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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Device: fine acupuncture needle; Device: Fu's Subcutaneous Needling(FSN)

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ching-Liang Hsieh, MD, PhD; Phone Number: 5094 +886 4 2205 2121; Email: clhsieh@mail.cmuh.org.tw

Study Locations

• Taiwan
  • Hsinchu County
    • Zhubei, Hsinchu County, Taiwan, 302
      • China Medical University Hsinchu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Study Chair: Chih-Ying Wu, MD, China Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): June 25, 2023

Study Registration Dates

• First Submitted: October 2, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 17, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Fu's Subcutaneous Needling, postoperative pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: CMUH109-REC2-116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No