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

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Device: fine acupuncture needle; Device: Fu's Subcutaneous Needling(FSN)

• Registration Number: NCT05572931
• Lead Sponsor: China Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-08
• Study First Submitted: 2022-10-02
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-10
• Primary Completion: 2023-02-01
• Study Completion: 2023-06-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-17
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham comparator	fine acupuncture needle	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.
Experimental	Fu's Subcutaneous Needling(FSN)	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.

Primary Outcome Measures

Name	Time	Method
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)
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

Secondary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

China Medical University Hsinchu Hospital; 🇨🇳 Zhubei, Hsinchu County, Taiwan