A Multicentre Double-blind Randomised Controlled Trial to Assess the Clinical- and Cost-effectiveness of Facet-joint Injections in Selected Patients With Non-specific Low Back Pain: a Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Change in Pain numerical rating scale (NRS)
研究概览
简要总结
Lumbar facet-joints are small, paired joints in the low back that provide stability, integrity and flexibility of movement to the spine. Diseased facet-joints may cause persistent low back pain, with significant socioeconomic impact. At present, there is insufficient high quality evidence to support the use of lumbar facet-joint injections (FJIs) in treating low back pain of less than 12 months' duration; the National Institute for Health and Care Excellence (NICE) therefore did not approved their use in their 2009 publication.
This study will investigate the feasibility of conducting a larger, definitive trial to assess lumbar FJIs (a needle is inserted into the facet-joint and steroid injected), by comparing it to a dummy or 'sham' procedure (a needle is inserted near the facet-joint but no therapeutic substance injected).
Patients with persistent low back pain, referred to a community or hospital-based pain, spinal or musculoskeletal clinic by their general practitioner, will be reviewed and assessed by a specialist physician. They will be screened and recruited based on clinical history and examination. Participants will receive diagnostic injections (medial branch nerve blocks); those with a positive response will randomly receive either FJIs or a sham procedure, under x-ray guidance. All participants will receive a combined physical and psychological programme recommended by NICE as a strategy to reduce pain and its impact on the person's day-to-day life, even if the pain cannot be cured completely.
Participants will be asked to complete questionnaires comparing a range of pain and disability-related issues. These will occur at baseline (before treatment) and at 6 weeks, 3 months and 6 months after their injections.
Criteria for the study to be considered successful (and a definitive trial feasible) include the abilities to standardise the methods for injection and to recruit and retain sufficient participants, and the acceptability of the study design to participants and clinicians.
详细描述
Design
This study seeks to examine the feasibility of undertaking a fully powered double-blind randomised controlled trial. Patients with non-specific low back pain of more than three months' duration with confirmed facet-joint disease will be individually randomised 1:1 to receive facet-joint injections plus a combined physical and psychological programme (intervention group) or to a sham (placebo) procedure plus a combined physical and psychological programme (control group).
Setting
The feasibility study will be conducted in three hospital-based pain medicine centres: Barts Health NHS Trust (formerly Barts and The London NHS Trust), Basildon and Thurrock University Hospitals NHS Foundation Trust, and The Walton Centre NHS Foundation Trust.
Target population
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 70 years attending pain clinics identified during routine clinical assessment of non-specific low back pain (clinical indicators for pain of facet-joint origin include tenderness over the facet-joints, referred leg pain above the knees, and worsening pain on extension, flexion and rotation).
- •Low back pain of greater than three months' duration.
- •Average pain intensity score of 4/10 or more in the seven days preceding recruitment despite NICE-recommended treatment (NICE recommends providing patients with advice and information to promote self-management of their low back pain, and offering one of the following treatments, taking into account patient preference: an exercise programme, a course of manual therapy, or a course of acupuncture).
- •Dominantly paraspinal (not midline) tenderness at two bilateral lumbar levels.
- •At least two components of NICE-recommended best non-invasive care completed, including education and one of a physical exercise programme, acupuncture, and manual therapy.
排除标准
- •Patient refusal.
- •More than four painful lumbar facet-joints.
- •Patient has not completed at least two components of NICE-recommended best non-invasive care.
- •'Red flag' signs ('Red flag' signs are possible indicators of serious spinal pathology, and include thoracic pain, fever, unexplained weight loss, bladder or bowel dysfunction, progressive neurological deficit, and saddle anaesthesia).
- •Hypersensitivity to study medications or X-ray contrast medium.
- •Radicular pain (Radicular pain is defined as pain perceived as arising in a limb or the trunk wall caused by ectopic activation of nociceptive afferent fibres in a spinal nerve or its roots or other neuropathic mechanisms. The pain is lancinating in quality and travels along a narrow band).
- •Dominantly midline tenderness over the lumbar spine.
- •Any other dominant pain.
- •Any major systemic disease or mental health illness that may affect the patient's pain, disability and/or their ability to exercise and rehabilitate.
- •Any active neoplastic disease, including primary or secondary neoplasm.
- •Pregnant or breastfeeding patients.
- •Previous lumbar facet-joint injections.
- •Previous lumbar spinal surgery.
- •Patients with morbid obesity (body mass index of 35 or greater).
- •Major trauma or infection to the lumbar spine.
- •Participation in another clinical trial in the past thirty days.
- •Patients unable to commit to the six-month study duration.
- •Patients involved in legal actions or employment or benefit tribunals related to their low back pain.
- •Patients with a history of substance abuse.
研究组 & 干预措施
Active Procedure
All patients will receive 6 X-ray guided peri-articular injections via a spinal needle at 2 bilateral lumbar levels using 0.5ml of 1% Lidocaine. This a test procedure to identify the patient has a 50% pain reduction from baseline pain numerical score. If patients pass this test injection, they will be randomised to the active or sham procedure.
4 X-ray guided intra-articular facet-joint injections via a spinal needle at 2 bilateral lumbar levels, using 0.5ml 0.5% bupivacaine + 20mg methylprednisolone per joint
干预措施: Active Procedure (Procedure)
Sham procedure
All patients will receive 6 X-ray guided peri-articular injections via a spinal needle at 2 bilateral lumbar levels using 0.5ml of 1% Lidocaine. This a test procedure to identify the patient has a 50% pain reduction from baseline pain numerical score. If patients pass this test injection, they will be randomised to the active or sham procedure.
4 X-ray guided peri-articular injections via a spinal needle at 2 bilateral lumbar levels using 0.5ml normal saline per injection
干预措施: Sham procedure (Procedure)
结局指标
主要结局
Change in Pain numerical rating scale (NRS)
时间窗: Baseline (visit 1) and diagnostic injections (visit 2)
The rationale for carrying out diagnostic medial branch nerve blocks is because of their safety, simplicity and prognostic value. There is currently no justification for double, comparative blocks as these are associated with a significant false-negative rate and are not shown to be cost-effective. The pain scores at baseline (recruitment) will be recorded using a numerical rating scale (0-10) and will be compared to the score taken 20-40 minutes and 180-200 minutes after the injections. If a positive response of 50% pain reduction is seen, we know the pain is definately coming from the facet- joint which entitles the patient to be eligible for the randomised procedure.
次要结局
- Change in Functional impairment: Oswestry Low Back Pain Disability Questionnaire, Pain Self Efficacy Questionnaire (PSEQ) at different follow-up visits(Baseline (visit 1))
- Change in Healthcare utilisation and costs, and impact on productivity at different follow up visits(6 months (visit 6))
- Change in Pain intensity and characteristics: Brief Pain Inventory (BPI) (Short Form) Modified, with its 11-point NRS Short Form McGill Pain Questionnaire.(6 months (visit 6))
- Expectation of benefit(Baseline)
- Change in Health-related quality of life: EQ5D-5L, 12-item Short Form Survey (SF-12) at different follow- up visits(Baseline (visit 1), 6 weeks (visit 4), 3 months (visit 5) and 6 months (visit 6))
- Change in Co-psychological well-being: Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale, SF-12, BPI at different follow up visits(6 months (visit 6))