Pregabalin for Chronic Pelvic Pain in Women: Study Protocol for a Randomized, Prospective, Multicenter, Open Label-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 308
- 主要终点
- Change in Mean Pain Intensity From Baseline to Week 12
研究概览
简要总结
This multicenter, randomized, prospective, open-label, controlled trial will evaluate the efficacy and safety of oral pregabalin as an adjunct to standard conservative treatment in women with chronic pelvic pain (CPP). Approximately 308 women aged 18 to 65 years with moderate to severe CPP lasting more than 6 months will be enrolled and randomly assigned in a 1:1 ratio to either standard conservative treatment alone or standard conservative treatment plus oral pregabalin.
Standard conservative treatment will follow a biopsychosocial management approach and may include patient education, body awareness therapy, cognitive interventions, and individualized conservative care. Participants assigned to the pregabalin group will receive oral pregabalin beginning at 150 mg/day in two divided doses. The dose may be gradually increased according to pain relief and tolerability, up to a maximum of 600 mg/day, and maintained for 12 weeks.
The primary outcome is the change in mean pain intensity from baseline to Week 12, measured using a visual analogue scale (VAS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable). Secondary outcomes include pain intensity at Weeks 2, 4, 8, and 12; pregabalin dosage; overall treatment satisfaction; health-related quality of life assessed using the Short Form-12 questionnaire; gynecologic pain assessed using the McCormack scale; and adverse events throughout the study.
The total follow-up period is 12 weeks, with assessments conducted at Weeks 2, 4, 8, and 12. Because of the open-label design, participants and treating physicians will know the treatment assignment. Outcome assessors and statisticians will be blinded to treatment allocation. The study will determine whether adding pregabalin to standard conservative treatment improves pain and related patient-reported outcomes while maintaining an acceptable safety profile in women with CPP.
详细描述
Chronic pelvic pain (CPP) in women is a persistent and multifactorial condition that can substantially affect physical functioning, emotional well-being, sexual health, and quality of life. Pain may arise from multiple overlapping pelvic, urinary, gynecologic, musculoskeletal, and psychosocial factors. Central sensitization, characterized by increased responsiveness of the nervous system to painful and nonpainful stimuli, is considered an important contributor to persistent pain in some patients. Consequently, symptom control often requires an individualized, multimodal approach.
Conservative management, including education, physical and behavioral therapies, and other biopsychosocial interventions, is recommended for women with CPP. However, the response is variable, and some patients continue to experience clinically important pain despite these measures. Common pharmacologic options have limitations: evidence for long-term benefit from nonsteroidal anti-inflammatory drugs is limited, hormonal treatments are applicable only to selected pain conditions, and prolonged opioid therapy is generally discouraged because of safety concerns. Evidence for gabapentinoids in women with CPP is also inconsistent, creating a need to evaluate alternative treatment strategies.
Pregabalin binds to the alpha-2-delta subunit of voltage-gated calcium channels and reduces the release of excitatory neurotransmitters involved in abnormal pain processing. Compared with gabapentin, pregabalin has more predictable absorption and dose-related pharmacokinetics, which may facilitate individualized dose adjustment. Although pregabalin has been studied in other chronic pain conditions and in men with chronic prostatitis/chronic pelvic pain syndrome, high-quality evidence in women with CPP remains limited.
This study is designed to determine whether adding pregabalin to standard conservative care provides clinically meaningful symptom relief for women with moderate to severe CPP. The flexible dose-adjustment approach is intended to reflect clinical practice by balancing analgesic response and tolerability. In addition to pain, the study will examine patient satisfaction, health-related quality of life, gynecologic pain-related symptoms, treatment adherence, and adverse events. The findings may clarify the role of pregabalin as an adjunctive option for women whose symptoms remain insufficiently controlled with conservative treatment alone.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-65 years.
- •Diagnosis of chronic pelvic pain based on the 2022 revisions to the European Association of Urology criteria.
- •Use of, or willingness to use, effective contraception to avoid pregnancy during the study period.
- •Moderate to severe chronic pelvic pain lasting more than 6 months. Moderate pain is defined as a VAS score of 4-6, and severe pain as a VAS score of 7 or higher.
- •Sufficient cognitive and language skills to comply with all study requirements.
排除标准
- •Dysmenorrhea as the sole pain complaint.
- •History of malignancy.
- •Current or previous use of pregabalin.
- •Planned surgery within the next 6 months.
- •Contraindication to pregabalin or a previous adverse reaction to pregabalin.
- •Current use of gonadotropin-releasing hormone agonists with inability or unwillingness to discontinue treatment.
- •Pregnancy, breastfeeding, or intention to become pregnant within the next 6 months.
研究组 & 干预措施
Standard treatment group
Participants will receive standard conservative treatment for chronic pelvic pain based on a biopsychosocial management approach. Treatment may include patient education, body awareness therapy, cognitive interventions, individualized advice, and other conservative measures provided according to clinical assessment and applicable guidelines. No pregabalin will be administered as part of the study intervention.
干预措施: Behavioral Treatment (Behavioral)
Standard treatment group
Participants will receive standard conservative treatment for chronic pelvic pain based on a biopsychosocial management approach. Treatment may include patient education, body awareness therapy, cognitive interventions, individualized advice, and other conservative measures provided according to clinical assessment and applicable guidelines. No pregabalin will be administered as part of the study intervention.
干预措施: Pregabalin (Drug)
Combined treatment group
Participants will receive the same standard conservative treatment as the Standard Conservative Treatment arm, together with oral pregabalin. Pregabalin will be initiated at 150 mg/day in two divided doses and may be increased gradually according to pain control and tolerability, up to a protocol-defined maximum of 600 mg/day. The individualized maintenance dose will be continued during the 12-week treatment period. After the treatment period, pregabalin will be tapered gradually according to the participant's maintenance dose, clinical condition, and withdrawal symptoms.
干预措施: Pregabalin (Drug)
结局指标
主要结局
Change in Mean Pain Intensity From Baseline to Week 12
时间窗: Baseline to Week 12
Change in mean chronic pelvic pain intensity measured using a visual analogue scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable).
次要结局
- Mean Pain Intensity at Follow-up Visits(Weeks 2, 4, 8, and 12)
- Pregabalin Dose(Weeks 2, 4, 8, and 12)
- Overall Treatment Satisfaction(Weeks 2, 4, 8, and 12)
- Health-related Quality of Life(Weeks 2, 4, 8, and 12)
- Gynecologic Pain-related Symptoms(Weeks 2, 4, 8, and 12)
- Safety outcomes(From treatment initiation through Week 12 and post-treatment safety assessment)
研究者
Fang Luo
Doctor
Beijing Tiantan Hospital