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Positive Piggy Bank for Back Pain

N/A

Waitlist Available

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months post intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a 30-day positive activities intervention can improve functional status compared to a wait-list control group. The primary outcome is improved functional status, while secondary outcomes are symptomatic (i.e., pain, fatigue and sleep) and related to mood and well-being.

Eligible Conditions

Low Back Pain
Lower Back Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in functional status measured by Oswestry Disability Questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Positive Piggy BankExperimental Treatment1 Intervention

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.

Group II: Waitlist ControlActive Control1 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.

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