Clinical Trials

The Dept. is at the forefront of innovating patient care, which is realized in the pioneering of new interventions. These Clinical Trials are currently being led by our faculty.


Metformin and Beyond: Individualizing Care for low Back Pain

Principal Investigator: Gwen Sowa

Co-Investigators: Megan Cortazzo, Anthony Delitto, Eric Helm, Suehun Ho, Oscar Marroquin, Gina McKernan, Barbara Methe, Alison Morris, Petr Pancoska, Nam Vo

Sponsor: UPMC ITTC

This trial is registered on clinicaltrials.gov.

Summary:  Low back pain is one of the most common musculoskeletal conditions requiring medical care and contributing to patient impairment and disability, with over 25% of the general population reporting low back pain at any given time and a lifetime incidence exceeding 80%. However, the care of low back pain represents one of the greatest challenges facing musculoskeletal care today. With increasing interest in the beneficial effects of metformin, the favorable side effect profile, and low cost make metformin an attractive therapeutic candidate for the treatment of low back pain.

Individuals are being asked to participate in a research study in which we will investigate if metformin improves low back pain. Currently, metformin is not approved by the FDA for treatment of low back pain. However, metformin is an FDA approved medication for Type 2 diabetes mellitus. For this double blind, wait-list controlled and placebo-controlled study, we will compare results from individuals who are randomized to take metformin for six months at either a high or low dose and those who take a placebo. We will also compare those results to individuals who wait three months to be randomized (wait-list control group).

If interested in participating in the study, please contact the study coordinator at:

(412) 692-2084 or kesslerl@upmc.edu


Prospective, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Investigate the Efficacy and Safety of NT 201 in the Treatment of Lower Limb Spasticity Caused by stroke or Traumatic Brain Injury in Adult Subjects, Followed by an Open Label Extension with or without Combined Upper Limb Treatment

Principal Investigator: Michael Munin

Co-Investigator: Kali Webb

Sponsor: Merz Pharmaceuticals

This trial is registered on clinicaltrials.gov.

Summary: The purpose of this study is to determine whether a single treatment with administration of 400 units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation.

The following four to five treatment cycles will investigate the safety and tolerabilty of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated).


For more information about participating in ongoing research studies at the University of Pittsburgh, visit Pitt+Me.