Pain, Postoperative Clinical Trial
Official title:
Effect of Fu's Subcutaneous Needling on Postoperative Acute Pain in Patients With Lumbar Spine Surgery: a Single-blinded Randomized, Control Study
Verified date | February 2024 |
Source | China Medical University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | June 25, 2023 |
Est. primary completion date | February 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | China Medical University Hsinchu Hospital | Zhubei | Hsinchu County |
Lead Sponsor | Collaborator |
---|---|
China Medical University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | Change of Blood serum C-reactive protein (CRP) | Biochemistry | Change from Baseline CRP at the 24th, 72nd hour, 1st month after surgery. | |
Secondary | Change of Blood serum IL-1??IL-2?IL-6 | Biochemistry | Change from Baseline IL-1??IL-2?IL-6 at the 24th, 72nd hour, 1st month after surgery. | |
Secondary | Change of Blood serum TNF-a | Biochemistry | Change from Baseline TNF-a at the 24th, 72nd hour, 1st month after surgery. | |
Secondary | 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. |
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