Effect of Fu's Subcutaneous Needling on Postoperative Acute Pain in Patients With Lumbar Spine Surgery: a Single-blinded Randomized, Control Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- The total dosage of analgesic drug
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: fine acupuncture needle (Device)
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.
Intervention: Fu's Subcutaneous Needling(FSN) (Device)
Outcomes
Primary Outcomes
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)
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
Secondary Outcomes
- Change of Blood serum TNF-α(Change from Baseline TNF-α at the 24th, 72nd hour, 1st month after surgery.)
- Change of Blood serum C-reactive protein (CRP)(Change from Baseline CRP at the 24th, 72nd hour, 1st month after surgery.)
- Change of Blood serum IL-1ẞ、IL-2、IL-6(Change from Baseline IL-1ẞ、IL-2、IL-6 at the 24th, 72nd hour, 1st month after surgery.)
- Change of Tissue hardness (TH)(Change from Baseline TH at the 1st、24th、48th、72nd hour after surgery.)
Investigators
Chih-Ying Wu
Attending physician
China Medical University Hospital