Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception in Men With Chronic Pain Syndrome
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: 1. To evaluate the effects of testosterone replacement on pain sensitivity, pain tolerance, and pain modulation in men with opioid-induced hypogonadism. 2. To determine the effects of testosterone replacement on health-related quality of life. 3. 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.
NCT00351819 — Pain
Status: Completed
http://inclinicaltrials.com/pain/NCT00351819/
Interest of Day Hospital Care for Patients With Chronic Regional Pain Syndrome Referred to the Chronic Pain Unit for the First Time
Chronic Regional Pain Syndrome (CRPS) is a chronic disabling disease. Patients present a variable picture associating pain localized to an articular or peri-articular region, motor and vasomotor disorders and trophic disorders. Its pathophysiology, still poorly understood to this day, results from local inflammatory phenomena complicated by peripheral sensitization and central spinal and cerebral sensitization. The diagnosis is made difficult by the fluctuating nature of the symptoms and the absence of specific complementary examination. The treatment of CRPS is symptomatic and requires multidisciplinary care. CRPS is responsible for an alteration in the patient's quality of life. This pathology has a global impact because it affects not only the biomedical sphere but also the socio-family, professional and psychological spheres. The investigators hypothesize that multidisciplinary intervention in the Day Hospital would improve the quality of life of patients with CRPS. The investigators also think that the passage in Day Hospital would make it possible to improve the pains, the functionality of the affected limb as well as the satisfaction of the patients.
NCT04913051 — Chronic Regional Pain Syndrome
Status: Recruiting
http://inclinicaltrials.com/chronic-regional-pain-syndrome/NCT04913051/
Neurophysiological Basis of Rehabilitation in Complex Regional Pain Syndrome, Type I and Chronic Low Back Pain
Complex Regional Pain syndrome Type I (CRPS-I) is a chronic progressive disease. Patients experience dramatic decline of overall well-being, despite the absence of any apparent physical cause. The main symptoms are hypersensitivity to pain (hyperalgesia) and experiencing normal tactile stimulation as painful (allodynia) in the absence of peripheral nerve damage. The debate on the aetiology of CRPS-I is still open. The therapy offered to CRPS-I patients is diverse and can involve invasive and non-invasive interventions. Current (inter)national guidelines recommend physiotherapy as the best non-invasive treatment for rehabilitation. Recently, cognitive and behavioural Graded Exposure in Vivo (GEXP) therapy aimed at reducing pain-related fear was found to be effective (De Jong et al. 2005), and more effective than standard physical therapy (ReMOVE study, articles in preparation). By reducing pain-related fear EXP might reconcile motor output and sensory feedback. Another type of pain is lower back pain (LBP), which affects 70% to 85% of general population, but usually heals within 12 weeks in 90% of patients. The rest of the patients suffer from intractable, chronic LBP despite no evident organic abnormality. Research shows that also in these patients cognitive and behavioural aspects of pain are important and related to physical performance and self-reported disability (Vlaeyen et al., 2000). Several studies have demonstrated the success of GEXP in this patient group: GEXP resulted in improvements in pain-related fear, catastrophizing, performance of daily relevant activities, and in pain intensity (Leeuw et al., 2008). This study aims to investigate the effect of GEXP on brain regions involved in the processing of harmless tactile stimuli in CRPS-I and CLBP patients, as well as its effect on tactile discrimination thresholds. We hypothesize that GEXP will induce 1) an improvement of tactile discrimination thresholds, 2) a functional reorganization of primary and secondary somatosensory cortex (in regions related to the affected limb in CRPS-I; and to the back in LBP), 3) changes in activation of emotional brain circuits during non-noxious stimulation, 4) changes in resting state connectivity between emotional and sensory brain areas, 5) changes in measures reflecting white matter integrity. No systematic changes are expected in the healthy controls. Patients diagnosed with CRPS-I and CLBP will participate in a Magnetic Resonance Imaging (MRI) experiment. In this observational study, we examine the effects of GEXP treatment that all patients receive as part of usual care. Anatomical as well as diffusion-weighted and T2*-weighted (Blood oxygenation level dependent) MR images will be acquired. The study has a 3x4 split plot design with group (CRPS-I patients and CLBP receiving GEXP treatment / healthy controls) as between-subjects variable and time (pre-, during, post-treatment and follow-up) as within-subject variable.
NCT02347579 — Chronic Pain
Status: Completed
http://inclinicaltrials.com/chronic-pain/NCT02347579/
Risk Factors for Chronic Prostatitis/Chronic Pelvic Pain Syndrome Patients in Northwest China
The goal of this observational study is to learn about the risk factors of lifestyle, medication and sexual habits in adult chronic prostatitis / chronic pelvic pain syndrome patients. The main questions it aims to answer are: - Is lifestyle, medication, and sexual habits related to chronic prostatitis / chronic pelvic pain syndrome - Is there any medication available to protect men from chronic prostatitis / chronic pelvic pain syndrome. Participants will: - Independently receive a survey questionnaire on lifestyle, medication, and sexual habits. - Symptomatic individuals will undergo additional prostate fluid examination for diagnosis. Researchers will compare healthy adult males to see if there are differences on lifestyle, medication and sexual habits between the two groups.
NCT06385977 — Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Status: Recruiting
http://inclinicaltrials.com/chronic-prostatitis-with-chronic-pelvic-pain-syndrome/NCT06385977/
Examination of the Efficacy of ESWT (Extracorporeal Shock Wave Therapy) and TENS (Transcutaneous Electrical Nerve Stimulation) in Individuals Receiving Drug Treatment for Chronic Pelvic Pain Syndrome: Randomized Controlled Study
The aim of this study is to evaluate the effectiveness of ESWT (Extracorporeal Shock Wave Therapy) and TENS (Transcutaneous Electrical Nerve Stimulation) in individuals diagnosed with chronic pelvic pain syndrome and treated with medication. The study was organized as a randomized controlled trial. The sample size is 30 patients suffering from chronic pelvic pain syndrome.
NCT06369545 — Pelvic Pain Syndrome
Status: Recruiting
http://inclinicaltrials.com/pelvic-pain-syndrome/NCT06369545/
Surgery and Exercise Versus Exercise Only for Chronic Patellofemoral Pain Syndrome: a Randomised Controlled Trial
The goal of this randomised controlled trial is to compare a tuberositas transposition (TTT) surgery with a home exercise program (HEP) in patients with patellofemoral pain syndrome (PFPS). The study aims to evaluate the efficiency of TTT in conjunction with a HEP compared to a HEP alone in patients with chronic PFPS. Participants will randomly be allocated to the surgery or HEP group. Researchers will compare the surgery and HEP groups to see if activity-related pain and patient reported outcome measures (PROMs) are different.
NCT06227806 — Patellofemoral Pain Syndrome
Status: Recruiting
http://inclinicaltrials.com/patellofemoral-pain-syndrome/NCT06227806/
Evaluation of the Segmental Distribution of Pain Hypersensitivity Among Patients With Central Sensitization Associated With Chronic Subacromial Pain Syndrome
This study aimed to determine the distribution of pain sensitivity according to body segments in patients with central sensitization associated with chronic subacromial pain syndrome (SPS).This cross-sectional study included patients with chronic SPS and central sensitization (patient group) and the same number of healthy participants as controls. The presence of central sensitization was determined using the Central Sensitization Inventory. To determine the segmental distribution of pain sensitivity, pressure pain threshold measurements were performed bilaterally from the shoulder, forearm, and leg.
NCT06139120 — Central Sensitisation
Status: Completed
http://inclinicaltrials.com/central-sensitisation/NCT06139120/
A Prospective, Multicenter, Randomized, Parallel and Positive Drug-controlled Clinical Study of Ningbitai Capsule in the Treatment of Chronic Pelvic Pain Syndrome With Erectile Dysfunction
Objective: The purpose of this study was to evaluate the clinical efficacy and safety of Ningmitai capsule alone or in combination with sildenafil compared with sildenafil alone in the treatment of CP/CPPS with erectile dysfunction. Study Design: A multicenter, prospective, randomized and positive drug-controlled clinical study design was adopted. Interventions: ① Western medicine group (sildenafil): Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks. ② Chinese medicine group (Ningmitai capsule): Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, taken after meals for 4 weeks continuously. ③ Combination group (Ningmitai capsule + sildenafil): Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, taken after meals; Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, was taken continuously for 4 weeks.
NCT06064448 — Erectile Dysfunction
Status: Completed
http://inclinicaltrials.com/erectile-dysfunction/NCT06064448/
Retrospective Data Analysis in Chronic Prostatitis/Chronic Pelvic Pain Syndrome Patients: Evaluation of the Relationship Between Presence of Microorganism and Severity of Symptom
Chronic prostatitis/chronic pelvic pain syndrome (CPPS) is a common health problem among men and can cause severe quality of life. The pathophysiology of CPPS is still poorly understood and effective treatments are a challenging issue. This study aims to investigate the possible relationship between the presence of microorganisms in the prostatic fluid and symptom severity by presenting a retrospective analysis based on data from CPPS patients.
NCT06016595 — Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Status: Completed
http://inclinicaltrials.com/chronic-prostatitis-with-chronic-pelvic-pain-syndrome/NCT06016595/
Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome：A Prospective, Randomized, Positive Drug-controlled, Multicenter Clinical Study
1. Clinical trial title：Efficacy and safety of Ningmitai capsule in patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome：A prospective, randomized, positive drug-controlled, multicenter clinical study 2. Version number/date：1.0 /2018-6-24 3. Principal investigator：Zhang Xiansheng 4. Main research units：The first affiliated hospital of Anhui medical university clinical medical research ethics committee 5. Clinical trial start and end dates：2018-10-1-2022-12-31 6. Objective: To observe whether Ningmitai capsule(NMT) alone or combined with Tamsulosin for 8 weeks is more effective than Tamsulosin in improving symptoms of CP/CPPS . 7. Study type:Interventional study 8. Total sample size:300 9. Inclusion criteria: ① Age: male patients aged 18-60 years; ② Long-term and repeated pelvic discomfort or pain (NIH-CPSI pain score ≥ 4 points), lasting more than 3 months, may be accompanied by different degrees of urination symptoms and sexual dysfunction; ③ Diagnosed as type III prostatitis. Exclusion criteria: - Use any antibiotics and α1 receptor blockers in the past two weeks; ② Suffering from seminal vesiculitis, epididymitis, varicocele, tumors in prostate, bladder and urethra and other diseases affecting bladder function; - Have received transurethral resection of the prostate(TURP), transurethral incision of the prostate (TUIP), bladder neck incision, transurethral hyperthermia/radiofrequency ablation/balloon dilatation, open prostatectomy, or any other prostate surgery and treatment, such as cryotherapy; - Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic diseases and psychosis; ⑤ Patients who are allergic to NMT or some of its components; ⑥ Patients who are involuntarily unable to cooperate with the completion of the test. 10. Interventions: 1. NMT group Oral Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks. Sample size:100 2. Tamsulosin group Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks. Sample size:100 3.Combination group Oral Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks.Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks. Sample size:100
NCT05890235 — Chronic Prostatitis
Status: Completed
http://inclinicaltrials.com/chronic-prostatitis/NCT05890235/