NCT01879826

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

January 22, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

2.3 years

First QC Date

June 13, 2013

Results QC Date

October 24, 2016

Last Update Submit

January 13, 2020

Conditions

PainAnxiety

Keywords

AculaserMicrolight ML830Kidney biopsyPainAnxietySedation

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (1)

  • Parent Perception of Patient Pain Report

    1 day

Study Arms (2)

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.

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.

Device: Aculaser applied to kidney points

Interventions

Aculaser applied to kidney pointsDEVICE

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.

Also known as: Aculaser: Microlight ML830
Aculaser applied to kidney points
Aculaser applied to sham pointsDEVICE

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.

Also known as: Aculaser: Microlight ML830
Aculaser applied to sham points

Eligibility Criteria

Age7 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • older than 6 years old
  • admitted for a transplant or native kidney biopsy performed by pediatric nephrology

You may not qualify if:

  • Prisoners
  • Pregnant females
  • Those who are unable to participate with the visual analog scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California San Francisco Hospital

San Francisco, California, 94143, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (5)

  • 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.

    PMID: 20633458BACKGROUND

  • Schlager 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.

    PMID: 9924226RESULT

  • Gottschling 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.

    PMID: 18022318RESULT

  • Resim 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.

    PMID: 15971087RESULT

  • Oates 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.

    PMID: 27749608DERIVED

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Results Point of Contact

Title
Cynthia Kim
Organization
University of California San Francisco
cynthia.kim@ucsf.edu
(415)353-1328

Study Officials

  • Cynthia Kim, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 18, 2013

Study Start

July 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 22, 2020

Results First Posted

January 22, 2020

Record last verified: 2020-01

Locations

US(2)