Trial Outcomes & Findings for The Positive Piggy Bank - A Positive Activities Intervention for Improving Functional Status in Patients With Back Pain (NCT NCT02476812)

NCT ID: NCT02476812

Last Updated: 2026-03-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

200 participants

Primary outcome timeframe

Baseline (T1), 30 days (T2), and 90 days (T3)

Results posted on

2026-03-02

Participant Flow

Participant milestones

Participant milestones
Measure
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. Positive Piggy Bank: Already noted.
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.
Overall Study
STARTED
60
60
Overall Study
Completed Baseline
57
58
Overall Study
30 Days Post Enrollment
47
47
Overall Study
Optional Treatment - 90 Days Post Enrollment
0
18
Overall Study
COMPLETED
43
44
Overall Study
NOT COMPLETED
17
16

Reasons for withdrawal

Reasons for withdrawal
Measure
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. Positive Piggy Bank: Already noted.
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.
Overall Study
Withdrawal by Subject
3
2
Overall Study
Lost to Follow-up
14
14

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Positive Piggy Bank
n=57 Participants
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. Positive Piggy Bank: Already noted.
Waitlist Control
n=58 Participants
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.
Total
n=115 Participants
Total of all reporting groups
Age, Continuous
55.4 years
STANDARD_DEVIATION 14.2 • n=41 Participants
57.1 years
STANDARD_DEVIATION 14.6 • n=35 Participants
56.3 years
STANDARD_DEVIATION 14.3 • n=76 Participants
Sex: Female, Male
Female
33 Participants
n=41 Participants
32 Participants
n=35 Participants
65 Participants
n=76 Participants
Sex: Female, Male
Male
24 Participants
n=41 Participants
26 Participants
n=35 Participants
50 Participants
n=76 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=76 Participants
Race (NIH/OMB)
Asian
0 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=76 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=76 Participants
Race (NIH/OMB)
Black or African American
7 Participants
n=41 Participants
2 Participants
n=35 Participants
9 Participants
n=76 Participants
Race (NIH/OMB)
White
49 Participants
n=41 Participants
54 Participants
n=35 Participants
103 Participants
n=76 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=76 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=41 Participants
2 Participants
n=35 Participants
3 Participants
n=76 Participants
Region of Enrollment
United States
57 Participants
n=41 Participants
58 Participants
n=35 Participants
115 Participants
n=76 Participants

PRIMARY outcome

Timeframe: Baseline (T1), 30 days (T2), and 90 days (T3)

Population: As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased.

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.

Outcome measures

Outcome measures
Measure
Positive Piggy Bank
n=57 Participants
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. Positive Piggy Bank: Already noted.
Waitlist Control
n=58 Participants
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.
Change in Functional Status Measured by Oswestry Disability Questionnaire
Baseline (T1)
41.5 units on a scale
Standard Deviation 15.1
39.0 units on a scale
Standard Deviation 12.1
Change in Functional Status Measured by Oswestry Disability Questionnaire
30 Days (T2)
37.1 units on a scale
Standard Deviation 17.8
32.8 units on a scale
Standard Deviation 16.3
Change in Functional Status Measured by Oswestry Disability Questionnaire
90 Days (T3)
38.7 units on a scale
Standard Deviation 18.0
33.6 units on a scale
Standard Deviation 14.5

SECONDARY outcome

Timeframe: approximately 30 days

Population: As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased.

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.

Outcome measures

Outcome measures
Measure
Positive Piggy Bank
n=57 Participants
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. Positive Piggy Bank: Already noted.
Waitlist Control
n=58 Participants
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.
Change in Pain Severity - Brief Pain Inventory (BPI)
Baseline (T1)
6.1 units on a scale
Standard Deviation 1.6
5.7 units on a scale
Standard Deviation 1.5
Change in Pain Severity - Brief Pain Inventory (BPI)
30 days post treatment (T3)
5.2 units on a scale
Standard Deviation 2.2
4.7 units on a scale
Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline (T1), approximately 90 days (T3)

Population: As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased.

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.

Outcome measures

Outcome measures
Measure
Positive Piggy Bank
n=57 Participants
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. Positive Piggy Bank: Already noted.
Waitlist Control
n=58 Participants
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.
Change in Fatigue. PROMIS Fatigue - Short Form 4a
Baseline (T1)
12.1 units on a scale
Standard Deviation 3.8
11.2 units on a scale
Standard Deviation 3.9
Change in Fatigue. PROMIS Fatigue - Short Form 4a
90 Days (T3)
11.4 units on a scale
Standard Deviation 4.3
10.5 units on a scale
Standard Deviation 3.8

SECONDARY outcome

Timeframe: Baseline (T1) approximately 90 days (T3)

Population: As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased.

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.

Outcome measures

Outcome measures
Measure
Positive Piggy Bank
n=57 Participants
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. Positive Piggy Bank: Already noted.
Waitlist Control
n=58 Participants
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.
Change in Perceived Sleep Problems - PROMIS -Sleep Disturbance (PROMIS-SD4a)
Baseline (T1)
12.3 units on a scale
Standard Deviation 3.0
12.4 units on a scale
Standard Deviation 3.4
Change in Perceived Sleep Problems - PROMIS -Sleep Disturbance (PROMIS-SD4a)
90 Days (T3)
11.6 units on a scale
Standard Deviation 3.6
11.6 units on a scale
Standard Deviation 3.6

SECONDARY outcome

Timeframe: Baseline (T1), approximately 90 days (T3)

Population: As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased.

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).

Outcome measures

Outcome measures
Measure
Positive Piggy Bank
n=57 Participants
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. Positive Piggy Bank: Already noted.
Waitlist Control
n=58 Participants
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.
Change in Depression and Anxiety- Hospital Anxiety and Depression Scale (HADS)
Change in Anxiety: Baseline (T1)
7.0 units on a scale
Standard Deviation 3.2
5.7 units on a scale
Standard Deviation 3.6
Change in Depression and Anxiety- Hospital Anxiety and Depression Scale (HADS)
Change in Depression: Baseline (T1)
6.3 units on a scale
Standard Deviation 3.7
5.2 units on a scale
Standard Deviation 3.2
Change in Depression and Anxiety- Hospital Anxiety and Depression Scale (HADS)
Change in Anxiety: 90Days (T3)
6.5 units on a scale
Standard Deviation 3.1
4.9 units on a scale
Standard Deviation 3.7
Change in Depression and Anxiety- Hospital Anxiety and Depression Scale (HADS)
Change in Depression: 90 Days (T3)
5.7 units on a scale
Standard Deviation 3.9
5.3 units on a scale
Standard Deviation 3.9

SECONDARY outcome

Timeframe: Baseline (T1) to approximately 90 days (T3)

Population: As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased.

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).

Outcome measures

Outcome measures
Measure
Positive Piggy Bank
n=57 Participants
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. Positive Piggy Bank: Already noted.
Waitlist Control
n=58 Participants
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.
Change in Happiness - Subjective Happiness Scale.
Baseline (T1)
20.8 units on a scale
Standard Deviation 4.5
21.5 units on a scale
Standard Deviation 4.2
Change in Happiness - Subjective Happiness Scale.
90 Days (T3)
20.2 units on a scale
Standard Deviation 4.2
20.3 units on a scale
Standard Deviation 5.4

SECONDARY outcome

Timeframe: Baseline (T1), approximately 90 days (T3)

Population: As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased.

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.

Outcome measures

Outcome measures
Measure
Positive Piggy Bank
n=57 Participants
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. Positive Piggy Bank: Already noted.
Waitlist Control
n=58 Participants
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.
Change in Subjective Well-Being Affect - Positive and Negative Affect Scale (PANAS)
Positive Affect: Baseline (T1)
29.8 units on a scale
Standard Deviation 7.4
30.0 units on a scale
Standard Deviation 8.0
Change in Subjective Well-Being Affect - Positive and Negative Affect Scale (PANAS)
Negative Affect: Baseline (T1)
18.7 units on a scale
Standard Deviation 7.3
17.2 units on a scale
Standard Deviation 6.6
Change in Subjective Well-Being Affect - Positive and Negative Affect Scale (PANAS)
Positive Affect: 90 Days (T3)
30.5 units on a scale
Standard Deviation 8.0
30.8 units on a scale
Standard Deviation 9.3
Change in Subjective Well-Being Affect - Positive and Negative Affect Scale (PANAS)
Negative Affect: 90 Days (T3)
17.0 units on a scale
Standard Deviation 5.3
15.3 units on a scale
Standard Deviation 5.1

SECONDARY outcome

Timeframe: Baseline (T1), approximately 90 days (T3)

Population: As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased. Participants could also choose to not answer any question.

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.

Outcome measures

Outcome measures
Measure
Positive Piggy Bank
n=57 Participants
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. Positive Piggy Bank: Already noted.
Waitlist Control
n=58 Participants
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.
Change in Subjective Well-Being Life Satisfaction - Satisfaction With Life Scale (SWLS)
Baseline (T1)
22.1 units on a scale
Standard Deviation 6.9
23.9 units on a scale
Standard Deviation 7.8
Change in Subjective Well-Being Life Satisfaction - Satisfaction With Life Scale (SWLS)
90 Days (T3)
22.2 units on a scale
Standard Deviation 7.3
22.1 units on a scale
Standard Deviation 8.2

SECONDARY outcome

Timeframe: Baseline (T1), approximately 90 days (T3)

Population: As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased. Participants could also choose to not answer any question.

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.

Outcome measures

Outcome measures
Measure
Positive Piggy Bank
n=57 Participants
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. Positive Piggy Bank: Already noted.
Waitlist Control
n=58 Participants
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.
Change in Fibromyalgia Symptoms - Fibromyalgia Survey Criteria
Baseline (T1)
10.8 score on a scale
Standard Deviation 5.2
9.8 score on a scale
Standard Deviation 4.0
Change in Fibromyalgia Symptoms - Fibromyalgia Survey Criteria
90 Days (T3)
9.9 score on a scale
Standard Deviation 5.4
8.4 score on a scale
Standard Deviation 4.0

SECONDARY outcome

Timeframe: 30 days (T2)

Population: This question was not asked of the waitlist control participants during the control period. Waitlist Control participants who continued to the optional treatment portion of the trial were given the option of submitting this survey 30 days post treatment. Data shown reflects the number of participants who submitted this survey. Additionally, some Positive Piggy Bank arm participants were lost to follow up.

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.

Outcome measures

Outcome measures
Measure
Positive Piggy Bank
n=47 Participants
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. Positive Piggy Bank: Already noted.
Waitlist Control
n=6 Participants
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.
Patient Global Impression of Change (PGIC)
Much Worse
2 Participants
0 Participants
Patient Global Impression of Change (PGIC)
Very Much Worse
0 Participants
0 Participants
Patient Global Impression of Change (PGIC)
Very Much Improved
2 Participants
0 Participants
Patient Global Impression of Change (PGIC)
Much Improved
11 Participants
0 Participants
Patient Global Impression of Change (PGIC)
Minimally Improved
13 Participants
2 Participants
Patient Global Impression of Change (PGIC)
No Change
19 Participants
3 Participants
Patient Global Impression of Change (PGIC)
Minimally Worse
0 Participants
1 Participants

SECONDARY outcome

Timeframe: 30 days (T2) to 90 days (T3)

Population: As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased.

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.

Outcome measures

Outcome measures
Measure
Positive Piggy Bank
n=57 Participants
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. Positive Piggy Bank: Already noted.
Waitlist Control
n=58 Participants
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.
Change in Patient Satisfaction - Patient Satisfaction Numeric Rating Scale
30 Days (T2)
8.4 units on a scale
Standard Deviation 2.0
8.0 units on a scale
Standard Deviation 2.3
Change in Patient Satisfaction - Patient Satisfaction Numeric Rating Scale
90 Days (T3)
8.3 units on a scale
Standard Deviation 2.3
7.7 units on a scale
Standard Deviation 2.9

Adverse Events

Positive Piggy Bank

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Waitlist Control

Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Positive Piggy Bank
n=57 participants at risk
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. Positive Piggy Bank: Already noted.
Waitlist Control
n=58 participants at risk
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.
Cardiac disorders
Stent Placement
0.00%
0/57 • 90 days
Severe AE - Inability to carry on normal activities, required professional medical or psychiatric attention.
1.7%
1/58 • Number of events 1 • 90 days
Severe AE - Inability to carry on normal activities, required professional medical or psychiatric attention.
General disorders
Cirrhosis
0.00%
0/57 • 90 days
Severe AE - Inability to carry on normal activities, required professional medical or psychiatric attention.
1.7%
1/58 • Number of events 1 • 90 days
Severe AE - Inability to carry on normal activities, required professional medical or psychiatric attention.

Other adverse events

Adverse event data not reported

Additional Information

Afton L. Hassett, PsyD

Back & Pain Center Clinical Research

Phone: 734-763-5226

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place