Hip Osteoarthritis and Foot Orthoses Trial (HOOT): A Randomized Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Feasibility: adherence
研究概览
简要总结
This trial is a randomized feasibility trial to determine the feasibility of comparing two different shoe inserts and on pain, quality of life and physical activity associated with hip osteoarthritis.
详细描述
Participants will be randomized to one of two groups - contoured prefabricated foot orthoses or flat shoe inserts (the comparator). Participants will be asked to use the inserts daily for a six week period. Adherence to the intervention will be monitored using a daily diary, as well as adverse events and co-interventions. The primary outcome is feasibility domains (Demand, Implementation, Acceptability, Practicality) with secondary outcomes of change in hip-related pain and quality of life and physical activity levels. The primary time-point will be 6-weeks.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Assessor blinding: Participants complete their own outcome measures (questionnaires) online and are thus not blind. Accelerometry data will be assessor blinded. All outcome measures will be analysed by an investigator blind to participant group allocation. Participants will be instructed not to divulge any aspect of their intervention to the research assistant conducting follow-up assessments.
Participant blinding: Participants will be advised that they have an equal chance of being allocated to the either shoe insert, and thus are blind to allocation. Participants will also be blind to the study hypothesis, so they are unaware which of the interventions is 'active'.
Physiotherapist blinding: It is not possible to blind the trial physiotherapist to group allocation. Trial Physiotherapists will however not be involved in assessment of outcome measures.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary symptomatic and radiographic hip OA, in accordance with the American College of Rheumatology
- •(i) aged > 45 years;
- •(ii) pain in the hip or groin for more than 3 months;
- •(iii) average pain intensity over the past week of > 3 out of 10 (Numerical Rating Scale) during functional tasks like walking, climbing stairs or climbing in/out of a car;
- •(iv) radiographic confirmation of hip osteoarthritis with a Kellgren-Lawrence score ≥ 2 within the last 12 months;
- •(v) mild to moderate disability indicated by;
- •able to reciprocally ascend and descend 10 stairs unaided,
- •able to safely walk one city block, and
- •able to jog five meters if required
排除标准
- •(i) other musculoskeletal lower limb or back conditions requiring assessment or treatment by a health professional (Doctor, Physiotherapist, Podiatrist etc) in the last 6 months;
- •(ii) have received active treatment for their hip pain by a health professional (eg physiotherapist) in the last 3 months;
- •(iii) history of hip trauma or surgery on the affected side;
- •(iv) corticosteroid use (oral or intra-articular injection) in the past 3 months
- •(v) neurological impairment or condition affecting lower limb function
- •(vi) conditions or factors affecting ability to take part in the intervention, e.g., unavailable for a 6 week intervention period, routine use of gait aids, uncontrolled hypertension, or morbid obesity (body mass index > 40);
- •(vii) Use of foot orthoses in the previous 12 months
- •(viii) systemic inflammatory disease (e.g. rheumatoid arthritis);
- •(ix) unable to write, read or comprehend English.
结局指标
主要结局
Feasibility: adherence
时间窗: 6 weeks
Recruitment rate (average 1 participant per week); 50% log-book completion rate (daily); drop-out \<20%; 35 hours per week adherence to intervention (log book)
次要结局
- Depressive symptoms(Baseline and 6 weeks)
- Hip-related pain(Baseline and 6 weeks)
- Hip-related physical function(Baseline and 6 weeks)
- Physical activity- Walking based physical activity(Baseline and 6 weeks)
- Global rating of change- Physical activity(Week 6)
- Hip-related quality of life(Baseline and 6 weeks)
- Fear of movement(Baseline and 6 weeks)
- Physical activity- Self-reported(Baseline and 6 weeks)
- Global rating of change- Symptoms(Week 6)