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Completed

NCT Number: NCT05572931

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

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.

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Key information

Conditions

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

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hsinchu Hospital

Zhubei, Hsinchu County, 302, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change of Taiwanese version of the Brief Pain Inventory (BPI-T) Short Form

    Time frame: Change from Baseline BPI-T at the 1st、24th、48th、72nd hour after surgery.

    BPI-T Short Form

  2. The total dosage of analgesic drug

    Time frame: The amount of intravenous opioid drug (Pethidine 50mg/vail) within 72 hours after surgery.

    opioid drug (Pethidine 50mg/vail)

Secondary outcomes

  1. Change of Blood serum C-reactive protein (CRP)

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

    Biochemistry

  2. Change of Blood serum IL-1ẞ、IL-2、IL-6

    Time frame: Change from Baseline IL-1ẞ、IL-2、IL-6 at the 24th, 72nd hour, 1st month after surgery.

    Biochemistry

  3. Change of Blood serum TNF-α

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

    Biochemistry

  4. Change of Tissue hardness (TH)

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

    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.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 10, 2022
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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