Effect of Fu's Subcutaneous Needling on Postoperative Acute Pain in Patients With Lumbar Spine Surgery.

Sponsor

China Medical University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05572931

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Device: Fu's Subcutaneous Needling(FSN) Device: fine acupuncture needle	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Fu's Subcutaneous Needling on Postoperative Acute Pain in Patients With Lumbar Spine Surgery: a Single-blinded Randomized, Control Study

Actual Study Start Date :

Mar 8, 2021

Anticipated Primary Completion Date :

Oct 8, 2024

Anticipated Study Completion Date :

Oct 8, 2025

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Sham comparator 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.	Device: fine acupuncture needle (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.
Experimental: Experimental 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.	Device: Fu's Subcutaneous Needling(FSN) 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.

Arm

Intervention/Treatment

Sham Comparator: Sham comparator

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.

Device: fine acupuncture needle

(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.

Experimental: Experimental

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.

Device: Fu's Subcutaneous Needling(FSN)

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.

Outcome Measures

Primary Outcome Measures

Change of Taiwanese version of the Brief Pain Inventory (BPI-T) Short Form [Change from Baseline BPI-T at the 1st、24th、48th、72nd hour after surgery.]
BPI-T Short Form
The total dosage of analgesic drug [The amount of intravenous opioid drug (Pethidine 50mg/vail) within 72 hours after surgery.]
opioid drug (Pethidine 50mg/vail)

Secondary Outcome Measures

Change of Blood serum C-reactive protein (CRP) [Change from Baseline CRP at the 24th, 72nd hour, 1st month after surgery.]
Biochemistry
Change of Blood serum IL-1ẞ、IL-2、IL-6 [Change from Baseline IL-1ẞ、IL-2、IL-6 at the 24th, 72nd hour, 1st month after surgery.]
Biochemistry
Change of Blood serum TNF-α [Change from Baseline TNF-α at the 24th, 72nd hour, 1st month after surgery.]
Biochemistry
Change of Tissue hardness (TH) [Change from Baseline TH at the 1st、24th、48th、72nd hour after surgery.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China Medical University Hsinchu Hospital	Zhubei	Hsinchu County	Taiwan	302

Sponsors and Collaborators

China Medical University Hospital

Investigators

Study Chair: Chih-Ying Wu, MD, China Medical University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chih-Ying Wu, Attending physician, China Medical University Hospital

ClinicalTrials.gov Identifier:

NCT05572931

Other Study ID Numbers:

CMUH109-REC2-116

First Posted:

Oct 10, 2022

Last Update Posted:

Oct 10, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chih-Ying Wu, Attending physician, China Medical University Hospital

Fu's Subcutaneous Needling, postoperative pain

Additional relevant MeSH terms:

Pain, Postoperative

Acute Pain

Study Results

No Results Posted as of Oct 10, 2022