跳至主要内容
临床试验/NCT03561688
NCT03561688已完成不适用

Foot Orthotic for Early Stage Rheumatoid Arthritis

Vendsyssel Hospital3 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2018年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
3
主要终点
Change in gait mechanics

研究概览

简要总结

The overall purpose of this project is to investigate the neuro adaptations of pain and biomechanical differences between placebo and a custom-made foot orthoses for patients with RA.

详细描述

Rheumatoid arthritis (RA) is an autoimmune, chronic, progressive, systemic inflammatory disease leading to substantial pain, disability, and other morbidities. In Denmark there are 40.000 patients with RA. In RA, synovitis, effusion, eventually erosive arthritis, bone loss and weakening of the muscle and tendon apparatus are thought to cause clinically recognizable valgus heel or pes planovalgus deformity. These symptoms gradually cause irreversible joint deformities and changes in the locomotion of muscles3. Over 85% of patients with RA experience painful feet and ankles during the course of the disease. Despite medical developments, foot orthotics (FO) are still an important adjunct treatment and are often prescribed with the intention to stabilize and align the foot. This is due to a number of reasons: 1) persistent foot and ankle problems still occuring even after clinical remission is reached. 2) patients with increased disease activity may have mechanical foot impairments that need treatment in conjunction with systemic management. and 3) patients, who have not responded to or are ineligible for biologic agents, continue to have active foot impairments. However, the scientific research literature within FO treatment has lagged behind clinical practice, often leading the clinician to recommend interventions based on opinion and past experience rather than published evidence9.

Production of FO is an enormous industry. Consequently, there is a great variety of products with different materials, design, manufacturing techniques and procedures. In the literature, some FO have been shown to reduce pain however there is a considerable amount for which the studies are either inconclusive or refute the effect of FO. This might be due to differences in methodology, sparse description of the orthotics and limited information on patient's disease type and stage. However, multidisciplinary studies are still limited and it is, therefore, too early to come up with guidelines about how these interventions affect the human body mechanically from current knowledge. Previous studies have primarily focused on how foot orthotics affect pain, foot function, walking speed, forefoot plantar pressure and gait parameters, while not considering the mechanical principles on which the rationales for FO were originally based. This has led to an abundance of clinical trials that are challenging to interpret, as FO clinical outcomes and FO gait mechanics have not been studied together.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

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

  • •Patients with RA (EUALAR 2010) without significant damage or with small erosions but without radiological subluxation in the feet, max Larsen rheumatoid arthritis score
  • •With clinical (medical) assessed needs for orthotics (e.g. valgus ankle, pes planus, pes planus transversus, and metatarsophalangeal instability).
  • •In stable disease phase (no clinically recognizable, swollen joints (but sore joints)).
  • •In stable treatment (no change in DMARD, NSAIDs and steroid treatment the last 4 weeks).

排除标准

  • •• Patients with RA using, or regularly used FO, or orthopedic shoes within the last 3 months.
  • •Clinically significant joint disease (inflammatory or degenerative) of the knee or hip joints (according to the clinician).
  • •Clinically significant back disorder (according to the clinician).
  • •Patients with severe ischemic or neurological sequelae in the lower extremities.
  • •BMI above
  • •Not suitable for a MRI scan (e.g. pacemaker, pregnancy or metal within the body).

研究组 & 干预措施

Standard insole

Sham Comparator

a flat insole

干预措施: Standard insole (Device)

Foot orthotics

Experimental

Custom-made foot orthoses

干预措施: Foot orthotics (Device)

结局指标

主要结局

Change in gait mechanics

时间窗: Week 4 and 8

Gait analysis will be performed using a 3D marker-based motion capture system from Qualisys, Sweden. To investigate gait mechanics, detailed patient-specific musculoskeletal (MS) computer models will be created based on clinical medical images (MRI), anthropometrics and motion capture data. The models will be created utilizing a musculoskeletal computer modeling software AnyBody Modeling System (AMS). A detailed cadaver-based model The Twente Lower Extremity Model 2.0 (TLEM 2.0) is developed for AMS to obtain patient-specific architecture, scale bones, joints, and muscles attachments relative to the patient in combination with image-based morphing techniques. These models will be used to estimate joint angles, joint torques, muscle forces and joint forces of the ankle, knee and hip joint.

次要结局

  • Insole wearing time(From week 4 to 8)
  • Pain - Pressure pain threshold(Week 0, 4 and 8)
  • Pain mapping(Week 0, 4 and 8)
  • Wearable activity monitor(From week 0 to week 8)
  • Change in foot pressure distribution(Week 4 and 8)
  • Questionnaire - Pain - Visual analog scale(Week 0, 4 and 8)

研究者

发起方
Vendsyssel Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Morten Bilde Simonsen

Principal Investigator

Vendsyssel Hospital

研究点 (3)

Loading locations...

相似试验