NCT02476812

The Positive Piggy Bank - A Positive Activities Intervention for Improving Functional Status in Patients With Back Pain

Completed NA Results posted Last updated 10 February 2026

What this trial tests

NA trial testing Positive Piggy Bank in Low Back Pain in 200 participants. Completed in 1 December 2023.

Timeline

1 June 2015

Primary endpoint
1 December 2023

1 December 2023

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	1 June 2015
Primary completion	1 December 2023
Estimated completion	1 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Positive Piggy Bank

Conditions studied

• Low Back Pain — all drugs for Low Back Pain →

Sponsor

University of Michigan

Who can join

Adults 18 to 80, any sex, with Low Back Pain. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Functional Status Measured by Oswestry Disability Questionnaire
  Time frame: Baseline (T1), 30 days (T2), and 90 days (T3)
  This questionnaire consists of 10 questions. Participants will select one of six options for each question, ranging from no extra pain (0) to the worst pain imaginable (5). Total scores can range from 0 to 50 points, where higher scores indicate higher pain intensity and more significant areas of disability.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.