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临床试验/NCT07163884
NCT07163884尚未招募不适用

Adheziv kapsülit tanılı Hastalarda Fasyal Tedavinin ağrı, Normal Eklem Hareket açıklığı, Propriosepsiyon ve Fasya Mimarisine Etkisinin araştırılması

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年9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
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
Ultrasonographic Measurement

研究概览

简要总结

Our study is unique in that it utilizes a self-designed fascial mobilization protocol and ultrasonographic evaluation for adhesive capsulitis. Therefore, the aim of our study is to investigate the effects of fascial therapy on pain, normal joint range of motion, proprioception, and fascial architecture in patients diagnosed with adhesive capsulitis.

详细描述

Adhesive capsulitis (AC) is a common shoulder condition characterized by a gradual increase in spontaneous pain and a limitation in glenohumeral joint range of motion. Its pathophysiology, a pathological process of capsular fibrosis following synovial inflammation, is relatively well understood, but its cause remains unknown. The literature on the treatment of frozen shoulder, whose etiology remains unknown, provides evidence of the effectiveness of conservative treatment approaches such as physiotherapy, analgesics, and steroid injections (1). Pain with movement is minimal in Stage 1 of primary frozen shoulder, while night pain accompanied by activity pain is observed in Stages 2 and 3. Similar pain is observed in secondary frozen shoulder, and the pain is primarily caused by inflammation in the shoulder joint capsule. Increasing range of motion without suppressing pain in patients with frozen shoulder is quite challenging. While heat or electrotherapy are theoretically considered to have positive effects on pain in their treatment, it is difficult to determine the impact of a single method on the natural course of the disease. Therefore, therapeutic methods are generally applied in addition to manual therapy and therapeutic exercises. (2) Pain with movement is minimal in Stage 1 of primary frozen shoulder, while night pain accompanying activity pain is observed in Stages 2 and 3. Similar pain is observed in secondary frozen shoulder, and the pain is primarily caused by inflammation in the shoulder joint capsule. Increasing range of motion without suppressing pain is quite difficult in patients with frozen shoulder. While heat or electrotherapy are considered to have theoretically positive effects on pain in treatment, it is difficult to determine the effect of a single method on the natural course of the disease. Therefore, therapeutic methods are generally applied in addition to manual therapy and therapeutic exercises (3). Studies have suggested the effectiveness of these treatment methods, but sufficient data on the effectiveness of these methods are not yet available (4). Manual therapy methods have begun to be used in adhesive capsulitis, but a meta-analysis has not yet determined the optimal treatment dose (5). Fascia therapy has recently become increasingly used, particularly for lumbar spine pathologies. However, no studies were found on shoulder fascia (6). Ultrasonography is a diagnostic method used in patients with adhesive capsulitis. Ultrasonographic evaluation studies have observed increased coracohumeral ligament thickness, increased supraspinatus tendon thickness, and effusion. However, no ultrasonographic study demonstrating changes in shoulder architecture following physiotherapy interventions was found (7,8). No studies were found on fascial treatment; only one study used instrument-assisted soft tissue mobilization (9). Our study is unique in that it utilized a self-designed fascial mobilization protocol and was evaluated with ultrasonography in adhesive capsulitis. Therefore, the aim of our study was to investigate the effects of fascial treatment on pain, normal joint range of motion, proprioception, and fascial architecture in patients with adhesive capsulitis.

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)

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients diagnosed with adhesive capsulitis by a specialist,
  • •Patients between the ages of 35 and 60,
  • •Those not diagnosed with cervical disc herniation that could cause other shoulder pathologies,
  • •Those who have not participated in an upper extremity-related physiotherapy program within the last 6 months,
  • •Individuals who volunteer to participate in the study,

排除标准

  • •Individuals who have undergone shoulder surgery consistent with any pathology,
  • •Individuals with a neurological history,
  • •Individuals diagnosed with diabetes mellitus (DM)

研究组 & 干预措施

Fascial therapy group

Experimental

In addition to electrotherapy, the patients in the study group will receive a total of five sessions (one day per week for five weeks) of fascial therapy. The protocol will be developed by us. Fascial mobilization will be performed by a trained physiotherapist on the pectoral fascia, deltoid fascia, axillary fascia, and supscapularis fascia, once a week, for 180 seconds each repetition. These sessions will be performed at the pain threshold, and care will be taken to ensure that the pain does not exceed a VAS score of 2.

干预措施: Facsial therapy (Other)

Control group

Active Comparator

Patients will receive 15 sessions of electrotherapy. A 15-minute hotpack will be applied, followed by a 20-minute TENS application, and then a 6-minute deep heating (1.5 Hz ultrasound) will be applied. Pre-treatment assessments will be repeated after treatment.

干预措施: electrotherapy treatment (Other)

结局指标

主要结局

Ultrasonographic Measurement

时间窗: through of the study, average 3 weeks

An ultrasound (measured by 7.5-10 MHz mobile ultrasound (ALEXUS A10HRL) device will be used to evaluate fascial architecture. The thickness and density of the coracohumeral ligament, supraspinatus tendon, infraspinatus tendon, long head of the biceps, and deltoid fascia, which constitute the patients' shoulder and fascial architecture and are among the structures most affected by adhesive capsulitis, will be evaluated.

The pain

时间窗: through of the study, average 3 weeks

Mc Gill Short Form will used to determine the type and severity of the pain. A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.

Range of Motion

时间窗: through of the study, average 3 weeks

A Universal Goniometer will be used to assess normal range of motion. Measurements will be made regarding shoulder flexion, extension, abduction, adduction, internal and external rotation ranges of motion in three planes of the upper extremity shoulder joint, and the results will be recorded in degrees.

Proprioception

时间窗: through of the study, average 3 weeks

Individuals shoulder proprioception will be measured with a laser pointer. A laser pointer is attached to the patient's arm, and the shoulder is flexed 90 degrees, and the laser reflection is marked on the wall. The patient is then asked to close their eyes and maintain the same degree of flexion. The laser reflection is marked. The distance between the two distances is recorded in centimeters. A greater deviation between the two distances indicates a greater loss of proprioception.

次要结局

  • Upper extremity functionality(through of the study, average 3 weeks)

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuğba GÖNEN

Asisst. Prof. Dr.

Hasan Kalyoncu University

研究点 (1)

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