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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
Study 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
- 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in functional status measured by Oswestry Disability Questionnaire
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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Who is running the clinical trial?
University of MichiganLead Sponsor
1,796 Previous Clinical Trials
6,377,756 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious mental health condition, such as severe depression or cognitive impairment, that may make it difficult for you to understand and take part in the study.You are currently receiving therapy at the Back & Pain Center.You have been diagnosed with back pain and are planning to have an epidural steroid injection.You must be between 18 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Waitlist Control
- Group 2: Positive Piggy Bank
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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