# Improving multimodal physical function in adults with heterogeneous chronic pain; Multi-site feasibility RCT

> **NIH NIH R01** · MASSACHUSETTS GENERAL HOSPITAL · 2022 · $580,945

## Abstract

PROJECT SUMMARY
Chronic pain is costly, challenging to treat, and associated with substantial impairment in physical function. Mild physical
activity such as walking is safe but engagement and adherence are problematic. IMMPACT criteria and the ICF frameworks
recommend that all chronic pain clinical trials assess and target physical function comprehensively using not only self-
report, but also performance based and ambulatory monitoring of activity (e.g., objective). No clinical trials to date have
followed these recommendations. A mind body program adapted for the unique needs of individuals with chronic
musculoskeletal pain that incorporates activity skills to help individuals increase step count using a Fitbit to provide
accountability to goals may be efficacious in improving all aspects of physical function. To begin testing these hypotheses
we completed an R34 NCCIH funded project, in which we: 1) adapted a multimodal, theory grounded mind body program
(The Relaxation Response Resilience Program; 3RP) for the unique needs of patients with chronic non-malignant,
musculoskeletal pain and to specifically target increased walking (their preferred activity) through time goals (GetActive)
or step count goals measured and reinforced by a Fitbit (GetActive-Fitbit); 2) completed an open pilot with exit interviews
of the 2 programs; and 3) conducted an RCT of the 2 programs and established single site feasibility, acceptability and
fidelity benchmarks including similar signal of improvement in physical function measurements. Directly building upon
this successful trial, we now propose a multisite pilot RCT implemented at MGH and 2 additional geographically diverse
sites (Rush and Duke) of GetActive-Fitbit (with evidence of superiority over GetActive from quantitative and qualitative
data) vs a Health Enhancement Program (HEP). We will establish: 1) multi-site fidelity to training and protocol; and 2)
multi-site feasibility and acceptability of study procedures including recruitment of sedentary individuals who benefit the
most from this program and a sample of racial and ethnic minorities that is representative of the USA (38%, 2020
numbers) .We will also refine our protocols using qualitative information from staff and participants to set the stage for a
large, multi-site efficacy RCT and subsequent implementation of GetActive-Fitbit in routine care of chronic pain patients.

## Key facts

- **NIH application ID:** 10509806
- **Project number:** 1R01AT012069-01
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Jonathan Greenberg
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $580,945
- **Award type:** 1
- **Project period:** 2022-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10509806

## Citation

> US National Institutes of Health, RePORTER application 10509806, Improving multimodal physical function in adults with heterogeneous chronic pain; Multi-site feasibility RCT (1R01AT012069-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10509806. Licensed CC0.

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