Clinical Research

Current Research Studies

University of Michigan Genomics Initiative (MGI)

All pre-operative patients 18 years of age or older are eligible for participation in the University Biorepository. The biorepository, is a genetic library for researchers at University of Michigan and at other research institutions, including the National Institute of Health to use for several types of studies. Participation includes a small blood sample on the day of surgery and filling out a short questionnaire regarding pre-operative pain and basic lifestyle questions. Patients may be contacted in the future for any study that is conducted through the biorepository. Blood samples are sequenced for the genome/genetic material and stored securely at the University of Michigan.

All Pre-operative patients 18 years of age or older are eligible for participation.

For detailed information about this study, please contact 734-232-0320

 

Analgesic outcomes Study (AOS)

Any patient who is receiving a first time total knee or hip arthroplasty is eligible for this study. Patients encountering a hysterectomy, some breast surgeries and some thoracic surgeries are also eligible. Patients must be 18 years of age or older. This study entails filling out 10-15 minutes worth of questionnaires pre-operatively about pre-operative pain and overall health and well-being.  Participation also includes a follow-up phone call at the two week and three month post-operative dates, as well as a packet in the mail and a phone call on the six month post-operative date. Phone call follow-ups are typically less than 10 minutes. The packet that is sent in the mail is very similar to the packets filled out on the day of surgery. 

For detailed information about this study, please contact 734-232-5153

 

Advancing The Treatment of Chronic Pain through Individualized Opioid Cessation

Opioid use in the context of pain management is a complex issue. Recent guidelines recommend against using long-term opioid therapy for most patients with chronic pain and strongly encourage the use of non-opioid interventions.  Opioid cessation programs need to be informed by and tailored to chronic pain patients’ unique needs, however there is a lack of research exploring opioid use and cessation from the patient’s perspective. We hypothesize that understanding patients’ thoughts and emotions regarding opioid use and identifying potential barriers to opioid cessation will be instrumental in helping us develop a patient-centered intervention. This study will enroll 300 patients at the Back and Pain Center and the Fibromyalgia Patient Education Workshop.  Current and former opioid users may be eligible to participate.  This study involves completing questionnaires and structured interviews as well as focus groups and in-depth interviews scheduled at a future date for some participants.  Participation will last about a half hour for the questionnaires and structured interviews, and an additional half hour to two hours for the follow up in-depth interviews and focus groups. The aim of the study is to use patients’ own experiences to develop effective interventions to help patients stop using opioids.

For detailed information about this study, please contact 734-763-5226.

 

Neuros Medical: High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study

The prospective, randomized, controlled pivotal clinical trial will consist of up to 130 patients at 15 institutions to evaluate the safety and efficacy of Neuros Medical’s Altius System. When completed, the results will support a PreMarket Approval Application to FDA in order to market the device. The pivotal study builds off their long-term pilot study which reported significant pain reduction, up to 30 months. In addition, more than half of the responders discontinued their pain medication use during the study.

For detailed information about this study, please contact 734-232-1265

 

Michigan Body Map (MBM)

Body maps have been used for many decades to assess the locations of pain complaints. However, the format of most body maps does not easily allow providers to easily quantify a patient’s painful areas. Given the increasing understanding of the pathophysiology of centralized pain conditions, in which widespread body pain is a common symptom, accurately assessing and quantifying body pain has important implications for research and clinical care. We created the Michigan Body Map as a means of assessing widespread body pain alone and together with the Symptom Severity Index for the 2011 Fibromyalgia Survey Criteria. The Michigan Body Map (MBM) has been validated in the paper format, and now is being validated in the electronic format via Qualtrics. Additionally, patients are being asked to indicate their pain severity in each body zone in which they report having pain.   The MBM is a valid, useful and reliable measure of widespread body pain. We hypothesize the electronic version of the MBM will be just as reliable as the paper version of the MBM, and that using body zones to define pain severity will add a reliable, useful dimension for patients to report their pain to the current measure. After a brief screening and consent process, patients are given the paper MBM and the electronic MBM. Patients are randomized to the order that they receive the body maps. A brief cognitive interview is conducted after the completion of both questionnaires to assess the subject’s understanding and perceptions of the two forms.  After this, patients will be asked to rate their pain severity in the body zones they select on the body map, and complete a second cognitive interview to assess their understanding and perception of the pain severity scale and the body zones.

For detailed information about this study, please contact 734-232-1265

 

Positive Piggy Bank

All patients meeting study criteria are contacted by research staff to be invited to participate in this study. Patients are recruited from University of Michigan’s Back and Pain Center as well as the Physical Medicine and Rehabilitation Clinic. Before their scheduled procedure, they learn more about the study and provide informed consent if they choose to participate. Participants complete the study questionnaires and are randomized 1:1 to the Positive Piggy Bank or the Wait List control group. This study involves noting at least one positive event each day, writing it down on a slip of paper and then depositing this piece of paper in a piggy bank. At the end of the “deposit period,” in the case of this study after 30 days, the participant “closes the account” and makes a full withdrawal by taking all of the slips out of the piggy bank and reading each one.  This intervention builds on eliciting other well-studied concepts such as positive daily reflection, gratitude and savoring. We hypothesize that patients with back pain who undergo an epidural steroid injection and complete the Positive Piggy Bank intervention will demonstrate a greater improvement in functional status compared to those who undergo the epidural steroid injection alone. All participants complete questionnaire follow ups by mail 1 month and 3 months after his or her procedure. After the study period, the patients in the Wait List control are offered the Positive Piggy Bank intervention.

For detailed information about this study, please contact 734-232-126