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.
COMPLETED
NA
200 participants
Baseline (T1), 30 days (T2), and 90 days (T3)
2026-03-02
Participant Flow
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
| 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
| 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
| 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 daysPopulation: 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
Waitlist Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place