The Positive Piggy Bank - A Positive Activities Intervention for Improving Functional Status in Patients With Back Pain
Low Back Pain
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
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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Sites / Locations
- Back & Pain Center, University of Michigan
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Positive Piggy Bank
Waitlist Control
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.
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.