Low Back PainNCT02476812
The Positive Piggy Bank - A Positive Activities Intervention for Improving Functional Status in Patients With Back Pain
A study testing Positive Piggy Bank in people with Low Back Pain, run by University of Michigan at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Positive Piggy Bank
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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. -
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. -
Trial locations and contacts
1 site in 1 country.
United States1 site
Back & Pain Center, University of Michigan
Ann Arbor, Michigan, 48106
About this study
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.
- Conditions
- Low Back Pain
- Being tested
- Positive Piggy Bank
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Piggy BankBehavioural
Already noted.
| Study group | Role | What they receive |
|---|---|---|
| Positive Piggy Bank | Experimental | 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. Receives: Behavioral: Positive Piggy Bank |
| Waitlist Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T1), 30 days (T2), and 90 days (T3)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days (T2) to 90 days (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afton Hassett, Psy.D., University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476812
- Sponsor's protocol ID
- HUM00100068
- Status last verified
- Dec 2025
- First submitted
- 17 Jun 2015
- Last updated
- 2 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Positive Piggy Bank - A Positive Activities Intervention for Improving Functional Status in Patients With Back Pain
- ClinicalTrials.gov ID
- NCT02476812
- Acronym / sponsor ID
- HUM00100068
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Posted 2 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Piggy Bank | Experimental | Behavioral: Positive Piggy BankPatients 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. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Piggy BankAlready noted. | Behavioural | Positive Piggy Bank |
Primary outcome
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.
10 secondary outcomes
Change in Pain Severity - Brief Pain Inventory (BPI)
Time frame: approximately 30 days
Change in Fatigue. PROMIS Fatigue - Short Form 4a
Time frame: Baseline (T1), approximately 90 days (T3)
Change in Perceived Sleep Problems - PROMIS -Sleep Disturbance (PROMIS-SD4a)
Time frame: Baseline (T1) approximately 90 days (T3)
Change in Depression and Anxiety- Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (T1), approximately 90 days (T3)
Change in Happiness - Subjective Happiness Scale.
Time frame: Baseline (T1) to approximately 90 days (T3)
Change in Subjective Well-Being Affect - Positive and Negative Affect Scale (PANAS)
Time frame: Baseline (T1), approximately 90 days (T3)
Change in Subjective Well-Being Life Satisfaction - Satisfaction With Life Scale (SWLS)
Time frame: Baseline (T1), approximately 90 days (T3)
Change in Fibromyalgia Symptoms - Fibromyalgia Survey Criteria
Time frame: Baseline (T1), approximately 90 days (T3)
Patient Global Impression of Change (PGIC)
Time frame: 30 days (T2)
Change in Patient Satisfaction - Patient Satisfaction Numeric Rating Scale
Time frame: 30 days (T2) to 90 days (T3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Piggy Bank in people with Low Back Pain, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Status Measured by Oswestry Disability Questionnaire (time frame: Baseline (T1), 30 days (T2), and 90 days (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.