Movement With Mobilization Technic Plus Exercising Versus Exercising Alone for Central Sensitization in Patients With Subacromial Pain: a Sham-controlled Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Central Sensitization Inventory
研究概览
简要总结
Subacromial pain syndrome (SIS) is a common cause of shoulder pain, estimated to be the cause for up to half of incident cases. Typically, pain is generated with elevation of the arm above the head though it can occur with rest in patients with SIS.There is evidence of central sensitization in those who experience chronic shoulder pain from SIS. Central sensitization is an augmentation of the nociceptive pathways of the central nervous system that is characterized by local and generalized lowered pain thresholds and an exaggerated pain response to painful and non painful stimulation.Mobilization with movement (MWM) technic is a kind of manual therapy and it is often used by clinicians for the treatment of musculoskeletal diseases. Usually manual therapy is used for its peripheral effects, however it also produces central analgesic effects activating descending anti-nociceptive pathways for a short period of time (30 - 35 mins.). Some speculate that repeated sessions of manual therapy may result in a long term activation of descending anti-nociceptive pathways. However, there is no evidence of this mechanism available yet. Therefore, the aim of this study is to investigate the effect of MWM on central sensitization (primary aim) and shoulder functions (secondary aim) in patients with SIS.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To have confirmed unilateral subacromial pain (positive testing at Neer Impingement and Hawkins-Kennedy tests),
- •To have <40 score in central sensitization inventory.
排除标准
- •To have bilateral subacromial pain,
- •To have any pathology (except subacromial pain) that give rise to central sensitization (This pathologies are summarized in central sensitization inventory - part B)
- •To have severe osteoarthritis or subluxation in shoulder joint,
- •To have adhesive capsulitis,
- •Being treated with physiotherapy for this disorder at least one month before the start of the study.
- •To have severe cervical or lumbar radiculopathy,
结局指标
主要结局
Central Sensitization Inventory
时间窗: Baseline, 3 weeks: change from baseline central sensitization at 3 weeks, 3 months: change from central sensitization at 3 months.
The central sensitization inventory (CSI), a patient reported outcome measure, is a reliable and valid comprehensive screening instrument for identification of central sensitization. The CSI inventory comprises of two sections - Part A and Part B. Part A consisted of 25-item self-report questionnaire with each item assessed on a 5-point Likert scale (0=never and 4=always), with total scores ranging from 0-100. Part B evaluates health-related symptoms that are common to central sensitization syndromes.Higher scores indicate more severe central sensitization. A CSI cut-off score of 40 exhibited good sensitivity in identifying central sensitization.
Pressure-Pain Threshold-Algometer
时间窗: Baseline, 3 weeks: change from baseline pressure pain threshold at 3 weeks, 3 months: change from pressure pain threshold at 3 months.
Pressure pain threshold (PPT) is defined as the minimal amount of pressure where a sense of pressure first changes to pain. A mechanical pressure algometer is used in this study to assess PPT. This device consists of a round rubber disk (area,1 cm2 ) attached to a pressure (force) gauge. The gauge displays values in kilograms. Because the surface of the rubber tip is 1 cm2, the readings are expressed in kilograms per square centimeter. The range of the algometer is 0 to 10 kg with 0.1-kg divisions. Higher scores indicate high PPT.
次要结局
- Quick Disabilities of the Shoulder, Arm and Hand Questionnaire(Baseline, 3 weeks: change from baseline shoulder functions at 3 weeks, 3 months: change from shoulder functions at 3 months.)
研究者
Volkan Deniz, PT
Director
Cukurova University