Effect of Fu's Subcutaneous Needling on Postoperative Acute Pain in Patients With Lumbar Spine Surgery.
Primary Purpose
Pain, Postoperative
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Fu's Subcutaneous Needling(FSN)
fine acupuncture needle
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Fu's Subcutaneous Needling, postoperative pain
Eligibility Criteria
Inclusion Criteria:
- Pain and neurological symptoms are caused by degeneration of the spine (L1-S1) and require surgery.
- One hour after lumbar spine surgery (evaluated after returning to the ward from the recovery room) Visual analogue scale (VAS) score ≥ 5 points
- After being explained, join the trial voluntarily and sign the subject's consent form.
Exclusion Criteria:
- Pain caused by acute trauma.
- major diseases such as heart and lung failure, cancer, chronic kidney disease.
- psychiatric disorder.
- History of substance abuse.
- A history of spinal surgery.
- Refused sign the consent form.
Sites / Locations
- China Medical University Hsinchu HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Sham comparator
Experimental
Arm Description
In addition to the routine analgesic (Acetaminophen 500mg, TID), the patients were treated with sham FSN at the 1st, 24th, and 48th hours after surgery. The sham FSN was used a fine acupuncture needle without swaying movement and reperfusion approach.
In addition to postoperative routine analgesic (Acetaminophen 500mg, TID), patients were received FSN treatment. The FSN insertion point and time are the same as control group. And then we performed swaying movement and reperfusion approach.
Outcomes
Primary Outcome Measures
Change of Taiwanese version of the Brief Pain Inventory (BPI-T) Short Form
BPI-T Short Form
The total dosage of analgesic drug
opioid drug (Pethidine 50mg/vail)
Secondary Outcome Measures
Change of Blood serum C-reactive protein (CRP)
Biochemistry
Change of Blood serum IL-1ẞ、IL-2、IL-6
Biochemistry
Change of Blood serum TNF-α
Biochemistry
Change of Tissue hardness (TH)
The points for measuring TH were the inferior border of the scapula, two centimeters horizontal from the midline of the L3 level, and the gluteus maximus.
Full Information
NCT ID
NCT05572931
First Posted
October 2, 2022
Last Updated
October 7, 2022
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05572931
Brief Title
Effect of Fu's Subcutaneous Needling on Postoperative Acute Pain in Patients With Lumbar Spine Surgery.
Official Title
Effect of Fu's Subcutaneous Needling on Postoperative Acute Pain in Patients With Lumbar Spine Surgery: a Single-blinded Randomized, Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
October 8, 2024 (Anticipated)
Study Completion Date
October 8, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this clinical trial is to evaluate Fu's Subcutaneous Needling (FSN) in postoperative pain in patients with Lumbar Spine Surgery (LSS). The main questions it aims to answer are:
Is FSN effective for postoperative pain?
Dose FSN decrease the tissue hardness after LSS?
Dose FSN have the effect of anti-inflammatory after LSS?
Participants will receive routine analgesic and FSN after LSS. Researchers will compare Sham group to see if FSN being effective for postoperative pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Fu's Subcutaneous Needling, postoperative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sham comparator
Arm Type
Sham Comparator
Arm Description
In addition to the routine analgesic (Acetaminophen 500mg, TID), the patients were treated with sham FSN at the 1st, 24th, and 48th hours after surgery. The sham FSN was used a fine acupuncture needle without swaying movement and reperfusion approach.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
In addition to postoperative routine analgesic (Acetaminophen 500mg, TID), patients were received FSN treatment. The FSN insertion point and time are the same as control group. And then we performed swaying movement and reperfusion approach.
Intervention Type
Device
Intervention Name(s)
Fu's Subcutaneous Needling(FSN)
Intervention Description
Insertion points are both sides of 1) inferior edge of the scapula; 2)the midpoint of inferior edge of the posterior superior iliac spine and the ischial tuberosity.
FSN (Trocar Acupuncture Needle, Nanjing FSN Medical Co. , Ltd, China.) ) is a solid needle with plastic cannula tube on the outside. Add on swaying movement (SM) and reperfusion approach (RA) after the needle inserting into the subcutaneous layer. The SM is a horizontal fan sway movement with the base of the needle for the fulcrum, The SM speed is 200 times in 2 minutes. Apply RA when performing SM. RA movement is hip extension in prone position with resistance by physician's hand for 10 seconds. And then rest for 10 seconds. Repeat 3 cycles. The same RA is performed over the other three insertion point.
Intervention Type
Device
Intervention Name(s)
fine acupuncture needle
Intervention Description
(36G, 0.5 inch, Wujiang city cloud & dragon medical device Co.,Ltd.) Only inserted to skin, not into the subcutaneous layer. No SM and RA.
Primary Outcome Measure Information:
Title
Change of Taiwanese version of the Brief Pain Inventory (BPI-T) Short Form
Description
BPI-T Short Form
Time Frame
Change from Baseline BPI-T at the 1st、24th、48th、72nd hour after surgery.
Title
The total dosage of analgesic drug
Description
opioid drug (Pethidine 50mg/vail)
Time Frame
The amount of intravenous opioid drug (Pethidine 50mg/vail) within 72 hours after surgery.
Secondary Outcome Measure Information:
Title
Change of Blood serum C-reactive protein (CRP)
Description
Biochemistry
Time Frame
Change from Baseline CRP at the 24th, 72nd hour, 1st month after surgery.
Title
Change of Blood serum IL-1ẞ、IL-2、IL-6
Description
Biochemistry
Time Frame
Change from Baseline IL-1ẞ、IL-2、IL-6 at the 24th, 72nd hour, 1st month after surgery.
Title
Change of Blood serum TNF-α
Description
Biochemistry
Time Frame
Change from Baseline TNF-α at the 24th, 72nd hour, 1st month after surgery.
Title
Change of Tissue hardness (TH)
Description
The points for measuring TH were the inferior border of the scapula, two centimeters horizontal from the midline of the L3 level, and the gluteus maximus.
Time Frame
Change from Baseline TH at the 1st、24th、48th、72nd hour after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pain and neurological symptoms are caused by degeneration of the spine (L1-S1) and require surgery.
One hour after lumbar spine surgery (evaluated after returning to the ward from the recovery room) Visual analogue scale (VAS) score ≥ 5 points
After being explained, join the trial voluntarily and sign the subject's consent form.
Exclusion Criteria:
Pain caused by acute trauma.
major diseases such as heart and lung failure, cancer, chronic kidney disease.
psychiatric disorder.
History of substance abuse.
A history of spinal surgery.
Refused sign the consent form.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chih-Ying Wu, MD
Phone
+886 4 2205 2121
Ext
5094
Email
zingwu1029@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Liang Hsieh, MD, PhD
Phone
+886 4 2205 2121
Ext
5094
Email
clhsieh@mail.cmuh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Ying Wu, MD
Organizational Affiliation
China Medical University, China
Official's Role
Study Chair
Facility Information:
Facility Name
China Medical University Hsinchu Hospital
City
Zhubei
State/Province
Hsinchu County
ZIP/Postal Code
302
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih-Ying Wu, MD
Phone
+886 4 2205 2121
Ext
5094
Email
zingwu1029@gmail.com
First Name & Middle Initial & Last Name & Degree
Chih Ying Wu, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Fu's Subcutaneous Needling on Postoperative Acute Pain in Patients With Lumbar Spine Surgery.
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