Treatment of Inflammation Versus Hand Training to Prevent and Revert Neuropsychiatric Comorbidity in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Difference in Tender Point score (TP18)
研究概览
简要总结
The purpose of this study is to investigate how RA affect the brain structures in RA-patients and if anti-inflammatory treatment that target TNF-α or JAK OR physical training of hands has positive impact on neuropsychiatric symptoms and morphological changes in the brain caused by the disease.
The goal of this research project is to improve the knowledge of morphological changes in brain developed in connection to RA and to identify clinical and serological markers to predict development of those changes and finally, to investigate if anti-rheumatic interventions counteract destructive processes in the central nervous system (CNS) and improve the patient's health with respect to functionality, pain experience and psychological well-being.
详细描述
Based on the information gained in previous studies the investigators want to examine if;
A. anti-inflammatory treatment that target TNF-α or JAK signalling or
B. physical training of hands
has a positive impact on neuropsychiatric symptoms and morphological changes in the brain caused by RA.
To examine this the investigators will employ a prospective open-label study design with two parts, one observation part (1) and one intervention part (2). Patients will be assigned to either:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed RA diagnosis, in the early stage of the disease (1-3 years after the diagnosis, n=20); in the established stage of the disease (5-8 years after the diagnosis, n=30) and in the late stage of the disease (>12 years after the diagnosis, n=30)
排除标准
- •any conditions precluding MRI imaging; e.g claustrophobia; pacemaker etc, medical history of ischemic stroke or cerebral hemorrhage; medical history of neurological disease; inability to read and communicate in Swedish, hence being able to give informed consent and fill out study questionnaires
研究组 & 干预措施
Pharmacological anti-inflammatory treatment
Use of anti-rheumatic treatment with TNF-α inhibitor (subcutaneous injection given once or twice a week) or JAK inhibitor (per oral tablet once or twice a day)
干预措施: TNF-α inhibitor OR JAK inhibitor (Drug)
Physical hand training
Physical hand training 10 min twice daily while on stable treatment
干预措施: Hand training (Other)
结局指标
主要结局
Difference in Tender Point score (TP18)
时间窗: Difference in TP18 score from base-line to follow-up study visit after 6 months
Scoring of tender Points for all patients will be performed at base-line and at follow-up visit after 6 months. Tender points are sensitive areas on the body that elicit pain and tenderness when pressure is applied. The TP 18 protocol is a standardised measurement of number of painful/tender points out of 18 bilateral points on the body. The difference in Tender Point score between study visits will be calculated.
Difference in Pain VAS score
时间窗: Difference in Pain VAS score from base-line to follow-up study visit after 3 and 6 months
Scoring of Pain VAS will be performed daily by all patients and recorded in a pain diary. Pain VAS is the patients scoring in mm of overall perceived pain on a 10 mm long visual analogue scale. The difference in Pain VAS score between daily recordings will be calculated.
Difference in hand grip strength
时间窗: Difference in hand grip strength from base-line to follow-up study visits after 3 and 6 months
Measurement of hand grip strength for all patients will be performed at base-line and at follow-up visit after 3 and 6 months. Hand grip strength is clinically assessed by occupational therapist and performed using Grippit®, a standardised electronic handheld instrument used for measuring hand strength in the cylinder grip. The patient is instructed to grip the Grippit® and squeeze it as hard as possible for 10 seconds. The instrument generates three values; the maximal value of force applied, the mean value of force applied during the 10 seconds and a final value measured during the last half a second. The values are reported in Newton (N). Both hands are examined and which of the hands that is dominant is noted. The difference in Newton between study visits will be calculated.
Difference in regional brain volume
时间窗: Difference in brain regional volume from base-line to follow-up study visit after 6 months
Magnetic resonance imaging (MRI) of all patients brains will be performed at base-line and at follow-up visit after 6 months. Measurement of 83 anatomical regions of the brain will be performed to detect subtle changes in volume. This is performed using multiatlas propagation with enhanced registration (MAPER) and the 2017 version of the Hammersmith atlas database. The difference in regional brain volume between study visits will be calculated.
Difference in Disease activity score (DAS28)
时间窗: Difference in DAS28 score from base-line to follow-up study visit after 6 months
Scoring of disease activity for all patients will be performed at base-line and at follow-up visit after 6 months. Disease Activity Score is a standardised indicator of RA disease activity calculated as a composite score of: number of tender and swollen joints (assessed by trained personnel), erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) and the patients assessment of pain on a visual analogue scale of 10 mm (VAS). The difference in Disease activity score between study visits will be calculated.
Difference in hand/finger joint deformities
时间窗: Difference in hand/finger joint deformities from base-line to follow-up study visits after 3 and 6 months
Documentation of hand/finger joint deformities for all patients will be performed at base-line and at follow-up visit after 3 and 6 months. Hand and finger joint deformities is clinically assessed by occupational therapist according to standardised protocol. Reported in text for each joint
Difference in SF-36 score
时间窗: Difference in SF-36 score from base-line to follow-up study visits after 3 and 6 months
SF-36, "Short Form Health Survey", is a self-administered questionnaire regarding overall health. The questionnaire will be filled out by all patients at base-line and at follow-up visit after 3 and 6 months and scored according to established protocol. The difference in SF-36 score between study visits will be calculated.
Difference in hand joint mobility
时间窗: Difference in hand joint mobility from base-line to follow-up study visits after 3 and 6 months
Measurement of hand joint mobility for all patients will be performed at base-line and at follow-up visit after 3 and 6 months. Hand joint mobility is clinically assessed by occupational therapist according to a standardised protocol and reported as degrees of mobility in extension/flexion and pronation/supination of the hand joint. The difference in degrees of hand joint mobility between study visits will be calculated.
Difference in inflammatory markers
时间窗: Difference in inflammatory markers from base-line to follow-up study visits after 3 and 6 months
Serum samples will be gathered from all patients at base-line and follow-up visit after 3 and 6 months. Levels of various inflammatory markers will be measured and the difference in levels between study visits will be calculated.
Difference in HAQ score
时间窗: Difference in HAQ score from base-line to follow-up study visits after 3 and 6 months
HAQ, "Health Assessment Questionnaire", is a self-administered questionnaire regarding functional ability and overall health. The questionnaire will be filled out by all patients at base-line and at follow-up visit after 3 and 6 months and scored according to established protocol. The difference in HAQ score between study visits will be calculated.
Difference in finger joint mobility
时间窗: Difference in finger joint mobility from base-line to follow-up study visits after 3 and 6 months
Measurement of finger joint mobility for all patients will be performed at base-line and at follow-up visit after 3 and 6 months. Finger joint mobility is clinically assessed by occupational therapist according to standardised protocol and reported as degrees of mobility in extension/flexion of each finger. The difference in degrees of finger joint mobility between study visits will be calculated.
Difference in FIQ score
时间窗: Difference in FIQ score from base-line to follow-up study visits after 3 and 6 months
FIQ, "Fibromyalgia Impact Questionnaire", is a self-administered questionnaire regarding pain, fatigue, functional ability, quality of life etc. The questionnaire will be filled out by all patients at base-line and at follow-up visit after 3 and 6 months and scored according to established protocol. The difference in FIQ score between study visits will be calculated.
Difference in IPAQ score
时间窗: Difference in IPAQ score from base-line to follow-up study visits after 3 and 6 months
IPAQ, "International Physical Activity Questionnaire", is a self-administered questionnaire regarding physical activity and inactivity. The questionnaire will be filled out by all patients at base-line and at follow-up visit after 3 and 6 months and scored according to established protocol. The difference in IPAQ score between study visits will be calculated.
Difference in RA-related skeletal changes
时间窗: Difference in RA-related skeletal changes from base-line to follow-up study visits after 6 months
Documentation of RA-related skeletal changes for all patients will be performed at base-line and at follow-up visit after 6 months. Radiological imaging of the hand joint will be performed using plain X-ray. The assessment of hand radiographs and scoring of possible joint damage will be performed by experienced rheumatologist. The difference in score between study visits will be calculated.
Difference in DASH score
时间窗: Difference in DASH score from base-line to follow-up study visits after 3 and 6 months
DASH, "Disabilities of the Arm, Shoulder and Hand", is a self-administered questionnaire regarding symptoms and ability to perform certain activities. The questionnaire will be filled out by all patients at base-line and at follow-up visit after 3 and 6 months and scored according to established protocol. The difference in DASH score between study visits will be calculated.
Difference in HADS score
时间窗: Difference in HADS score from base-line to follow-up study visits after 3 and 6 months
HADS, "Hospital Anxiety and Depression Scale", is a self-administered questionnaire regarding anxiety and depression. The questionnaire will be filled out by all patients at base-line and at follow-up visit after 3 and 6 months and scored according to established protocol. The difference in HADS score between study visits will be calculated.
次要结局
- Difference in intestinal microbiome composition(Difference in intestinal microbiome composition from base-line to follow-up study visits after 6 months)