N/A Completed N=500 Randomized Double-blind Treatment

A Proactive Walking Trial to Reduce Pain in Black Veterans

Postoperative Pain

Source: ClinicalTrials.gov NCT01983228 ↗

Enrolled (actual)

500

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcomePrimary: 30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months — 38; 46 participants w/ >= 30% improvement — p=0.09

Summary

The long term goal is to improve the quality and equity of chronic pain treatment among VA patients. The primary objective of this study is to improve pain outcomes among black VA patients with chronic, musculoskeletal (MSK) pain, who experience poorer pain treatment and outcomes than their white counterparts. The work proposed is expected to result in a non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve functioning among black patients with MSK pain, by promoting walking. This intervention is specifically designed to address factors that contribute to MSK pain among black Veterans; however, the investigators expect that it will also benefit non-black Veterans. The proposed research is innovative, in its use of proactive outreach and recent advances in self-regulation strategies (such as Action Planning) to help black Veterans overcome psychological, environmental, utilization-related, and provider-related barriers that contribute to pain.

Outcome Measures

Outcome	Result	p-value
PRIMARY 30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months	38; 46	0.09
SECONDARY Change in Brief Pain Intensity Scale at 6 Months	-0.24; -0.45	0.34
SECONDARY Change in Generalized Anxiety Disorder at 6 Months	-0.43; -0.95	0.38
SECONDARY Change in Depression at 6 Months	-0.96; -1.56	0.28
SECONDARY Overall Improvement Assessed by Patient Global Impression of Change Scale at 6 Months	3.87; 4.26	0.05
SECONDARY Mean Change in Average Daily Total Steps at 6 Months	397.21; 591.11	0.56
SECONDARY 30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 3 Months	34; 40	0.16
SECONDARY Change in Brief Pain Intensity Scale at 3 Months	0.02; -0.58	0.002 sig
SECONDARY Change in Generalized Anxiety Disorder, at 3 Months	-0.75; -0.39	0.54
SECONDARY Change in Depression Using 3 Month	-1.27; -0.79	0.41
SECONDARY Overall Improvement Assessed by Patient Global Impression of Change Scale at 3 Months	4.51; 3.79	<0.0001 sig
SECONDARY Mean Change in Average Daily Total Steps, at 3 Months	92.97; 633.75	0.06

Eligibility Criteria

Inclusion Criteria

Eligible patients must receive care at the Atlanta VAMC and
have back, hip or knee pain for a duration of at least 6 months,
moderate-severe pain intensity and interference with function (defined as a PEG score of 5 or greater),
self-reported ability to walk at least 1 block, and
must be able to communicate effectively by telephone (no cognitive disability). The investigators will not exclude patients who are on medication or receiving interventions to treat their chronic pain. The investigators will include the approximately 10% of patients who have no race data; race data will be collected on the brief screening survey.

Exclusion Criteria

The investigators will not include any vulnerable populations or those who meet any of the following exclusion criteria that may interfere with the outcome assessment: a) moderately severe cognitive impairment defined as > 2 errors on a brief cognitive screener; b) anticipated back, knee, hip, or other major surgery within the next 6 months; c) patients who say they are unable to walk at least a block; d) patients who say they would be unavailable to participate in a 6 month study; e) patients with active psychotic symptoms, suicidality, and/or active manic episode or poorly controlled bipolar disorder, as determined by chart review.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01983228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.