Post Operative Pain, AcuteNCT06197620
Effectiveness of Thread Embedding Acupuncture Analgesia at the EX-B2 Point Combined With Standard Therapy After Laparoscopic Living Donor Nephrectomy
A study testing Thread embedding acupuncture and standard therapy in people with Post Operative Pain, Acute and Renal Transplant Donor of Left Kidney, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Kidney transplantation is the main option besides hemodialysis and continuous ambulatory peritoneal dialysis (CAPD) to prolong and improve the quality of life for patients with end-stage renal disease. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Acute, Renal Transplant Donor of Left Kidney, Quality of Life
- What is being tested?
- Thread embedding acupuncture and standard therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIndonesia
- Study dates
- 20 Oct 2023to 3 Jan 2024
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects are prospective kidney donors who will undergo laparoscopic living donor nephrectomy (LLDN).
- Adult patients with an age range of 21-60 years.
- Willing to take part in this research and sign informed consent.
Who cannot join
- The patient has a history of hypersensitive reactions to thread embedding acupuncture (TEA).
- The patient has a history of keloids or is prone to keloid formation.
- The patient has skin disease at the location of the TEA installation area in the back area.
- There are abnormalities in the neurological examination of the lower extremities.
- Have a history of spinal surgery or are scheduled to undergo spinal surgery within 7 months after the LLDN procedure.
- There is scoliosis based on clinical examination.
Show all 10Show fewer
- There are other specific diagnoses that can cause secondary low back pain such as inflammatory spondylitis, spinal infection, or tumor.
- Female patients who plan to become pregnant within 7 months after the LLDN procedure.
- The patient has a body mass index (BMI) below 18 kg/m2
- The patient has uncontrolled diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: Effectiveness of Thread Embedding Acupuncture Analgesia at the EX-B2 Point at the First Lumbar Level Combined With Standard Therapy on Acute Pain and Quality of Life After Post Laparoscopic Living Donor Nephrectomy
Kidney transplantation is the main option besides hemodialysis and continuous ambulatory peritoneal dialysis (CAPD) to prolong and improve the quality of life for patients with end-stage renal disease. The main option for obtaining organs from living donors is surgical action to remove the kidney (nephrectomy) using the laparoscopic method (laparoscopic live donor nephrectomy or LLDN). Postoperative management of LDNH in the form of intravenous paracetamol 1000 mg cannot overcome innovative pain and has drug-related risk effects.
Non-pharmacological pain management is the first line of pain management. One non-pharmacological therapy that can be an option is acupuncture. Thread embedding acupuncture (TEA) is an acupuncture method that uses certain medical threads such as catgut or polydioxanone (PDO) which are inserted into subcutaneous tissue or muscle at certain acupuncture points.
The working mechanism of TEA in treating pain is through local mechanisms in the form of releasing adenosine which binds to adenosine A1 receptors, releasing substance P, inhibiting the expression and activation of Nuclear Factor Kappa B; through a segmental mechanism in the form of a control gate mechanism; through extrasegmental mechanisms in the form of downward pain inhibition pathways; through a central mechanism in the form of release of endogenous opioids in the hypothalamus. ATB can provide a continuous stimulating effect of infiltration and acceleration of tissue regeneration, increasing anti-pain.
Read the detailed description
The main outcome is to determine the effect of thread embedding acupuncture at the EX-B2 point on first lumbar on pain intensity in patients after laparoscopic living donor nephrectomy (LLDN) and to determine the effect of thread embedding acupuncture at the EX-B2 point on first lumbar on the quality of life in patients after laparoscopic living donor nephrectomy (LLDN).
The thread embedding will use Polydioxanone thread size 30G x 25,4 mm. This thread will last maximum 7 months before fully absorbed.
Pain intensity will be assessed using the VAS score 7 days before LLDN surgery (before the thread implant acupuncture procedure); and on the first, second, third, and fourteenth days after the LLDN procedure.
Quality of life scores will be measured with the Indonesian version of SF-36 questionnaire carried out seven days before LLDN surgery, on the first postoperative day, and on the fourteenth day after LLDN surgery.
The research design in this study was a case series with 6 subject only.
- Conditions
- Post Operative Pain, Acute, Renal Transplant Donor of Left Kidney, Quality of Life, Acupuncture Analgesia
- Being tested
- Thread embedding acupuncture and standard therapy
- Keywords
- Laparoscopic Living Donor Nephrectomy, Post Operative Acute Pain, Quality of Life, Thread Embedding Acupuncture
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thread embedding acupuncture and standard therapyOther
In the treatment, thread embedding acupuncture was performed using a needle containing polydioxanone (PDO) thread at the EX-B2 acupuncture point (12.5 mm lateral to the spinous process) at the level of the 1st lumbar vertebra with an insertion angle perpendicular to the skin surface. All patients are also given standard therapy after surgery in the form of intravenous Paracetamol 1000 mg, 3 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Thread Embedding Acupuncture and Standard Therapy | Experimental | The patients are pre-operative laparoscopic living donor nephrectomy patients that receive standard analgetic drug treatment according to post-operative kidney donor transplant protocol and receive thread embedding acupuncture. All patients are also given standard therapy after surgery in the form of intravenous Paracetamol 1000 mg, 3 times a day. Receives: Other: Thread embedding acupuncture and standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity with Visual Analog Scale
Visual Analog Scale (VAS) that score 0 is no pain to 100 the worse pain A higher result means worse outcomes and lower result means better outcomes
Measured: 7 days before laparoscopic living donor nephrectomy and on 1st, 2nd, 14th day after laparoscopic living donor nephrectomy procedure
Secondary outcomes (1)
Quality of Life with Short Form 36
Quality of life using Short Form 36 scoring system. It contains 8 domains such as physical function, role limitation due to physical health, role limitation due to emotional health, energy/fatigue, emotional well-being, social functioning, pain, general health. The scoring s calculated with online calculator provided by MDApp website. The result is in percentage, with higher result means better quality of life.
Measured: 7 days before laparoscopic living donor nephrectomy, and on 1st, 2nd, and 14th day after laparoscopic living donor nephrectomy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start20 Oct 2023
- Primary completion22 Dec 2023
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hartono Gunarso, Universitas Indonesia
- Investigators
- KEPK FKUI RSCM, Principal investigator, Urology, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197620
- Sponsor's protocol ID
- 23-08-1375
- Status last verified
- Jan 2024
- First submitted
- 23 Nov 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Thread Embedding Acupuncture Analgesia at the EX-B2 Point at the First Lumbar Level Combined With Standard Therapy on Acute Pain and Quality of Life After Post Laparoscopic Living Donor Nephrectomy
- ClinicalTrials.gov ID
- NCT06197620
- Acronym / sponsor ID
- 23-08-1375
- Conditions
- Post Operative Pain, Acute, Renal Transplant Donor of Left Kidney, Quality of Life, Acupuncture Analgesia
- Keywords
- Laparoscopic Living Donor Nephrectomy, Post Operative Acute Pain, Quality of Life, Thread Embedding Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 9 Jan 2024 (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.
Kidney transplantation is the main option besides hemodialysis and continuous ambulatory peritoneal dialysis (CAPD) to prolong and improve the quality of life for patients with end-stage renal disease. The main option for obtaining organs from living donors is surgical action to remove the kidney (nephrectomy) using the laparoscopic method (laparoscopic live donor nephrectomy or LLDN). Postoperative management of LDNH in the form of intravenous paracetamol 1000 mg cannot overcome innovative pain and has drug-related risk effects.
Non-pharmacological pain management is the first line of pain management. One non-pharmacological therapy that can be an option is acupuncture. Thread embedding acupuncture (TEA) is an acupuncture method that uses certain medical threads such as catgut or polydioxanone (PDO) which are inserted into subcutaneous tissue or muscle at certain acupuncture points.
The working mechanism of TEA in treating pain is through local mechanisms in the form of releasing adenosine which binds to adenosine A1 receptors, releasing substance P, inhibiting the expression and activation of Nuclear Factor Kappa B; through a segmental mechanism in the form of a control gate mechanism; through extrasegmental mechanisms in the form of downward pain inhibition pathways; through a central mechanism in the form of release of endogenous opioids in the hypothalamus. ATB can provide a continuous stimulating effect of infiltration and acceleration of tissue regeneration, increasing anti-pain.
Detailed description
The main outcome is to determine the effect of thread embedding acupuncture at the EX-B2 point on first lumbar on pain intensity in patients after laparoscopic living donor nephrectomy (LLDN) and to determine the effect of thread embedding acupuncture at the EX-B2 point on first lumbar on the quality of life in patients after laparoscopic living donor nephrectomy (LLDN).
The thread embedding will use Polydioxanone thread size 30G x 25,4 mm. This thread will last maximum 7 months before fully absorbed.
Pain intensity will be assessed using the VAS score 7 days before LLDN surgery (before the thread implant acupuncture procedure); and on the first, second, third, and fourteenth days after the LLDN procedure.
Quality of life scores will be measured with the Indonesian version of SF-36 questionnaire carried out seven days before LLDN surgery, on the first postoperative day, and on the fourteenth day after LLDN surgery.
The research design in this study was a case series with 6 subject only.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thread Embedding Acupuncture and Standard Therapy | Experimental | Other: Thread embedding acupuncture and standard therapyThe patients are pre-operative laparoscopic living donor nephrectomy patients that receive standard analgetic drug treatment according to post-operative kidney donor transplant protocol and receive thread embedding acupuncture. All patients are also given standard therapy after surgery in the form of intravenous Paracetamol 1000 mg, 3 times a day. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects are prospective kidney donors who will undergo laparoscopic living donor nephrectomy (LLDN).
- Adult patients with an age range of 21-60 years.
- Willing to take part in this research and sign informed consent.
Key exclusion criteria (10 listed)
- The patient has a history of hypersensitive reactions to thread embedding acupuncture (TEA).
- The patient has a history of keloids or is prone to keloid formation.
- The patient has skin disease at the location of the TEA installation area in the back area.
- There are abnormalities in the neurological examination of the lower extremities.
- Have a history of spinal surgery or are scheduled to undergo spinal surgery within 7 months after the LLDN procedure.
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 |
|---|---|---|
| Thread embedding acupuncture and standard therapyIn the treatment, thread embedding acupuncture was performed using a needle containing polydioxanone (PDO) thread at the EX-B2 acupuncture point (12.5 mm lateral to the spinous process) at the level of the 1st lumbar vertebra with an insertion angle perpendicular to the skin surface. All patients are also given standard therapy after surgery in the form of intravenous Paracetamol 1000 mg, 3 times a day. | Other | Thread Embedding Acupuncture and Standard Therapy |
Primary outcome
Pain severity with Visual Analog Scale
Time frame: 7 days before laparoscopic living donor nephrectomy and on 1st, 2nd, 14th day after laparoscopic living donor nephrectomy procedure
Visual Analog Scale (VAS) that score 0 is no pain to 100 the worse pain A higher result means worse outcomes and lower result means better outcomes
1 secondary outcome
Quality of Life with Short Form 36
Time frame: 7 days before laparoscopic living donor nephrectomy, and on 1st, 2nd, and 14th day after laparoscopic living donor nephrectomy procedure
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 23 Jan 2024.
- Individual participant dataSharing planned: Yes
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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.
KEPK FKUI RSCM principal investigator
Urology, University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thread embedding acupuncture and standard therapy in people with Post Operative Pain, Acute and Renal Transplant Donor of Left Kidney, run by Universitas Indonesia at 1 site in Indonesia.
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 10 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 23 Jan 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 Indonesia. 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. 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?
Pain severity with Visual Analog Scale (time frame: 7 days before laparoscopic living donor nephrectomy and on 1st, 2nd, 14th day after laparoscopic living donor nephrectomy procedure). 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 23 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.