Fu’s subcutaneous needling versus massage for chronic non-specific low-back pain: long-term follow-up results from a randomized controlled clinical trial

Registration number:

ITMCTR2100005278

Date of Last Refreshed on:

2021-09-05

Date of Registration:

2021-09-05

Registration Status:

Prospective registration

Public title:

Fu’s subcutaneous needling versus massage for chronic non-specific low-back pain: long-term follow-up results from a randomized controlled clinical trial

English Acronym:

Scientific title:

Clinical study on the treatment of chronic non-specific low-back pain

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2100050866 ; ChiMCTR2100005278

Applicant:

Kunlong Ma

Study leader:

Kunlong Ma

Applicant telephone:

15123021572

Study leader's telephone:

15123021572

Applicant Fax:

Study leader's fax:

Applicant E-mail:

makunlong666@163.com

Study leader's E-mail:

makunlong666@163.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

NO. 439 Xuanhua Road, Yongchuan, Chongqing

Study leader's address:

NO. 439 Xuanhua Road, Yongchuan, Chongqing

Applicant postcode:

402160

Study leader's postcode:

402160

Applicant's institution:

Yongchuan Hospital of Chongqing Medical University

Approved by ethic committee:

Approved No. of ethic committee:

2019科伦审100号

Approved file of Ethical Committee:

View

Name of the ethic committee:

Human ethics committee of Yongchuan hospital of Chongqing medical university

Date of approved by ethic committee:

1990/1/1 0:00:00

Contact Name of the ethic committee:

Fang Liang

Contact Address of the ethic committee:

Yongchuan Hospital of Chongqing Medical University

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

Yongchuan hospital of Chongqing medical university

Primary sponsor's address:

NO. 439 Xuanhua Road, Yongchuan, Chongqing

Secondary sponsor:

Country:

China

Province:

Chongqing

City:

Chongqing

Institution
hospital:

Yongchuan hospital of Chongqing medical university

Address:

NO. 439 Xuanhua Road, Yongchuan, Chongqing

Source(s) of funding:

Yongchuan District Social People's Livelihood Science and Technology Innovation Special Project (Ycstx,2020cc0205)

Target disease:

chronic non-specific low-back pain

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

New Treatment Measure Clinical Study

Objectives of Study:

The purpose of this study was to compare the long-term efficiency of Fus subcutaneous needling therapy with massage therapy for the management of chronic nonspecific low back pain

Description for medicine or protocol of treatment in detail:

Inclusion criteria

(1) Meets diagnostic criteria of chronic NLBP (pain affecting the lumbosacral area and adjacent tissues, located from the bottom of ribs to inferior gluteal fold; (2) Complaint of pain lasting longer than 3 months with the VAS scores of at least 3; (3) No accompanying systemic diseases, such as tumors and tuberculosis, no psychiatric diseases, no neurological diseases that require surgery; (4) Age between 18-80 years old; (5) American Society of Anesthesiologists (ASA) grade I to III; and (6) Voluntarily signed the informed consent.

Exclusion criteria:

(1) Fear of needles; (2) Patients with a history of spinal surgery; (3) Known or suspected serious spinal pathology (fractures, tumors, inflammatory, rheumatologic disorders, infectious diseases of the spine, spinal degeneration with nerve root or cauda equina nerve damage); (4) Severe cardiovascular or cerebrovascular diseases;(5) Pregnancy; and (6)Coagulation abnormality.

Study execute time:

From 2021-09-04

To      2022-12-26

Recruiting time:

From 2021-09-04

To      2022-05-22

Interventions:

60

Group:

Fu's subcutaneous needling therapy group

Sample size:

Intervention:

Fu's subcutaneous needling therapy

Intervention code:

60

Group:

Massage therapy group

Sample size:

Intervention:

Massage therapy

Intervention code:

Total sample size : 120

Countries of recruitment
and research settings:

Country:

China

Province:

Chongqing

City:

Chongqing

Institution/hospital:

Yongchuan Hospital of Chongqing Medical University

Level of the institution:

Grade III A hospital

Outcomes:

Outcome:

functional outcomes

Type:

Primary indicator

Measure time point of outcome:

at baseline, the post-treatment, 3 months after treatment, and 12 months after treatment.

Measure method:

Japanese Orthopaedic Association Scores system

Outcome:

quality of life

Type:

Primary indicator

Measure time point of outcome:

at baseline, the post-treatment, 3 months after treatment, and 12 months after treatment.

Measure method:

Short Form Health Survey Questionnaire

Outcome:

functional disability

Type:

Primary indicator

Measure time point of outcome:

at baseline, the post-treatment, 3 months after treatment, and 12 months after treatment.

Measure method:

Oswestry Disability Index

Outcome:

pain intensity

Type:

Primary indicator

Measure time point of outcome:

at baseline, the post-treatment, 3 months after treatment, and 12 months after treatment.

Measure method:

visual analogue scale

Collecting sample(s)
from participants:

Sample Name:

no

Tissue:

Fate of sample 

Destruction after use

Note:

Recruiting

18
Min age years
80
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

Randomization was performed using Microsoft Excel for Windows software by a trained evaluator who was not involved in the recruitment of participants.

Blinding:

IPD sharing:

Yes

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

Clinical data will not be made public until the paper is published

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

Clinical data of patients are collected and collated by a trained research staff. Case Record Form will be used for data collection.

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