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Eine Studie entspricht den Filterkriterien
Kartenansicht
Accessible Acupuncture for the Warrior With Acute Low Back Pain
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT04236908 ist eine interventionsstudie zur Untersuchung von Akupunktur, Kreuzschmerzen und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 25. August 2020 und soll 276 Teilnehmer aufnehmen. Durchgeführt von David Moss ist der Abschluss für 1. Dezember 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 6. Mai 2025 aktualisiert.
Kurzbeschreibung
The objective of this study is to determine if auricular acupuncture and/or the acupuncture point governor vessel 26 (GV26) with manual tonification is superior to conservative management (NSAIDs) at reducing acute low back pain (less than 4 weeks in duration).
Ausführliche Beschreibung
The study will be a randomized control trial of Active Duty and DoD Beneficiaries aged 18 years or older with complaints of acute lower back pain (four weeks or less in duration). Subjects will be randomized into one of four study groups receiving either 1) NSAIDs only (naproxen 500mg by mouth twice a day as needed) or 2) acupuncture to include use of GV 26 with manual tonification (twisting or rotating the needle) plus NSAIDs (naproxen 500mg by mouth twice a day as needed) or 3) Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men) plus NSAIDs (naproxen 500mg by mouth twice a day as needed) or 4) GV26 with manual tonification + Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men) plus NSAIDs (naproxen 500mg by mouth twice a day as needed). We seek to determine if acupuncture is superior to conservative management alone in treating acute low back pain (4 weeks or less in duration).
Offizieller Titel
Accessible Acupuncture for the Warrior With Acute Low Back Pain
Erkrankungen
AkupunkturKreuzschmerzenPublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:- Armed Forces Health Surveillance Branch. Absolute and relative morbidity burdens attributable to various illnesses and injuries, active component, U.S. Armed Forces, 2015. MSMR. 2016 Apr;23(4):2-7. No abstract available.
- Armed Forces Health Surveillance Branch. Absolute and relative morbidity burdens attributable to various illnesses and injuries, active component, U.S. Armed Forces, 2016. MSMR. 2017 Apr;24(4):2-8. No abstract available.
- Clark LL, Hu Z. Diagnoses of low back pain, active component, U.S. Armed Forces, 2010-2014. MSMR. 2015 Dec;22(12):8-11.
- Armed Forces Health Surveillance Center (AFHSC). Medical evacuations from Afghanistan during Operation Enduring Freedom, active and reserve components, U.S. Armed Forces, 7 October 2001-31 December 2012. MSMR. 2013 Jun;20(6):2-8.
- Cohen SP, Nguyen C, Kapoor SG, Anderson-Barnes VC, Foster L, Shields C, McLean B, Wichman T, Plunkett A. Back pain during war: an analysis of factors affecting outcome. Arch Intern Med. 2009 Nov 9;169(20):1916-23. doi: 10.1001/archinternmed.2009.380.
- Ruscio BA, Jones BH, Bullock SH, Burnham BR, Canham-Chervak M, Rennix CP, Wells TS, Smith JW. A process to identify military injury prevention priorities based on injury type and limited duty days. Am J Prev Med. 2010 Jan;38(1 Suppl):S19-33. doi: 10.1016/j.amepre.2009.10.004.
- Liu YT, Chiu CW, Chang CF, Lee TC, Chen CY, Chang SC, Lee CY, Lo LC. Efficacy and Safety of Acupuncture for Acute Low Back Pain in Emergency Department: A Pilot Cohort Study. Evid Based Complement Alternat Med. 2015;2015:179731. doi: 10.1155/2015/179731. Epub 2015 Aug 4.
- Knox JB, Orchowski JR, Scher DL, Owens BD, Burks R, Belmont PJ Jr. Occupational driving as a risk factor for low back pain in active-duty military service members. Spine J. 2014 Apr;14(4):592-7. doi: 10.1016/j.spinee.2013.06.029. Epub 2013 Aug 27.
- Simon-Arndt CM, Yuan H, Hourani LL. Aircraft type and diagnosed back disorders in U.S. Navy pilots and aircrew. Aviat Space Environ Med. 1997 Nov;68(11):1012-8.
- Niebuhr DW, Krampf RL, Mayo JA, Blandford CD, Levin LI, Cowan DN. Risk factors for disability retirement among healthy adults joining the U.S. Army. Mil Med. 2011 Feb;176(2):170-5. doi: 10.7205/milmed-d-10-00114.
- Sikorski C, Emerson MA, Cowan DN, Niebuhr DW. Risk factors for medical disability in U.S. enlisted Marines: fiscal years 2001 to 2009. Mil Med. 2012 Feb;177(2):128-34. doi: 10.7205/milmed-d-11-00250.
- Holm, S. 1979. A simple sequential rejective multiple test procedure. Scand. J. Statistics, 6: 65-70.
- R Core Team. R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. 2016
- Niemtzow RC. Battlefield Acupuncture: My Story. Med Acupunct. 2018 Apr 1;30(2):57-58. doi: 10.1089/acu.2018.29077.rcn. No abstract available.
Weitere Studien-IDs
- FWH20200025H
NCT-Nummer
Studienbeginn (tatsächlich)
2020-08-25
Zuletzt aktualisiert
2025-05-06
Studienende (vorauss.)
2025-12
Geplante Rekrutierung
276
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Aktiv, nicht rekrutierend
Stichwörter
acupuncture
low back pain
low back pain
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellGroup 1 (NSAIDS only) NSAIDs only (naproxen 500mg by mouth twice a day as needed) | NSAIDS Naproxen 500mg by mouth twice a day as needed. |
ExperimentellGroup 2 (Acupuncture+GV26) Acupuncture to include use of GV 26 with manual tonification (twisting or rotating the needle) plus NSAIDs (naproxen 500mg by mouth twice a day as needed) | NSAIDS Naproxen 500mg by mouth twice a day as needed. GV26 with Manual Tonification Acupuncture to include use of GV 26 with manual tonification (twisting or rotating the needle).
The protocol for using GV26 is as follows: With the patient in a seated position the acupuncturist places a 40mm needle in the acupuncture point GV26 (located on the philtrum, on the anterior midline, at the junction of the upper 1/3 and lower 2/3 of the distance from the nose to the margin of the upper lip). The acupuncturist then rapidly rotates the needle at the handle clockwise and counterclockwise (known as manual tonification) for 20-40 seconds at a time. The patient then stands up and assesses their pain. This will be performed up to 6 cycles. If a patient is unable to sit or stand, this may also be performed in a supine position with the patient attempting to sit or stand every 20-40 seconds. |
ExperimentellGroup 3 (Battlefield Acupuncture+NSAIDS) Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men) plus NSAIDs (naproxen 500mg by mouth twice a day as needed) | NSAIDS Naproxen 500mg by mouth twice a day as needed. Schlachtfeldakupunktur Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men).
Battlefield acupuncture utilizes up to 10 ASP acupuncture needles (5 in each ear). The Battlefield Acupuncture points include: cingulate gyrus, thalamus, omega-2, point zero, and shen men. The semi-permanent needles are left in place and typically stay in place for 2-7 days. Needles will usually fall out on their own, can be removed by the patient or the patient can call study staff and come in for removal if desired. |
ExperimentellGroup 4 (Battlefield Acupuncture+GV26+NSAIDS) GV26 with manual tonification + Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men) plus NSAIDs (naproxen 500mg by mouth twice a day as needed). | NSAIDS Naproxen 500mg by mouth twice a day as needed. Schlachtfeldakupunktur Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men).
Battlefield acupuncture utilizes up to 10 ASP acupuncture needles (5 in each ear). The Battlefield Acupuncture points include: cingulate gyrus, thalamus, omega-2, point zero, and shen men. The semi-permanent needles are left in place and typically stay in place for 2-7 days. Needles will usually fall out on their own, can be removed by the patient or the patient can call study staff and come in for removal if desired. GV26 with Manual Tonification Acupuncture to include use of GV 26 with manual tonification (twisting or rotating the needle).
The protocol for using GV26 is as follows: With the patient in a seated position the acupuncturist places a 40mm needle in the acupuncture point GV26 (located on the philtrum, on the anterior midline, at the junction of the upper 1/3 and lower 2/3 of the distance from the nose to the margin of the upper lip). The acupuncturist then rapidly rotates the needle at the handle clockwise and counterclockwise (known as manual tonification) for 20-40 seconds at a time. The patient then stands up and assesses their pain. This will be performed up to 6 cycles. If a patient is unable to sit or stand, this may also be performed in a supine position with the patient attempting to sit or stand every 20-40 seconds. |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Change in Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | Pre-treatment: time 0 (week 1); post-treatment (week 2 followup) |
Number of days missed from work due to lower back pain. | The number of days missed from work is self-explanatory and will be treated as a parametric interval variable. | Post-treatment (Visit 2, 1 week followup) |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- Male and Female Active Duty and DoD Beneficiaries aged 18 years or older.
- Complaints of acute back pain (4 weeks or less in duration).
- Known history of underlying rheumatologic condition.
- Chronic low back pain (greater than 4 weeks in duration).
- Contraindications to NSAID use (including peptic ulcer disease, underlying coagulopathy, severe coronary artery disease, underlying renal disease, allergy, thrombocytopenia).
- Red flag symptoms of low back pain (to include bowel or bladder incontinence, sudden onset sensorineural deficits, loss of sensation in the perineal region).
- Requiring narcotic use to control symptoms.
- Patients currently taking opioid medications.
- pregnant, may be pregnant, or attempting to become pregnant
David MossVerantwortliche Partei
David Moss, Prüfsponsor, Principal Investigator, Mike O'Callaghan Military Hospital
Keine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern
Nevada
Mike O'Callaghan Military Medical Center, Nellis Air Force Base, Nevada, 89191, United States