An EDucation and eXercise Intervention (EDX-Ireland) for Gluteal Tendinopathy in an Irish Setting: a Feasibility Randomised Controlled Trial (LEAP-Ireland Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Success of different patient recruitment methods (including community recruitment, primary care and secondary care)
研究概览
简要总结
Gluteal tendinopathy, a degenerative condition of the gluteal tendons, is a common cause of lateral hip pain. It is three times more common in women, affecting up to 25% of those aged over 40 years. Research evidence supporting the most effective interventions remains limited. A 2018 landmark three-arm RCT (LEAP trial) in Australia compared EDucation on load management plus eXercise (EDX) against corticosteroid injection (CSI), and a 'wait-and see' control on pain and global improvement in 205 individuals with gluteal tendinopathy (Mellor et al, 2016; 2018). Results showed superior and significant positive effects in the EDX group, compared with CSI and wait-and-see groups at 8 weeks and 1 year. A total of 14 EDX sessions was provided over 8 weeks in LEAP, but in the public healthcare system in Ireland, typically 5-6 physiotherapy treatments are provided.
Therefore, whilst the LEAP trial demonstrated positive effects for EDX, implementation into clinical practice in Ireland is questionable as 6 or less treatment sessions are typically provided in public and private settings in Ireland (French et al, 2020). This two-arm feasibility RCT aims to evaluate the feasibility of conducting a future RCT of a reduced dose (6 sessions) of a recently proven efficacious physiotherapy treatment of EDucation plus eXercise (EDX-Ireland) to usual care for gluteal tendinopathy in an Irish setting. A Study Within A Trial will evaluate if exercise adherence is improved with use of a smartphone app compared with paper-based diaries.
详细描述
Study design: A two-arm assessor-blinded feasibility RCT will be conducted, incorporating a Study Within a Trial (SWAT) and embedded qualitative research. The CONSORT statement for pilot and feasibility randomised studies will be followed in the conduct and reporting of this trial.
Participants: Patients with gluteal tendinopathy in Ireland can present to their GP, self-refer to private physiotherapy, or attend secondary care rheumatology clinics. Various recruitment sources will be targetted in this feasibility trial, including: community recruitment, GP practices, sports medicine physicians and secondary care rheumatology or musculoskeletal triage clinics to establish optimal recruitment methods for a full-scale RCT. The following recruitment sources in the greater Dublin area will be notified of the study, provided with study information and a meeting arranged with the trial manager, if they are interested in being a recruitment source.
Procedure: Potential participants will initially be informed of the trial through the recruitment sites (hospitals and GPs), social media or through sports/leisure clubs and organisations. A study invitation letter will be sent out to all recruitment sites. This will also include a participant information sheet providing details of the study, participant eligibility criteria, and clear instructions on how to participate.
If participants indicate a willingness to hear more about the trial, the referral source will provide a leaflet/invitation with contact information of the trial manager and a link to the trial webpage and the Participant Information Leaflet. Interested participants will be initially screened via a phone screening procedure to ensure their eligibility. Those who progress through phone screening, will be invited to schedule an appointment for physical screening with the trial manager.
Once a person has successfully passed physical screening, an appointment will be made for them to attend for a hip MRI by the trial manager. Presence of MRI-confirmed gluteal tendinopathy will deem the person eligible for study inclusion. Participants will be informed that they can withdraw at any stage from the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 35-70 years
- •Lateral hip pain for at least 3 months, of ≥ 4/10 on an 11-point numeric rating scale on most days of the last 3 months
- •Tenderness on palpation of the greater trochanter
- •Reproduction of pain on at least one of following diagnostic clinical tests: (FADER test, FADER with Static muscle test (internal rotation) at end of range (FADER-R), FABER test, passive hip Adduction in side lying (ADD) test, adduction with resisted isometric abduction (ADD-R), and single leg stand (SLS) for 30 seconds
- •Demonstrated tendon pathology on MRI
- •Access to a computer, smartphone or tablet with internet connection
排除标准
- •Previous cortisone injection in the region of the lateral hip in the last 12 months
- •Physiotherapy (including regular appropriate Pilates) for lateral hip pain in the last 3 months
- •Lumbar spine or lower limb surgery in the last 6 months
- •Any known advanced hip joint pathology where groin pain is the primary complaint and/or where groin pain is experienced at an average intensity of ≥2 on most days of the week, or Kellgren-Lawrence score of >2 (mild) on X-Ray
- •If the following clinical criteria for the diagnosis of hip osteoarthritis (American College Rheumatology) are fulfilled:
- •Self-reported hip pain with either hip internal rotation <15° and hip flexion ≤115° or ≥15° hip internal rotation and pain on hip internal rotation
- •Μorning stiffness ≤ 60 minutes
- •Αge ≥ 50 years
- •Hip joint flexion is <90°, bilaterally
- •Lumbar radiculopathy or pain in another body location that is greater than the hip pain (NRS)
- •Known advanced knee pathology or restricted knee range of motion (must have minimum 90° flexion and full extension, bilaterally)
- •Any systemic diseases affecting the muscular or nervous system, and uncontrolled diabetes
- •Fibromyalgia
- •Use of cane or walking aid
- •Malignant tumour (current or in the past 6 months)
- •Systemic inflammatory disease
- •Any factors that would preclude the participant from having an MRI (e.g. pacemaker, metal implants, pregnancy, or trying to become pregnant, claustrophobia)
- •If the participant is involved in any injury claim
- •If the participant is unable to commit to an 8-week programme of up to 6 sessions of exercise
- •If the participant is unable to write, read or comprehend English
- •Unable or unwilling to use technology for exercise prescription and adherence
结局指标
主要结局
Success of different patient recruitment methods (including community recruitment, primary care and secondary care)
时间窗: Through study completion, an average of 1 year
Number of participants recruited using different recruitment methods, and the number retained at the 8-week and 3-month time-points will be recorded.
Usual care treatment/recommendations for Gluteal Tendinopathy in Ireland
时间窗: Through study completion, an average of 1 year
The constituents of care received from the referral source (GP, orthopedics, rheumatologists, musculoskeletal triage physiotherapists) for Gluteal Tendinopathy in Ireland will be assessed at baseline for all those allocated to the usual care arm
Cost-effectiveness information of Gluteal Tendinopathy in Ireland
时间窗: Baseline, 8 weeks and 3 months
Healthcare costs change from baseline, at 8 weeks and 3 months (including pain medication usage, GP visits, investigations, attendance at physiotherapy/other healthcare practitioners or hospital attendance) by trial participants for their hip pain will be recorded.
次要结局
- VISA Gluteal (VISA-G)(baseline, and at 8weeks, and 3months)
- The Central Sensitisation Inventory (CSI)(Baseline, 8 weeks and 3 months)
- Pain severity - Numeric Pain Rating scale (NPRS)(baseline, and at 8weeks, and 3months)
- Patient-Specific Functional Scale (PSFS)(baseline, and at 8weeks, and 3months)
- The EuroQol 5-D-5L(Baseline, 8 weeks and 3 months)
- Pain Self-Efficacy Questionnaire(Baseline, 8 weeks and 3 months)
- Patient Health Questionnaire-9 (PHG-9)(Baseline, 8 weeks and 3 months)
- Global Rating of Change (GROC)(Baseline, 8 weeks and 3 months)
- Isometric Hip Abductor Muscle Strength(Baseline, 8 weeks and 3 months)
- Pain Catastrophising Scale(Baseline, 8weeks, and 3 months)