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NCT Number: NCT02476812

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Back & Pain Center, University of Michigan

Ann Arbor, Michigan, 48106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • ages 18 to 80;
  • able to read/understand English and give consent;
  • willing and able to comply with all aspects of study procedures;
  • if on antidepressants, medications stable for ≥4 weeks prior to study;
  • 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);
  • 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:

  • 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;
  • currently undergoing psychotherapeutic care at the Back & Pain Center;
  • 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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Treatment and study plan

Positive Piggy Bank

Behavioral

Already noted.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Pain Severity - Brief Pain Inventory (BPI)

    Time frame: approximately 30 days

    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.

  2. Change in Fatigue. PROMIS Fatigue - Short Form 4a

    Time frame: Baseline (T1), approximately 90 days (T3)

    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.

  3. Change in Perceived Sleep Problems - PROMIS -Sleep Disturbance (PROMIS-SD4a)

    Time frame: Baseline (T1) approximately 90 days (T3)

    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.

  4. Change in Depression and Anxiety- Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline (T1), approximately 90 days (T3)

    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).

  5. Change in Happiness - Subjective Happiness Scale.

    Time frame: Baseline (T1) to approximately 90 days (T3)

    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).

  6. Change in Subjective Well-Being Affect - Positive and Negative Affect Scale (PANAS)

    Time frame: Baseline (T1), approximately 90 days (T3)

    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.

  7. Change in Subjective Well-Being Life Satisfaction - Satisfaction With Life Scale (SWLS)

    Time frame: Baseline (T1), approximately 90 days (T3)

    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.

  8. Change in Fibromyalgia Symptoms - Fibromyalgia Survey Criteria

    Time frame: Baseline (T1), approximately 90 days (T3)

    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.

  9. Patient Global Impression of Change (PGIC)

    Time frame: 30 days (T2)

    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.

  10. Change in Patient Satisfaction - Patient Satisfaction Numeric Rating Scale

    Time frame: 30 days (T2) to 90 days (T3)

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Jun 19, 2015
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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