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临床试验/NCT07827898
NCT07827898招募中不适用

Central Sensitization, Ultrasonographic Findings, Functional Status, and Psychosocial Factors in Lateral Epicondylitis

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2026年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
128
试验地点
1
主要终点
Pressure Pain Threshold (PPT)

研究概览

简要总结

Lateral epicondylitis (LE) is a common musculoskeletal disorder characterized by pain and tenderness over the lateral elbow and may become chronic despite conservative treatment. Although LE is primarily associated with local tendon pathology, central sensitization, radial nerve involvement, and psychosocial factors may contribute to persistent pain and disability. This cross-sectional case-control study aims primarily to compare remote pressure pain thresholds between individuals with chronic LE and healthy controls. Secondary objectives are to compare clinical, functional, psychosocial, and ultrasonographic findings between the groups and to investigate the factors associated with functional impairment in individuals with chronic LE.

详细描述

Lateral epicondylitis (LE), commonly known as tennis elbow, is a prevalent musculoskeletal disorder characterized by pain and tenderness over the lateral epicondyle. It is generally associated with repetitive mechanical loading, microtrauma, and degenerative changes affecting the common extensor tendon origin. Because LE may impair upper-extremity function, daily activities, and work productivity, it represents an important clinical and socioeconomic problem. Although conservative treatment is generally effective, symptoms may persist or become chronic in some individuals.The pathophysiology of chronic LE may extend beyond local tendon pathology. Emerging evidence suggests that altered nociceptive processing and central sensitization may contribute to persistent pain. Pressure pain threshold (PPT) assessment at both local and remote sites may help identify localized and widespread pressure pain hypersensitivity. The radial nerve may also be relevant because radial nerve entrapment and LE can produce overlapping clinical findings and may coexist. Ultrasonographic evaluation of both the common extensor tendon and radial nerve may therefore provide additional information about the peripheral components of the condition.

Psychosocial factors, including pain catastrophizing, kinesiophobia, depressive symptoms, and anxiety, may also influence pain severity, functional impairment, and the development or maintenance of sensitization. Although these factors have been extensively investigated in chronic musculoskeletal pain, their combined relationships with pain sensitivity, functional status, and ultrasonographic findings in chronic LE remain insufficiently characterized.

The primary objective of this cross-sectional case-control study is to compare remote PPT values between individuals with chronic LE and healthy controls. The secondary objectives are to compare local PPT, central sensitization, pain catastrophizing, kinesiophobia, depression, anxiety, functional status, radial nerve cross-sectional area, and common extensor tendon thickness between the groups. In the patient group, the study will also examine the relationships of functional status with local and remote PPT values, central sensitization, psychosocial factors, and ultrasonographic findings.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

入选标准

  • Inclusion Criteria:
  • Have unilateral lateral elbow pain persisting for at least 3 months Have a visual analog scale score of 4/10 or higher Have tenderness upon palpation of the common extensor tendon and/or lateral epicondyle region Experience elbow pain that occurs or worsens with hand grip or lateral elbow pain that occurs with resistant static contraction or stretching of the wrist extensors Have read and signed the volunteer consent form (VCF)

排除标准

  • Having undergone surgery on the upper extremity or cervical region before
  • Presence of cervical or shoulder pathology
  • Mechanical symptoms in the elbow (locking, limited range of motion) and other elbow pathologies
  • History of trauma to the elbow
  • Presence of upper extremity neurological deficit
  • History of fibromyalgia, central nervous system disease, or rheumatic disease
  • Last 1 month history of physical therapy or injection for lateral epicondylitis
  • Pregnancy
  • HEALTHY GROUP
  • Inclusion Criteria:
  • Not having experienced elbow pain before
  • Having read and signed the volunteer agreement form (BGOF)
  • 2.Exclusion criteria
  • Presence of upper extremity, shoulder, or neck pain within the last year
  • History of upper extremity fractures
  • Presence of neurological deficits

研究组 & 干预措施

lateral epicondylitis

individuals with lateral epicondylitis

干预措施: Pressure pain threshold (Other)

lateral epicondylitis

individuals with lateral epicondylitis

干预措施: Ultrasonography (Other)

Control Group

Healthy people

干预措施: Pressure pain threshold (Other)

Control Group

Healthy people

干预措施: Ultrasonography (Other)

结局指标

主要结局

Pressure Pain Threshold (PPT)

时间窗: Baseline

The pressure pain threshold is defined as the lowest pressure level that causes pain. The measurement will be taken from the anterior-medial region of the tibia (a distant, painless, and irrelevant area) using a Wagner manual pressure algometer (1 cm² probe-10 kg/20 lb). The measurement will be applied twice at 1-minute intervals, and the average of these applications will be recorded. A trial test will be conducted on the patient before the actual test. Pressure will be applied to the selected points with a pressure algometer until pain is induced, and the test in that area will be terminated when the patient feels pain.

次要结局

  • Central Sensitization Inventory(Baseline)
  • Tampa Scale for Kinesiophobia (TSK)(Baseline)
  • Pain Catastrophizing Scale (PCS)(Baseline)
  • Patient-Rated Tennis Elbow Evaluation(Baseline)
  • Hospital Anxiety and Depression Scale(Baseline)
  • short form-12(Baseline)
  • Pressure Pain Threshold - Local(Baseline)
  • Radial Nerve CSA (in spiral groove and antecubital fossa)(Baseline)
  • Common extansor tendon thickness(Baseline)
  • Grip Strength Measurement(Baseline)

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Sponsor

研究点 (1)

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