Testosterone Treatment to Improve Pain and Quality of Life in Men with Opioid-Induced Low Testosterone and Chronic Spinal Pain

What this Trial Is About

This trial is studying men aged 18 years and older who have chronic non-cancer spinal pain and opioid-induced hypogonadism caused by long-term opioid use. Researchers aim to evaluate whether testosterone replacement therapy can improve pain perception, pain tolerance, sexual function, fatigue, and overall quality of life compared to a placebo. The study is a randomized, double-blind, placebo-controlled trial to assess these effects over time. Participants will receive either testosterone undecanoate injections or placebo injections. The injections are given intramuscularly at a dose of 750 mg at the start of the study, then again at weeks 4 and 14, for a total treatment period of 6 months. There are two groups one receiving the testosterone treatment and the other receiving placebo, to compare their outcomes. During the study, participants will attend visits at baseline, 3 months, and 6 months for assessments. These include questionnaires measuring pain interference, and various tests evaluating pain response to pressure, mechanical, heat, and cold stimuli. Brain connectivity will also be evaluated at baseline and 6 months. Researchers will monitor safety and treatment effects throughout the 6-month treatment period.

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism