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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Device: Fu's Subcutaneous Needling(FSN)
* Device: fine acupuncture needle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham comparator<br>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<br>* (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.<br>|
| Experimental: Experimental<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Blood serum C-reactive protein (CRP) | Biochemistry | Change from Baseline CRP at the 24th, 72nd hour, 1st month after surgery. | 
| Change of Blood serum IL-1ẞ、IL-2、IL-6 | Biochemistry | Change from Baseline IL-1ẞ、IL-2、IL-6 at the 24th, 72nd hour, 1st month after surgery. | 
| Change of Blood serum TNF-α | Biochemistry | Change from Baseline TNF-α at the 24th, 72nd hour, 1st month after surgery. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fu's Subcutaneous Needling, postoperative pain