The Effect of TCM Orthopedic Manipulation Combined with Functional Training in the Treatment of Upper Crossed Syndrome: A RCT

Registration number:

ITMCTR2025000426

Date of Last Refreshed on:

2025-02-27

Date of Registration:

2025-02-27

Registration Status:

Retrospective registration

Public title:

The Effect of TCM Orthopedic Manipulation Combined with Functional Training in the Treatment of Upper Crossed Syndrome: A RCT

English Acronym:

Scientific title:

The Effect of TCM Orthopedic Manipulation Combined with Functional Training in the Treatment of Upper Crossed Syndrome: A RCT

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

Applicant:

Dong Yan

Study leader:

Dong Yan

Applicant telephone:

13437803094

Study leader's telephone:

13437803094

Applicant Fax:

Study leader's fax:

Applicant E-mail:

yandongtcm@qq.com

Study leader's E-mail:

yandongtcm@qq.com

Study leader's website(voluntary supply):

http://www.cqljxqzyy.cn/

Study leader's website
(voluntary supply):

Applicant address:

No.4-2-2-1 Jing Shi Nan Li Jia Street Liangjiang New Area Chongqing

Study leader's address:

No.4-2-2-1 Jing Shi Nan Li Jia Street Liangjiang New Area Chongqing

Applicant postcode:

400000

Study leader's postcode:

400000

Applicant's institution:

Chongqing Liangjiang New Area Traditional Chinese Medicine Hospital

Approved by ethic committee:

Approved No. of ethic committee:

202303

Approved file of Ethical Committee:

View

Name of the ethic committee:

Ethics Committee of the Traditional Chinese Medicine Hospital in Liangjiang New Area Chongqing

Date of approved by ethic committee:

2023/9/26 0:00:00

Contact Name of the ethic committee:

Jindou Zou

Contact Address of the ethic committee:

No. 3 Nan Zhu Road Da Zhulin Liangjiang New Area Chongqing

Contact phone of the ethic committee:

13983462383

Contact email of the ethic committee:

986274926@qq.com

Primary sponsor:

Chongqing Liangjiang New Area Traditional Chinese Medicine Hospital

Primary sponsor's address:

No. 3 Nan Zhu Road Da Zhulin Liangjiang New Area Chongqing

Secondary sponsor:

Country:

China

Province:

Chongqing

City:

Chongqing

Institution
hospital:

Chongqing Liangjiang New Area Traditional Chinese Medicine Hospital

Address:

No. 3 Nan Zhu Road Da Zhulin Liangjiang New Area Chongqing

Source(s) of funding:

Chongqing Liangjiang New Area Traditional Chinese Medicine Hospital

Target disease:

Upper Cross Syndrome

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Pilot clinical trial

Objectives of Study:

This study aims to evaluate the efficacy of traditional Chinese orthopedic manipulation combined with functional training of the thoracic and dorsal muscle groups in treating Upper Cross Syndrome.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

The inclusion criteria are as follows: (1) Patients must meet the diagnostic criteria for upper cross syndrome (see Morns CE Bonnefin D Darville C. The Torsional Upper Crossed Syndrome: A multi-planar update to Jandas model with a case series introduction of the mid-pectoral fascial lesion as an associated etiological factor [J]. Journal of Bodywork And Movement Therapies. 2015 19(4): 681-689.) and be confirmed through clinical symptoms and X-ray examination; (2) The age range of patients is between 30 and 49 years old.

Exclusion criteria:

Exclusion criteria include: (1) Patients with a history of neck trauma; (2) Patients with conditions such as spinal canal stenosis spinal canal tumors ankylosing spondylitis osteoporosis etc.; (3) Patients with acute exacerbation of the condition manifested as cervical disc herniation radiating pain in the upper limbs compression of surrounding nerves and blood vessels etc.; (4) Patients who have undergone surgical treatment on the neck or back; (5) Patients with other conditions that cannot withstand the treatment.

Study execute time:

From 2024-01-01

To      2024-12-31

Recruiting time:

From 2024-01-01

To      2024-06-30

Interventions:

30

Group:

Control Group

Sample size:

Intervention:

Back Massage Techniques for Relaxation + Functional Training of the Thoracic and Dorsal Muscle Groups

Intervention code:

30

Group:

Observation Group

Sample size:

Intervention:

Traditional Chinese Orthopedic Manipulation + Thoracic and Dorsal Muscle Functional Training

Intervention code:

Total sample size : 60

Countries of recruitment
and research settings:

Country:

China

Province:

Chongqing

City:

Chongqing

Institution/hospital:

Chongqing Liangjiang New Area Traditional Chinese Medicine Hospital

Level of the institution:

Grade II-A Hospital

Outcomes:

Outcome:

FHA

Type:

Primary indicator

Measure time point of outcome:

Before treatment 2 weeks after treatment

Measure method:

Measure three times with a goniometer and take the average value.

Outcome:

NDI Score

Type:

Secondary indicator

Measure time point of outcome:

Before treatment 2 weeks after treatment

Measure method:

Score according to the scoring table add up the scores and record the total score.

Outcome:

NPAD Score

Type:

Secondary indicator

Measure time point of outcome:

Before treatment 2 weeks after treatment

Measure method:

Score according to the scoring table add up the scores and record the total score.

Outcome:

FSA

Type:

Secondary indicator

Measure time point of outcome:

Before treatment 2 weeks after treatment

Measure method:

Measure three times with a goniometer and take the average value.

Outcome:

FMA Score

Type:

Secondary indicator

Measure time point of outcome:

Before treatment 2 weeks after treatment

Measure method:

Score according to the scoring table add up the scores and record the total score.

Collecting sample(s)
from participants:

Sample Name:

None

Tissue:

None

Fate of sample 

Destruction after use

Note:

Completed

30
Min age years
49
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

This study employed a completely random method enrolling cases that met the criteria in the order of their first visit. A computer-generated Excel spreadsheet was used to randomly produce 60 numbers. These random numbers were then arranged from largest to smallest with the first 30 assigned to the observation group and the next 30 to the control group. Subsequently the groups were re-arranged according to the original sequence of the randomly generated numbers. The grouping results were concealed in opaque sealed envelopes for backup. The envelopes were opened in the order of patient admission to assign the random numbers and determine the group assignment ensuring that the observed cases were randomly allocated to the two groups with 30 cases in each group.

Blinding:

IPD sharing:

No

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

Upload this system in the form of an Excel table within 1 year of publication.

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

The relevant raw data for each case is collected using a Case Report Form (CRF) and is compiled by the principal investigator of this project in Excel for subsequent statistical analysis.

Data Managemen Committee:

No

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

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above