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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05572931
Other study ID # CMUH109-REC2-116
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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