Clinical trial NCT02476812: The Positive Piggy Bank - A Positive Activities Intervention for Improving Functional Status in Patients With Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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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.

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Primary outcomes:
measure: Change in functional status measured by Oswestry Disability Questionnaire
timeFrame: 2 months post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Back & Pain Center, University of Michigan
state: Michigan
Study officials:
References: