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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: Positive Piggy Bank

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Back & Pain Center, University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Primary diagnosis of back pain and schedule to undergo an epidural steroid injection. :

1. ages 18 to 80;
2. able to read/understand English and give consent;
3. willing and able to comply with all aspects of study procedures;
4. if on antidepressants, medications stable for ≥4 weeks prior to study;
5. no plan to initiate a new non-pharmacological pain intervention during the 30-day study period (e.g., back surgery, physical therapy, cognitive-behavioral therapy);

6. if on pain medications, medications stable for ≥4 weeks prior to study and no plans to switch medications during the 30-day study period.

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Exclusion Criteria: Participants may meet all criteria above, but will be excluded under the following additional conditions:

1. having a known psychotic disorder or the presence of another psychiatric condition (e.g., severe depression, suicidal ideation) or cognitive impairment (e.g., severe dyslexia, traumatic brain injury) limiting ability to give consent and/or participate fully in the study;
2. currently undergoing psychotherapeutic care at the Back & Pain Center;

3. other factors that at the discretion of the investigators would adversely affect study participation. We will not exclude participants who undergo unanticipated changes in treatment, but will handle these data as described later.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive Piggy Bank; Patients randomized to this group will meet with a research assistant who provides an overview of the intervention, explains the rationale for this treatment, and then gives the patients the instructions, piggy bank, and currency slips. Participants in this group will receive instructions. At the end of the monitoring period, 30 days, they are to "close their account" by opening the piggy bank and reviewing all of the slips of paper. Study personnel will contact patients within 72 hours to answer questions. Participants will also be contacted at 30 days to let patients know that they should read all of their currency slips in one sitting. They are also told that the intervention part of the study is over and are asked they complete the follow up questionnaires. Then, study personnel will call again to let the participant know that the second set of questionnaires will be arriving by mail.	Behavioral: Positive Piggy Bank; Already noted.
No Intervention: Waitlist Control; The control group will serve to show the relative benefits of the Positive Piggy Bank intervention. Those in the control group who meet study criteria will also receive regular care after their epidural steroid injection (e.g., physician visits, medication maintenance, standard patient education). These patients will follow the same questionnaire follow up procedures as listed above including phone calls. The phone call at 72 hours will be to simply thank them for their participation in the study. At the end of the study period, approximately three months, Wait List control patients will also be offered the Positive Piggy Bank intervention along with the supportive phone calls. Should they choose to try the Positive Piggy Bank intervention, they will be required to return to the center to pick up supplies and receive instruction. They will also complete study questionnaires by mail at 30 days to assess intra-individual change.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Status Measured by Oswestry Disability Questionnaire	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.	Baseline (T1), 30 days (T2), and 90 days (T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Severity - Brief Pain Inventory (BPI)	There are 4 questions in this questionnaire. For each question, participants will select one of eleven options, ranging from "no pain" (0) to "pain as bad as you can imagine" (10). Then each participant's score was averaged from T1 and T3. Total scores range from 0 to 10. Participants in the active and waitlist were both given the survey 30 days after enrollment. Waitlist control participants did not receive the survey after their optional treatment.	approximately 30 days
Change in Fatigue. PROMIS Fatigue - Short Form 4a	There are 4 questions in this questionnaire. For each question, participants will select one of five options, ranging from "not at all" (1) to "very much" (5). Total scores can range from 4 to 20 points, where higher scores indicate higher fatigue.	Baseline (T1), approximately 90 days (T3)
Change in Perceived Sleep Problems - PROMIS -Sleep Disturbance (PROMIS-SD4a)	There are 4 questions in this questionnaire. For each question, participants will select one of five options. Question 1 participants will select from "very poor" (5) to "very good" (1). Questions 2-4 participants will select from "not at all" (5) to "very much" (1). Total scores can range from 4 to 20 points, where higher scores indicate higher sleep disturbance.	Baseline (T1) approximately 90 days (T3)
Change in Depression and Anxiety- Hospital Anxiety and Depression Scale (HADS)	There are 14 questions in this questionnaire. The anxiety and depression questions are scored separately with seven questions for both categories. For each question, participants will select one of four options, and total scores for each category can range from 0 to 21 points, where higher scores indicate higher anxiety or depression. . The anxiety question range from a variation of most of the time (3) and not at all (0). The depression questions range from a variation of definitely (0) to not at all (3).	Baseline (T1), approximately 90 days (T3)
Change in Happiness - Subjective Happiness Scale.	There are 4 questions in this questionnaire. For each question, participants will select one of seven options, and total scores can range from 7 to 28 points, where higher scores indicate greater levels of happiness. Questions 1 to 3 range from a variation of "not at all' (1) to a variation of "a great deal" (7). Question 4 is reversed codes, so the answers range from "not at all" (7) to "a great deal" (1).	Baseline (T1) to approximately 90 days (T3)
Change in Subjective Well-Being Affect - Positive and Negative Affect Scale (PANAS)	This questionnaire consists of two mood scales, Positive and Negative, with 10 questions each. For each question, participants will select one of five options, ranging from "very slightly or not at all" (1) to "extremely" (5). The statements were separated into the Positive and Negative categories and summed to make a final score. The final scores for both the Positive and Negative Affect can range from 10 to 50 points. The higher scores in the Positive Affect indicate higher positive emotions. The higher scores in the Negative Affect indicate higher negative emotions.	Baseline (T1), approximately 90 days (T3)
Change in Subjective Well-Being Life Satisfaction - Satisfaction With Life Scale (SWLS)	This questionnaire consists of five questions. For each question, participants will select one of seven options, ranging from "strongly disagree" (1) to "strongly agree" (7). Total scores can range from 7 to 35 points, where higher scores indicate higher life satisfaction.	Baseline (T1), approximately 90 days (T3)
Change in Fibromyalgia Symptoms - Fibromyalgia Survey Criteria	There are 8 questions in this questionnaire. Questions 1 to 3 participants can select one of 4 options, "no problem" (0) to "severe" (3). Questions 4 to 7, participants can select from one of two options, "no" (0) and "yes" (1). Question 8, is a map of the human body and participants can select multiple. The scale is a continuous with a range of 0-31, where higher scores indicate higher fibromyalgia-like symptoms.	Baseline (T1), approximately 90 days (T3)
Patient Global Impression of Change (PGIC)	There is one question in this survey about the participant's perception of their improvement post treatment. Participants will select one of seven options. The answers ranged from "very much worse" (-3) to "very much improved" (3). A higher score indicates greater improvement since the start of the study.	30 days (T2)
Change in Patient Satisfaction - Patient Satisfaction Numeric Rating Scale	There is one question, and participants will select one of eleven options. The answers ranged from "extremely dissatisfied" (0) to "extremely satisfied" (10). A higher score indicates greater satisfaction.	30 days (T2) to 90 days (T3)

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: June 17, 2015
• First Submitted That Met QC Criteria: June 18, 2015
• First Posted (Estimated): June 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain
• Other Study ID Numbers: HUM00100068