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临床试验/NCT02884531
NCT02884531已完成不适用

Assessment and Treatment Responses to Patient Education and Basic Body Awareness Therapy in Hip Osteoarthritis: a Randomized Controlled Trial

University of Bergen2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
2
主要终点
Hip disability and Osteoarthritis Outcome Score (HOOS), change in ADL

研究概览

简要总结

The incidence of hip osteoarthritis (OA) is rising in western countries due to an ageing population and the epidemic of obesity. Patients with hip OA tend to complain of hip pain and stiffness which affect alignment and mobility of the whole body and typically result in general musculoskeletal pain and disability. Clinical guidelines recommend a combination of exercise therapy, weight loss and education, adjusted to the individuals needs, to be tried out before arthroplasty eventually is offered. However, to obtain a satisfactory long-term outcome is a challenge as patients may not be motivated to comply with a training program including functional strength and mobility training, if not guided by a therapist. Basic Body Awareness Therapy (BBAT) may be an alternative training modality with a better potential for lasting effects. It is a low-impact movement therapy focusing on alignment of the body and quality of movements, implemented in daily life activities. In the BBAT learning process by doing, reflecting on and transferring body awareness into daily life movements, the investigators hypothesize that the patients will obtain self-efficacy and mastering, of importance for continued training on their own. This hypothesis will be examined in the present randomized controlled trial, comparing Patient Education combined with BBAT and Patient Education alone. The investigators will, accordingly, examine the supplementary effects of BBAT for patients with hip OA. They will also explore the importance of movement quality as observed by physiotherapist using Body Awareness Rating Scale, and how it relates to how patients perceive their movement performance. In the study the investigators will particularly address long-term effects of the intervention by comparing survival of the native hip in the two groups included in the study. Data from the study will be included in a national database of patients with non-surgical treatment of hip and knee OA (NOAR), giving rise to comparison of different movement therapies.

详细描述

INTRODUCTION Musculoskeletal disorders are reported to be the second largest contributor to years lived with disability worldwide, and osteoarthritis (OA) of the hips and knees among the most prevalent(1). The diagnosis of hip OA should be based on radiographic findings and symptomatic evidence (2), and a prevalence of 5.8% was reported in Norway (3). OA increases with age, every person over 60 years showing signs of osteoarthritis in at least one joint (3).

The dominant factors in OA pathogenesis is loss of articular cartilage accompanied by joint deformation, bone sclerosis, capsule shrinkage, muscle atrophy and varying degrees of synovitis (4). Physical activity is restricted by pain, and patients tend to become increasingly unfit with diminished muscle strength. Intra-articular changes are accompanied by compensatory adjustment in body posture and muscular tension, including a decrease of lumbar lordosis and thoracic kyphosis and asymmetry of the pelvis and the trunk (5). Symptoms and compensational movement adjustments have consequences for patients' daily movement and functioning, social life and self-confidence (6). A substantial increase of primary hip insertions over the last 20 years is shown in Norway by data from the Norwegian Arthroplasty Register (7). The 2014 Annual Report shows 8.099 primary hip prosthesis, and 1284 revisions, arthroplasty being more frequent in women than men (8). The risk for revisions has decreased over the years due to less aseptic loosening of prosthetic components (9), but infection is still a challenge (10).

The impact of being overweight or obese Being overweight or obese is increasingly recognized to be an important risk factor for OA in weight bearing joints (11,12). The evidence of association between obesity and development of hip OA is, however, conflicting (3,13,14). Reduction of body fat for overweight or obese people is still recommended in order to reduce both mechanical and biochemical stressors that contribute to joint degeneration (15-17).

Recommendations for non-surgical management of hip OA. There is insufficient high-quality evidence regarding non-pharmacological and nonsurgical interventions of hip OA (18-21), but clinical guidelines are rather similar in their recommendations (19,21,22).The European League Against Rheumatism (EULAR) recommends a broad range of topics like patient education, lifestyle changes, exercise modalities, weight loss, assistive technologies and adaptations, footwear and work modification, along with a biopsychosocial approach to assessment and treatment and an individualized treatment plan (21).

Patient education (PE) Empowerment of the patients by information and counseling is an important element of an up-to-date conservative treatment plan. PE was developed in Sweden by Klässbo et al. (23) aiming to empower the patients, called Better Management of Patients with Osteoarthritis (BOA www.boaregistret.se). In Sweden PE is implemented all over the country, and participation is required before total hip arthroplasty is offered (Socialstyrelsen 2012). In Denmark, PE (Good Life with osteoarthritsis in Denmark, GLA:D (www.glaid.dk ) is combined with six weeks of individualized supervised neuromuscular exercise. Even better results were shown after this program regarding pain than after BOA (24). A study examining the supplementary effects of supervised exercise vs. education alone is presently carried out on patients with severe hip OA (25). A PE called ActiveA (active living with lower limb osteoarthritis) has also been tried out for patients with hip and knee OA in Oslo (26). PE based on ActiveA principles has now been established at "Lærings- og mestringssenteret", Haukeland University Hospital (HUS) for patients with hip and knee osteoarthritis from Hordaland County.

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)

盲法说明

The assessment at inclusion was done before randomization, and was also blinded at follow-ups

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Women and men with primary OA according to the American College of Rheumatology Clinical Criteria, living in Bergen or within a reasonable travelling distance (judged by the patients).

排除标准

  • Other known major physical or mental problems or disease that precludes movement training and participation in an educational program, known drug abuse, not speaking or understanding Norwegian language, pregnancy 5-9 months.

研究组 & 干预措施

Patient Education and BBAT

Experimental

Patients will participate in Patient Education and Basic Body Awareness Therapy

干预措施: Patient Education and Basic Body Awareness Therapy (Other)

Patient Education and BBAT

Experimental

Patients will participate in Patient Education and Basic Body Awareness Therapy

干预措施: Patient Education (Behavioral)

Patient Education

Active Comparator

Patients will only participate in Patient Education

干预措施: Patient Education (Behavioral)

结局指标

主要结局

Hip disability and Osteoarthritis Outcome Score (HOOS), change in ADL

时间窗: Baseline, 4 months and 1 year

Self-reported disability

Numeric Rating Scale, change in pain

时间窗: Baseline, 4 months and 1 year

Pain intensity during walking

次要结局

  • The Patient Global Impression of Change (PGIC)(4 months and 1 year)
  • Arthritis Self-efficacy Scale (ASES)(Baseline, 4 months and 1 year)
  • Body Awareness Rating Scale (BARS)(Baseline, 4 months)
  • Chair test.(Baseline, 4 months)
  • Stairs test.(Baseline, 4 months)
  • UCLA Activity Score(Baseline, 4 months and 1 year)
  • Harris Hip Score (HHS)(Baseline, 4 months and 1 year)
  • The EuroQol (EQ-5D-5L)(Baseline, 4 months and 1 year)
  • 6-minutes walking - test(Baseline, 4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liv Inger Strand

Professor, dr. philos.

University of Bergen

研究点 (2)

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