Treatment of the PIP Joint Flexion Contracture: Combined Static and Dynamic Orthotic Intervention Compared With Traditional Combine Therapy. A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Active Range of motion AROM (degrees)
研究概览
简要总结
Study Design: Randomized controlled clinical study. Introduction: Physiotherapeutic intervention aiming to restore mobility using different techniques as stretching, hot packs, exercises, therapeutic ultrasound and orthotics. No scientific evidence has been found correlating improved joint mobility and the use of these techniques. Application techniques of orthoses to reshape the soft tissues have been well detailed, however, no scientific evidence supporting their effectiveness on proximal interphalangeal joint (PIPJ) lag extension resolution using them as a single treatment has been found.
Purpose of the Study: The purpose of the study was to test the effectiveness of static and dynamic orthosis in patients with a PIPJ flexion retraction using them as a single treatment compared with traditional combined therapies.
Method: 63 participants were included in the study. Patients who used splints were compared to a control group who received conventional treatment. Active and passive mobility were measured before the experiment and again three months after. All the patients were measured under the same conditions and treated by the same hand therapist. The relationship between contracture resolution and function was measured using the DASH Spanish Version.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIO:
- •18 years old
- •had given their consent
- •having suffered trauma to the hand or finger which has resulted in joint damage with a consequent loss of full extension of the PIPJ
- •duration of the injury being between four and 30 weeks.
排除标准
- •Patients who had no proper joint alignment,
- •Patients those with a presence of nerve or tendon associated dupuytren,
- •campodactilea
- •tubular bone fractures
- •acute inflammatory signs
- •joint instability
- •avascular necrosis
- •infection of the affected finger were not included in the study.
研究组 & 干预措施
Control group
Conventional treatment: The treatment consisted of 10 minutes of local thermotherapy (paraffin), active exercises at the PIPJ and DIPJ (Distal interphalangeal joint), 3 sets of 15 repetitions of each exercise extending and flexing of the PIPJ with metacarpophalangeal joint from 0° to 90° respectively. Distal interphalangeal joint exercises were conducted with identical repetitions. The metacarpophalangeal joint and PIPJ exercises took place at 0 ° and involved stretching (5 sets of 3 reps, holding for 10 seconds) and Therapeutic U.S (0.8 w/cm2 / 7 minutes).
干预措施: conventional treatment Physical Therapy (Procedure)
Experimental group
dynamic extension contracture orthotic. A mobilizing force of 250 - 300 gm/cm2 was set in each one. Patients were instructed to wear it for at least 6 hours per day and then removed it for ADL (Activity Daily Living). A static orthosis was constructed using orfitcast material to the maximum, pain-free length allowed by the tissues at night. Static and dynamic orthoses were checked once a week and adjusted as necessary.
干预措施: dynamic extension contracture orthotic (Procedure)
结局指标
主要结局
Active Range of motion AROM (degrees)
时间窗: baseline; post-treatment (3 moths)
AROM and function were measured in all patients at inclusion and at three months after the start of the study. which was measured using a short arm goniometer Stainless Baseline 180°. A lateral measurement following the standardized protocol recommended by the American Society of Hand Therapists was used.
次要结局
- Disability of the arm shoulder AND HAND (DASH QUESTIONNAIRE)(baseline; post-treatment (3 moths); 24 weeks follow up)
- changes from postreatment Active range of Motion (AROM) degrees(24 weeks follow up)
研究者
Dr. Antonio I Cuesta-Vargas
PhD
University of Malaga