PainNCT01879826
Pediatric Laser Acupuncture and Renal Biopsy
A study testing Aculaser applied to kidney points in people with Pain and Anxiety, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The purpose of this study is to test if treatment with laser therapy in pediatric patients undergoing renal biopsies will improve patient satisfaction of the overall procedure. In this study, the participant will receive a laser acupuncture treatment targeting either kidney acupoints or targeting "sham" points not… Read more about this study
- Who is it for?
- Ages 7 to 25 years
- What is being tested?
- Aculaser applied to kidney points
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- older than 6 years old
- admitted for a transplant or native kidney biopsy performed by pediatric nephrology
Who cannot join
- Prisoners
- Pregnant females
- Those who are unable to participate with the visual analog scale
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California San Francisco Hospital
San Francisco, California, 94143
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Efficacy of Laser Therapy as an Adjuvant Treatment During Kidney Biopsies to Decrease Anxiety and Pain.
The purpose of this study is to test if treatment with laser therapy in pediatric patients undergoing renal biopsies will improve patient satisfaction of the overall procedure. In this study, the participant will receive a laser acupuncture treatment targeting either kidney acupoints or targeting "sham" points not associated with the kidney; the participant will not get both. Both treatment sessions are given by a certified medical acupuncturist. The patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure. All medication will be administered without regard for which group the participant has been randomized, as the treatment team will also be blinded.
Hypothesis:
Read more
We will test the hypothesis that treatment with laser acupuncture in patients undergoing renal biopsies will improve patient satisfaction of the overall procedure.
Specific Aims:
Specific Aim 1: Determine whether the use of laser acupuncture improves patient's overall satisfaction of renal biopsy.
Specific Aim 2: Determine whether the use of laser acupuncture decreases the amount of sedative medication given during renal biopsy.
Read the detailed description
At University of California San Francisco, there are approximately 100 pediatric renal biopsies per year. All of these patients receive sedation, which is prescribed and supervised by the pediatric pain and palliative care team, with either ketamine or fentanyl and versed. Child life is involved; however, many children still experience anxiety and/or pain with the procedure. Use of a modality such as aculaser which may decrease these symptoms could enhance their experience.
The term "laser" stands for light amplification by stimulated emission of radiation. In laser acupuncture, a low power, cold light produced by a low-level laser diode is used to stimulate an acupuncture point. As it is non-invasive, laser acupuncture is thought to be safer than needle acupuncture, especially in the setting of patients with blood-borne infectious diseases. In a systematic review analyzing the evidence to support the effectiveness of laser acupuncture, randomized control trials in which adults with soft tissue injury, acute or chronic pain condition, or any systemic illness were included. This review reports moderate level of evidence for treatment of myofascial pain and post-operative nausea/vomiting and limited evidence of the clinical effectiveness of treating chronic tension headaches. Of note, no complications of the use of aculaser were reported in this review (1).
- Baxter GD, Bleakley C, McDonough S. Clinical effectiveness of laser acupuncture: a systematic review. J Acupunct Meridian Stud. 2008 Dec;1(2):65-82.
- Being tested
- Aculaser applied to kidney points, Aculaser applied to sham points
- Keywords
- Aculaser, Microlight ML830, Kidney biopsy, Pain, Anxiety, Sedation
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aculaser applied to kidney pointsDevice
Also called Aculaser: Microlight ML830
The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.
Aculaser applied to sham pointsDevice
Also called Aculaser: Microlight ML830
The patient will receive aculaser, performed by licensed acupuncturist, to "sham" acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Aculaser applied to sham points | Sham comparator | The patient will receive aculaser, performed by licensed acupuncturist, to "sham" acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure. Receives: Device: Aculaser applied to sham points |
| Aculaser applied to kidney points | Experimental | The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure. Receives: Device: Aculaser applied to kidney points |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Pain/Anxiety
The patient will complete a visual analog scale (rate 0-10) to assess pain after the procedure. Zero is no pain and 10 is worse pain. Change was calculated by baseline minus day one.
Measured: 1 day
Secondary outcomes (1)
Parent Perception of Patient Pain Report
Parent Perception of Patient Pain, scale is from 0 to 10, minimum value is 0, maximum value is 10, higher scores mean better outcome.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Kim, University of California, San Francisco
- Investigators
- Cynthia Kim, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879826
- Sponsor's protocol ID
- Laser
- Status last verified
- Jan 2020
- First submitted
- 13 Jun 2013
- Last updated
- 22 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Baxter GD, Bleakley C, McDonough S. Clinical effectiveness of laser acupuncture: a systematic review. J Acupunct Meridian Stud. 2008 Dec;1(2):65-82. doi: 10.1016/S2005-2901(09)60026-1.
PubMed 20633458Schlager A, Offer T, Baldissera I. Laser stimulation of acupuncture point P6 reduces postoperative vomiting in children undergoing strabismus surgery. Br J Anaesth. 1998 Oct;81(4):529-32. doi: 10.1093/bja/81.4.529.
PubMed 9924226Gottschling S, Meyer S, Gribova I, Distler L, Berrang J, Gortner L, Graf N, Shamdeen GM. Laser acupuncture in children with headache: a double-blind, randomized, bicenter, placebo-controlled trial. Pain. 2008 Jul 15;137(2):405-412. doi: 10.1016/j.pain.2007.10.004. Epub 2007 Nov 19.
PubMed 18022318Resim S, Gumusalan Y, Ekerbicer HC, Sahin MA, Sahinkanat T. Effectiveness of electro-acupuncture compared to sedo-analgesics in relieving pain during shockwave lithotripsy. Urol Res. 2005 Aug;33(4):285-90. doi: 10.1007/s00240-005-0473-7. Epub 2005 Jun 22.
PubMed 15971087Oates A, Benedict KA, Sun K, Brakeman PR, Lim J, Kim C. Laser acupuncture reduces pain in pediatric kidney biopsies: a randomized controlled trial. Pain. 2017 Jan;158(1):103-109. doi: 10.1097/j.pain.0000000000000734.
PubMed 27749608
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Laser Therapy as an Adjuvant Treatment During Kidney Biopsies to Decrease Anxiety and Pain.
- ClinicalTrials.gov ID
- NCT01879826
- Acronym / sponsor ID
- Laser
- Keywords
- Aculaser, Microlight ML830, Kidney biopsy, Pain, Anxiety, Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test if treatment with laser therapy in pediatric patients undergoing renal biopsies will improve patient satisfaction of the overall procedure. In this study, the participant will receive a laser acupuncture treatment targeting either kidney acupoints or targeting "sham" points not associated with the kidney; the participant will not get both. Both treatment sessions are given by a certified medical acupuncturist. The patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure. All medication will be administered without regard for which group the participant has been randomized, as the treatment team will also be blinded.
Hypothesis:
We will test the hypothesis that treatment with laser acupuncture in patients undergoing renal biopsies will improve patient satisfaction of the overall procedure.
Specific Aims:
Specific Aim 1: Determine whether the use of laser acupuncture improves patient's overall satisfaction of renal biopsy.
Specific Aim 2: Determine whether the use of laser acupuncture decreases the amount of sedative medication given during renal biopsy.
Detailed description
At University of California San Francisco, there are approximately 100 pediatric renal biopsies per year. All of these patients receive sedation, which is prescribed and supervised by the pediatric pain and palliative care team, with either ketamine or fentanyl and versed. Child life is involved; however, many children still experience anxiety and/or pain with the procedure. Use of a modality such as aculaser which may decrease these symptoms could enhance their experience.
The term "laser" stands for light amplification by stimulated emission of radiation. In laser acupuncture, a low power, cold light produced by a low-level laser diode is used to stimulate an acupuncture point. As it is non-invasive, laser acupuncture is thought to be safer than needle acupuncture, especially in the setting of patients with blood-borne infectious diseases. In a systematic review analyzing the evidence to support the effectiveness of laser acupuncture, randomized control trials in which adults with soft tissue injury, acute or chronic pain condition, or any systemic illness were included. This review reports moderate level of evidence for treatment of myofascial pain and post-operative nausea/vomiting and limited evidence of the clinical effectiveness of treating chronic tension headaches. Of note, no complications of the use of aculaser were reported in this review (1).
- Baxter GD, Bleakley C, McDonough S. Clinical effectiveness of laser acupuncture: a systematic review. J Acupunct Meridian Stud. 2008 Dec;1(2):65-82.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aculaser applied to sham points | Sham comparator | Device: Aculaser applied to sham pointsThe patient will receive aculaser, performed by licensed acupuncturist, to "sham" acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure. |
| Aculaser applied to kidney points | Experimental | Device: Aculaser applied to kidney pointsThe patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure. |
Who may qualify
- Ages
- 7 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- older than 6 years old
- admitted for a transplant or native kidney biopsy performed by pediatric nephrology
Key exclusion criteria (3 listed)
- Prisoners
- Pregnant females
- Those who are unable to participate with the visual analog scale
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 |
|---|---|---|
| Aculaser applied to kidney pointsAlso: Aculaser: Microlight ML830The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure. | Device | Aculaser applied to kidney points |
| Aculaser applied to sham pointsAlso: Aculaser: Microlight ML830The patient will receive aculaser, performed by licensed acupuncturist, to "sham" acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure. | Device | Aculaser applied to sham points |
Primary outcome
Patient Pain/Anxiety
Time frame: 1 day
The patient will complete a visual analog scale (rate 0-10) to assess pain after the procedure. Zero is no pain and 10 is worse pain. Change was calculated by baseline minus day one.
1 secondary outcome
Parent Perception of Patient Pain Report
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20633458Baxter GD, Bleakley C, McDonough S. Clinical effectiveness of laser acupuncture: a systematic review. J Acupunct Meridian Stud. 2008 Dec;1(2):65-82. doi: 10.1016/S2005-2901(09)60026-1.
- Results publication: PubMed 9924226Schlager A, Offer T, Baldissera I. Laser stimulation of acupuncture point P6 reduces postoperative vomiting in children undergoing strabismus surgery. Br J Anaesth. 1998 Oct;81(4):529-32. doi: 10.1093/bja/81.4.529.
- Results publication: PubMed 18022318Gottschling S, Meyer S, Gribova I, Distler L, Berrang J, Gortner L, Graf N, Shamdeen GM. Laser acupuncture in children with headache: a double-blind, randomized, bicenter, placebo-controlled trial. Pain. 2008 Jul 15;137(2):405-412. doi: 10.1016/j.pain.2007.10.004. Epub 2007 Nov 19.
- Results publication: PubMed 15971087Resim S, Gumusalan Y, Ekerbicer HC, Sahin MA, Sahinkanat T. Effectiveness of electro-acupuncture compared to sedo-analgesics in relieving pain during shockwave lithotripsy. Urol Res. 2005 Aug;33(4):285-90. doi: 10.1007/s00240-005-0473-7. Epub 2005 Jun 22.
- Derived from this study: PubMed 27749608Oates A, Benedict KA, Sun K, Brakeman PR, Lim J, Kim C. Laser acupuncture reduces pain in pediatric kidney biopsies: a randomized controlled trial. Pain. 2017 Jan;158(1):103-109. doi: 10.1097/j.pain.0000000000000734.
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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.
Cynthia Kim, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aculaser applied to kidney points in people with Pain and Anxiety, run by University of California, San Francisco at 2 sites in United States.
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 2 inclusion and 3 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 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 22 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Pain/Anxiety (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01879826, which also lists 5 linked publications.
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 22 Jan 2020.