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

China Medical University

Status: Completed

Conditions: Pain, Postoperative

Treatments: Device: Fu's Subcutaneous Needling(FSN); Device: fine acupuncture needle

Study type: Interventional

Funder types: Other

Identifiers

NCT05572931

CMUH109-REC2-116

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 2 patient groups

Sham comparator

Sham Comparator group

Description:

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.

Treatment:

Device: fine acupuncture needle

Experimental

Experimental group

Description:

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.

Treatment:

Device: Fu's Subcutaneous Needling(FSN)