Pain, PostoperativeNCT05572931
Effect of Fu's Subcutaneous Needling on Postoperative Acute Pain in Patients With Lumbar Spine Surgery.
A study testing Fu's Subcutaneous Needling(FSN) and fine acupuncture needle in people with Pain, Postoperative, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Fu's Subcutaneous Needling(FSN) and fine acupuncture needle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Mar 2021to 25 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
China Medical University Hsinchu Hospital
Zhubei, Hsinchu County, 302
About this study
Official title: Effect of Fu's Subcutaneous Needling on Postoperative Acute Pain in Patients With Lumbar Spine Surgery: a Single-blinded Randomized, Control Study
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.
- Conditions
- Pain, Postoperative
- Being tested
- Fu's Subcutaneous Needling(FSN), fine acupuncture needle
- Keywords
- Fu's Subcutaneous Needling, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
fine acupuncture needleDevice
(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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Fu's Subcutaneous Needling(FSN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Taiwanese version of the Brief Pain Inventory (BPI-T) Short Form
BPI-T Short Form
Measured: 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)
Measured: The amount of intravenous opioid drug (Pethidine 50mg/vail) within 72 hours after surgery.
Secondary outcomes (4)
Change of Blood serum C-reactive protein (CRP)
Biochemistry
Measured: Change from Baseline CRP at the 24th, 72nd hour, 1st month after surgery.
Change of Blood serum IL-1ẞ、IL-2、IL-6
Biochemistry
Measured: 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
Measured: 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.
Measured: Change from Baseline TH at the 1st、24th、48th、72nd hour after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start8 Mar 2021
- Primary completion1 Feb 2023
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Ying Wu, China Medical University Hospital
- Investigators
- Chih-Ying Wu, MD, Study chair, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572931
- Sponsor's protocol ID
- CMUH109-REC2-116
- Status last verified
- Feb 2024
- First submitted
- 2 Oct 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fu's Subcutaneous Needling on Postoperative Acute Pain in Patients With Lumbar Spine Surgery: a Single-blinded Randomized, Control Study
- ClinicalTrials.gov ID
- NCT05572931
- Acronym / sponsor ID
- CMUH109-REC2-116
- Conditions
- Pain, Postoperative
- Keywords
- Fu's Subcutaneous Needling, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham comparator | Sham comparator | Device: fine acupuncture needleIn 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 | Device: Fu's Subcutaneous Needling(FSN)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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fu'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. | Device | Experimental |
| fine 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. | Device | Sham comparator |
Primary outcome
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
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)
4 secondary outcomes
Change of Blood serum C-reactive protein (CRP)
Time frame: Change from Baseline CRP at the 24th, 72nd hour, 1st month after surgery.
Change of Blood serum IL-1ẞ、IL-2、IL-6
Time frame: Change from Baseline IL-1ẞ、IL-2、IL-6 at the 24th, 72nd hour, 1st month after surgery.
Change of Blood serum TNF-α
Time frame: Change from Baseline TNF-α at the 24th, 72nd hour, 1st month after surgery.
Change of Tissue hardness (TH)
Time frame: Change from Baseline TH at the 1st、24th、48th、72nd hour after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih-Ying Wu, MD study chair
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fu's Subcutaneous Needling(FSN) and fine acupuncture needle in people with Pain, Postoperative, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.