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

NCT05572931 | Completed

• 1 other identifier: CMUH109-REC2-116
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Fu's Subcutaneous Needling, postoperative pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change of Blood serum C-reactive protein (CRP)

  Change from Baseline CRP at the 24th, 72nd hour, 1st month after surgery.

• 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.

• Change of Blood serum TNF-α

  Change from Baseline TNF-α at the 24th, 72nd hour, 1st month after surgery.

• Change of Tissue hardness (TH)

  Change from Baseline TH at the 1st、24th、48th、72nd hour after surgery.

Study Arms (2)

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

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)

Interventions

Fu's Subcutaneous Needling(FSN) DEVICE

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.

Experimental

fine acupuncture needle DEVICE

(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.

Sham comparator

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hsinchu Hospital

Zhubei, Hsinchu County, 302, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Chih-Ying Wu, MD

  China Medical University, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: October 10, 2022
• Study Start: March 8, 2021
• Primary Completion: February 1, 2023
• Study Completion: June 25, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)