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Immediate efficacy observation of acupuncture in the treatment of postoperative pain after hip replacement surgery for femoral neck fracture

Registration number：

ITMCTR2025000459

Date of Last Refreshed on：

2025-03-04

Date of Registration：

2025-03-04

Registration Status：

Prospective registration

Public title：

Immediate efficacy observation of acupuncture in the treatment of postoperative pain after hip replacement surgery for femoral neck fracture

English Acronym：

Scientific title：

Immediate efficacy observation of acupuncture in the treatment of postoperative pain after hip replacement surgery for femoral neck fracture

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Wang hong yang

Study leader：

Liao jiang long

Applicant telephone：

13550085124

Study leader's telephone：

15877953130

Applicant Fax：

Study leader's fax：

Applicant E-mail：

why905422141@163.com

Study leader's E-mail：

373772123@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 1076 Yuhua Road Chenggong District Kunming Yunnan Province China

Study leader's address：

No. 2628 Xiangyuan Street Chenggong District Kunming China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The Second Clinical Medical College of Yunnan University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

伦审（2024-016-01）号

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Kunming Municipal Hospital of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/12/6 0:00:00

Contact Name of the ethic committee：

Li chun xiang

Contact Address of the ethic committee：

No. 2628 Xiangyuan Street Chenggong District Kunming China

Contact phone of the ethic committee：

13577129117

Contact email of the ethic committee：

283800573@qq.com

Primary sponsor：

Kunming Municipal Hospital of Traditional Chinese Medicine

Primary sponsor's address：

No. 2628 Xiangyuan Street Chenggong District Kunming China

Secondary sponsor：

Country：

China

Province：

Yunnan

City：

Kunming

Institution
hospital：

Kunming Municipal Hospital of Traditional Chinese Medicine

Address：

No. 2628 Xiangyuan Street Chenggong District Kunming China

Source(s) of funding：

Yunnan High-level Talents in Traditional Chinese Medicine Subject Leaders (Acupuncture and Moxibustion) Cultivation Objects

Target disease：

Postoperative pain after hip arthroplasty for femoral neck fracture

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

In this study we proposed patients after hip arthroplasty for femoral neck fracture using acupuncture as an intervention and sham acupuncture as a control aiming to verify the immediate efficacy of acupuncture in treating postoperative pain after hip arthroplasty for femoral neck fracture.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Patients with unilateral pain after hip arthroplasty for femoral neck fracture between the ages of 50-75 years old men and women are not limited; ② Patients with acute pain episodes; ③ Patients with moderate to severe pain (4 points ≤ VAS score ≤ 9 points); ④ No previous history of allergy to opioid analgesic; ⑤ Able to actively cooperate complete the clinical study and sign the informed consent form. (Note: Patients who also meet the above 5 items can be included in this study.)

Exclusion criteria：

① patients with multiple fractures or pathological fractures; ② patients with combination of serious primary diseases such as cardiovascular cerebrovascular hepatic renal hematopoietic systems and other organic diseases or infections coagulation disorders allergies skin diseases etc.; ③ patients with combination of serious anxiety depression insomnia and other mental illnesses or intellectual disabilities who are unable to cooperate with the questionnaires; ④ patients who have already taken analgesic medicines after the operation; ⑤ patients with malignant tumors; ⑥ patients who are intolerant of or Patients who are intolerant to acupuncture or allergic to acupuncture needles; ⑦ Patients who are participating in other programs. (Patients with any one of these conditions cannot be included in this study.)

Study execute time：

From 2024-12-06

To      2027-06-30

Recruiting time：

From 2025-03-31

To      2027-03-31

Interventions：

77

Group：

Control Group

Sample size：

Intervention：

Sham acupuncture

Intervention code：

77

Group：

Observation Group

Sample size：

Intervention：

acupuncture

Intervention code：

Total sample size ： 154

Countries of recruitment
and research settings：

Country：

China

Province：

Yunnan

City：

Kunming

Institution/hospital：

Kunming Municipal Hospital of Traditional Chinese Medicine

Level of the institution：

Level-III Chinese Medicine Hospital

Outcomes：

Outcome：

blinded evaluation

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

VAS after 10 minutes of needling

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

expected evaluation of treatment effect

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

VAS at 2, 4, 6, and 8 minutes of patient treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Effectiveness

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

none

Tissue：

Fate of sample 

Others

Note：

Not yet recruiting

50
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Randomized grouping will be carried out using SPSS28.0 software: first the study subjects will be numbered from 1 to 154; random numbers will be systematically generated using SPSS28.0 software and randomly assigned to the two groups of this trial in a ratio of 1:1 and the generation and saving of the random numbers will be carried out by a third party who is not involved in the trial. The grouping information will be placed in opaque envelopes and the numbers will be filled on the surface of the envelopes in the order of the study subjects' numbers. When cases are included the envelopes will be opened in the order of inclusion of the study subjects and different methods of intervention will be administered to the patients depending on the grouping.

Blinding：

IPD sharing：

Yes

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

The Second Clinical Medical College of Yunnan University of Traditional Chinese Medicine http://www.ztkfxy.ynucm.edu.cn/

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

Case Record Form

Data Managemen Committee：

Not yet

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

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