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Investigators will conduct a randomized controlled trial of a 30-day positive activities intervention, Positive Piggy Bank, compared to a Wait-List control group (Figure 2). Prior to their scheduled appointment to undergo epidural steroid injection, all patients meeting study criteria will be contacted by research staff to be invited to participate in this study. Those interested will be asked to arrive 45 minutes before their regularly scheduled appointment. At that time they will learn more about the study and provide informed consent if they choose to participate. Participants will then complete the study questionnaires and be randomized 1:1 to the Positive Piggy Bank condition (n=100) or the Wait List control group (n = 100). All participants will receive the usual treatment provided at the Back & Pain Center at the University of Michigan, Department of Anesthesiology (e.g., maintenance of medication regimen, standard office visits). Post-intervention (Day 30) and 2 months after that (Day 90), participants will complete the same questionnaires by mail. The primary outcome will be improved functional status, while secondary outcomes will be symptomatic (i.e., pain, fatigue and sleep) and related to mood and well-being. After the study period, the patients in the Wait List control will be offered the Positive Piggy Bank intervention and will be asked to complete one more set of questionnaires at 30 days by mail.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Piggy Bank | Behavioral | Already noted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Status Measured by Oswestry Disability Questionnaire | This questionnaire consists of 10 questions. Participants will select one of six options for each question, ranging from no extra pain (0) to the worst pain imaginable (5). Total scores can range from 0 to 50 points, where higher scores indicate higher pain intensity and more significant areas of disability. | Baseline (T1), 30 days (T2), and 90 days (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Severity - Brief Pain Inventory (BPI) | There are 4 questions in this questionnaire. For each question, participants will select one of eleven options, ranging from "no pain" (0) to "pain as bad as you can imagine" (10). Then each participant's score was averaged from T1 and T3. Total scores range from 0 to 10. Participants in the active and waitlist were both given the survey 30 days after enrollment. Waitlist control participants did not receive the survey after their optional treatment. |
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Inclusion Criteria: Primary diagnosis of back pain and schedule to undergo an epidural steroid injection. :
ages 18 to 80;
able to read/understand English and give consent;
willing and able to comply with all aspects of study procedures;
if on antidepressants, medications stable for ≥4 weeks prior to study;
no plan to initiate a new non-pharmacological pain intervention during the 30-day study period (e.g., back surgery, physical therapy, cognitive-behavioral therapy);
if on pain medications, medications stable for ≥4 weeks prior to study and no plans to switch medications during the 30-day study period.
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Exclusion Criteria: Participants may meet all criteria above, but will be excluded under the following additional conditions:
having a known psychotic disorder or the presence of another psychiatric condition (e.g., severe depression, suicidal ideation) or cognitive impairment (e.g., severe dyslexia, traumatic brain injury) limiting ability to give consent and/or participate fully in the study;
currently undergoing psychotherapeutic care at the Back & Pain Center;
other factors that at the discretion of the investigators would adversely affect study participation. We will not exclude participants who undergo unanticipated changes in treatment, but will handle these data as described later.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Back & Pain Center, University of Michigan | Ann Arbor | Michigan | 48106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
60 participants were enrolled in each arm of the study. We excluded the 5 participants that withdrew from the final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased. | Posted | Mean | Standard Deviation | units on a scale | Baseline (T1), 30 days (T2), and 90 days (T3) |
|
90 days
Severe AE - Inability to carry on normal activities, required professional medical or psychiatric attention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stent Placement | Cardiac disorders | NCI CTC Grade 3 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Afton L. Hassett, PsyD | Back & Pain Center Clinical Research | 734-763-5226 | afton@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2024 | May 20, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 18, 2018 | May 7, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| approximately 30 days |
| Change in Fatigue. PROMIS Fatigue - Short Form 4a | There are 4 questions in this questionnaire. For each question, participants will select one of five options, ranging from "not at all" (1) to "very much" (5). Total scores can range from 4 to 20 points, where higher scores indicate higher fatigue. | Baseline (T1), approximately 90 days (T3) |
| Change in Perceived Sleep Problems - PROMIS -Sleep Disturbance (PROMIS-SD4a) | There are 4 questions in this questionnaire. For each question, participants will select one of five options. Question 1 participants will select from "very poor" (5) to "very good" (1). Questions 2-4 participants will select from "not at all" (5) to "very much" (1). Total scores can range from 4 to 20 points, where higher scores indicate higher sleep disturbance. | Baseline (T1) approximately 90 days (T3) |
| Change in Depression and Anxiety- Hospital Anxiety and Depression Scale (HADS) | There are 14 questions in this questionnaire. The anxiety and depression questions are scored separately with seven questions for both categories. For each question, participants will select one of four options, and total scores for each category can range from 0 to 21 points, where higher scores indicate higher anxiety or depression. . The anxiety question range from a variation of most of the time (3) and not at all (0). The depression questions range from a variation of definitely (0) to not at all (3). | Baseline (T1), approximately 90 days (T3) |
| Change in Happiness - Subjective Happiness Scale. | There are 4 questions in this questionnaire. For each question, participants will select one of seven options, and total scores can range from 7 to 28 points, where higher scores indicate greater levels of happiness. Questions 1 to 3 range from a variation of "not at all' (1) to a variation of "a great deal" (7). Question 4 is reversed codes, so the answers range from "not at all" (7) to "a great deal" (1). | Baseline (T1) to approximately 90 days (T3) |
| Change in Subjective Well-Being Affect - Positive and Negative Affect Scale (PANAS) | This questionnaire consists of two mood scales, Positive and Negative, with 10 questions each. For each question, participants will select one of five options, ranging from "very slightly or not at all" (1) to "extremely" (5). The statements were separated into the Positive and Negative categories and summed to make a final score. The final scores for both the Positive and Negative Affect can range from 10 to 50 points. The higher scores in the Positive Affect indicate higher positive emotions. The higher scores in the Negative Affect indicate higher negative emotions. | Baseline (T1), approximately 90 days (T3) |
| Change in Subjective Well-Being Life Satisfaction - Satisfaction With Life Scale (SWLS) | This questionnaire consists of five questions. For each question, participants will select one of seven options, ranging from "strongly disagree" (1) to "strongly agree" (7). Total scores can range from 7 to 35 points, where higher scores indicate higher life satisfaction. | Baseline (T1), approximately 90 days (T3) |
| Change in Fibromyalgia Symptoms - Fibromyalgia Survey Criteria | There are 8 questions in this questionnaire. Questions 1 to 3 participants can select one of 4 options, "no problem" (0) to "severe" (3). Questions 4 to 7, participants can select from one of two options, "no" (0) and "yes" (1). Question 8, is a map of the human body and participants can select multiple. The scale is a continuous with a range of 0-31, where higher scores indicate higher fibromyalgia-like symptoms. | Baseline (T1), approximately 90 days (T3) |
| Patient Global Impression of Change (PGIC) | There is one question in this survey about the participant's perception of their improvement post treatment. Participants will select one of seven options. The answers ranged from "very much worse" (-3) to "very much improved" (3). A higher score indicates greater improvement since the start of the study. | 30 days (T2) |
| Change in Patient Satisfaction - Patient Satisfaction Numeric Rating Scale | There is one question, and participants will select one of eleven options. The answers ranged from "extremely dissatisfied" (0) to "extremely satisfied" (10). A higher score indicates greater satisfaction. | 30 days (T2) to 90 days (T3) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Secondary | 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. | As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased. | Posted | Mean | Standard Deviation | units on a scale | approximately 30 days |
|
|
|
| Secondary | 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. | As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased. | Posted | Mean | Standard Deviation | units on a scale | Baseline (T1), approximately 90 days (T3) |
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|
|
| Secondary | 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. | As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased. | Posted | Mean | Standard Deviation | units on a scale | Baseline (T1) approximately 90 days (T3) |
|
|
|
| Secondary | 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). | As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased. | Posted | Mean | Standard Deviation | units on a scale | Baseline (T1), approximately 90 days (T3) |
|
|
|
| Secondary | 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). | As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased. | Posted | Mean | Standard Deviation | units on a scale | Baseline (T1) to approximately 90 days (T3) |
|
|
|
| Secondary | 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. | As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased. | Posted | Mean | Standard Deviation | units on a scale | Baseline (T1), approximately 90 days (T3) |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (T1), approximately 90 days (T3) |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (T1), approximately 90 days (T3) |
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | 30 days (T2) |
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|
| Secondary | 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. | As participants dropped out due to withdrawing or being lost to follow-up, the number of participants being analyzed decreased. | Posted | Mean | Standard Deviation | units on a scale | 30 days (T2) to 90 days (T3) |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | 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. | 0 | 58 | 2 | 58 | 0 | 58 |
| Cirrhosis | General disorders | NCI CTC Grade 3 | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| 30 days post treatment (T3) |
|
|
| 90 Days (T3) |
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| 90 Days (T3) |
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| Change in Depression: Baseline (T1) |
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| Change in Anxiety: 90Days (T3) |
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| Change in Depression: 90 Days (T3) |
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| 90 Days (T3) |
|
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| Negative Affect: Baseline (T1) |
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| Positive Affect: 90 Days (T3) |
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| Negative Affect: 90 Days (T3) |
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| 90 Days (T3) |
|
|
| 90 Days (T3) |
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| Minimally Improved |
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| No Change |
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| Minimally Worse |
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| Much Worse |
|
| Very Much Worse |
|
| 90 Days (T3) |
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