PUlsed electroMagnetic Field Treatment for Painful Periods: A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- A reduction in dysmenorrhea as measured by the highest pain score on a 10cm visual analogue scale.
研究概览
简要总结
A single-centre, randomised controlled, double blind study comparing use of the Allay pulsed shortwave therapy treatment versus a placebo device or no treatment for management of primary dysmenorrhea.
详细描述
Women participating in the trial will be randomly allocated to any of the three arms of the study.
- Treatment for 2 menstrual cycles using the PSWT Allay device (BioElectronics Corp, Frederick USA)
- Treatment for 2 menstrual cycles using a placebo device
- No treatment. If they are allocated to a device both the participant and the clinician will be blinded at to weather they are using the active device or the placebo.
Primary Outcome measures are:
- A reduction in dysmenorrhea as measured by the highest pain score on a 10cm visual analogue scale.
- A reduction in average pain score on a 10cm visual analogue scale
- A reduction in use of analgesia as recorded in a pain diary
- Improvement in quality of life as measured through a validated quality of life assessment tool (SF-36 questionnaire)
- Improvement in menstrual symptoms as recorded through a validated questionnaire (the Modified Menorrhagia Multi-attribute Scale (MMAS)).
- Device acceptability as measured on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable".
- Impact upon associated cyclical symptoms as recorded in a patient symptom diary
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants will be randomly allocated to a treatment arm through telephone randomisation. If they are allocated to "no treatment" they will be aware of the management, however if allocated to use of a device the participant and care provider will be blinded to weather it is an active device or placebo device. The outcome assessor will be blinded to the treatment allocation.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female with persistent (>3months) cyclical period pain associated with menstruation (defined as 5 or more on VAS).
- •Able to give written, Informed consent
- •Able to wear device and keep up-to-date records of use
- •Agrees to attend follow up
- •If currently using hormonal contraception agrees to continue on the same dose for the duration of the trial.
排除标准
- •Age under 16 years.
- •Trying to conceive or <6 weeks post partum
- •Currently participating or planning to participate in another clinical trial
研究组 & 干预措施
No treatment
No intervention is given and a menstrual diary is completed for 2 cycles.
Active Treatment
Treatment for 2 menstrual cycles using the pulsed shortwave therapy Allay® device (BioElectronics Corp, Frederick USA)
干预措施: Allay (Device)
Placebo
Treatment for 2 menstrual cycles using a placebo device which is identical in appearance to the active device but does not emit any pulsed shortwave therapy.
干预措施: Placebo (Device)
结局指标
主要结局
A reduction in dysmenorrhea as measured by the highest pain score on a 10cm visual analogue scale.
时间窗: 2 months
Measured as highest pain score on a 10cm visual analogue scale
次要结局
- Impact upon associated cyclical symptoms(2 months)
- Improvement in quality of life as measured through a validated quality of life assessment tool (SF-36 questionnaire).(2 months)
- Device acceptability as measured on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable".(2 months)
- Reduction in use of analgesia(2 months)
研究者
Thomas Justin Clark
Chief Investigator
Birmingham Women's NHS Foundation Trust