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Clinical trial of spirit-regulation with acupuncture in improving chronic musculoskeletal pain

Registration number：

ITMCTR2024000338

Date of Last Refreshed on：

2024-08-31

Date of Registration：

2024-08-31

Registration Status：

Prospective registration

Public title：

Clinical trial of spirit-regulation with acupuncture in improving chronic musculoskeletal pain

English Acronym：

Scientific title：

Clinical trial of spirit-regulation with acupuncture in improving chronic musculoskeletal pain

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Yanan Yang

Study leader：

Yanan Yang

Applicant telephone：

15972224592

Study leader's telephone：

15972224592

Applicant Fax：

Study leader's fax：

Applicant E-mail：

yangyanan10@crmedical.hk

Study leader's E-mail：

yangyanan10@crmedical.hk

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 209 Yejin Avenue, Qingshan District, Wuhan, China

Study leader's address：

No. 209 Yejin Avenue, Qingshan District, Wuhan, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

China Resources & Wugang General Hospital

Approved by ethic committee：

Approved No. of ethic committee：

CRWG2024R006

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of China Resources & Wugang General Hospital

Date of approved by ethic committee：

2024/7/19 0:00:00

Contact Name of the ethic committee：

He Yu

Contact Address of the ethic committee：

No. 209 Yejin Avenue, Qingshan District, Wuhan, China

Contact phone of the ethic committee：

027-86212358

Contact email of the ethic committee：

273764719@qq.com

Primary sponsor：

China Resources & Wugang General Hospital

Primary sponsor's address：

No. 209 Yejin Avenue, Qingshan District, Wuhan, China

Secondary sponsor：

Country：

China

Province：

Hubei

City：

Wuhan

Institution
hospital：

China Resources & Wugang General Hospital

Address：

China Resources & Wugang General Hospital

Source(s) of funding：

Joint fundation project of Hubei Province Key Laboratory of Occupational Hazard Identification and Control （JF2023-Y02）

Target disease：

chronic musculoskeletal pain

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

（1）Demonstrate the presence of negative emotions such as anxiety and depression in patients with chronic musculoskeletal pain through emotional assessment scales; （2）Confirm whether the severity of negative emotions is associated with neurotransmitter levels through correlation analysis, specifically, that fluctuations in negative emotions may lead to changes in the levels or components of related neurotransmitters; （3）Preliminary explore the possible mechanisms by which conventional electroacupuncture combined with mind-regulating electroacupuncture can simultaneously improve pain and alleviate negative emotions.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Consistent with the diagnostic criteria for chronic musculoskeletal pain proposed in the "Expert Consensus on Drug Therapy for Chronic Musculoskeletal Pain (2018)", that is, pain that has occurred in muscles, skeletons, joints, tendons, or soft tissues for ≥3 months, such as patients with rheumatoid arthritis, low back pain, neck and shoulder pain, knee arthritis, etc.; 2. VAS score ≥4; 3. Age ≥18 years; 4. Clear consciousness, accurate language expression, and the ability to communicate normally.

Exclusion criteria：

1) Patients with other severe major diseases such as cardiopulmonary, hepatic, or renal disorders; 2) Individuals with severe mental illnesses and cognitive dysfunction; 3) Patients who decline to participate; 4) Patients with chronic musculoskeletal pain caused by infectious diseases; 5) Women who are pregnant or breastfeeding; 6) Individuals intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).

Study execute time：

From 2024-09-01

To      2025-03-31

Recruiting time：

From 2024-09-01

To      2024-12-31

Interventions：

20

Group：

drug group

Sample size：

Intervention：

Oral administration of celecoxib capsules

Intervention code：

20

Group：

regular electroacupuncture combined with spirit-regulation electroacupuncture group

Sample size：

Intervention：

regular electroacupuncture combined with spirit-regulation electroacupuncture

Intervention code：

20

Group：

healthy volunteers

Sample size：

Intervention：

no intervention

Intervention code：

20

Group：

regular electroacupuncture group

Sample size：

Intervention：

Combination of Local and Meridian Acupoint Selection

Intervention code：

Total sample size ： 80

Countries of recruitment
and research settings：

Country：

中国

Province：

湖北省

City：

武汉市

Institution/hospital：

China Resources & Wugang General Hospital

Level of the institution：

Tertiary Grade A Hospital

Outcomes：

Outcome：

Hamilton Anxiety Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

VAS score of pain

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Hamilton Depression Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Serum levels of neurotransmitters

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Venous blood

Tissue：

Venous blood

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
60
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 by random number method: The principal investigator generates a series of random numbers and corresponding groups using a computer. Patients are assigned random numbers and allocated to corresponding groups according to the order of enrollment, with only patients with chronic musculoskeletal pain required to undergo random grouping.

Blinding：

IPD sharing：

No

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

N/A

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

Record using a medical case record form.

Data Managemen Committee：

Yes

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

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