ACTRN12615001270505已完成不适用
In patients with low back pain, does general spine and body conditioning, compared to manual therapy, improve intervertebral disc characteristics?
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 25 Years 至 45 Years（—）
- 性别
- All
入选标准
- •Key inclusion criteria:
- •* Low back pain of at least 3 months duration. Can be recurrent intermittent low back pain.
- •* NRS scale (via telephone): minimum of 2 and maximum of 8
- •* Aged 25-45
- •* Sedentary: Less than 150 minutes moderate to vigorous physical activity per week. Moderate = make you breathe somewhat harder than normal
- •* Available to attend up to 3d/week to a facility at either Deakin University or Boronia
- •* Able to attend during work hours
- •* Able to attend a 3 hour testing sessions at baseline, 3 and 6 months at Deakin with an additional MRI scan on a different day
排除标准
- •1. Unable to attend of up to 2 sessions per week of 1 hours over a 6 month period.
- •2. Formal organised sport
- •3. Gym exercise more than one day a week
- •4. Any current parallel treatment
- •5. Unable to complete the testing protocol
- •6. Spinal pain/treatment exclusions:
- •* Any other current interventional treatment (aside from seeing GP and/or taking medication)
- •* Plans at the time of enrolment to undergo invasive treatment (injections or surgery) in the subsequent 6 months
- •* History of spinal surgery
- •* Is on a waiting list for spinal surgery
- •* Have a compensable claim for their back injury
- •* History of traumatic injury to the spine (e.g. fractures, car accident)
- •* Known scoliosis for which prior medical consultation has been sought.
- •* Have cauda equina syndrome based on imaging and bladder or bowel disturbance
- •* Neurological symptoms: radicular pain (symptoms on clinical subjective examination), pins/needles/numbness
- •* Non-musculoskeletal causes of low back pain (as defined upon review of baseline MRIs)
- •7. Current smoker
- •8. Known anaemia
- •9. Unable to communicate easily in English
- •10. Females:
- •* Pregnancy
- •* Possible pregnancy
- •* Breastfeeding
- •* Plans to become pregnant in next 6 months
- •* If during the course of the study a female subject thinks there is even a chance she may have become pregnant, she will be excluded from the study. The female subjects will be asked this before each testing session (0,3,6 months).
- •* Given birth in the last 9 months
- •11. Further DXA specific criteria:
- •* Had nuclear medicine done within 3 months (radioactive contrast agent)
- •* Metal or other implants in the spine
- •* Unable to fit onto the DXA table: weighs more than 130kg
- •* Possible pregnancy
- •12. MR specific criteria:
- •* Claustrophobia
- •* Any metal implants or fragments
- •* Any electronic implants (e.g. pacemaker)
- •* Piercings that cannot be removed
- •* Body weight above 120kg
- •13. TMS specific criteria:
- •* Epilepsy
- •* Chronic migraine
- •* History of seizures
- •* Family history of seizures
- •* Serious head injury (including neurosurgery) : a one off incident of concussion is OK, but repeated incidents or anything more serious is an exclusion
- •* Any illness that caused brain injury
- •* Any other brain-related condition
- •* Head implants or pacemakers
- •* Medication for mental health or neurological diseases (pain killers are ok)
研究者
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