Protocol summary

Study aim
This study is critical not just for increasing our understanding of PLNP, but also for developing novel, evidence-based therapies that might greatly improve the quality of life for those living with this terrible disorder.
Design
A concealed, experimental, blinded, randomized clinical trial with a control group design of 30 patients enrolled between October 2023 and November 2023 and followed for 4 weeks
Settings and conduct
This will be conducted at The First People Hospital,Wuhan &trial assesor blind
Participants/Inclusion and exclusion criteria
Patients aged between 18-65 years diagnosed with PLNP and reporting a pain level of at least 4 on a 10-point visual analog scale (VAS) were eligible for the study. Exclusion criteria included pregnancy, current use of anti-inflammatory medications, history of spinal surgery, and contraindications to acupuncture.
Intervention groups
1. UGIHA Group: Patients in the UGIHA group received acupuncture sessions twice a week for four weeks. A 0.3 mm × 40 mm disposable needle (DongBang Acupuncture Inc., Korea) was percutaneously inserted and advanced to a depth of 15-25 mm into the intervertebral foramen under real-time ultrasound guidance. The needle was then electronically activated to produce heat. Acupuncture points targeted specific regions of discomfort or dysfunction.(13) 2. Control Group: Participants in the control group received non-therapeutic ultrasound therapy sessions twice a week for four weeks. The ultrasound therapy was administered without the application of heat and did not involve needle insertion
Main outcome variables
1. Primary Outcome: Pain severity was assessed using a 10-point visual analog scale (VAS) at baseline, after the 4-week intervention period, and during follow-up visits. 2. Secondary Outcomes: Serum levels of IL1β, TNF-α, and PGE2 were measured before and after the treatment period using established biochemical assays.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231026059863N1
Registration date: 2023-10-31, 1402/08/09
Registration timing: retrospective

Last update: 2023-10-31, 1402/08/09
Update count: 0
Registration date
2023-10-31, 1402/08/09
Registrant information
Name
Daojing Su
Name of organization / entity
Hubei University of Medicine
Country
China
Phone
+86 150 0273 5690
Email address
zhangandy@taihehospital.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-15, 1402/07/23
Expected recruitment end date
2023-10-18, 1402/07/26
Actual recruitment start date
2023-10-17, 1402/07/25
Actual recruitment end date
2023-10-23, 1402/08/01
Trial completion date
empty
Scientific title
Effectiveness of Ultrasound-Guided Internal Heat Acupuncture for Alleviating Posterior Lumbar Nerve Pain and Modulating Serum IL1-β, TNF-α, and PGE2 Levels.
Public title
effect of Ultrasound-Guided Internal Heat Acupuncture for Alleviating Posterior Lumbar Nerve Pain and Modulating Serum IL1-β, TNF-α, and PGE2 Levels.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 18-65 years diagnosed with PLNP and reporting a pain level of at least 4 on a 10-point visual analog scale (VAS) were eligible for the study.
Exclusion criteria:
Exclusion criteria included pregnancy, current use of anti-inflammatory medications, history of spinal surgery, and contraindications to acupuncture
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants who fulfilled the inclusion criteria were selected convenient sampling technique and were then allocated randomly to Group A and Group B using lottery method. This distribution process is hidden between participants and researchers. This was done by a research assistant who did not participate in any further research.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study was double-blinded. The outcome assessor who was blinded to the therapy group was recruited to take readings at pre-treatment and post-treatment values. And the patients were also blinded as they didn’t know they all have the same disorder and different techniques had been given to these patients.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of the First People's Hospital
Street address
Zhifang Culture Avenue, Jiangxia Distric Wuhan City
City
Wuhan
Postal code
442000
Approval date
2023-10-01, 1402/07/09
Ethics committee reference number
Ref/ET/FPH/01/01-10-2023

Health conditions studied

1

Description of health condition studied
Posterior Lumbar Nerve Pain
ICD-10 code
M54. 16
ICD-10 code description
Posterior Lumbar Nerve Pain

Primary outcomes

1

Description
1. Primary Outcome: Pain severity was assessed using a 10-point visual analog scale (VAS) at baseline, after the 4-week intervention period, and during follow-up visits.
Timepoint
4 weeks
Method of measurement
1. Primary Outcome: Pain severity was assessed using a 10-point visual analog scale (VAS)

Secondary outcomes

1

Description
Secondary Outcomes: Serum levels of IL1β, TNF-α, and PGE2 were measured before and after the treatment period using established biochemical assays.
Timepoint
4 weeks
Method of measurement
Secondary Outcomes: Serum levels of IL1β, TNF-α, and PGE2 were measured before and after the treatment period using established biochemical assays.

Intervention groups

1

Description
Intervention group: 1. Ultrasound-guided internal heat acupuncture Group: Patients in the UGIHA group received acupuncture sessions twice a week for four weeks. A 0.3 mm × 40 mm disposable needle (DongBang Acupuncture Inc., Korea) was percutaneously inserted and advanced to a depth of 15-25 mm into the intervertebral foramen under real-time ultrasound guidance. The needle was then electronically activated to produce heat. Acupuncture points targeted specific regions of discomfort or dysfunction
Category
Treatment - Other

2

Description
Control group: Participants in the control group received non-therapeutic ultrasound therapy sessions twice a week for four weeks. The ultrasound therapy was administered without the application of heat and did not involve needle insertion.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
The First People's Hospital
Full name of responsible person
Zengfeng Cheng
Street address
Zhifang Culture Avenue, Jiangxia Distric Wuhan City
City
Wuhan
Postal code
442000
Phone
+86 150 0273 5690
Email
zhangandy@taihehospital.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The First People's Hospital
Full name of responsible person
Zengfeng Cheng
Street address
Zhifang Culture Avenue, Jiangxia Distric Wuhan City
City
Wuhan
Postal code
442000
Phone
+86 150 0273 5690
Email
zhangandy@taihehospital.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
No
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Taihe Hospital affiliated to Hubei University of Medicine
Full name of responsible person
Daojing Su
Position
Professor
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Wudang Mountain Branch, Shiyan City,Hubei Province
City
Shiyan
Province
Hubei
Postal code
442000
Phone
+86 150 0273 5690
Email
605278189@qq.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
First People's Hospital of Jiangxia District, Wuhan/Concorde Jiangnan Hospital
Full name of responsible person
Zengfeng Chen
Position
Professor
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Wudang Mountain Branch, Shiyan City,Hubei Province
City
Shiyan
Province
Hubei
Postal code
442000
Phone
+86 150 0273 5690
Email
284133170@qq.com

Person responsible for updating data

Contact
Name of organization / entity
Hubei University of Medicine
Full name of responsible person
Daojing Su
Position
Professor
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Wudang Mountain Branch, Shiyan City,Hubei Province
City
Shiyan
Province
Hubei
Postal code
442000
Phone
+86 150 0273 5690
Fax
Email
zhangandy@taihehospital.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Effectiveness of Ultrasound-Guided Internal Heat Acupuncture for Alleviating Posterior Lumbar Nerve Pain and Modulating Serum IL1-β, TNF-α, and PGE2 Levels.
When the data will become available and for how long
When the trial has been completed after the end November 2023.The data will be available for the future use and after the completion of the trial when it get published approximately after the 4 weeks in the end of the November 2023.The summary will be available after the article get published
To whom data/document is available
It will be available to all teaching institue and hospital for the better cure of the patient and more over it will be avilable for the researcher as wel
Under which criteria data/document could be used
Only for the research and for the benefits of the public
From where data/document is obtainable
Daojing Su Orthopedic Rehabilitation(1 Ward) of Shiyan Taihe Hospital affiliated to Hubei University of Medicine 32 renmin south road,maojian district,shiyan city,hubei province 605278189@qq.com
What processes are involved for a request to access data/document
By application sent to 605278189@qq.com
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