Back & Pain Center, University of Michigan
Ann Arbor, Michigan, 48106, United States
NCT Number: NCT02476812
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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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48106, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Primary diagnosis of back pain and schedule to undergo an epidural steroid injection. :
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Exclusion criteria
Participants may meet all criteria above, but will be excluded under the following additional conditions:
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Already noted.
Time frame: Baseline (T1), 30 days (T2), and 90 days (T3)
This questionnaire consists of 10 questions. Participants will select one of six options for each question, ranging from no extra pain (0) to the worst pain imaginable (5). Total scores can range from 0 to 50 points, where higher scores indicate higher pain intensity and more significant areas of disability.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
University of Michigan
Other
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