Effectiveness of Conservative Multimodal Physiotherapy in Chronic Whiplash-associated Disorders With Facet-mediated Pain Undergoing Platelet Rich Plasma (PRP) Treatment: a Series of Single Case Experimental Designs (SCEDs).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Self-efficacy whilst performing daily activities in chronic WAD.
研究概览
简要总结
The investigators will explore a standardized and previously published evidence-based conservative multimodal physiotherapy treatment fulfilling clinical practice guidelines in individuals with chronic whiplash-associated disorders (WAD) with facet-mediated pain (appropriate response to dual medial branch blocks) undergoing cervical facet joint Plasma-Rich Platelet (PRPt) and compare health outcomes to individuals' undergoing cervical facet joint PRP with usual care (PRPu), which consists of advice, supervised home exercise and pharmacological management for treatment of residual pain. To be clear, the investigators are not investigating the efficacy or effectiveness of cervical facet joint PRP - these individuals have already consented to proceed with PRP treatment. The investigators are evaluating the role of adjuvant conservative multimodal physiotherapy treatment. It must be noted that these patients have previously failed to respond to conservative physiotherapy. The investigators will use a design which is quite novel in physiotherapy, Single Case Experimental Designs (SCEDs). In contrast to an experimental group design in which one group is compared with another, participants in single-subject research provide their own control data for the purpose of comparison in a within-subject rather than a between-subjects design. SCEDs provide a method to determine response and benefit for every individual patient.
Therefore, the investigators will assess effectiveness of conservative multimodal physiotherapy for chronic WAD with facet-mediated pain undergoing cervical facet joint PRP, using patients as their own control, in a multiple baseline design.
详细描述
This will be a single case with randomized multiple baseline experimental design with enrolment of 3 patients undergoing PRPt, and 3 patients undergoing PRPu following PRP. There will be a variable length baseline (A1) and then a staggered start to provide internal validity - one patient starting at 5 days (post-PRP), one at 8 (post-PRP) and one at 11 days post-PRP, randomly allocated. This study will utilise an A1-B-A2 design: a baseline (A1 no intervention); intervention phase (B); and a no intervention (A2 follow up).
Primary outcome measures will be collected daily during this time period. The baseline phase will be followed by a 6-week intervention period (B). Participants will have 10 one hour sessions over a 6-week period. The intervention will be delivered by an experienced physiotherapist with postgraduate qualifications. During the intervention period, once or twice per week the daily collection of the primary outcome measures will coincide with the delivery of each intervention session. The intervention phase will be followed by a 12-week follow-up phase (A2) where participants will have no contact with the intervention personnel. This follow-up phase is implemented in order to determine the possible duration of improvement post intervention. All outcome measures will be collected at the completion of this 12-week follow-up period.
Secondary outcome measures for generalisation purposes will be collected prior to commencing PRP, at the end of the intervention period (which coincides with the commencement of the no-intervention period), and at the end of the no-intervention period; totalling 3 sampling points throughout the study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participant is not made aware of intervention arm - treat as usual or physiotherapy. Radiologist providing PRP tells participant to refrain from treatment for 6-weeks, or to immediately commence physiotherapy.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with Grade II Whiplash Associated Disorder with > 80% relief of familiar neck pain after dual medial branch blocks
- •> 12 weeks since injury and failed to respond to previous (> 6 weeks) conservative treatment
- •Neck pain on numerical pain rating scale ≥ 4/10
- •Neck Disability Index > 28%
排除标准
- •Presence of dizziness symptoms
- •Known or suspected serious spinal pathology (e.g. metastatic disease of the spine);
- •Confirmed fracture or dislocation at time of injury (i.e., WAD Grade IV)
- •Nerve root compromise (i.e., WAD Grade III)
- •Spinal surgery in the past 12 months; and
- •History of any mental health conditions such as bipolar disorder, psychosis, schizophrenia, anxiety, PTSD or severe depression
- •Inability to stop taking anti-inflammatory medications for 3-days prior to, or 10-days following PRP
- •Unable to understand +/- complete validated questionnaire items in English
研究组 & 干预措施
Physiotherapy (PRPt)
The 6-week exercise program (2 sessions in each of weeks 1-4 and 1 session in each of weeks 5 and 6) will comprise specific individually-tailored exercises to improve the movement and control of the neck and shoulder girdle. The exercises will be of a low load nature and designed to be pain free. At the same time, the physiotherapist will provide pragmatic multimodal physiotherapy to facilitate ability to pursue exercises and guide the participant's return to normal activities. This specific treatment program has been described in detail (Jull et al., 2008; Ritchie et al., 2015b) and focuses on activating and improving the coordination and endurance capacity of the neck flexor, extensor and scapular muscles in specific exercises and functional tasks. Participants will also perform the exercises at home, once per day. Written and illustrated exercise instructions will be provided. The exercise program follows Australian guidelines for the management of chronic whiplash (TRACsa, 2008).
干预措施: Multimodal physiotherapy (Other)
Wait and See (PRPu)
Individuals randomized to usual care will be provided with an advice booklet Whiplash Injury Recovery: A Self Help Guide (MAIC, Qld, 2nd edition). It provides information about whiplash; assurance about prognosis; advice to stay active and resume working as well as information on correct posture; pictorial descriptions of specific exercises for the neck and upper limbs and information on resuming functional daily activities. The booklet is based on the recommendations of the current Australian Guidelines for Whiplash Management (SIRA, 2014).
Usual care involves a 'wait and see' approach (in combination with provision of home exercises) and will include weekly review appointments with a medical doctor, primarily to review the information in the booklet and progress the 'general' exercises and activity recommendations within the booklet. No hands-on physiotherapy will be provided. Education regarding PRP and associated healing cycles will also be provided during this time period.
结局指标
主要结局
Self-efficacy whilst performing daily activities in chronic WAD.
时间窗: 12 weeks
This question will ask participants to identify "how confident are you in your ability to perform your daily tasks in the presence of your neck pain or disability?" with 1 indicating not at all confident; 2 indicating a little confident 3 indicating moderately confident; 4 very confident and 5 indicating extremely confident.
Pain, Enjoyment of Life and General Activity (PEG)
时间窗: 12 weeks
PEG measures average neck pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G) on the continuous numeric rating scale (NRS) of 0 to 10 during the last 24 hours (Krebs et al., 2009).
次要结局
- Patient Global Impression of Change (-3 to +3 scale)(Up to 11 days + 12 weeks)
- The Pain Catastrophizing Scale (PCS)(Up to 11 days + 12 weeks)
- Neck Disability Index (NDI)(Up to 11 days + 12 weeks)
- Depression & Anxiety Stress Scales (DASS-21)(Up to 11 days + 12 weeks)
- Medical Outcomes Survey Short Form (SF-12)(Up to 11 days + 12 weeks)