Anterior Cruciate Ligament (ACL) TearNCT02947633
Sciatic Technique Comparison of Nerve Blockade for Pain Control Following Hamstring Autograft Harvest in Adolescents
A study testing Single-injection sciatic PNB and Continuous sciatic PNB in people with Anterior Cruciate Ligament (ACL) Tear, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this research is to compare the effect of single-injection sciatic PNB to continuous sciatic PNB on 1) postoperative pain control as measured by self-reported pain scores, pain medication use, and unplanned hospital admission due to poor pain control, 2) active knee flexion, and 3) patient satisfaction… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Tear
- What is being tested?
- Single-injection sciatic PNB and Continuous sciatic PNB
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Apr 2024
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- A subject may be INCLUDED in this study if:
- The subject is male or female;
- The subject is of any racial or ethnic group;
- The subject is age 10 years to 18 years (inclusive);
- The subject is scheduled for the following: Unilateral ACL reconstruction with a hamstring autograft under general anesthesia on an outpatient basis, and not being performed in conjunction with any other surgical procedures;
- The subject is American Society of Anesthesiologists (ASA) patient classification I-II;
- The subject or legally authorized representative has consented to femoral and sciatic peripheral nerve blockade for the procedure and the consent for peripheral nerve blockade has been obtained by a clinician (MD, DO, CRNA or APN) authorized to obtain consent;
- The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.
Who cannot join
- A subject will be EXCLUDED from this study if:
- Additional surgical procedures are being performed concurrently;
- The subject is ASA classification > II;
- The subject has pre-existing allergies to amide local anesthetics;
- The subject receives sedation preoperatively;
- The subject is schedule for overnight hospital admission;
- The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study, including but not limited to coagulopathy, preexisting central or peripheral nervous systems disorders, and local infection or sores at the anticipated site of needle insertion;
- Unsuccessful PNB or CPI catheter placement occurs during the study. -
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Sciatic Peripheral Nerve Blockade for Pain Control Following Hamstring Autograft Harvest in Adolescents: A Comparison of Two Techniques
The purpose of this research is to compare the effect of single-injection sciatic PNB to continuous sciatic PNB on 1) postoperative pain control as measured by self-reported pain scores, pain medication use, and unplanned hospital admission due to poor pain control, 2) active knee flexion, and 3) patient satisfaction with pain control following ACL reconstruction with a hamstring autograft. The results of this research have the potential to positively impact pain control for the adolescent population undergoing this surgical procedure and foster responsible utilization of limited resources.
Read the detailed description
SPECIFIC AIM 1. The first aim of the study is to explore the impact of sciatic PNB technique on hamstring donor site pain control postoperatively.
H1.a. The extended duration of analgesia offered by continuous sciatic PNB decreases pain scores during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.
H1.b. The extended duration of analgesia offered by continuous sciatic PNB decreases oral pain medication use during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.
H1.c. The extended duration of analgesia offered by continuous sciatic PNB decreases the incidence of unplanned admission due to poor pain control during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.
SPECIFIC AIM 2. The second aim of the study is to explore the impact of sciatic PNB technique on active knee flexion postoperatively.
H2. The extended duration of analgesia offered by continuous sciatic PNB does not delay active knee flexion during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.
SPECIFIC AIM 3. The third aim of the study is to explore the impact of sciatic PNB technique on patient satisfaction with postoperative pain control.
H3.1. The extended duration of analgesia offered by continuous sciatic PNB improves patient satisfaction during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.
- Conditions
- Anterior Cruciate Ligament (ACL) Tear
- Being tested
- Single-injection sciatic PNB, Continuous sciatic PNB
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-injection sciatic PNBDrug
Single-injection sciatic PNB is a regional anesthetic technique employed to anesthetize the sciatic nerve with a single dose of local anesthetic. This technique offers pain control for a limited amount of time based on the volume and concentration of local anesthetic used.
Continuous sciatic PNBDrug
Continuous sciatic PNB entails placing a continuous perineural infusion (CPI) catheter so that local anesthetic may be released slowly but continuously adjacent to the sciatic nerve (perineural) for several days postoperatively. The continuous PNB has the ability to reliably provide analgesia on subsequent postoperative days.
Participants my be randomized to receive an additional experimental continuous pain ball during surgery which can provide up to 48 hours of pain relief.
| Study group | Role | What they receive |
|---|---|---|
| Continuous sciatic PNB | Experimental | If a CPI catheter is placed, the CPI catheter will be placed under ultra-sound guidance, with the tip of the catheter being placed immediately adjacent to the sciatic nerve, after the local anesthesia has been deposited. CPI catheters will only remain in-situ for 48 hours. Receives: Drug: Continuous sciatic PNB |
| Single-injection sciatic PNB | Active comparator | Under ultrasound-guidance, the sciatic nerve can readily be identified in the posterior thigh. The nerve appears hyperechoic and can be traced distally to the popliteal fossa, where it divides into the tibial and common peroneal nerves. Local anesthesia is injected under real-time visualization following a negative aspiration. If a single-injection block is done, local anesthesia is deposited adjacent to the sciatic nerve within the fascial plane, but not within the epineurium. As such, single-injection sciatic PNB, which can last up to 24 hours, should provide adequate analgesia precluding the need for oral narcotic or nonsteroidal anti-inflammatory medications following ACL reconstruction with a hamstring autograft. Receives: Drug: Single-injection sciatic PNB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction
Guardian collects Numeric Rating Scale (NRS) pain score. The range is 0 - 10. 0 being no pain, 10 being the worst pain imaginable.
Measured: 72 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startMar 2015
- Primary completionApr 2024
- Study completionApr 2024
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 (17)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament (ACL) TearStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie Furstein, CRNA, Principal investigator, AANA Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947633
- Sponsor's protocol ID
- 2014-6533
- Status last verified
- Apr 2026
- First submitted
- 11 Nov 2015
- Last updated
- 22 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Agin CW, Glass PSA. Tolerance and aging: optimizing analgesia in pain management. Anesth Analg. 2005 Jun;100(6):1731-1732. doi: 10.1213/01.ANE.0000152203.17541.16. No abstract available.
PubMed 15920205Beales JG, Holt PJ, Keen JH, Mellor VP. Children with juvenile chronic arthritis: their beliefs about their illness and therapy. Ann Rheum Dis. 1983 Oct;42(5):481-6. doi: 10.1136/ard.42.5.481.
PubMed 6625698Bushnell BD, Sakryd G, Noonan TJ. Hamstring donor-site block: evaluation of pain control after anterior cruciate ligament reconstruction. Arthroscopy. 2010 Jul;26(7):894-900. doi: 10.1016/j.arthro.2009.11.022. Epub 2010 May 13.
PubMed 20620788Distad BJ, Weiss MD. Clinical and electrodiagnostic features of sciatic neuropathies. Phys Med Rehabil Clin N Am. 2013 Feb;24(1):107-20. doi: 10.1016/j.pmr.2012.08.023. Epub 2012 Oct 31.
PubMed 23177034Frost S, Grossfeld S, Kirkley A, Litchfield B, Fowler P, Amendola A. The efficacy of femoral nerve block in pain reduction for outpatient hamstring anterior cruciate ligament reconstruction: a double-blind, prospective, randomized trial. Arthroscopy. 2000 Apr;16(3):243-8. doi: 10.1016/s0749-8063(00)90047-1.
PubMed 10750003Gagnier JJ, Morgenstern H, Chess L. Interventions designed to prevent anterior cruciate ligament injuries in adolescents and adults: a systematic review and meta-analysis. Am J Sports Med. 2013 Aug;41(8):1952-62. doi: 10.1177/0363546512458227. Epub 2012 Sep 12.
PubMed 22972854Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686Mathews L. Pain in children: neglected, unaddressed and mismanaged. Indian J Palliat Care. 2011 Jan;17(Suppl):S70-3. doi: 10.4103/0973-1075.76247.
PubMed 21811376Mehta VM, Mandala C, Foster D, Petsche TS. Comparison of revision rates in bone-patella tendon-bone autograft and allograft anterior cruciate ligament reconstruction. Orthopedics. 2010 Jan;33(1):12. doi: 10.3928/01477447-20091124-15.
PubMed 20055340Pallis M, Svoboda SJ, Cameron KL, Owens BD. Survival comparison of allograft and autograft anterior cruciate ligament reconstruction at the United States Military Academy. Am J Sports Med. 2012 Jun;40(6):1242-6. doi: 10.1177/0363546512443945. Epub 2012 Apr 24.
PubMed 22534281Pinczewski LA, Lyman J, Salmon LJ, Russell VJ, Roe J, Linklater J. A 10-year comparison of anterior cruciate ligament reconstructions with hamstring tendon and patellar tendon autograft: a controlled, prospective trial. Am J Sports Med. 2007 Apr;35(4):564-74. doi: 10.1177/0363546506296042. Epub 2007 Jan 29.
PubMed 17261567Shaw T, Williams MT, Chipchase LS. Do early quadriceps exercises affect the outcome of ACL reconstruction? A randomised controlled trial. Aust J Physiother. 2005;51(1):9-17. doi: 10.1016/s0004-9514(05)70048-9.
PubMed 15748120Silvers HJ, Mandelbaum BR. Prevention of anterior cruciate ligament injury in the female athlete. Br J Sports Med. 2007 Aug;41 Suppl 1(Suppl 1):i52-9. doi: 10.1136/bjsm.2007.037200. Epub 2007 Jul 3.
PubMed 17609222Tran KM, Ganley TJ, Wells L, Ganesh A, Minger KI, Cucchiaro G. Intraarticular bupivacaine-clonidine-morphine versus femoral-sciatic nerve block in pediatric patients undergoing anterior cruciate ligament reconstruction. Anesth Analg. 2005 Nov;101(5):1304-1310. doi: 10.1213/01.ANE.0000180218.54037.0B.
PubMed 16243985Twycross A. Educating nurses about pain management: the way forward. J Clin Nurs. 2002 Nov;11(6):705-14. doi: 10.1046/j.1365-2702.2002.00677.x.
PubMed 12427174
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sciatic Peripheral Nerve Blockade for Pain Control Following Hamstring Autograft Harvest in Adolescents: A Comparison of Two Techniques
- ClinicalTrials.gov ID
- NCT02947633
- Acronym / sponsor ID
- 2014-6533
- Conditions
- Anterior Cruciate Ligament (ACL) Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Apr 2024 (actual)
- Study completion
- Apr 2024 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Posted 22 Apr 2026
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 research is to compare the effect of single-injection sciatic PNB to continuous sciatic PNB on 1) postoperative pain control as measured by self-reported pain scores, pain medication use, and unplanned hospital admission due to poor pain control, 2) active knee flexion, and 3) patient satisfaction with pain control following ACL reconstruction with a hamstring autograft. The results of this research have the potential to positively impact pain control for the adolescent population undergoing this surgical procedure and foster responsible utilization of limited resources.
Detailed description
SPECIFIC AIM 1. The first aim of the study is to explore the impact of sciatic PNB technique on hamstring donor site pain control postoperatively.
H1.a. The extended duration of analgesia offered by continuous sciatic PNB decreases pain scores during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.
H1.b. The extended duration of analgesia offered by continuous sciatic PNB decreases oral pain medication use during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.
H1.c. The extended duration of analgesia offered by continuous sciatic PNB decreases the incidence of unplanned admission due to poor pain control during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.
SPECIFIC AIM 2. The second aim of the study is to explore the impact of sciatic PNB technique on active knee flexion postoperatively.
H2. The extended duration of analgesia offered by continuous sciatic PNB does not delay active knee flexion during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.
SPECIFIC AIM 3. The third aim of the study is to explore the impact of sciatic PNB technique on patient satisfaction with postoperative pain control.
H3.1. The extended duration of analgesia offered by continuous sciatic PNB improves patient satisfaction during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous sciatic PNB | Experimental | Drug: Continuous sciatic PNBIf a CPI catheter is placed, the CPI catheter will be placed under ultra-sound guidance, with the tip of the catheter being placed immediately adjacent to the sciatic nerve, after the local anesthesia has been deposited. CPI catheters will only remain in-situ for 48 hours. |
| Single-injection sciatic PNB | Active comparator | Drug: Single-injection sciatic PNBUnder ultrasound-guidance, the sciatic nerve can readily be identified in the posterior thigh. The nerve appears hyperechoic and can be traced distally to the popliteal fossa, where it divides into the tibial and common peroneal nerves. Local anesthesia is injected under real-time visualization following a negative aspiration. If a single-injection block is done, local anesthesia is deposited adjacent to the sciatic nerve within the fascial plane, but not within the epineurium. As such, single-injection sciatic PNB, which can last up to 24 hours, should provide adequate analgesia precluding the need for oral narcotic or nonsteroidal anti-inflammatory medications following ACL reconstruction with a hamstring autograft. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- The subject is male or female;
- The subject is of any racial or ethnic group;
- The subject is age 10 years to 18 years (inclusive);
- The subject is scheduled for the following: Unilateral ACL reconstruction with a hamstring autograft under general anesthesia on an outpatient basis, and not being performed in conjunction with any other surgical procedures;
- The subject is American Society of Anesthesiologists (ASA) patient classification I-II;
Key exclusion criteria (8 listed)
- Additional surgical procedures are being performed concurrently;
- The subject is ASA classification > II;
- The subject has pre-existing allergies to amide local anesthetics;
- The subject receives sedation preoperatively;
- The subject is schedule for overnight hospital admission;
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 |
|---|---|---|
| Single-injection sciatic PNBSingle-injection sciatic PNB is a regional anesthetic technique employed to anesthetize the sciatic nerve with a single dose of local anesthetic. This technique offers pain control for a limited amount of time based on the volume and concentration of local anesthetic used. | Drug | Single-injection sciatic PNB |
| Continuous sciatic PNBContinuous sciatic PNB entails placing a continuous perineural infusion (CPI) catheter so that local anesthetic may be released slowly but continuously adjacent to the sciatic nerve (perineural) for several days postoperatively. The continuous PNB has the ability to reliably provide analgesia on subsequent postoperative days. Participants my be randomized to receive an additional experimental continuous pain ball during surgery which can provide up to 48 hours of pain relief. | Drug | Continuous sciatic PNB |
Primary outcome
Pain Reduction
Time frame: 72 Hours
Guardian collects Numeric Rating Scale (NRS) pain score. The range is 0 - 10. 0 being no pain, 10 being the worst pain imaginable.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15920205Agin CW, Glass PSA. Tolerance and aging: optimizing analgesia in pain management. Anesth Analg. 2005 Jun;100(6):1731-1732. doi: 10.1213/01.ANE.0000152203.17541.16. No abstract available.
- Background: PubMed 6625698Beales JG, Holt PJ, Keen JH, Mellor VP. Children with juvenile chronic arthritis: their beliefs about their illness and therapy. Ann Rheum Dis. 1983 Oct;42(5):481-6. doi: 10.1136/ard.42.5.481.
- Background: PubMed 20620788Bushnell BD, Sakryd G, Noonan TJ. Hamstring donor-site block: evaluation of pain control after anterior cruciate ligament reconstruction. Arthroscopy. 2010 Jul;26(7):894-900. doi: 10.1016/j.arthro.2009.11.022. Epub 2010 May 13.
- Background: PubMed 23177034Distad BJ, Weiss MD. Clinical and electrodiagnostic features of sciatic neuropathies. Phys Med Rehabil Clin N Am. 2013 Feb;24(1):107-20. doi: 10.1016/j.pmr.2012.08.023. Epub 2012 Oct 31.
- Background: PubMed 10750003Frost S, Grossfeld S, Kirkley A, Litchfield B, Fowler P, Amendola A. The efficacy of femoral nerve block in pain reduction for outpatient hamstring anterior cruciate ligament reconstruction: a double-blind, prospective, randomized trial. Arthroscopy. 2000 Apr;16(3):243-8. doi: 10.1016/s0749-8063(00)90047-1.
- Background: PubMed 22972854Gagnier JJ, Morgenstern H, Chess L. Interventions designed to prevent anterior cruciate ligament injuries in adolescents and adults: a systematic review and meta-analysis. Am J Sports Med. 2013 Aug;41(8):1952-62. doi: 10.1177/0363546512458227. Epub 2012 Sep 12.
- Background: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Background: PubMed 21811376Mathews L. Pain in children: neglected, unaddressed and mismanaged. Indian J Palliat Care. 2011 Jan;17(Suppl):S70-3. doi: 10.4103/0973-1075.76247.
- Background: PubMed 20055340Mehta VM, Mandala C, Foster D, Petsche TS. Comparison of revision rates in bone-patella tendon-bone autograft and allograft anterior cruciate ligament reconstruction. Orthopedics. 2010 Jan;33(1):12. doi: 10.3928/01477447-20091124-15.
- Background: PubMed 22534281Pallis M, Svoboda SJ, Cameron KL, Owens BD. Survival comparison of allograft and autograft anterior cruciate ligament reconstruction at the United States Military Academy. Am J Sports Med. 2012 Jun;40(6):1242-6. doi: 10.1177/0363546512443945. Epub 2012 Apr 24.
- Background: PubMed 17261567Pinczewski LA, Lyman J, Salmon LJ, Russell VJ, Roe J, Linklater J. A 10-year comparison of anterior cruciate ligament reconstructions with hamstring tendon and patellar tendon autograft: a controlled, prospective trial. Am J Sports Med. 2007 Apr;35(4):564-74. doi: 10.1177/0363546506296042. Epub 2007 Jan 29.
- Background: PubMed 15748120Shaw T, Williams MT, Chipchase LS. Do early quadriceps exercises affect the outcome of ACL reconstruction? A randomised controlled trial. Aust J Physiother. 2005;51(1):9-17. doi: 10.1016/s0004-9514(05)70048-9.
- Individual participant dataSharing planned: Undecided
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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.
Jamie Furstein, CRNA principal investigator
AANA Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-injection sciatic PNB and Continuous sciatic PNB in people with Anterior Cruciate Ligament (ACL) Tear, run by Children's Hospital Medical Center, Cincinnati at 1 site 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 8 inclusion and 8 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 Apr 2026. 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 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. 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 Apr 2026). 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?
Pain Reduction (time frame: 72 Hours). 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 NCT02947633, which also lists 17 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 Apr 2026.