骶髂关节功能障碍患者中松动术与肌筋膜释放技术有效性的比较
比较动员和肌筋膜释放技术对骶髂关节功能障碍患者疼痛、姿势控制和脊柱活动度的有效性
骶髂关节功能障碍（SIED）是慢性机械性腰痛的主要原因之一，与疼痛、姿势控制障碍和功能受限相关。虽然手法治疗常用于治疗骶髂关节疼痛，但不同手法技术的临床优势证据有限。
本研究设计为一项前瞻性随机对照试验，旨在比较肌筋膜释放技术和骶髂关节松动术（在传统物理治疗方案基础上应用）对诊断为骶髂关节功能障碍的女性在疼痛强度、脊柱活动度、姿势控制和功能状态方面的影响。
研究计划纳入年龄18-65岁、视觉模拟评分（VAS）≥3分、根据国际诊断标准诊断为骶髂关节功能障碍的女性个体。参与者将被随机分为两组：一组接受传统治疗结合肌筋膜释放技术，另一组接受传统治疗结合骶髂关节松动术。干预将每周进行三天，持续六周。
主要和次要结局指标包括疼痛强度（VAS）、姿势控制（Biodex平衡系统）、脊柱活动度和姿势耐力（Spinal Mouse）评估。所有评估将在治疗前和六周干预期结束时进行。
本研究旨在为手法治疗在骶髂关节功能障碍保守治疗中的比较效果提供临床证据，并有助于临床决策过程。
研究概览
详细说明
骶髂关节功能障碍（SIED）的特征是骶骨与髂骨之间关节复合体的活动受限或异常活动性，被认为是慢性机械性下腰痛的主要原因之一。 SIED与疼痛、脊柱活动受限、姿势控制障碍和功能损伤有关。 尽管手法治疗、运动和物理因子治疗在保守治疗中常用，但关于不同手法治疗方法比较效果的文献证据有限且存在矛盾。
本研究是一项前瞻性、随机对照临床试验，旨在比较在传统物理治疗方案基础上增加肌筋膜松解技术与骶髂关节松动术对诊断为骶髂关节功能障碍女性的疼痛、脊柱活动性、姿势控制和功能状态的影响。 该研究尚未开始，计划按照指定方案进行。
研究计划纳入年龄18-65岁、视觉模拟量表（VAS）评分≥3分、根据国际疼痛研究协会推荐标准和骶髂关节特异性激发试验诊断为SIED的女性志愿者。 考虑到分娩和激素因素对骶髂关节生物力学的影响，本研究仅针对女性个体进行。 有脊柱或下肢手术史、急性椎间盘突出、椎管狭窄、梨状肌综合征、或神经性或风湿性疾病史的个体将被排除在研究之外。
符合条件的参与者将使用随机化方法分为两组。 两组均将接受为期六周、每周三天的传统物理治疗方案。 传统治疗方案将包括腹背肌强化训练（桥式、背伸和仰卧起坐练习）以及骶髂区域的治疗性超声波应用。
第一组参与者将在传统治疗方案基础上，接受针对竖脊肌、腰方肌、胸腰筋膜、梨状肌和臀中肌的肌筋膜松解技术。 第二组参与者将在传统治疗方案基础上，接受针对骶髂关节的松动和手法技术。 所有干预将由经验丰富的物理治疗师执行。
结果评估将在治疗前和六周干预计划结束时进行。 疼痛强度将使用视觉模拟量表（VAS）作为主要结局指标进行评估。 次要结局指标将包括姿势控制（使用Biodex平衡系统进行静态和动态平衡评估）、脊柱活动性和姿势耐力（使用Spinal Mouse系统）。 所有评估将由同一名评估者进行，该评估者对分组情况不知情。
本研究旨在通过揭示肌筋膜松解与松动方法在骶髂关节功能障碍中的比较效果，为临床实践中的循证治疗选择做出贡献。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Kirşehi̇r
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Center、Kirşehi̇r、土耳其（türkiye）
- Kirşehir Ahi Evran University
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
纳入标准：
- 年龄在18至65岁之间的女性个体。
- 被诊断为骶髂关节功能障碍（根据国际疼痛研究协会标准）。
- 骶髂关节区域有局部疼痛，且疼痛可能放射至臀部、腹股沟或下肢。
- 在5项骶髂关节特异性激发试验（Vorlauf试验、Gillet试验、激痛点阳性、后剪切试验、压缩试验）中至少3项呈阳性。
- 通过视觉模拟评分法（VAS）评估的疼痛强度≥3分。
- 自愿参与研究并提供书面知情同意书。
排除标准：
- 有脊柱、骨盆或下肢手术史。
- 存在腰椎间盘突出、椎管狭窄或髋关节急性病变。
- 诊断为梨状肌综合征或非骶髂关节来源的腰背/髋部疼痛。
- 已知的中枢或周围神经系统疾病或进行性神经功能缺损。
- 有风湿性疾病史（类风湿关节炎、强直性脊柱炎等）。
- 妊娠或存在可能妨碍参与研究的严重全身性疾病。
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Myofascial Release
Participants received posterior chain-focused myofascial release in addition to the standardized conventional physiotherapy program. Each technique was applied for approximately 90-120 seconds and repeated twice during each treatment session. The intervention included manual techniques targeting the erector spinae muscles, lumbosacral region, thoracolumbar and lumbar fascial structures, diaphragm-related fascial restrictions, gluteal fascia, and gluteus medius. Sustained cross-hand pressure, transverse knuckle pressure, lumbosacral decompression, fascial release, and distal-to-proximal deep massage techniques were used according to the targeted tissue and participant tolerance. |
每块肌肉的筋膜释放时间为90至120秒，每次治疗应用两次。
1. 竖脊肌筋膜释放：患者取俯卧位；治疗师站在患者骨盆水平处的治疗侧，应用交叉手技术。
2. 为增加肌肉张力，患者的下肢被置于髋关节屈曲和内收的最高点。
治疗师站在患者身后，在患者骨盆水平处，应用指关节进行横向叩击技术。
4. 臀中肌筋膜释放：患者取未治疗侧的侧卧位。
治疗师站在患者身后，在患者骨盆水平处，应用指关节进行垂直叩击技术。
Both groups received a standardized conventional physiotherapy program consisting of therapeutic exercise and therapeutic ultrasound. The exercises included bridging, trunk extension, and abdominal curl exercises and were performed in three sets of 15 repetitions. The exercises were progressed from initial to intermediate and advanced levels at two-week intervals when participants completed the prescribed sets with appropriate technique and without increased pain. Therapeutic ultrasound was applied over the right and left sacroiliac joint regions with the participant in the prone position. Continuous ultrasound was delivered at a frequency of 1 MHz and an intensity of 1.5 W/cm² using a 4-cm-diameter probe for a total duration of 6 minutes. Treatment was delivered three times per week for six weeks, for a total of 18 supervised sessions. |
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实验性的：Mobilization
Participants received sacroiliac joint mobilization in addition to the standardized conventional physiotherapy program. The mobilization techniques were performed with the participant in side-lying and prone positions. The intervention included mobilization of the restricted sacroiliac joint in side-lying, controlled lumbar flexion, mobilization directed from the iliac crest toward the greater trochanter, caudal traction of the sacrum, mobilization of the sacrum relative to the ilium, and stretching techniques initiated from the iliac crests. Each mobilization technique was applied for 2 minutes using low-amplitude rhythmic movements within the participant's pain-free range. The technique was discontinued if pain increased or the participant was unable to tolerate the application. |
患者侧卧，骶髂关节受限位于顶部，并进行骶髂关节手法操作。
随后，物理治疗师通过向大腿上部移动来屈曲腰椎，使用间歇拉伸技术从髂嵴向主要胸椎方向施加脉冲。
在俯卧位时，将施加尾向牵引、骶骨相对于髂骨的牵引，以及从髂嵴开始的牵引拉伸。
Both groups received a standardized conventional physiotherapy program consisting of therapeutic exercise and therapeutic ultrasound. The exercises included bridging, trunk extension, and abdominal curl exercises and were performed in three sets of 15 repetitions. The exercises were progressed from initial to intermediate and advanced levels at two-week intervals when participants completed the prescribed sets with appropriate technique and without increased pain. Therapeutic ultrasound was applied over the right and left sacroiliac joint regions with the participant in the prone position. Continuous ultrasound was delivered at a frequency of 1 MHz and an intensity of 1.5 W/cm² using a 4-cm-diameter probe for a total duration of 6 minutes. Treatment was delivered three times per week for six weeks, for a total of 18 supervised sessions. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Static and Dynamic Postural Control
大体时间：Baseline and immediately after the 6-week intervention.
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Postural control will be assessed statically and dynamically.
The Biodex balance system (Biodex Medical System Inc., NY, USA, SW45 30D E6N Model, SD 950 304) will be used.
This device creates stability indices by evaluating movements in the overall, anterior-posterior, and medial-lateral directions.
For static balance assessment, the subject is asked to hold a small circle containing a black dot representing their center of gravity without moving it for 20 seconds, repeated 3 times.
For dynamic assessment, the floor movement level is set to 12 at the start and gradually reduced to 9 throughout the test.
At these levels, the subject attempts to keep their center of gravity balanced within the small circle.
Total, anterior-posterior (A-P), and medial-lateral (M-L) values are recorded.
Increased values indicate worsening balance activity
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Baseline and immediately after the 6-week intervention.
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Change in Posture, Spinal Mobility, Postural Endurance, and Total Spine Check Score
大体时间：Baseline and immediately after the 6-week intervention.
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It was measured using the computer-assisted wireless Spinal Mouse device (the Spinal Mouse System, Idiag, Fehraltorf, Switzerland).
The Spinal Mouse device is moved over the spine using its wheel, measuring the length of the spine, posture, and joint movements, and transferring this sequence to a computer environment.
It is a reliable method that can noninvasively measure the physical characteristics and movement of the spine in a practical way.
Measurements are taken from the spinous process of the seventh cervical vertebra to the third sacral vertebra.
For spinal mobility, the trunk flexion posture is recorded.
For postural competence values, an upright posture measurement is performed, and then a weight equal to 5% of the person's body weight is held parallel between the shoulders for 30 seconds.
After the weight is still in the person's hands, the upright posture is measured again
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Baseline and immediately after the 6-week intervention.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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残疾
大体时间：6周
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OSWESTRY 腰痛功能障碍问卷 Oswestry 腰痛功能障碍问卷用于获取有关背部（或腿部）疼痛对个人日常活动影响程度的信息。
问卷包含 10 个部分。
要求患者为自己标记最合适的答案。
计算得分，并根据以下给出的百分比值进行解读：0% - 20% - 轻微功能障碍 20% - 40% - 中度功能障碍 40% - 60% - 严重功能障碍 60% - 80% - 功能障碍 80% - 100% - 卧床不起
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6周
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Change in Resting, Activity-Related, and Night Pain
大体时间：Baseline and immediately after the 6-week intervention.
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Resting, activity-related, and night pain were assessed separately using a 10-cm Visual Analog Scale.
A score of 0 indicated no pain, and a score of 10 indicated the worst imaginable pain.
Higher scores indicated greater pain intensity.
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Baseline and immediately after the 6-week intervention.
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合作者和调查者
调查人员
- 研究主任：Şafak KUZU、Kirsehir Ahi Evran Universitesi
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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