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

NCT ID: NCT05572931

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2023-06-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

fine acupuncture needle

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Fu's Subcutaneous Needling(FSN)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chih-Ying Wu

Attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chih-Ying Wu, MD

Role: STUDY_CHAIR

China Medical University, China

Locations

China Medical University Hsinchu Hospital

Zhubei, Hsinchu County, Taiwan

Countries

Taiwan

Other Identifiers

CMUH109-REC2-116

Identifier Type: -

Identifier Source: org_study_id