Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain: A Multi-Center Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Foot and Ankle Ability Measure
研究概览
简要总结
A recent study has demonstrated that a physical therapist directed exercise program did not result in greater reductions in disability and pain when compared to a home exercise program. However, no manual therapy procedures were incorporated into the physical therapy treatment program despite recent evidence suggesting that thrust and non-thrust manual therapy techniques may be beneficial in reducing disability, pain and improving gait. Therefore, the purpose of this study is to compare the effectiveness of a physical therapy management approach consisting of manual therapy and exercise to a home program of exercise only. The investigators hypothesize that the group receiving manual therapy and exercise will have better outcomes.
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 (Participant)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •A combination of physical examination and self-report measures will be used to assess the patient's potential eligibility according to each inclusion/exclusion criterion.
- •The following inclusion criteria will be used to determine eligibility for this study:
- •Primary complaint of ankle pain, status post inversion ankle sprain.
- •The investigators decided to include patients with both acute and chronic ankle sprains since our previous work has shown that patients from both stage have exhibited positive benefits with manual therapy.66
- •Age between 16-60 years old
- •NPRS score > 3 points (average score) over past 24 hrs.
- •Does not meet criteria for needing radiographs per the Ottawa Ankle Rules
- •The following exclusion criteria will be used to determine ineligibility for this study:
- •Red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, RA, osteoporosis, prolonged history of steroid use, severe vascular disease, etc.)
- •Prior surgery to the distal tibia, fibula, ankle joint, or rearfoot region (proximal to the base of the metatarsals).
- •Grade III ankle sprain (as defined by the West Point Ankle Sprain Grading System and/or tenderness along the anterior medial malleolus as described by,51 fracture, or other absolute contraindications to manual therapy.
- •Insufficient English language skills to complete all questionnaires
- •Inability to comply with treatment and follow-up schedule
研究组 & 干预措施
Manual Therapy and Exercise
Manual Therapy and Exercise
干预措施: Manual Therapy and Exercise (Other)
Home Exercise
Home Exercise
干预措施: Home exercises (Other)
结局指标
主要结局
Foot and Ankle Ability Measure
时间窗: 4-weeks and 6-months
次要结局
- Numeric Pain Rating Scale(4-weeks and 6-months)
研究者
Joshua Cleland, DPT, OCS
Professor
Franklin Pierce University