Exercise and Meditation: A Pilot Study of Alternative Techniques in the Treatment of Chronic Pelvic Pain Related to Painful Bladder Syndrome (PBS)/Interstitial Cystitis (IC) PI: Dr. Christopher Payne
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
研究概览
简要总结
Complementary and alternative medicine (CAM) is the term for medical products and/or practices that are not part of the current standard of care. Standard care is what medical doctors, doctors of osteopathy and allied health professionals, such as registered nurses and physical therapists, practice. Alternative medicine means treatments that you use instead of standard ones. Complementary medicine means nonstandard treatments that you use along with standard ones. The purpose of this study is to determine whether there is any improvement in symptoms reported by patients with chronic painful bladder syndrome when participating in alternative medical therapy/ exercise and meditative techniques. The specific alternative techniques participants will be randomized to in this trial include: Tai Chi instruction or walking exercise combined with sitting meditation.
详细描述
Participants will be referred for trial screening if they have a diagnosis of painful bladder syndrome/IC in the opinion of the investigator. Participants will be required to read the informed consent form and sign it prior to the screening of any medical information. The eligibility criteria will be reviewed and participants who qualify will complete the visit one study screening procedures. Participants will be asked to track there daily pain level and medication use for 7 days prior to randomization an in addition will be required to complete one 24-hour void diary during this same screening time period. Participants will be asked to give a urine sample on the day of screening and the day of randomization to screen for bladder infection. Female participants will be asked to provide a urine sample for pregnancy testing prior to randomization.
Participants will be required to be on a stable medical regime for 30 days prior to randomization. No new IC therapy or new pain treatments will be allowed to begin during the screening period and/or the 3 month study trial period. Participants will be allowed to continue on any IC/pain therapy they have used prior to screening.
Randomization to the treatment groups will occur 5-7 days prior to treatment start date. At that visit the patient#s medical history will be reviewed for eligibility and adverse events. The recorded pain scores collected and all quality of life measurements obtained. Participants who continue to qualify will be randomized to the specified treatment group.
Once 12 participants have been screened and are ready for randomization the participants will be scheduled for the randomization visit--Participants assigned to the Tai Chi group will be instructed on the logistics of the class, participants in this group will attend two classes/week- each class will be 1.5 hours in duration. The first 30 minutes will consist of standing meditation and progressive relaxation, the remaining 60 minutes will be TaiChi form instruction. The classes will meet bi-weekly for 3 months.
Participants will be contacted by the blinded coordinator at 2 week intervals to assess pain level, medication use, and adverse event monitoring, all data will be documented.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has signed and dated the appropriate Informed Consent document.
- •Participant is equal or > 18 years old
- •Participant has a clinical diagnosis of IC/PBS and or CP/CPPS in the opinion of the investigator
- •Participant with IC/PBS has reported a bladder pain or discomfort symptom score of 3 or greater on a 0-10 Likert scale over the previous four weeks. This bladder pain/discomfort criterion must be met at each of the two baseline screening visits as reported by the participant.
- •Participant with IC/PBS has reported a symptom score of abnormal urinary frequency of 3 or greater on 0-10 Likert scale over the previous four weeks. This frequency criterion must be met at least each of the two baseline screening visits.
- •Participant has had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.
- •Participant has previously undergone at least one course of other form of standard therapy for his/her symptoms
排除标准
- •Participant can not stand in place for at least 15 minutes.
- •Exclusion Criteria:
- •Participants have severe lower extremity disease that would prohibit participation in walking or Tai Chi movements.
- •Participant cannot hold urine for at least 30 minutes
- •Participant has relevant neurologic disorder that affects bladder and/or neuromuscular function in the opinion of the investigator.
- •Participant has active urethral or ureteral calculi, urethral diverticulum.
- •Participant has a history of pelvic radiation therapy, tuberculous cystitis, bladder cancer, carcinoma in situ, prostate cancer, or urethral cancer.
- •Participant has/reports any severe debilitating or urgent concurrent medical condition.
- •Participant has a potentially significant pelvic pathology or abnormalities on examination or prior imaging, including prolapse beyond the hymenal ring, pelvic mass, etc. that could cause or contribute to the clinical symptoms or require treatment.