 out of 41 participants (54%) scored above the scale midpoint for expectancy: acceptable |
Therapist adherence to the manual | Rater agreement (κ)=98%, therapist adherence to the manual was 98%: good | Rater agreement (κ)=97%, therapist adherence to the manual was 94%: good |
Feasibility of quantitative measures | 41 out of 41 (100%) were not fully missing questionnaires on quantitative measures at baseline: excellent; 34 out of 35 (97%) were not fully missing questionnaires on quantitative measures at posttest: excellent | 40 out of 41 (97.56%) were not fully missing questionnaires on quantitative measures at baseline: excellent; 37 out of 37 (100%) were not fully missing questionnaires on quantitative measures at posttest: excellent |
Adherence to homework | 98% of logs handed in met adherence criteria (ie, 3 home practice components completed 3 out of 7 days per week or 1 component completed 5 out of 7 days per week): excellent | 98% of logs handed in met adherence criteria (ie, 3 home practice components completed 3 out of 7 days per week or 1 component completed 5 out of 7 days per week): excellent |
Adherence to ActiGraphs and Fitbit | 31 out of 33 participants (94%) who received the ActiGraph at baseline wore it for ≥5 out of 7 days: excellent; 25 out of 27 participants (93%) who received the ActiGraph at posttest wore it for 5 out of 7 days: excellent; 30 out of 33 (91%) participants who received the ActiGraph at baseline had at least 5 out of 7 valid days (minimum of 7 wear hours): excellent; 19 out of 27 (70%) participants who received the ActiGraph at posttest had at least 5 out of 7 days (minimum of 7 wear hours): good | 36 out of 39 participants (92%) who received the ActiGraph at baseline wore it for ≥5 out of 7 days: excellent; 29 out of 33 participants (88%) who received the ActiGraph at posttest wore it for 5 out of 7 days: excellent; 28 out of 39 participants (72%) who received the ActiGraph at baseline had at least 5 out of 7 valid (minimum of 7 wear hours): good; 25 out of 33 participants (76%) who received the ActiGraph posttest had at least 5 out of 7 valid (minimum of 7 wear hours): good; 34 out of 41 participants (83%) wore the Fitbit for at least 5 out of 7 days for 8 out of 10 weeks of the program: good |
Client satisfaction | 34 out of 34 participants (100%) scored above the scale midpoint: excellent | 35 out of 36 participants (97%) scored above the scale midpoint: excellent |
Program safety and adverse events | 3 participants were hospitalized for reasons unrelated to the program (1 for a lung infection, 1 for a pain flare, and 1 for a stroke); 1 patient reported Sciatica: excellent | 7 participants were hospitalized for reasons unrelated to the program (1 for sickle cell anemia flare-up; 1 for diverticulitis attack; 1 for chemotherapy; 1 for a pain flare; 1 for unknown reasons; 1 for falling; and 1 admitted twice for elevated heartrate, and then hurting leg); 1 patient reported a sprained quadricep muscle: good |
aFeasibility of recruitment and internal-reliability portion of the feasibility of quantitative measures are reported in the text for the entire sample.
As a whole, neither the
Participants in both the
Both groups exhibited significant improvements with medium effect size in both the WHODAS (
The
Both groups exhibited clinically meaningful and significant reductions in medium effect size in pain at rest (
Both groups showed significant and medium-sized effects for improvements in pain catastrophizing (
Both groups exhibited significant medium-sized effects for improvements in mindfulness (
Perceived improvement in pain, physical activity, and physical and emotional function were high for both programs. Improvement due to Fitbit was high in the
Outcome measures.
Measures | GetActive | GetActive-Fitbit | ||||||||||
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Baseline, mean (SD) | Posttest, mean (SD) | Pretest-posttest change, mean (95% CI) | Cohen |
Baseline, mean (SD) | Posttest, mean (SD) | Pretest-posttest change, mean (95% CI) | Cohen |
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ActiGraph average steps | 6330.57 (3556.10) | 6139.25 (3424.39) | 191.32 (−758.56 to 1141.19) | 0.42 (22) | .68 | 0.088 | 5447.55 (2597.42) | 5455.48 (2320.37) | −7.93 (−705.02 to 689.16) | −0.023 (29) | .98 | −0.00 |
6-min walk test distance (m) | 358.393 (85.11) | 399.14 (77.19) | −40.75 (−56.71 to −24.79) | −5.24 (27) | <.001 | −0.99 | 343.83 (77.56) | 393.58 (71.88) | −49.74 (−70.53 to −28.95) | −4.87 (32) | <.001 | −0.85 |
Physical function (PROMISa) | 40.55 (6.63) | 42.97 (7.46) | −2.41 (−4.10 to −0.72) | −2.90 (34) | .006 | −0.49 | 38.10 (7.86) | 40.76 (8.41) | −2.65 (−4.86 to −0.44) | −2.44 (36) | .02 | −0.40 |
Physical function (WHODASb) | 25.02 (15.52) | 17.45 (13.72) | 7.56 (3.39 to 11.73) | 3.684 (34) | .001 | 0.62 | 34.65 (21.02) | 27.13 (16.70) | 7.52 (0.96 to 14.09) | 2.32 (36) | .03 | 0.38 |
Self-reported physical activity | 9.60 (7.04) | 11.15 (8.51) | −1.55 (−4.64 to 1.55) | −1.02 (34) | .32 | −0.17 | 15.37 (18.65) | 17.13 (14.93) | −1.76 (−7.89 to 4.37) | −0.583 (36) | .56 | −0.09 |
Depression | 51.63 (10.34) | 49.34 (9.29) | 2.29 (−0.58 to 5.16) | 1.62 (34) | .11 | 0.27 | 59.47 (9.53) | 55.60 (7.72) | 3.87 (1.45 to 6.28) | 3.25 (35) | .003 | 0.54 |
Anxiety | 52.48 (10.14) | 50.81 (8.52) | 2.87 (−0.40 to 6.14) | 1.78 (34) | .08 | 0.30 | 58.87 (9.07) | 56.12 (9.50) | 2.95 (0.49 to 5.42) | 2.43 (36) | .02 | 0.40 |
Pain at rest | 4.77 (2.51) | 3.57 (2.5) | 1.2 (0.35 to 2.04) | 2.89 (34) | .007 | 0.49 | 5.78 (2.18) | 4.56 (2.16) | 1.22 (0.51 to 1.94) | 3.47 |
.001 | 0.58 |
Pain with activity | 6.63 (1.99) | 4.97 (2.54) | 1.66 (0.85 to 2.46) | 4.17 (34) | <.001 | 0.70 | 7.24 (2.23) | 6.08 (2.55) | 1.16 (0.51 to 1.81) | 3.62 (36) | .001 | 0.59 |
Pain resilience | 37.57 (9.65) | 43.49 (9.99) | −5.91 (−9.10 to −2.73) | −3.77 (34) | .001 | −0.64 | 33.16 (10.07) | 36.46 (11.11) | −3.30 (−7.24 to 0.64) | −1.70 (36) | .09 | −0.28 |
Pain catastrophizing | 18.34 (11.06) | 9.77 (7.66) | 8.57 (4.47 to 12.67) | 4.24 (34) | <.001 | 0.72 | 21.41 (11.94) | 16.36 (10.84) | 5.03 (1.13 to 8.93) | 2.61 (36) | .01 | 0.43 |
Kinesiophobia | 37.23 (7.72) | 30.76 (7.36) | 6.46 (3.41 to 9.52) | 4.30 (33) | <.001 | 0.74 | 38.86 (8.87) | 34.78 (8.25) | 4.08 (1.84 to 6.32) | 3.70 (36) | .001 | 0.61 |
Adaptive coping | 28.49 (1.56) | 36.37 (1.44) | −7.89 (−11.43 to −4.34) | −4.52 (34) | <.001 | 0.76 | 27.08 (1.65) | 34 (1.38) | −6.92 (−9.69 to −4.15) | −5.07 (36) | <.001 | 0.83 |
Mindfulness | 32.57 (6.58) | 36.31 (6.48) | −3.74 (−5.96 to −1.53) | −3.43 (34) | .002 | −0.58 | 30.43 (7.02) | 33.14 (6.18) | −2.70 (−4.76 to −0.64) | −2.66 (36) | .012 | −0.44 |
aPROMIS: Patient-Reported Outcomes Measurement Information System.
bWHODAS: World Health Organization Disability Assessment Schedule.
Perceived improvement of change (1=very much improved and 7=very much worse).
Group | Impression of change in pain | Impression of change in physical activity | Impression of change in physical function | Impression of change in emotional function | Impression of change in resiliency | Impression of change from use of Fitbit |
GetActive, mean (SD) | 2.51 (1.17) | 2.31 (1.18) | 2.57 (1.19) | 2.40 (1.01) | 2.14 (0.91) | N/Aa |
GetActive-Fitbit, mean (SD) | 2.70 (1.20) | 2.30 (1.10) | 2.78 (0.95) | 2.54 (0.84) | 2.32 (1.03) | 1.86 (0.95) |
aN/A: not applicable.
Previous intervention research in chronic pain has not comprehensively assessed improvement in physical function and has yielded modest improvements in self-reported emotional and physical function. To address this problem, we used evidence-based frameworks for intervention development and adaptation [
Consistent with our first hypothesis and the goals of both the ORBIT and NCCIH intervention development stage models, both programs met or exceeded the a-priori set feasibility benchmarks. Retention was considerably higher than other mind-body trials for chronic pain [
Consistent with our second hypothesis, we found that participation in both programs is associated with improvement in physical function. As this is not an efficacy trial, we limited analyses to effect sizes for within-group changes between pretest and posttest and refrained from between-group comparisons [
This study has several strengths. First, we used evidence-based frameworks and mixed methods to iteratively develop our mind-body program and refine our methodology. The study utilized strong scientific rigor and an RCT design that minimized the risks of selection bias and confounding. The emphasis on feasibility markers in preparation for efficacy is an additional strength of the study, which helps ensure the scientific rigor of the next step of the efficacy trial. Second, this study is the first RCT that follows recommendations from recent IMMPACT [
The results of this study provide strong evidence that 2 novel mind-body and physical activity programs for patients with chronic pain are feasible, acceptable, credible, and yield high satisfaction. Furthermore, the programs show potential for improvement in physical function, pain and related coping, and other psychosocial variables. This study supports future testing of
GetActive and GetActive-Fitbit program development.
Participant flow.
Program content.
CONSORT-EHEALTH checklist (V 1.6.1).
cognitive and affective mindfulness scale-revised
International Classification of Functioning, Disability and Health
Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials
minimum clinically important difference
measures of current status
National Center for Complementary and Integrative Health
numerical rating scale
Obesity Related Behavioral Intervention Trials
self-reported physical activity scale for individuals with physical disabilities
Patient-Reported Outcomes Measurement Information System
randomized controlled trial
Specific, Measurable, Achievable, Relevant and Time-based
World Health Organization Disability Assessment Schedule
This study was funded by an R34 grant from the National Center for Complementary and Integrative Health (1R34AT009356-01A1) to the senior author.
EM served as a Data Safety Monitoring Board member for Novartis Pharmaceuticals and Shire Human Genetic Therapies; served on an advisory committee for Biogen; consulted for Cerevance, Intrance, Inventram, Lavin Consulting, and Myolex; and his institution received grants on his behalf from Amylyx Pharmaceuticals, GlaxoSmithKline, and Mitsubishi Tanabe Pharmaceuticals. All other authors declare that they have no relevant conflicts of interest.