In Patients With Acute Non-specific Low Back Pain, do Lumbar Inter-vertebral Motion Variables Change Following a Course of Manual Therapy: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Ratio of patients approached vs. number of participants who consent to trial
研究概览
简要总结
The aim of this study is to determine the feasibility of conducting a full-scale trial to explore if there is a change in intervertebral movement following a course of manual therapy in patients with acute non-specific low back pain (NSLBP).
Research Questions:
- In patients with acute NSLBP, does lumbar intervertebral movement change following a course of manual therapy?
- In patients with acute NSLBP, do those who respond to manual therapy (established by patient reported outcomes measures) have different intervertebral movement to those who do not?
详细描述
Non-specific low back pain (NSLBP) is a leading cause of disability and work-days lost worldwide. Yet, in most cases we do not know the specific cause. It is thought to be due to abnormal movement between the spinal bones (vertebrae). The investigators can now measure movement between vertebrae using low-dose quantitative fluoroscopy (QF), or motion x-ray videos. QF is a reliable method of measuring spinal movement which is non-invasive and does not expose the patient to a lot of radiation. In this study, QF will be used as a measuring tool to measure spinal movement in patients with acute NSLBP before manual therapy versus after manual therapy to explore if there is a change in spinal movement. Research suggests that some patients respond to manual therapy and some do not, a secondary question in this study is to explore if there are differences in spinal movement between those who respond to manual therapy (measured using pain and disability questionnaires) and those who do not.
This study is a feasibility study to determine whether the study can be carried out as a full-scale trial. Participants will be recruited from the AECC University College (AECC UC) Clinic. Following an examination, patients with acute low back pain, and who are eligible for the study will be invited to join. Participants will proceed with initial measurements which include validated questionnaires and QF. Following these measurements participants will be randomised into two groups, each containing 15 participants. Both groups will receive an evidence-informed home management booklet, the manual therapy group will receive five manual therapy treatments in two weeks. Participants will return for follow-up measurements two weeks after baseline measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor is blinded as to which intervention each participant received.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute non-specific low back pain (NSLBP), without leg pain, of at least 2 weeks duration, but no more than 4 weeks duration
- •Patients between the ages of 18 and 65
排除标准
- •Patients who cannot understand written English and unable to provide full informed consent.
- •Patients who are currently involved in another research study
- •Patients with a BMI over 30 (less likely to obtain the required information from the images)
- •Pregnancy or potentially pregnant
- •Previous ionising radiation exposure within the last 6 months greater than 8mSv.
- •Previous lumbar spine surgery, as well as recent abdominal or pelvic surgery (within the last 12 months).
- •Scoliosis or positive Adams forward Bending Test for Scoliosis.
- •Diagnosed Osteoporosis (Bone Density Scan)
- •Patients with a numeric pain scale of 8 or more, or 2 or less, taken at the New Patient Examination Appointment.
- •Manual therapy already received for this episode of NSLBP
- •Litigation or compensation pending
- •Diagnosis of depression (by a medical doctor) within the last 12 months.
结局指标
主要结局
Ratio of patients approached vs. number of participants who consent to trial
时间窗: 1 year
Rate of conversion from number of patients approached (who are eligible for the trial) to number of participants who consent to be a part of the trial.
Incidence of participant being withdrawn
时间窗: 1 year
Total participant number in the trial vs. number of participants who have been withdraw from the trial (where the practitioner withdraws the participant from the trial)
Ratio of presenting patients and eligible patients
时间窗: 1 year
Ratio of the number of patients seeking care for acute non-specific low back pain vs. number of eligible patients (according to eligibility criteria)
Incidence of participant withdrawal
时间窗: 1 year
Total participant number in the trial vs. number of participants who withdraw from the trial (where the participant withdraws from the trial)
Number of participants who experienced adverse or serious adverse events
时间窗: 1 year
Ratio of total number of participants (in both groups) vs. serious adverse events, as well as adverse events.
Participant compliance in arm two
时间窗: 1 year
Ratio of total participants in arm two vs. number of participants who were non-compliant with the intervention (in arm two)
Participant compliance in arm one
时间窗: 1 year
Ratio of total participants in arm one vs. number of participants who were non-compliant with the intervention (in arm one)
次要结局
- Laxity(2 weeks)
- Anterior disc height(2 weeks)
- Bournemouth Questionnaire(2 weeks)
- Roland Morris Disability Questionnaire - 24(2 weeks)
- Inter-vertebral range of angular motion(2 weeks)
- Sagittal translation(2 weeks)
- Motion Sharing Variability (MSV)(2 weeks)
- Motion Sharing Inequality (MSI)(2 weeks)