A Zhineng Qigong Intervention for Patients With Chronic Low Back Pain and/or Leg Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 9
- 主要终点
- Pain intensity
研究概览
简要总结
The purpose of this study is to evaluate a Zhineng Qigong intervention for patients with chronic low back pain and/or leg pain, and to test feasibility aspects.
详细描述
Zhineng Qigong is a self-training method which enables the participant to take an active part in a possible recovery process.
The aims of this study are: 1) evaluate a Zhineng Qigong intervention regarding health aspects (both subjective and objective outcomes) in patients with chronic low back pain and/or leg pain; 2) test different aspects of feasibility including recruiting from different patient populations and testing outcome measurements; and, 3) get a basis for power calculation for a future Randomised Controlled Trial.
Based on previous experiences after Zhineng Qigong training with European Zhineng Qigong, this study is based on the following hypotheses:
- Zhineng Qigong training gives pain reduction and reduced consumption of analgesics.
- Zhineng Qigong training reduces lumbar spine-related symptoms (other than pain).
- Zhineng Qigong training reduces healthcare utilisation, including lumbar spine surgery.
- Zhineng Qigong training improves walking ability, mobility, and functional capacity.
- Zhineng Qigong training improves Health-Related Quality of Life, including perceived concentration ability, distress, sleeping quality, vitality, depression, mood, and anxiety.
The investigators´ idea was to give patients with chronic low back pain and/or leg pain the opportunity to practise Zhineng Qigong in an intervention arranged by European Zhineng Qigong. To this prospective interventional study without control group, patients were recruited from the Swedish spine surgery register (SweSpine), Orthopaedic clinic, and Primary Healthcare. The intervention period was 12 weeks, with measurements once before and once after intervention. However, because of difficulties in recruiting, 15 of the respondents were enrolled to 3 weeks shorter intervention, joining respondents who already started the 12 weeks intervention. Totally, 55 respondents were enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General inclusion criteria:
- •Low back pain and/or leg pain (caused by lumbar disorder) with at least 3 months duration.
- •Pain intensity in lumbar spine and/or leg (caused by lumbar disorder) at least 30 on a 0-100 Visual Analogue Scale (VAS), being "the best description of pain the past 2 weeks". (As enrolment initially went slow, also patients scoring VAS pain intensity 25 to 30 became eligible if their pain situations were qualitatively assessed severe, resulting in enrolment of 5 such patients).
- •Resident in the county of Skåne (southern part of Sweden).
- •Comfortable with the Swedish language.
- •Acceptance not to practise Yoga, Meditation, or any other Qigong exercises during or 1 month after the intervention.
- •Specific inclusion criteria, clinical pathway:
- •Postoperative after lumbar spine surgery: one lumbar spine surgery 1-6 years earlier, for either spinal stenosis, spondylolisthesis, or segmental pain. Pain intensity (back and/or leg) at least 30 on 0-100 mm VAS in latest SweSpine follow-up protocol.
- •Patients from Primary Healthcare Centres: chronic low back pain (at least 3 months duration) with or without leg pain.
- •Patients on waiting list for lumbar spine surgery: Planned first surgery for either spinal stenosis, spondylolisthesis, or segmental pain.
排除标准
- •Lumbar spine or other major surgery planned before, during, or within 1 month after the intervention period.
- •History of serious mental disease, epilepsy, or narcolepsy.
- •Current abuse of medicament, drug, or alcohol.
- •Pregnancy (due to practical reasons only).
研究组 & 干预措施
Zhineng Qigong
Zhineng Qigong intervention
干预措施: Zhineng Qigong intervention (Other)
结局指标
主要结局
Pain intensity
时间窗: Filled in once daily during 2 weeks, directly before and directly after the intervention period, respectively
"Pain diary" (designed for this study) measured most usual pain intensity (NRS; 0-10) in lumbar spine and/or leg (caused by lumbar spine disorder).
次要结局
- Timed get-up-and-go(Before and after the intervention period)
- Additional aspects concerning Health-Related Qualify of Life(Before intervention and as soon as possible after)
- Retention rate(After intervention)
- Pain symptoms(Before intervention and as soon as possible after)
- Non-pain symptoms(Before intervention and as soon as possible after)
- How often "free from pain"(Before intervention and as soon as possible after)
- Change in intake of analgesics(At baseline concerning past 3 months, after intervention since intervention start)
- Change in intake of other medications(At baseline concerning past 3 months, after intervention since intervention start)
- How often "free from non-pain symptoms"(Before intervention and as soon as possible after)
- Active maximal functional shoulder mobility(Before and after the intervention period)
- Oswestry Disability Index version 2.1a(Before intervention and as soon as possible after)
- Healthcare utilisation(At baseline concerning past 3 months, after intervention since intervention start)
- Performed lumbar spine surgery(6 months after intervention)
- Walking ability(Before and after the intervention period)
- Active cervical range of motion(Before and after the intervention period)
- Passive hip mobility(Before and after the intervention period)
- Finger tip-floor distance(Before and after the intervention period)
- Schober test(Before and after the intervention period)
- Single leg stance(Before and after the intervention period)
- Straight leg raising test(Before and after the intervention period)
- Short Form 36 version 2(Before intervention and as soon as possible after)
- Recruitment rate(Before intervention)
- Attendance in group activities(During intervention)
- EQ-5D-5L (including EQ VAS)(Before intervention and as soon as possible after)
- Individual Zhineng Qigong training time(During intervention and 2 weeks after intervention)
- Ability to collect outcome measures(At baseline and after intervention)