Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception in Men With Chronic Pain Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory (BPI) at Week 14
研究概览
简要总结
Naturally occurring opiates (endorphins) decrease testosterone levels by inhibiting the synthesis of gonadotropin releasing hormone (GnRH) and also inhibiting testosterone synthesis by the testes. Similarly, men with addiction to narcotics and those on exogenous opioids for pain control have decreased serum testosterone levels. Indeed, these men complain of decreased libido, erectile dysfunction and impaired quality of life. Animal studies have shown that gonadectomy results in a decrease in pain threshold in rats and repletion of testosterone elevates that threshold. These observations suggest that testosterone may possess analgesic properties. Hence, the investigators hypothesize that hypogonadism developing in men on opioids results in an increased sensitivity to pain and requirement of higher doses of opioids. In this study, the investigators plan to administer testosterone to men with opioid-induced hypogonadism and evaluate their pain perception, pain sensitivity in response to noxious stimuli and changes in the requirement of opioids in response to testosterone administration.
Hypothesis:
Testosterone replacement in men with opioid-induced hypogonadism will improve pain tolerance, pain perception and quality of life.
Specific aims:
- To evaluate the effects of testosterone replacement on pain sensitivity, pain tolerance, and pain modulation in men with opioid-induced hypogonadism.
- To determine the effects of testosterone replacement on health-related quality of life.
- To determine whether testosterone replacement in hypogonadal men induces changes in the dosage requirements of opioid medications for pain control.
To accomplish our specific aims, the investigators propose a randomized, double blind, placebo-controlled, parallel arm study in which hypogonadal men with non-cancer chronic back pain syndrome on chronic opioids and low testosterone levels (<300 ng/dl) will be randomized to exogenous testosterone replacement therapy vs placebo. Our primary outcome is change in pain tolerance using various external painful stimuli. Secondary outcomes are change in pain sensitivity and modulation, quality of life and opioid requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Non-cancer chronic pain
- •Serum total testosterone level <350 ng/dl
- •Consumption of at least 20 mg of hydrocodone (or analgesic equivalent of another opioid) for at least 4 weeks
- •Absence of hospitalization in the past 2 months
- •No acute illness in the past 2 months
- •No current anabolic therapy (growth hormone, DHEA, etc)
- •No current use or consumption in the past 2 months of melatonin
- •Normal prostate exam
- •Normal PSA level
排除标准
- •Cancer-related chronic pain
- •Liver enzymes > 3 times upper limit of normal
- •Serum creatinine > 2 times upper limit of normal
- •Neurological disease
- •Active psychiatric illness
- •Any addictive drug use
- •Alcoholism (>3 drinks/day)
- •Patients currently receiving melatonin or anabolic agents
- •Hospitalization in the past 2 months
- •Acute illness in the past 2 months
- •Consumption of < 20 mg of hydrocodone (or analgesic equivalent of another opioid)
- •Severe BPH
- •PSA > 4.0 ng/ml
- •Prostate cancer
- •Breast cancer
研究组 & 干预措施
Androgel (testosterone gel)
Testosterone replacement therapy
干预措施: AndroGel (Drug)
Placebo
Placebo gel
干预措施: Placebo (Other)
结局指标
主要结局
Brief Pain Inventory (BPI) at Week 14
时间窗: Week14 after intervention
BPI is a self-administered questionnaire that measuring chronic pain. BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score assesses the severity of pain on a continuous scale from 0 (no pain) to 10 (severe pain). The pain interference score corresponds to the item on pain interference, ranging from 0 (does not interfere) to 10(completely interferes). The total score is the sum of the pain severity score and pain interference score, ranging from 0(no pain) to 20 (severe and completely interfered pain).
Weighted Pinprick Stimulator-induced Mechanical Pain at Week 14
时间窗: Week 14 after intervention
Weighted pinprick stimulators are used to assess mechanical pain. Lower values represent better tolerance of pain.
Algometer-induced Pressure Pain at Week 14
时间窗: Week 14 after intervention
A digital pressure algometer at the trapezius muscle and the metacarpophalangeal joint of the thumb was used to measure pressure pain thresholds. Higher values represent a better tolerance of pressure pain.
Ice Water-induced Cold Pain and Its After-sensation at Week 14
时间窗: Week 14 after intervention
Cold-pressor tests measure cold-induced pain and its sensation. Time was measured when a participant reached pain tolerance in cold water and after sensation. Higher values of time in Cold pain tolerance and lower values of time in Cold pain after-sensation (30 seconds) represent better tolerance of pain.
次要结局
- Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14(Week 14 after intervention)
- Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14(Week14 after intervention)
- Pain Catastrophizing Scale (PCS) at Week 14(Values at week 14 after intervention)
研究者
Shehzad Basaria
ASSOCIATE PROFESSOR
Brigham and Women's Hospital