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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05572931
• Other study ID #: CMUH109-REC2-116
• Status: Completed
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: June 25, 2023

Study information

• Verified date: February 2024
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 25, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	China Medical University Hsinchu Hospital	Zhubei	Hsinchu County

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Change of Blood serum C-reactive protein (CRP)	Biochemistry	Change from Baseline CRP at the 24th, 72nd hour, 1st month after surgery.
Secondary	Change of Blood serum IL-1??IL-2?IL-6	Biochemistry	Change from Baseline IL-1??IL-2?IL-6 at the 24th, 72nd hour, 1st month after surgery.
Secondary	Change of Blood serum TNF-a	Biochemistry	Change from Baseline TNF-a at the 24th, 72nd hour, 1st month after surgery.
Secondary	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.