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EFFECT OF INTEGRATED VISCERAL AND SPINAL MANIPULATION IN ADULTS PATIENT WITH FUNCTIONAL DYSPEPSIA: A RANDOMIZED CONTROLLED TRIAL

注册号：

Registration number：

ITMCTR2024000020

最近更新日期：

Date of Last Refreshed on：

2024-02-20

注册时间：

Date of Registration：

2024-02-20

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

Public title：

EFFECT OF INTEGRATED VISCERAL AND SPINAL MANIPULATION IN ADULTS PATIENT WITH FUNCTIONAL DYSPEPSIA: A RANDOMIZED CONTROLLED TRIAL

注册题目简写：

English Acronym：

EFFECT OF INTEGRATED VISCERAL AND SPINAL MANIPULATION IN ADULTS PATIENT WITH FUNCTIONAL DYSPEPSIA: A RANDOMIZED CONTROLLED TRIAL

研究课题的正式科学名称：

Scientific title：

EFFECT OF INTEGRATED VISCERAL AND SPINAL MANIPULATION ON ABDOMINAL PAIN, DYSPEPSIA STATUS, PSYCHOLOGICAL STATUS, SLEEP STATUS, AND QUALITY OF LIFE IN ADULTS PATIENT WITH FUNCTIONAL DYSPEPSIA: A RANDOMIZED CONTROLLED TRIAL

研究课题的正式科学名称简写：

Scientific title acronym：

EFFECT OF INTEGRATED VISCERAL AND SPINAL MANIPULATION IN ADULTS PATIENT WITH FUNCTIONAL DYSPEPSIA: A RANDOMIZED CONTROLLED TRIAL

研究课题代号(代码)：

Study subject ID：

2020668002

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：

研究负责人：

Applicant：

Arisandy Achmad

Study leader：

Arisandy Achmad

申请注册联系人电话：

Applicant telephone：

+6282336187911

研究负责人电话：

Study leader's telephone：

+6282336187911

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：

fisioandyy@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

fisioandyy@gmail.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

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：

研究负责人通讯地址：

Applicant address：

Jalan Abdul Wahab Syahranie IV, Blok X, No.1, Samarinda City, East Kalimantan

Study leader's address：

Jalan Abdul Wahab Syahranie IV, Blok X, No.1, Samarinda City, East Kalimantan

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

Applicant's institution：

Universiti Teknologi Mara Malaysia

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

DP.04.03/7.1/12146/2023

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

Name of the ethic committee：

KEMENTERIAN KESEHATAN REPUBLIK INDONESIA POLTEKKES KEMENKES KALIMANTAN TIMUR KOMISI ETIK PENELITIAN KESEHATAN

伦理委员会批准日期：

Date of approved by ethic committee：

2023/7/20 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

KEPK Politeknik Kesehatan Kemenkes Kalimantan Timur

伦理委员会联系地址：

Contact Address of the ethic committee：

Kampus A, Jalan Kurnia Makmur No.64, Kecamatan Loa Janan Ilir, Samarinda City, East Kalimantan Indonesia

伦理委员会联系人电话：

Contact phone of the ethic committee：

+6285246947844

伦理委员会联系人邮箱：

Contact email of the ethic committee：

kepk.polkestim@gmail.com

研究实施负责（组长）单位：

Primary sponsor：

Arisandy Achmad

研究实施负责（组长）单位地址：

Primary sponsor's address：

Jalan Abdul Wahab Syahranie IV, Blok X, No.1, Samarinda City, East Kalimantan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Source(s) of funding：

Arisandy Achmad

研究疾病：

研究疾病代码：

Target disease：

Functional Dyspepsia

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

Objectives of Study：

a. To determine the validity of Integrated Visceral and Spinal Manipulation (InViSMa) intervention protocol for patients with functional dyspepsia (FD) b. To determine the feasibility (study adherence, compliance, recruitment rates, participation retention) of 4-week InViSMa interventional program in patient with FD c. To investigate the effects of 4-week InViSMa intervention program on abdominal pain, dyspepsia status, psychological status, sleep status and quality of life in patient with FD

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

Research Procedure - At the beginning of the study The research team will briefly explain the research and will provide an opportunity to ask any questions you may have. If you are satisfied with the details of the research, then you can sign the Consent Form. A survey form containing details of your background and medical history will be completed (Form A). Next, you are asked to fill out a questionnaire that the research team gave you to assess your abdominal pain, dyspepsia status (such as burning sensation in the chest, bloating, nausea and vomiting), psychological status, sleep patterns and your quality of life, as long as you have functional dyspepsia. Our research team will help you fill out a questionnaire that includes, abdominal pain questionnaire, dyspepsia status questionnaire, psychological questionnaire, sleep pattern questionnaire, and your quality of life questionnaire. You need to undergo physiotherapy treatment with the InViSMa approach to evaluate the quality and quantity; (1) abdominal pain, (2) dyspepsia status, (3) psychological status, (4) sleep patterns and (5) your quality of life, between before treatment (pre-test treatment) and after treatment (post-test treatment), for 4 weeks. Where every week, the research team will evaluate the changes you feel during treatment. With this procedure, you are expected to participate in this physiotherapy treatment program 3 times a week for 4 weeks, with a duration of 30 minutes per treatment session. - 4 weeks of the study For 4 weeks, researcher will gently apply the InViSMa treatment to you abdomen, at a dose of 3 times a week for 30 minutes. In the application of InViSMa, you are asked to participate in partially removing your clothes to the extent of your abdomen according to the area to be treated. At the end of each treatment session (1 treatment session 3 times a week), our research team will evaluate the results of the treatment given to you, by filling out (check-list) the questionnaire that you have agreed to, objectively according to the changes you feel. Integrated visceral and spinal manipulation (InViSMa) This treatment will be using in intervention group as a treatment in adults patient with functional dyspepsia for 4 weeks (3 times a week) with a duration 45 minutes per session. The first, patients underwent spinal manipulation techniques to the mid-cervical spine (the origin of the phrenic nerve, C3-C5), and the thoraco-lumbar spine (the origin of the lesser splanchnic nerve and the levels of the diaphragmatic insertion (T5-L2) for 15 minutes. The secondly, followed by visceral manipulation of the gastroduodenal in the three plane of motion (sagittal plane, frontal plane and transverse plane) for 30 minutes. Integrated abdominal massage and spinal manipulation (InVaSMa) This treatment will be using in intervention group as a treatment in adults patient with functional dyspepsia for 4 weeks (3 times a week) with a duration 45 minutes per session. The first, patients underwent spinal manipulation techniques to the mid-cervical spine (the origin of the phrenic nerve, C3-C5), and the thoraco-lumbar spine (the origin of the lesser splanchnic nerve and the levels of the diaphragmatic insertion (T5-L2) for 15 minutes. The secondly, followed by general abdominal massage for 30 minutes.

纳入标准：

Inclusion criteria

- Having functional dyspepsia more than 3 months - Symptoms including abdominal discomfort or pain, heartburn, bloating, nausea, and vomiting of acid fluids - Problems with psychological distress, sleep disturbances, and impaired quality of life - Ages range of 18 - 65 years old - Currently unrelated medication were permitted onto the study provided that their medication remained - Both males and females of any race - Understand Indonesia language

排除标准：

Exclusion criteria：

- Pregnancy - Having red flag symptoms - Taking non-steroidal anti inflammatory (NSAID) medication - Had known gastric pathology, including but not limited to any of the following: gastric cancer, peptic ulcer, liver and biliary tract disease

研究实施时间：

Study execute time：

从From 2022-01-01

至To      2023-06-29

征募观察对象时间：

Recruiting time：

从From 2023-06-01

至To      2024-06-29

干预措施：

Interventions：

组别：

样本量：

27

Group：

Intervention Group

Sample size：

干预措施：

干预措施代码：

Intervention：

Integrated visceral and spinal manipulation (In-ViSMa)

Intervention code：

组别：

样本量：

27

Group：

Control Group

Sample size：

干预措施：

干预措施代码：

Intervention：

Integrated Abdominal Massage and Spinal Manipulation (In-VaSMa)

Intervention code：

样本总量 Total sample size ： 54

研究实施地点：

Countries of recruitment
and research settings：

国家：

省(直辖市)：

市(区县)：

Country：

Indonesia

Province：

East Kalimantan

City：

Samarinda

单位(医院)：

单位级别：

Institution/hospital：

Institut Teknologi Sains dan Kesehatan Wiyata Husada Samarinda

Level of the institution：

Institute

测量指标：

Outcomes：

指标中文名：

指标类型：

次要指标

Outcome：

Pittsburg Sleep Quality Index (PSQI)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline, After 1st, 2nd, 3rd, and 4th week (End of program)

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Leeds Dyspepsia Questionnaire (LDQ)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline, After 1st, 2nd, 3rd, and 4th week (End of program)

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Perceived Stress Scale (PSS)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline, After 1st, 2nd, 3rd, and 4th week (End of program)

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

Short Form-Nepean Dyspepsia Index (SF-NDI)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline, After 1st, 2nd, 3rd, and 4th week (End of program)

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Abdominal Pain Index (API)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline, After 1st, 2nd, 3rd, and 4th week (End of program)

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

None

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

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

Randomization was done with a computer-generated random number by an assistant's research.

盲法：

Blinding：

Patient's blinding

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）：

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

Undecided

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：

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

The data collected manually using paper-based questionnaire.

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

Not yet determined

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