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

Browse trials for

• Pain, Postoperative 5,093
• Acute Pain 876

Keywords

• Fu's Subcutaneous Needling, postoperative pain

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 49 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Lead sponsor

China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Study arms

• 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

• DeviceFu'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.

• Devicefine 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.

Primary outcomes

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

   BPI-T Short Form

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

2. The total dosage of analgesic drug

   opioid drug (Pethidine 50mg/vail)

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

Secondary outcomes

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

   Biochemistry

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

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

   Biochemistry

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

3. Change of Blood serum TNF-α

   Biochemistry

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

4. 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.

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

Individual participant data

Plan to share: No