Low Back Pain
Conditions
Brief summary
Investigators will conduct a randomized controlled trial of a 30-day positive activities intervention, Positive Piggy Bank, compared to a Wait-List control group (Figure 2). Prior to their scheduled appointment to undergo epidural steroid injection, all patients meeting study criteria will be contacted by research 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.
Interventions
BEHAVIORALPositive Piggy Bank
Already noted.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Primary diagnosis of back pain and schedule to undergo an epidural steroid injection. : 1. ages 18 to 80; 2. able to read/understand English and give consent; 3. willing and able to comply with all aspects of study procedures; 4. if on antidepressants, medications stable for ≥4 weeks prior to study; 5. 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); 6. if on pain medications, medications stable for ≥4 weeks prior to study and no plans to switch medications during the 30-day study period. \-
Exclusion criteria
Participants may meet all criteria above, but will be excluded under the following additional conditions: 1. 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; 2. currently undergoing psychotherapeutic care at the Back \& Pain Center; 3. 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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Status Measured by Oswestry Disability Questionnaire | Baseline (T1), 30 days (T2), and 90 days (T3) | This questionnaire consists of 10 questions. Participants will select one of six options for each question, ranging from no extra pain (0) to the worst pain imaginable (5). Total scores can range from 0 to 50 points, where higher scores indicate higher pain intensity and more significant areas of disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Severity - Brief Pain Inventory (BPI) | approximately 30 days | There are 4 questions in this questionnaire. For each question, participants will select one of eleven options, ranging from "no pain" (0) to "pain as bad as you can imagine" (10). Then each participant's score was averaged from T1 and T3. Total scores range from 0 to 10. Participants in the active and waitlist were both given the survey 30 days after enrollment. Waitlist control participants did not receive the survey after their optional treatment. |
| Change in Fatigue. PROMIS Fatigue - Short Form 4a | Baseline (T1), approximately 90 days (T3) | There are 4 questions in this questionnaire. For each question, participants will select one of five options, ranging from "not at all" (1) to "very much" (5). Total scores can range from 4 to 20 points, where higher scores indicate higher fatigue. |
| Change in Perceived Sleep Problems - PROMIS -Sleep Disturbance (PROMIS-SD4a) | Baseline (T1) approximately 90 days (T3) | There are 4 questions in this questionnaire. For each question, participants will select one of five options. Question 1 participants will select from "very poor" (5) to "very good" (1). Questions 2-4 participants will select from "not at all" (5) to "very much" (1). Total scores can range from 4 to 20 points, where higher scores indicate higher sleep disturbance. |
| Change in Depression and Anxiety- Hospital Anxiety and Depression Scale (HADS) | Baseline (T1), approximately 90 days (T3) | There are 14 questions in this questionnaire. The anxiety and depression questions are scored separately with seven questions for both categories. For each question, participants will select one of four options, and total scores for each category can range from 0 to 21 points, where higher scores indicate higher anxiety or depression. . The anxiety question range from a variation of most of the time (3) and not at all (0). The depression questions range from a variation of definitely (0) to not at all (3). |
| Change in Happiness - Subjective Happiness Scale. | Baseline (T1) to approximately 90 days (T3) | There are 4 questions in this questionnaire. For each question, participants will select one of seven options, and total scores can range from 7 to 28 points, where higher scores indicate greater levels of happiness. Questions 1 to 3 range from a variation of "not at all' (1) to a variation of "a great deal" (7). Question 4 is reversed codes, so the answers range from "not at all" (7) to "a great deal" (1). |
| Change in Subjective Well-Being Affect - Positive and Negative Affect Scale (PANAS) | Baseline (T1), approximately 90 days (T3) | This questionnaire consists of two mood scales, Positive and Negative, with 10 questions each. For each question, participants will select one of five options, ranging from "very slightly or not at all" (1) to "extremely" (5). The statements were separated into the Positive and Negative categories and summed to make a final score. The final scores for both the Positive and Negative Affect can range from 10 to 50 points. The higher scores in the Positive Affect indicate higher positive emotions. The higher scores in the Negative Affect indicate higher negative emotions. |
| Change in Subjective Well-Being Life Satisfaction - Satisfaction With Life Scale (SWLS) | Baseline (T1), approximately 90 days (T3) | This questionnaire consists of five questions. For each question, participants will select one of seven options, ranging from "strongly disagree" (1) to "strongly agree" (7). Total scores can range from 7 to 35 points, where higher scores indicate higher life satisfaction. |
| Change in Fibromyalgia Symptoms - Fibromyalgia Survey Criteria | Baseline (T1), approximately 90 days (T3) | There are 8 questions in this questionnaire. Questions 1 to 3 participants can select one of 4 options, "no problem" (0) to "severe" (3). Questions 4 to 7, participants can select from one of two options, "no" (0) and "yes" (1). Question 8, is a map of the human body and participants can select multiple. The scale is a continuous with a range of 0-31, where higher scores indicate higher fibromyalgia-like symptoms. |
| Patient Global Impression of Change (PGIC) | 30 days (T2) | There is one question in this survey about the participant's perception of their improvement post treatment. Participants will select one of seven options. The answers ranged from "very much worse" (-3) to "very much improved" (3). A higher score indicates greater improvement since the start of the study. |
| Change in Patient Satisfaction - Patient Satisfaction Numeric Rating Scale | 30 days (T2) to 90 days (T3) | There is one question, and participants will select one of eleven options. The answers ranged from "extremely dissatisfied" (0) to "extremely satisfied" (10). A higher score indicates greater satisfaction. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 14.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 103 Participants |
| Region of Enrollment United States | 58 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 58 |
| other Total, other adverse events | 0 / 57 | 0 / 58 |
| serious Total, serious adverse events | 0 / 57 | 2 / 58 |
Outcome results
None listed