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盆脊促通疗法改善后天性骨盆倾斜减轻腰痛的应用研究：干预性可行性试验研究方案
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注册号：

Registration number：

 ChiCTR2600117178 

最近更新日期：

Date of Last Refreshed on：

 2026-01-20 17:46:18 

注册时间：

Date of Registration：

 2026-01-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

盆脊促通疗法改善后天性骨盆倾斜减轻腰痛的应用研究：干预性可行性试验研究方案

Public title：

Application Research of Pelvic-Spine Facilitation Therapy in Improving Acquired Pelvic Tilt and Alleviating Low Back Pain: Research Protocol for Interventional Feasibility Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

盆脊促通疗法改善后天性骨盆倾斜减轻腰痛的应用研究：干预性可行性试验研究方案

Scientific title：

Application Research of Pelvic-Spine Facilitation Therapy in Improving Acquired Pelvic Tilt and Alleviating Low Back Pain: Research Protocol for Interventional Feasibility Trial

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

吴娇 

研究负责人：

蒋惠瑜 

Applicant：

Jiao Wu 

Study leader：

HuiYu Jiang 

申请注册联系人电话：

Applicant telephone：

 +86 186 8478 4023

研究负责人电话：

Study leader's
telephone：

+86 135 1886 0111

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 1603775785@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 hkjhyjack@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 海南医科大学第二附属医院

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

海南省海口市龙华区海南医科大学第二附属医院康复治疗科

研究负责人通讯地址：

海南省海口市龙华区海南医科大学第二附属医院康复治疗科

Applicant address：

Department of Rehabilitation Therapy, the Second Affiliated Hospital of Hainan Medical University, Longhua District, Haikou City, Hainan Province

Study leader's address：

Department of Rehabilitation Therapy, the Second Affiliated Hospital of Hainan Medical University, Longhua District, Haikou City, Hainan Province

申请注册联系人邮政编码：

Applicant postcode：

 570311

研究负责人邮政编码：

Study leader's postcode：

 570311

申请人所在单位：

海南医科大学西英格兰学院

Applicant's institution：

Hainan Medical University Western England College

研究负责人所在单位：

海南医科大学第二附属医院康复治疗科

Affiliation of the Leader：

Department of Rehabilitation Therapy, The Second Affiliated Hospital of Hainan Medical University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2026-K14

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

海南医科大学第二附属医院伦理审查委员会

Name of the ethic committee：

Ethics Review Committee of the Second Affiliated Hospital of Hainan Medical College

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-01-05 00:00:00

伦理委员会联系人：

刘春华

Contact Name of the ethic committee：

QuanWen

伦理委员会联系地址：

海南省海口市龙华区椰海大道168号海南医科大学第二附属医院

Contact Address of the ethic committee：

Department of Rehabilitation Therapy, the Second Affiliated Hospital of Hainan Medical University, Longhua District, Haikou City, Hainan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 898 6680 9063

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

海南医科大学第二附属医院

Primary sponsor：

HuiYu Jiang

研究实施负责（组长）单位地址：

海南省海口市龙华区海南医科大学第二附属医院康复治疗科

Primary sponsor's address：

Department of Rehabilitation Therapy, the Second Affiliated Hospital of Hainan Medical University, Longhua District, Haikou City, Hainan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

海南

市(区县)：

海口

Country：

China

Province：

Hainan

City：

Haikou

单位(医院)：

海南医科大学第二附属医院

具体地址：

海南省海口市龙华区海南医科大学第二附属医院康复治疗科

Institution
hospital：

the Second Affiliated Hospital of Hainan Medical University

Address：

Department of Rehabilitation Therapy, the Second Affiliated Hospital of Hainan Medical University, Longhua District, Haikou City, Hainan Province

经费或物资来源：

单位自筹

Source(s) of funding：

Provincial finance and self-financing units

研究疾病：

后天性骨盆倾斜、腰痛  

Target disease：

Acquired pelvic tilt ,low back pain

研究疾病代码：

M95.503

Target disease code：

M95.503

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1.探究盆脊促通疗法改善后天性骨盆倾斜所致腰痛患者骨盆倾斜、肌张力，疼痛及生活满意度的确切疗效。 2.阐明盆脊促通疗法改善后天性骨盆倾斜所致腰痛患者骨盆倾斜及盆底肌张力的机制研究。  

Objectives of Study：

1. To explore the exact efficacy of pelvic-spinal facilitation therapy in improving pelvic tilt, muscle tone, pain, and life satisfaction in patients with low back pain caused by acquired pelvic tilt. 2.To clarify the mechanism of pelvic-spinal facilitation therapy in improving pelvic tilt and pelvic floor muscle tone in patients with low back pain caused by acquired pelvic tilt.

药物成份或治疗方案详述：

实验组采用盆脊促通疗法治疗（30min），盆脊促通疗法每周三次，连续四周治疗。 （1）盆底肌筋膜手法：患者仰卧位，屈髋屈膝，观察会阴皮肤无红肿、白带无异常后，治疗师手指进入阴道找到盆底肌筋膜触发点，在闭孔内肌、髂骨尾骨肌、坐骨尾骨肌及梨状肌以适当的压力按揉，配合受累肌肉的收缩和放松，降低肌肉张力，减轻疼痛，15分钟/次，每周三次。 （2）骶尾骨调理术：患者侧卧位，头下垫枕头，双膝之间垫枕头，可左侧或右侧卧位，但按乙状结肠直肠走向，最好左侧卧位，嘱患者暴露臀部，医者一手置于上方的股骨大转子位置，给患者一个本体输入感。观察臀部皮肤是否破溃及肛门外括约肌有无痔疮。大棉签划双侧臀部S2-4位置，评估患者S2-4感觉；用大棉签在肛门处进行肛门眨眼反射评估；带上手套，润滑油润滑手指，松解浅层肌群，手指进入肛门，根据之前指诊评估结果了解骶骨偏移、旋转方向，再结合X-ray拍片结果，触诊到骶骨偏移、旋转处，感知骶尾骨的律动，进行骶骨、尾骨关节松动及复位调整，恢复骶骨、尾骨活动及位置，并结合横膈膜手法进行处理。（15分钟一次，每周三次） 

Description for medicine or protocol of treatment in detail：

The experimental group was treated with pelvic and spinal stimulating therapy (30min), three times a week for four consecutive weeks. (1) Pelvic floor myofascial manipulation: The patient was supine, the hip was bent, and the perineal skin was observed to have no redness or swelling and no abnormal leucorrhea. After that, the therapist entered the vagina to find the trigger point of pelvic floor muscle fascia, pressed and knead the internal obturator muscle, iliac coccygeal muscle, ischiococcygeal muscle and piriformis muscle with appropriate pressure, combined with the contraction and relaxation of the involved muscle to reduce muscle tension and relieve pain, 15 minutes/time, three times a week. (2) Sacrococcygeal conditioning: The patient lies on his side, with pillows under his head and pillows between his knees. He can lie on the left or right side, but according to the direction of sigmoid rectum, it is best to lie on the left side. The patient is asked to expose his buttocks, and the doctor places his hand on the greater trochanter of femur above to give the patient a sense of ontology input. Observe whether the buttock skin is ruptured and the external anal sphincter is hemorrhoids. The S2-4 sensation was evaluated by swabs on both buttocks. The anus blink reflex was evaluated with a large cotton swab at the anus. Put on gloves, lubricate the fingers, loosen the superficial muscle group, and enter the anus. Based on the previous digital assessment results, understand the sacral offset and rotation direction, and combine with the X-ray film results, palpate the sacral offset and rotation, perceive the sacrococcygeal rhythm, loosen and adjust the sacral and coccygeal joints, and restore the sacral and coccygeal movement and position. Combined with diaphragmatic manipulation. (Every 15 minutes, three times a week) 

纳入标准：

Inclusion criteria

排除标准：

排除标准 ：（1）与中枢神经系统（CNS）和/或运动系统相关的综合征可能导致姿势病变的疾病；（2）遗传综合征、荷尔蒙失调、神经肌肉疾病、先天性运动系统缺陷；（3）盆腔感染、有骨盆外伤或手术史；（4）腰部肿瘤与腰椎结构病变 （5）怀孕状态；（6）过去一个月内接受过其他治疗。

Exclusion criteria：

Exclusion criteria: (1) syndromes associated with the central nervous system (CNS) and/or motor system that may cause postural disorders: (2) genetic syndromes, hormonal disorders, neuromuscular disorders, congenital motor system defects; (3) pelvic trauma or surgical history; (4) pregnancy; (5) Those who have participated in other treatments within the past month.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-02-01 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 97

Group：

control group

Sample size：

干预措施：

实施常规传统推拿手法，患者采取俯卧位，操作者对受试者的骶髂关节区域及骨盆周围组织进行按揉，力度以患者耐受度为基准，旨在缓解骨盆周围肌肉的异常张力。每次治疗持续30分钟，每周进行三次（隔1～2日一次），连续治疗四周（月经期停一周不参与治疗）。

干预措施代码：

Intervention：

Conventional traditional massage techniques are applied. The patient takes a prone position, and the operator kneads and rubs the sacroiliac joint area and the tissues around the pelvis of the subject. The intensity is based on the patient's tolerance, aiming to relieve the abnormal tension of the muscles around the pelvis. Each treatment lasts for 30 minutes, is performed three times a week (once every 1-2 days), and continues for four weeks (treatment is suspended for one week during menstruation).

Intervention code：

组别：

试验组

样本量：

 97

Group：

experimental group

Sample size：

干预措施：

研究者在临床实践中首次基于盆底肌筋膜手法基础上进行改良，将此方法命名为“盆脊促通疗法”，以对盆底肌、髋关节、骶尾骨进行手法调整。每次治疗时长为30分钟，每个部位操作10分钟。每周进行三次（隔1～2日一次），连续治疗四周（月经期停一周不参与治疗）。

干预措施代码：

Intervention：

For the first time in clinical practice, researchers improved the method based on the pelvic floor myofascial manipulation, and named this method "Pelvic-Spine Facilitation Therapy" to manually adjust the pelvic floor muscles, hip joints, and sacrococcygeal bone. Each treatment lasts for 30 minutes, with 10 minutes of operation on each part. It is performed three times a week (once every 1-2 days) for four consecutive weeks (treatment is suspended for one week during menstruation).

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 海南 

市(区县)：

 海口 

Country：

China

Province：

Hainan

City：

Haikou

单位(医院)：

 海南医科大学第二附属医院 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital of Hainan Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

冠状面骨盆侧倾度

指标类型：

主要指标

Outcome：

Pelvic obliquity (PO)

Type：

Primary indicator

测量时间点：

治疗前、治疗末次后

测量方法：

3D人体成分分析仪

Measure time point of outcome：

Before treatment, after the last treatment

Measure method：

3D Body Composition Analyzer

指标中文名：

矢状面骨盆倾斜角

指标类型：

主要指标

Outcome：

pelvic inclination angle(PIA)

Type：

Primary indicator

测量时间点：

治疗前、治疗末次后

测量方法：

3D人体成分分析仪

Measure time point of outcome：

Before treatment, after the last treatment

Measure method：

3D Body Composition Analyzer

指标中文名：

骨盆旋转

指标类型：

主要指标

Outcome：

Pelvis rotation (PR)

Type：

Primary indicator

测量时间点：

治疗前、治疗末次后

测量方法：

3D人体成分分析仪

Measure time point of outcome：

Before treatment, after the last treatment

Measure method：

3D Body Composition Analyzer

指标中文名：

骶骨倾斜角

指标类型：

主要指标

Outcome：

Sacral Slope(SS)

Type：

Primary indicator

测量时间点：

治疗前、治疗末次后

测量方法：

3D人体成分分析仪

Measure time point of outcome：

Before treatment, after the last treatment

Measure method：

3D Body Composition Analyzer

指标中文名：

疼痛数字评定量表（NRS）

指标类型：

主要指标

Outcome：

Numerical Rating Scale (NRS) for Pain Assessment

Type：

Primary indicator

测量时间点：

治疗前、治疗末次后

测量方法：

量表评估

Measure time point of outcome：

Before treatment, after the last treatment

Measure method：

Scale assessment

指标中文名：

焦虑抑郁评估（HEDS）

指标类型：

次要指标

Outcome：

Anxiety and Depression Evaluation Scale (HEDS)

Type：

Secondary indicator

测量时间点：

治疗前、治疗末次后

测量方法：

量表评估

Measure time point of outcome：

Before treatment, after the last treatment

Measure method：

Scale assessment

指标中文名：

Glazer肌电评估

指标类型：

次要指标

Outcome：

Glazer electromyography assessment

Type：

Secondary indicator

测量时间点：

治疗前、治疗末次后

测量方法：

盆底表面机电生物反馈

Measure time point of outcome：

Before treatment, after the last treatment

Measure method：

Pelvic floor surface electromechanical biofeedback

指标中文名：

盆底指诊评估

指标类型：

次要指标

Outcome：

Pelvic floor examination assessment

Type：

Secondary indicator

测量时间点：

治疗前、治疗末次后

测量方法：

手测盆底浅层、深层肌群张力情况

Measure time point of outcome：

Before treatment, after the last treatment

Measure method：

Manually test the tension of the superficial and deep pelvic floor muscles

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 20 岁 years
最大 Max age 50 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

本试验拟在海南省开展为期24个月的随机对照试验。试验对象为2026年-2027在海南医学院第二附属医院康复治疗科进行诊疗并通过体态评估、GLAZER、盆底指诊评估、情绪量表等确诊后天性骨盆倾斜患者，根据研究内容选择194名受试者。 随机分配序列将委托专门的统计分析人员应用统计软件SAS9.1程序的 PROC PLAN过程编程产生随机数字，将合格对象按纳入的顺序编号以1:1的比例随机分配进入试验组、对照组。

Randomization Procedure (please state who generates the random number sequence and by what method)：

This trial is intended to be a 24-month randomized controlled trial in Hainan Province. The experimental subjects were patients with acquired This trial plans to conduct a 24-month randomized controlled trial in Hainan Province. The subjects of the trial are patients with acquired pelvic tilt who will receive diagnosis and treatment in the Rehabilitation Department of the Second Affiliated Hospital of Hainan Medical University from 2026 to 2027 and are confirmed through posture assessment, GLAZER, pelvic floor digital examination, emotional scales, etc. A total of 194 subjects will be selected according to the research content. The random allocation sequence will be generated by professional statistical analysts using the PROC PLAN procedure of the statistical software SAS9.1 to program and generate random numbers. Eligible subjects will be numbered in the order of inclusion and randomly assigned to the experimental group and the control group at a 1:1 ratio.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

国家生物信息中心 China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/).

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

None

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

None

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-01-20 17:46:13
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