The Positive Piggy Bank - A Positive Activities Intervention for Improving Functional Status in Patients With Back Pain
Completed · Not applicable
Conditions studied: Low Back Pain
In brief
Investigators will conduct a randomized controlled trial of a 30-day positive activities intervention, Positive Piggy Bank, compared to a Wait-List control group (Figure 2). Prior to their scheduled appointment to undergo epidural steroid injection, all patients meeting study criteria will be contacted by research staff to be invited to participate in this study. Those interested will be asked to arrive 45 minutes before their regularly scheduled appointment. At that time they will learn more about the study and provide informed consent if they choose to participate. Participants will then complete the study questionnaires and be randomized 1:1 to the Positive Piggy Bank condition (n=100) or the Wait List control group (n = 100). All participants will receive the usual treatment provided at the Back \& Pain Center at the University of Michigan, Department of Anesthesiology (e.g., maintenance of medication regimen, standard office visits). Post-intervention (Day 30) and 2 months after that (Day 90), participants will complete the same questionnaires by mail. The primary outcome will be improved functional status, while secondary outcomes will be symptomatic (i.e., pain, fatigue and sleep) and related to mood and well-being. After the study period, the patients in the Wait List control will be offered the Positive Piggy Bank intervention and will be asked to complete one more set of questionnaires at 30 days by mail.
Key facts
- Study ID
- NCT02476812
- Run by
- University of Michigan
- People needed
- 200
- Starts
- 2015-06-01
- Expected to finish
- 2023-12-01
- Last updated by the study team
- 2026-03-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
Where it is running
- Back & Pain Center, University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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