A Clinical Trial of a Multi-Element Exercise Program for Plantar Fasciopathy in Workers Required to Stand for Prolonged Periods of Time
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change from Baseline in Foot and Ankle Disability Index (FADI) at 6 weeks
研究概览
简要总结
Chronic plantar fasciopathy is a painful condition common in the workplace, particularly for those workers required to stand for long periods of time, and is typically associated with point tenderness at heel and arch of the foot. This clinical trial will investigate the effectiveness of an innovative multi-element exercise program versus the standard of care for plantar fasciopathy. The observation period will be 12-weeks. Outcomes are determined through questionnaire and ultrasound imaging. Workers with long-standing plantar fasciopathy who must stand for prolonged periods of time (i.e. > 6 hours) during their workday will be invited to participate in this study. After ensuring eligibility, each subject will be randomly assigned to either the intervention group who will receive a multi-element exercise program, or the control group who will receive a cortisone injection followed by a stretching program for their calf-muscles (standard of care). The treatment length for both groups will be 12-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
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult workers (men and women) between the ages of 19 and 60
- •Workers required to stand for 6 hours or more in their respective workplaces
- •Diagnosed with plantar fasciopathy (plantar fasciitis). All diagnoses will be made by a physiotherapist based on the presentation of palpable pain at or around the plantar medial heel, in addition to pain during weight-bearing activities and the presence of morning pain.
- •Only individuals with pain for longer than 12 months will be included.
排除标准
- •A history of surgery to their plantar fascia
- •Osteoarthritis or other degenerative musculoskeletal disorders affecting the lower extremity
- •Individuals who have received corticosteroid injections into their affected plantar fascia at any time in the past will be excluded.
研究组 & 干预措施
Exercise
Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.
干预措施: Karaoke Exercise (Other)
Exercise
Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.
干预措施: Balance walking exercise (Other)
Exercise
Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.
干预措施: Forefoot extension exercise (Other)
Exercise
Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.
干预措施: Ankle inversion/eversion exercise (Other)
Exercise
Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.
干预措施: Gastrocnemius and soleus stretching (Other)
Exercise
Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.
干预措施: Tissue-specific plantar fascia self massage (Other)
Standard of Care
This arm will consist of a single injection of a corticosteroid, followed by stretching exercises for the calf.
干预措施: Gastrocnemius and soleus stretching (Other)
Standard of Care
This arm will consist of a single injection of a corticosteroid, followed by stretching exercises for the calf.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Change from Baseline in Foot and Ankle Disability Index (FADI) at 6 weeks
时间窗: 6 weeks
Patient-centered health-realted quality of life indicator measuriing disability at the foot and ankle.
Change from Baseline in Foot and Ankle Disability Index (FADI) at 12 weeks
时间窗: 12 weeks
Patient-centered health-realted quality of life indicator measuriing disability at the foot and ankle.
次要结局
- Change in Ultrasound-Based Grading of Pathology at 12 weeks(12 weeks)
- Change in Acoustoelastographic Analysis of Plantar Fascia Elasticity at 12 Weeks(12 weeks)
- Change in Visual Analog Scale for Pain at 12 weeks(12 weeks)