Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants will receive routine analgesic and FSN after LSS. Researchers will compare Sham group to see if FSN being effective for postoperative pain.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chih-Ying Wu, MD | China Medical University, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hsinchu Hospital | Zhubei | Hsinchu County | 302 | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |